A Phase 3 interventional study of Romidepsin and Pralatrexate in Lymphoma, T-Cell, Peripheral, sponsored by Jennifer Amengual. Withdrawn. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2018-12-19.
Sponsored by Jennifer Amengual · Phase 3, Interventional, and Other
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Among 18 studies testing romidepsin in Lymphoma, T-Cell, Peripheral — none open to participants now, none under way, none of them phase 3. romidepsin · Lymphoma, T-Cell, Peripheral.
Among the 18 studies testing romidepsin in Lymphoma, T-Cell, Peripheral, this one is the 18th largest by enrollment, is one of 2 that started in 2018, is one of 2 in phase 3, and was the 16th registered.
372 studies on the registry are indexed under Lymphoma, T-Cell, Peripheral; 110 are open to participants now.
Browse Lymphoma, T-Cell, Peripheral studies →None of the 18 studies testing romidepsin in Lymphoma, T-Cell, Peripheral is open now. The open studies under Lymphoma, T-Cell, Peripheral, anywhere →
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 76 Lymphoma, T-Cell, Peripheral studies recruiting now, 30 (39%) set no upper age limit and 38 (50%) stop at 75 or younger; 5 take children under 18; none take healthy volunteers.
This study: 18 Years to 90 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
18 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 12 · Phase 2 11 · Phase 3 2
First in 2001; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
Median enrollment 34 across the 18 interventional studies. Of the 17 that completed or were terminated, 9 (53%) have results posted.
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2 of 18 have an industry lead sponsor. The 10 most frequent:
Jennifer Amengual is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Jennifer Amengual has 2 studies filed under Lymphoma, T-Cell, Peripheral — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 18 studies testing romidepsin in Lymphoma, T-Cell, Peripheral, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This study employs a 1:1 randomization of patients to receive romidepsin alone verses romidepsin plus pralatrexate for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The primary objectives will be to identify a 75% improvement in progression free survival (PFS) among patients receiving the combination compared to single agent romidepsin.
Over the past 8 years, 3 new classes of drugs have been approved for the group of diseases recognized as peripheral T-cell lymphoma (PTCL). The novel anti-folate pralatrexate was the first drug approved for patients with relapsed or refractory PTCL in 2009. Four histone deacetylase (HDAC) inhibitors have been approved including vorinostat, romidepsin, belinostat, and chidamide (approved in China). The antibody drug conjugate Brentuximab vedotin was approved in one subtype of PTCL, anaplastic large T-cell lymphoma. The HDAC inhibitors and pralatrexate exhibit near lineage-specific activity with limited-to-no activity in B-cell lymphomas. As single agents in the relapsed setting romidepsin and pralatrexate exhibit response rates of 25-38% and 29-54% respectively across published phase I and II studies. While these studies are not identical in their patient composition, they included patients who are heavily pre-treated from a diversity of PTCL subtypes. A recent case match control analysis has demonstrated that patients treated with pralatrexate on PROPEL achieve a statistically significant survival advantage when compared to a matched historical population. In addition, sub-analysis of patients treated on PROPEL revealed that response and clinical benefit metrics (ORR, CR, duration of response (DOR) and progression free survival (PFS)) with pralatrexate improved significantly as the therapy moved up earlier in their treatment course. Patients achieving a response to romidepsin also exhibited a prolonged DOR of 28 months, with the median DOR not being reached in patients achieving complete response (CR).
The curative treatment of PTCL is not likely to be accomplished by the use of any single agent therapies. Clinically it makes sense to identify rational combinations of active agents in an attempt to identify disease specific active combinations. In preclinical models of T-cell lymphoma, in vitro cytotoxicity assays have clearly established a synergistic interaction between pralatrexate and several HDACI, including romidepsin. In addition, pralatrexate and romidepsin have differing mechanisms of actions and different toxicity profiles which lends to the probability that the combination of these agents will be combined safely with likely improved efficacy. Despite this rationale, the identification of a biological rationale will provide important insights into the optimal strategies for combing these different classes of drugs. It will also provide opportunities to develop biomarkers of response.
Peripheral T-cell lymphoma (PTCL) is extremely rare especially in the United States and Europe and is associated with considerable heterogeneity. Of the lymphomas, T-cell lymphomas make up a larger fraction in Asia and Latin America likely owing to genetic predisposition and early exposure to viral infections such as human T-lymphotropic virus type -1 (HTLV-1) and Epstein barr virus (EBV). Although there are differences between subtypes, in general patients with T-cell lymphomas have an inferior overall survival as compared to those with their B-cell lymphoma counterparts. The median overall survival of patients with T-cell lymphoma is only 1 to 3 years. There is presently no consensus on the best front-line therapy for these patients, though most recognize cyclophosphamide- doxorubicin hydrochloride (Adriamycin)-vincristine (Oncovin)-prednisolone (CHOP) or CHOP-based treatment as the standard despite the poor results. While clinical trials have been important in identifying novel agents active in relapsed disease, accrual to trials is often difficult given the rarity of the disease. Incorporation of novel agents into the front-line setting has not yet been realized.
Modest attempts to improve responses and duration of response have been made by intensifying front-line chemotherapy with the addition of etoposide and by consolidating response with autologous stem cell transplantation in the first remission, though these maneuvers have likely not significantly impacted the natural history of the disease.
Over the past several years, the investigators have adopted a strategy of trying to develop novel T-cell lymphoma active combinations, based on drug: drug synergy experiments in the preclinical setting. For example, the investigators have established biological preclinical and clinical evidence for the following doublets: (1) pralatrexate plus romidepsin (2) hypomethylating agents and HDAC inhibitors (3) pralatrexate plus gemcitabine.(4) pralatrexate plus bortezomib and (5) alisertib plus romidepsin. Each of these combinations leveraged a strong rationale for the companion agent used in combination with the HDAC inhibitor and or pralatrexate, leading to a clinical study in most cases.
Results from the phase I portion of the study demonstrate that the combination is safe and produces clinically meaningful responses across a diversity of PTCL subtypes in patients who are heavily treated. Twenty-nine patients were enrolled and were evaluable for toxicity. There were 3 dose-limiting toxicities (DLTs) in cohort 4 (pralatrexate 20mg/m2 \& romidepsin 12mg/m2given weekly x 2 Q21D) consisting of 2 Grade 3 oral mucositis and 1 Grade 4 sepsis. The every other week (QOW Q28D) schedule had no DLTs at equivalent and higher doses. The grade 3/4 toxicities reported in >5% of patients included: neutropenia (28%), thrombocytopenia (28%), anemia (29%), oral mucositis (14%), hyponatremia (7%), pneumonia (7%) and sepsis (7%). Twenty-three patients were evaluable for response. The overall response rate (ORR) in the total, non-PTCL and PTCL populations was 57%; 33% (no CR) and 71% (40% CR) respectively. Given these are two approved agents for relapsed PTCL, there is a clear regulatory strategy following the completion of this study.
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.
Exclusion Criteria:
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.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
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.
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.
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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 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.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
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.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
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.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
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.
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.
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.
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.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Control Arm: Subjects will receive Romidepsin 14 mg/m2 on Days 1, 8, 15.
Drug: Romidepsin
Combination Arm: Subjects will receive Romidepsin 12 mg/m2 and Pralatrexate 25 mg/m2.
Drug: Romidepsin · Drug: Pralatrexate
Intravenous administration on a 28 day cycle
Also known as: Istodax
Intravenous administration on a 28 day cycle
Also known as: Folotyn
Progression Free Survival
Compare the progression free survival (PFS) in patients with R/R PTCL treated with romidepsin versus the combination of romidepsin plus pralatrexate.
Time frame: up to 3 years
Complete Response (CR)
Contrast the complete response rate (CR) for patients treated with romidepsin or romidepsin plus pralatrexate.
Time frame: up to 3 years
Duration of response (DOR)
Contrast the duration of response (DOR) for patients treated with romidepsin or romidepsin plus pralatrexate.
Time frame: up to 3 years
Overall survival (OS)
Contrast the overall survival (OS)for patients treated with romidepsin or romidepsin plus pralatrexate.
Time frame: up to 3 years
Overall response rate (ORR)
Contrast the overall response rate (ORR) for patients treated with romidepsin or romidepsin plus pralatrexate.
Time frame: up to 3 years
Time to Treatment Progression (TTP)
TTP measured for patients with relapsed or refractory PTCL treated with romidepsin or romidepsin plus pralatrexate.
Time frame: up to 3 years
Time to Relapse (TTR)
TTR measured for patients with relapsed or refractory PTCL treated with romidepsin or romidepsin plus pralatrexate.
Time frame: up to 3 years
Maximum Number of Treatment Cycles
Describe the maximum number of cycles and planned dose intensity of all drugs in both arms in patients with R/R PTCL treated with romidepsin or romidepsin plus pralatrexate.
Time frame: Up to 6 months
No study locations are listed for this record.
Ran from Sep 2018 to primary completion in Nov 2018, 2 months.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Romidepsin
Lymphoma, T-Cell, Peripheral →
Jennifer Amengual