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COMPLETEDPHASE1/PHASE2

Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies

Phase I/IIA Study of the Novel Antifolate Agent Pralatrexate in Combination With the Histone Deacetylase Inhibitor Romidepsin for the Treatment of Patients With Peripheral T-cell Lymphoma

NCT01947140•Jennifer Amengual

View on ClinicalTrials.gov

Summary

This is a study to test how safe the combination of the drugs Romidepsin and Pralatrexate are in patients with lymphoid malignancies and to determine the dose of the combination of drugs that is safest. If the combination is determined to be safe, the study will continue accrual patients with peripheral T-Cell lymphoma (PTCL).

Detailed Description

The non- Hodgkin lymphomas (NHL) represent a heterogeneous group of malignancies. Under the rubric of lymphoma exist some of the fastest growing cancers known to science, (Burkett's lymphoma, lymphoblastic lymphoma/leukemia), as well as some of the most indolent (small lymphocytic lymphoma, follicular lymphoma, and marginal zone lymphoma). This remarkable diversity of biology imposes significant challenges. Researchers are seeking to understand the cell of origin and differentiate what are sometimes subtle differences between the related sub-types of disease; and to identify the best treatments for these subtypes, with the ever-increasing likelihood that new understanding of the molecular pathogenesis of these diseases will result in an increase in new drugs for specific target populations.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Phase I: Patients must have histologically confirmed relapsed or refractory Non-Hodgkin's lymphoma, Hodgkin's Disease or multiple myeloma (defined by World Health Organization (WHO) criteria).
•Phase II: Patients must have histologically confirmed relapsed or refractory T-Cell Lymphoma (as defined by WHO criteria).
•Must have received first line chemotherapy. No upper limit for the number of prior therapies
•Evaluable Disease
•Age ≥18 years
•Eastern Cooperative Oncology Group (ECOG) performance status ≤2
•Patients must have adequate organ and marrow function as defined in the protocol
•Adequate Contraception
•Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

•Prior Therapy
•* Exposure to chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier
•* Systemic steroids that have not been stabilized to the equivalent of ≤10 mg/day prednisone prior to the start of the study drugs
•* No other investigational agents are allowed
•Central nervous system metastases, including lymphomatous meningitis
•History of allergic reactions to Pralatrexate or Romidepsin
•Uncontrolled intercurrent illness
•Pregnant women
•Nursing women
•Current malignancy or history of a prior malignancy, as outlined in the protocol
+2 more criteria

Locations (3)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Columbia University Irving Medical Center

New York, New York, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

September 9, 2013

Primary Completion Date

September 1, 2022

Completion Date

September 1, 2022

Last Updated

November 23, 2022

Enrollment

ACTUAL participants

Conditions

Lymphoid MalignanciesMultiple MyelomaLymphomaHodgkin LymphomaNon-hodgkin Lymphoma

Interventions

Pralatrexate

DRUG

Romidepsin

DRUG

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

NCT05529069

Mantle Cell LymphomaNon Hodgkin Lymphoma+1 more

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RECRUITINGPHASE3

MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)

NCT06152575

Multiple Myeloma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 23, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies

Inclusion Criteria

Exclusion Criteria

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)

Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma

Iberdomide Versus Observation Off Therapy After Idecabtagene Vicleucel CAR-T for Multiple Myeloma

Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)