A Phase 3 interventional study of pralatrexate and Vitamin B12 and folic acid in Refractory Peripheral T-Cell Lymphoma and Relapsed T-Cell Lymphoma, sponsored by Mundipharma (China) Pharmaceutical Co. Ltd. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-01.
Sponsored by Mundipharma (China) Pharmaceutical Co. Ltd (part of Mundipharma) · Phase 3, Interventional, and Treatment
This is a single arm, open-label, multi-center study designed to demonstrate the efficacy and safety of pralatrexate when administered concurrently with vitamin B12 and folic acid supplementation to patients with relapsed or refractory peripheral T-cell lymphoma(PTCL).
The primary objective of this study is to confirm the objective response rate (ORR) among Chinese subjects with relapsed or refractory PTCL treated with pralatrexate together with concurrent vitamin B12 and folic acid supplementation
Primary endpoint is objective Response Rate by International Working Group Criteria
This study includes 3 phases: Screening, Treatment (pralatrexate) and Follow-up phases.
Screening Phase:
The screening phase will be up to 28 days duration (depending on availability of lab results).
Treatment (pralatrexate) Phase:
The start of study treatment (pralatrexate) is defined as the initiation of pralatrexate. Patients will attend the clinic weekly for 6 weeks of a 7-week cycle to receive pralatrexate, and will be examined by the treating physician. One cycle of pralatrexate therapy is 7 weeks in duration and consists of 6 weekly doses of pralatrexate administered via intravenous (IV) push over 3-5 minutes, followed by 1 week of rest.
Evaluation of response must be performed within 7 days prior to the projected first dose of cycle 2-4 and then within 7 days prior to the projected first dose of every even-numbered subsequent cycle (ie, prior to cycles 6, 8, etc.). Although radiological response assessments have been scheduled every 14 weeks, unscheduled radiological response assessments will be performed earlier if clinical progression is suspected.
Treatment with pralatrexate will continue until 24 months of administration, or until documented disease progression; unacceptable adverse event(s) indicating intolerance of the lowest study dose allowed (20 mg/m2/week); omission of 3 sequential doses of pralatrexate due to a treatment-related AE; 3-week lapse between pralatrexate doses; development of an AE, intercurrent illness, condition, or procedural complication that may interfere with the subject's participation; investigator's decision to withdraw the subject; subject withdraws consent; pregnancy of the subject; noncompliance with trial treatment or procedure requirements; or administrative reasons.
Follow-up phase:
All patients who received at least 1 dose of pralatrexate are to attend the Safety Follow-up Visit [30 (± 5) days after the last dose of pralatrexate] and the protocol defined procedures and evaluations will be performed.
After the Safety Follow-up Visit, Routine Follow-up Visits will be based on standard clinical care. All patients who received at least 1 dose of pralatrexate are to attend Routine Follow-up Visits, which will occur every 3 months (± 2 weeks) for determination of progression of disease, subsequent treatment initiation for T-cell lymphoma and survival after the Safety Follow-up Visit for a total duration of 24 months after the last dose of pralatrexate. The protocol-defined procedures/evaluations should be performed at each Routine Follow-up Visit.
372 studies on the registry are indexed under Lymphoma, T-Cell, Peripheral; 110 are open to participants now.
This study's enrollment of 85 is above the median of 44 across 328 interventional studies indexed under Lymphoma, T-Cell, Peripheral.
Browse Lymphoma, T-Cell, Peripheral studies →Mundipharma (China) Pharmaceutical Co. Ltd is the lead sponsor of 19 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subject has histologically/ confirmed PTCL, using the World Health Organization (WHO) disease classification:
Adequate hematological, hepatic, and renal function as defined by:
Exclusion Criteria:
Subject has:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vitamin B12 and folic acid will be taken concurrently with pralatrexate
Drug: pralatrexate · Dietary Supplement: Vitamin B12 and folic acid
Pralatrexate will be administered at a dose of 30 mg/m2/week for 6 weeks followed by 1 week of rest in a 7-week cycle. Pralatrexate administration occurs once a week during week 1 through week 6 of each cycle.
Drug pages: Vitamin B 12 · Folic Acid
The eligible subjects will receive vitamin supplementation at screening phase, at least 10 days prior to pralatrexate administration on cycle 1, dose 1. Vitamin supplementation will consist of vitamin B12 1 mg intramuscular (IM) q 8-10 weeks and folic acid 1.2mg by mouth (PO) once a day (QD). Once pralatrexate is permanently discontinued, vitamin supplementation should continue at least 1 month after the last pralatrexate dose, or longer at the discretion of the investigator.
Objective Response Rate(ORR) by International Working Group Criteria
ORR defined as the percentage of subjects with CR, CRu or PR as Best Overall Response.Evaluation of response must be performed within 7 days prior to the projected first dose of cycle 2-4 and then within 7 days prior to the projected first dose of every even-numbered subsequent cycle (i.e. prior to cycles 6, 8, etc). Unscheduled radiological response assessments will be performed earlier if clinical progression is suspected.The primary analysis will be conducted once all subjects have completed cycle 5 treatment or discontinued before. Study treatment may continue per investigator judgment for a maximum of 24 months. Response will be assessed on the basis of clinical, radiological, and pathological criteria. Response will be assessed by independent central review and by the treating investigator. Central review assessors will be blinded to the response assessments by the treating investigator. The primary analysis will be based on response assessed by central review.
Time frame: 2 years
Time to Response (TTR)
Time to response was measured from first day of treatment to the first date of documented response.
Time frame: 2 years
Progression-Free Survival (PFS)
PFS was measured from treatment day 1 until event or censoring. An event was defined as the earliest of the following: death from any cause or disease progression. Subjects undergoing transplant or any other subsequent therapy prior to documentation of PD was censored at that time. Progression of disease deems as 1. 50% increase from nadir in the SPD of any previously identified abnormal node for PRs or nonresponders, 2.Appearance of any new lesion during or at the end of therapy as per IWC criteria.
Time frame: 2 years
Overall Survival (OS)
OS was measured from treatment day 1 until death or censoring.
Time frame: 4 years
Duration of Responses
Duration of response was measured from first day of documented response to disease progression or death, whatever comes first.
Time frame: 4 years
Percentage of Participants With Treatment Emergent Adverse Events
treatment emergent AE was scheduled to be collected during all subject visits, the data evaluated as clinical significant will be summarized and presented.
Time frame: 4 years
Area Under the Curve [AUC] for R-pralatrexate
The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of \>5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population.
Time frame: Cycle 1 day1，Cycle 1 week 6(Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection)
Area Under the Curve [AUC] for S-pralatrexate
The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of \>5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population.
Time frame: Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection）
Steady State Volume of Distribution [Vdss] for R-pralatrexate
The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of \>5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population.
Time frame: Cycle 1 day 1, Cycle 1 week6(Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection)
Steady State Volume of Distribution [Vdss] for S-pralatrexate
The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of \>5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population.
Time frame: Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection）
Steady State Clearance [CLss] for R-pralatrexate
The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of \>5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population.
Time frame: Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection）
Steady State Clearance [CLss] for S-pralatrexate
The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of \>5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population.
Time frame: Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection）
Maximum Observed Plasma Concentration [Cmax] for R-pralatrexate
The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of \>5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population.
Time frame: Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection）
Maximum Observed Plasma Concentration [Cmax] for S-pralatrexate
The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of \>5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population.
Time frame: Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection）
Time of Cmax Observation [Tmax] for R-pralatrexate
The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of \>5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population.
Time frame: Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection）
Time of Cmax Observation [Tmax] for S-pralatrexate
The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of \>5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population.
Time frame: Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection）
Terminal Phase Half-life [t1/2Z] for R-pralatrexate
The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of \>5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population.
Time frame: Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection）
Terminal Phase Half-life [t1/2Z] for S-pralatrexate
The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of \>5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population.
Time frame: Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection）
| Milestone | Pralatrexate |
|---|---|
| Started | 71 |
| Completed | 0 |
| Not completed | 71 |
| Withdrew: Progression of disease | 36 |
| Withdrew: Adverse event | 11 |
| Withdrew: Other | 6 |
| Withdrew: Withdrawal by subject | 5 |
| Withdrew: Conditions interfere with participation | 2 |
| Withdrew: Physician decision | 2 |
| Withdrew: 3-week lapse between pralatrexate doses | 1 |
| Withdrew: Patients in treatment less than 24 month | 8 |
ORR defined as the percentage of subjects with CR, CRu or PR as Best Overall Response.Evaluation of response must be performed within 7 days prior to the projected first dose of cycle 2-4 and then within 7 days prior to the projected first dose of every even-numbered subsequent cycle (i.e. prior to cycles 6, 8, etc). Unscheduled radiological response assessments will be performed earlier if clinical progression is suspected.The primary analysis will be conducted once all subjects have completed cycle 5 treatment or discontinued before. Study treatment may continue per investigator judgment for a maximum of 24 months. Response will be assessed on the basis of clinical, radiological, and pathological criteria. Response will be assessed by independent central review and by the treating investigator. Central review assessors will be blinded to the response assessments by the treating investigator. The primary analysis will be based on response assessed by central review.
| Participants | Pralatrexate |
|---|---|
| Objective Response Rate(ORR) by International Working Group Criteria | 37 |
Time to response was measured from first day of treatment to the first date of documented response.
| months | Pralatrexate |
|---|---|
| Time to Response (TTR) | 2.0947 ± 1.6590 |
PFS was measured from treatment day 1 until event or censoring. An event was defined as the earliest of the following: death from any cause or disease progression. Subjects undergoing transplant or any other subsequent therapy prior to documentation of PD was censored at that time. Progression of disease deems as 1. 50% increase from nadir in the SPD of any previously identified abnormal node for PRs or nonresponders, 2.Appearance of any new lesion during or at the end of therapy as per IWC criteria.
| months | Pralatrexate |
|---|---|
| Progression-Free Survival (PFS) | 4.76 (3.06 to 8.75) |
OS was measured from treatment day 1 until death or censoring.
| months | Pralatrexate |
|---|---|
| Overall Survival (OS) | 18.00 (10.35 to NA) |
Duration of response was measured from first day of documented response to disease progression or death, whatever comes first.
| months | Pralatrexate |
|---|---|
| Duration of Responses | 8.67 (3.32 to 14.13) |
treatment emergent AE was scheduled to be collected during all subject visits, the data evaluated as clinical significant will be summarized and presented.
| percentage of participants | Pralatrexate |
|---|---|
| Percentage of Participants With Treatment Emergent Adverse Events | 98.6 |
The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of \>5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population.
| h*ng/ml | Pralatrexate |
|---|---|
| Pralatrexate-R in Cycle 1 week 6（20mg/m2） | 2350.7402 ± 28.22 |
| Pralatrexate-R in Cycle 1 week 6（30mg/m2） | 3979.1069 ± 152.16 |
| Pralatrexate-R in Cycle 1 day 1（30mg/m2） | 3586.2925 ± 43.70 |
The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of \>5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population.
| h*ng/ml | Pralatrexate |
|---|---|
| Pralatrexate-S in Cycle 1 week 6（20mg/m2） | 1364.7686 ± 22.65 |
| Pralatrexate-S in Cycle 1 week 6（30mg/m2） | 2182.5078 ± 264.05 |
| Pralatrexate-S in Cycle 1 day 1（30mg/m2） | 1674.8773 ± 38.32 |
The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of \>5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population.
| L | Pralatrexate |
|---|---|
| Pralatrexate-R Cycle 1 day1（30mg/m2） | 194.1589 ± 87.4028 |
| Pralatrexate-R Cycle 1 week6（20mg/m2） | 344.2511 ± 109.8671 |
| Pralatrexate-R Cycle 1 week6（30mg/m2） | 329.1892 ± 251.4938 |
The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of \>5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population.
| L | Pralatrexate |
|---|---|
| Pralatrexate-S Cycle 1 Day 1 (30 mg/m2) | 517.1628 ± 292.2888 |
| Pralatrexate-S Cycle 1 Week 6 (20 mg/m2) | 1110.6541 ± 548.2687 |
| Pralatrexate-S Cycle 1 Week 6 (30 mg/m2) | 1680.6116 ± 2292.0216 |
The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of \>5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population.
| L/h | Pralatrexate |
|---|---|
| Pralatrexate-R Cycle 1 Day 1 (30 mg/m2) | 17.1914 ± 6.7903 |
| Pralatrexate-R Cycle 1 Week 6 (20 mg/m2) | 16.3789 ± 5.3859 |
| Pralatrexate-R Cycle 1 Week 6 (30 mg/m2) | 19.8406 ± 8.9265 |
The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of \>5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population.
| L/h | Pralatrexate |
|---|---|
| Pralatrexate-S Cycle 1 Day 1 (30 mg/m2) | 34.6341 ± 17.9816 |
| Pralatrexate-S Cycle 1 Week 6 (20 mg/m2) | 27.9794 ± 8.4317 |
| Pralatrexate-S Cycle 1 Week 6 (30 mg/m2) | 45.2022 ± 22.4576 |
The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of \>5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population.
| ng/mL | Pralatrexate |
|---|---|
| Pralatrexate-R in Cycle 1 day 1（30mg/m2） | 4649.6811 ± 83.74 |
| Pralatrexate-R in Cycle 1 week 6（20mg/m2） | 2488.1502 ± 17.78 |
| Pralatrexate-R in Cycle 1 week 6（30mg/m2） | 5064.6667 ± 421.48 |
The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of \>5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population.
| ng/mL | Pralatrexate |
|---|---|
| Pralatrexate-S in Cycle 1 day 1（30mg/m2） | 3727.8582 ± 118.25 |
| Pralatrexate-S in Cycle 1 week 6（20mg/m2） | 2325.5105 ± 24.22 |
| Pralatrexate-S in Cycle 1 week 6（30mg/m2） | 3439.9695 ± 697.55 |
The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of \>5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population.
| h | Pralatrexate |
|---|---|
| Pralatrexate-R in Cycle 1 day 1（30mg/m2） | 0.1000 (0.067 to 0.333) |
| Pralatrexate-R in Cycle 1 week 6（20mg/m2） | 0.1000 (0.100 to 0.167) |
| Pralatrexate-R in Cycle 1 week 6（30mg/m2） | 0.1000 (0.067 to 0.250) |
The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of \>5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population.
| h | Pralatrexate |
|---|---|
| Pralatrexate-S in Cycle 1 day 1（30mg/m2） | 0.1000 (0.067 to 0.333) |
| Pralatrexate-S in Cycle 1 week 6（20mg/m2） | 0.1000 (0.100 to 0.167) |
| Pralatrexate-S in Cycle 1 week 6（30mg/m2） | 0.1000 (0.067 to 0.250) |
The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of \>5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population.
| h | Pralatrexate |
|---|---|
| Pralatrexate-R Cycle 1 Day 1 (30 mg/m2) | 8.5040 ± 3.4927 |
| Pralatrexate-R Cycle 1 Week 6 (20 mg/m2) | 14.6089 ± 0.1970 |
| Pralatrexate-R Cycle 1 Week 6 (30 mg/m2) | 11.8249 ± 4.3282 |
The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of \>5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population.
| h | Pralatrexate |
|---|---|
| Pralatrexate-S Cycle 1 Day 1 (30 mg/m2) | 10.8634 ± 5.6517 |
| Pralatrexate-S Cycle 1 Week 6 (20 mg/m2) | 26.2505 ± 7.7381 |
| Pralatrexate-S Cycle 1 Week 6 (30 mg/m2) | 24.8987 ± 23.2607 |
Collected over AEs were recorded in the eCRF from the point at which the ICF was signed until 30 (± 5) days after the last dose of pralatrexate. This included new AEs that were reported in the 30 (± 5) days after the last dose of pralatrexate.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pralatrexate | 29/71 (40.8%) | 35/71 (49.3%) | 70/71 (98.6%) |
| Event | Pralatrexate |
|---|---|
| Platelet count decreasedInvestigations | 10/71 |
| Lung infectionInfections and infestations | 7/71 |
| ThrombocytopeniaBlood and lymphatic system disorders | 4/71 |
| PneumoniaInfections and infestations | 4/71 |
| StomatitisGastrointestinal disorders | 3/71 |
| Febrile neutropeniaBlood and lymphatic system disorders | 3/71 |
| PancytopeniaBlood and lymphatic system disorders | 2/71 |
| Hepatic function abnormalHepatobiliary disorders | 1/71 |
| Liver injuryHepatobiliary disorders | 1/71 |
| Event | Pralatrexate |
|---|---|
| StomatitisGastrointestinal disorders | 48/71 |
| NeutropeniaBlood and lymphatic system disorders | 22/71 |
Safety population is 71
| Age, Customized(years) | PTCL Subtype |
|---|---|
| Age(years) | 54.5 ± 12.52 |
| Sex: Female, Male(Participants) | PTCL Subtype |
|---|---|
| Female | 24 |
| Male | 47 |
| Race (NIH/OMB)(Participants) | PTCL Subtype |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 71 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | PTCL Subtype |
|---|---|
| China | 71 |
| Baseline Characteristics(Participants) | PTCL Subtype |
|---|---|
| Subtype of PTCL from investigator — PTCL not otherwise specified (NOS) | 34 |
| Subtype of PTCL from investigator — Angioimmunoblastic T-cell lymphoma | 19 |
| Subtype of PTCL from investigator — Anaplastic large cell lymphoma, ALK+ | 2 |
| Subtype of PTCL from investigator — Anaplastic large cell lymphoma, ALK- | 7 |
| Subtype of PTCL from investigator — Extranodal NK/T-cell lymphoma - nasal type | 5 |
| Subtype of PTCL from investigator — Subcutaneous panniculitis-like T-cell lymphoma | 2 |
| Subtype of PTCL from investigator — Enteropathy-associated T cell lymphoma | 1 |
| Subtype of PTCL from investigator — Adult T-cell lymphoma/leukemia (human T-cell leuke | 1 |
| Subtype of PTCL from investigator — other | 0 |
| Subtype of PTCL from central review — PTCL not otherwise specified (NOS) | 34 |
| Subtype of PTCL from central review — Angioimmunoblastic T-cell lymphoma | 20 |
| Subtype of PTCL from central review — Anaplastic large cell lymphoma, ALK+ | 2 |
| Subtype of PTCL from central review — Anaplastic large cell lymphoma, ALK- | 6 |
| Subtype of PTCL from central review — Extranodal NK/T-cell lymphoma - nasal type | 5 |
| Subtype of PTCL from central review — Subcutaneous panniculitis-like T-cell lymphoma | 1 |
| Subtype of PTCL from central review — Enteropathy-associated T cell lymphoma | 1 |
| Subtype of PTCL from central review — Adult T-cell lymphoma/leukemia (human T-cell leuke | 1 |
| Subtype of PTCL from central review — other | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2015 to primary completion in Jul 2017, 22 months.
Results were first posted in Sep 2019, 2 years 1 month after primary completion.
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Studies of the drug tested here: Pralatrexate
Lymphoma, T-Cell, Peripheral →
Mundipharma (China) Pharmaceutical Co. Ltd →