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Anti-metabolites

B: durvalumab, pralatrexate, romidepsin for T-Cell Lymphoma

Phase 1 & 2

Waitlist Available

Led By Enrica Marchi, M.D., PhD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial is testing different combinations of drugs to see what is the best and most tolerated option for patients with peripheral T-cell lymphoma.

Eligible Conditions

T-Cell Lymphoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum Tolerated Dose (MTD)

Secondary outcome measures

Duration of Response (DoR)

Overall Response Rate (ORR)

Progression Free Survival (PFS)

Trial Design

4Treatment groups

Experimental Treatment

Group I: D: durvalumab, 5-azacitidineExperimental Treatment2 Interventions

Arm D: Patients will first undergo a 7-day lead-in phase of 5-azacitidine. 5-azacitidine will be administered orally from day 1 to day 14 (including the lead-in phase) and durvalumab will be administered intravenously on day 8 of a 28-day treatment cycle

Group II: C: durvalumab, romidepsinExperimental Treatment2 Interventions

Arm C: Durvalumab will be administered intravenously on day 1 and romidepsin will be administered intravenously on days 1, 8, and 15 of a 28-day treatment cycle

Group III: B: durvalumab, pralatrexate, romidepsinExperimental Treatment3 Interventions

Arm B: Durvalumab will be administered intravenously on day 1, pralatrexate will be administered intravenously on days 1 and 15, and romidepsin will be administered intravenously on days 1 and 15. Each treatment cycle will last 28 days. All patients receiving pralatrexate will receive folic acid and vitamin B12 supplementation according to the drug package insert. Leucovorin rescue is also allowed at the dose of 15 mg orally twice daily on days 3 to 6 and 17 to 20.

Group IV: A: Oral 5-azacitidine, durvalumab, romidepsinExperimental Treatment3 Interventions

Arm A: Patients will first undergo a 7-day lead-in phase of 5-azacitidine. 5-azacitidine will be administered orally from day 1 to day 14 (including the lead-in phase), durvalumab will be administered intravenously on day 8 and romidepsin intravenously on days 8 and 15 of a 28-day treatment cycle

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Romidepsin

2011

Completed Phase 2

~790

5-Azacitidine

2011

Completed Phase 2

~130

Durvalumab

2017

Completed Phase 2

~3870

Pralatrexate

2012

Completed Phase 3

~810

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,433 Previous Clinical Trials

2,460,867 Total Patients Enrolled

University of VirginiaLead Sponsor

754 Previous Clinical Trials

1,244,925 Total Patients Enrolled

Enrica Marchi, M.D., PhDPrincipal Investigator - University of Virginia

Columbia University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants may join this research initiative?

"Affirmative. According to clinicaltrials.gov, this experiment is actively seeking applicants and was initially made available on May 30th 2018 before its most recent update on March 16th 2022. A total of 148 participants are being sought at 2 different trial sites."

Answered by AI

Is this experiment still accessible to participants?

"Affirmative. According to the clinicaltrials.gov database, this trial is actively seeking participants; it was initially announced on May 30th 2018 and modified most recently on March 16th 2022. A total of 148 patients need to be recruited across two sites."

Answered by AI

Are there any other investigations that have been conducted to evaluate this treatment?

"The initial clinical trial on this medication was conducted in 2006 at the Chinese University of Hong Kong-Prince of Wales Hospital. Since then, there have been 324 research studies completed and 518 active trials are taking place across the globe; Charlottesville, Virginia is a major hub for these ongoing experiments."

Answered by AI

To what purposes is this treatment commonly applied?

"Metastatic ureter urothelial carcinoma is conventionally treated with this intervention, which has also been known to help patients manage neutropenia and/or thrombocytopenia, anemia, and refractory anemia."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Durvalumab in Different Combinations With Pralatrexate, Romidepsin and Oral 5-Azacitidine for Lymphoma

Enrica Marchi 2018. "Durvalumab in Different Combinations With Pralatrexate, Romidepsin and Oral 5-Azacitidine for Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03161223.