A Phase 2 interventional study of Pralatrexate Injection in Peripheral T-cell Lymphoma, sponsored by Acrotech Biopharma Inc.. Completed at 32 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-19.
Sponsored by Acrotech Biopharma Inc. · Phase 2, Interventional, and Treatment
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Secondary
This is a Phase 2, single arm, non-randomized, open-label, multi-center study designed to evaluate the safety and effectiveness of pralatrexate when administered with vitamin B12 and folic acid supplementation to patients with relapsed or refractory PTCL.
Pralatrexate will be given over 3-5 minutes intravenously (IV), which means through a vein. If pralatrexate is tolerated well, the patient will receive IV injections of pralatrexate every week for 6 weeks, followed by 1 week without receiving pralatrexate. These 7 week cycles will be repeated depending on response and tolerability.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 115 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Acrotech Biopharma Inc. is the lead sponsor of 27 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Histologically/cytologically confirmed PTCL, using the Revised European American Lymphoma (REAL) World Health Organization (WHO) disease classification:
Exclusion Criteria:
Patient has:
Pralatrexate 30 mg/m2 via IV push over 3-5 minutes for 6 weeks in a 7 week cycle.
Also known as: FOLOTYN, Pralatrexate, Pralatrexate Solution for Infusion, (RS)-10-propargyl-10-deazaaminopterin
Response Rate Per Independent Central Review
Patient response to treatment was determined by independent central review using International Workshop Criteria (IWC). Results present the best overall response. The initial response assessment was scheduled at week 7 (prior to Cycle 2) and then prior to every even-numbered cycle (every 14 weeks) for up to two years after first dose.
Time frame: Response was assessed at 7 weeks (prior to Cycle 2) and then prior to every other even-numbered cycle (every 14 weeks) until disease progression or death for up to 2 years after initial dose
Duration of Response Per Independent Central Review
Calculated only for those pts with an objective response. Pts receiving subsequent therapy (including transplant) before progressive disease (PD) was documented were censored at date of last response assessment obtained prior to subsequent therapy, with a note indicating censoring occurrence \& reason. Pts who withdrew consent to participate in the study prior to PD were censored at the date of their last evaluable assessment of response. Pts who withdrew from treatment prior to PD or initiation of subsequent therapy without withdrawing consent were followed for disease status when possible.
Time frame: Measured from the first day of documented response, assessed at prior to every other even-numbered cycle (every 14 weeks) until disease progression or death for up to 2 years after initial dose
Progression-free Survival Per Independent Central Review
Patients (pts) with subsequent therapy prior to PD were censored at date of last response assessment prior to subsequent therapy. Pts who were alive without PD were censored at the date of last assessment of first dose. Pts who withdrew consent to participate in the study prior to PD were censored at the date of their last disease assessment or treatment day 1. Pts who withdrew consent from treatment prior to PD without withdrawing consent for follow-up were followed for disease status \& survival. Pts who did not have response assessments after baseline were censored at treatment day 1.
Time frame: Calculated as the number of days from treatment day 1 to the date of disease progression or death, regardless of cause for up to 2 years after initial dose
Overall Survival Per Independent Central Review
Calculated as date of death - date of enrollment +1, estimated using the product-limit estimator. Pts who had not died (no record of death) or were lost to follow-up were censored at the date of last contact. Pts who withdrew consent to participate in the study including consent to be followed, were censored on the date of withdrawal. Pts who withdrew from treatment without withdrawing consent were followed for survival status whenever possible.
Time frame: Assessed every 14 weeks while on treatment, and after disease progression no less frequently than every 6 months for up to 2 years after first dose.
Patients were enrolled between 24 August 2006 and 14 April 2008 across 25 study sites, 15 sites in the United States (US), 8 in Europe, and 2 in Canada.
| Milestone | Full Population |
|---|---|
| Started | 111 |
| Completed | 107 |
| Not completed | 4 |
| Withdrew: Treatment with pralatrexate ongoing | 4 |
| Milestone | Full Population |
|---|---|
| Started | 107 |
| Completed | 83 |
| Not completed | 24 |
| Withdrew: Pts still in follow-up at data cutoff | 24 |
Patient response to treatment was determined by independent central review using International Workshop Criteria (IWC). Results present the best overall response. The initial response assessment was scheduled at week 7 (prior to Cycle 2) and then prior to every even-numbered cycle (every 14 weeks) for up to two years after first dose.
| of Patients who Responded | Evaluable Population |
|---|---|
| Response Rate Per Independent Central Review | 32 |
Calculated only for those pts with an objective response. Pts receiving subsequent therapy (including transplant) before progressive disease (PD) was documented were censored at date of last response assessment obtained prior to subsequent therapy, with a note indicating censoring occurrence \& reason. Pts who withdrew consent to participate in the study prior to PD were censored at the date of their last evaluable assessment of response. Pts who withdrew from treatment prior to PD or initiation of subsequent therapy without withdrawing consent were followed for disease status when possible.
| Days | Evaluable Population |
|---|---|
| Duration of Response Per Independent Central Review | 306 (1 to 673) |
Patients (pts) with subsequent therapy prior to PD were censored at date of last response assessment prior to subsequent therapy. Pts who were alive without PD were censored at the date of last assessment of first dose. Pts who withdrew consent to participate in the study prior to PD were censored at the date of their last disease assessment or treatment day 1. Pts who withdrew consent from treatment prior to PD without withdrawing consent for follow-up were followed for disease status \& survival. Pts who did not have response assessments after baseline were censored at treatment day 1.
| Days | Evaluable Population |
|---|---|
| Progression-free Survival Per Independent Central Review | 106 (1 to 726) |
Calculated as date of death - date of enrollment +1, estimated using the product-limit estimator. Pts who had not died (no record of death) or were lost to follow-up were censored at the date of last contact. Pts who withdrew consent to participate in the study including consent to be followed, were censored on the date of withdrawal. Pts who withdrew from treatment without withdrawing consent were followed for survival status whenever possible.
| Months | Evaluable Population |
|---|---|
| Overall Survival Per Independent Central Review | 14.5 (1 to 24.1) |
Collected over All adverse events (AEs) were captured from the first dose of pralatrexate through 30 days after the last study treatment. From 31 days after the last dose of pralatrexate, pralatrexate-related AEs were recorded until the start of subsequent therapy.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Full Population | — | 50/111 (45%) | 111/111 (100%) |
| Event | Full Population |
|---|---|
| pyrexiaGeneral disorders | 8/111 |
| sepsisInfections and infestations | 5/111 |
| febrile neutropeniaBlood and lymphatic system disorders | 5/111 |
| stomatitisGastrointestinal disorders | 5/111 |
| dyspneaRespiratory, thoracic and mediastinal disorders | 4/111 |
| dehydrationMetabolism and nutrition disorders | 4/111 |
| herpes zosterInfections and infestations | 3/111 |
| pneumoniaInfections and infestations | 3/111 |
| neutropeniaBlood and lymphatic system disorders | 3/111 |
| thrombocytopeniaBlood and lymphatic system disorders | 3/111 |
| Event | Full Population |
|---|---|
| stomatitisGastrointestinal disorders | 76/111 |
| nauseaGastrointestinal disorders | 45/111 |
| constipationGastrointestinal disorders | 38/111 |
| fatigueGeneral disorders | 38/111 |
| thrombocytopeniaBlood and lymphatic system disorders | 33/111 |
| pyrexiaGeneral disorders | 32/111 |
| coughRespiratory, thoracic and mediastinal disorders | 32/111 |
| anemiaBlood and lymphatic system disorders | 32/111 |
| edema peripheralGeneral disorders | 31/111 |
| epistaxisRespiratory, thoracic and mediastinal disorders | 29/111 |
| Age, Categorical(Participants) | Full Population |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 71 |
| >=65 years | 40 |
| Age, Continuous(years) | Full Population |
|---|---|
| Mean | 57.7 ± 15 |
| Sex: Female, Male(Participants) | Full Population |
|---|---|
| Female | 35 |
| Male | 76 |
| Region of Enrollment(participants) | Full Population |
|---|---|
| United States | 76 |
| Canada | 9 |
| Europe | 26 |
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Acrotech Biopharma Inc.