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Romidepsin Versus Combination of Romidepsin Plus Pralatrexate in PTCL

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ClinicalTrials.gov Identifier: NCT03355768
Recruitment Status : Withdrawn (Study was never opened due to lack of funding)
First Posted : November 28, 2017
Last Update Posted : December 19, 2018
Sponsor:
Collaborator:
Columbia University
Information provided by (Responsible Party):
Jennifer Amengual, Columbia University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lymphoma, T-Cell, Peripheral Drug: Romidepsin Drug: Pralatrexate Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Randomized Study of Romidepsin Versus the Combination of Romidepsin Plus Pralatrexate in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : November 1, 2018
Actual Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Romidepsin Arm
Control Arm: Subjects will receive Romidepsin 14 mg/m2 on Days 1, 8, 15.
Drug: Romidepsin
Intravenous administration on a 28 day cycle
Other Name: Istodax

Experimental: Romidepsin + Pralatrexate Combination Arm
Combination Arm: Subjects will receive Romidepsin 12 mg/m2 and Pralatrexate 25 mg/m2.
Drug: Romidepsin
Intravenous administration on a 28 day cycle
Other Name: Istodax

Drug: Pralatrexate
Intravenous administration on a 28 day cycle
Other Name: Folotyn




Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: up to 3 years ]
    Compare the progression free survival (PFS) in patients with R/R PTCL treated with romidepsin versus the combination of romidepsin plus pralatrexate.


Secondary Outcome Measures :
  1. Complete Response (CR) [ Time Frame: up to 3 years ]
    Contrast the complete response rate (CR) for patients treated with romidepsin or romidepsin plus pralatrexate.

  2. Duration of response (DOR) [ Time Frame: up to 3 years ]
    Contrast the duration of response (DOR) for patients treated with romidepsin or romidepsin plus pralatrexate.

  3. Overall survival (OS) [ Time Frame: up to 3 years ]
    Contrast the overall survival (OS)for patients treated with romidepsin or romidepsin plus pralatrexate.

  4. Overall response rate (ORR) [ Time Frame: up to 3 years ]
    Contrast the overall response rate (ORR) for patients treated with romidepsin or romidepsin plus pralatrexate.

  5. Time to Treatment Progression (TTP) [ Time Frame: up to 3 years ]
    TTP measured for patients with relapsed or refractory PTCL treated with romidepsin or romidepsin plus pralatrexate.

  6. Time to Relapse (TTR) [ Time Frame: up to 3 years ]
    TTR measured for patients with relapsed or refractory PTCL treated with romidepsin or romidepsin plus pralatrexate.

  7. Maximum Number of Treatment Cycles [ Time Frame: Up to 6 months ]
    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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically confirmed relapsed or refractory aggressive peripheral T-cell lymphoma as defined by 2016 World Health Organization (WHO) criteria (excluding nasal natural killer t-cell (NK-T) and blastic natural killer (NK))
  • Patients are required to have no more than 5 lines of prior therapy (with cytoreductive therapy followed by autologous stem cell transplant counting as one line of therapy. Patients are eligible if they have relapsed after prior autologous or allogeneic stem cell transplant
  • Measurable Disease
  • Age >18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status <2
  • Patients must have adequate organ and marrow function
  • Adequate contraception
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Prior Therapy
  • Prior exposure to pralatrexate or a histone deacetylase inhibitor (romidepsin, chidamide, belinostat, or vonrinostat)
  • Exposure to chemotherapy or radiotherapy within 2 weeks 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 concurrent investigational agents are allowed.
  • Central nervous system metastases, including lymphomatous meningitis
  • Uncontrolled intercurrent illness
  • Pregnant women
  • Nursing women
  • Current malignancy or history of a prior malignancy
  • Patient known to be Human Immunodeficiency Virus (HIV)-positive
  • Active Hepatitis A, Hepatitis B, or Hepatitis C infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03355768


Sponsors and Collaborators
Jennifer Amengual
Columbia University
Investigators
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Principal Investigator: Jennifer E Amengual, MD Center for Lymphoid Malignancies Columbia University Medical Center

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Responsible Party: Jennifer Amengual, Assistant Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT03355768     History of Changes
Other Study ID Numbers: AAAR5550
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jennifer Amengual, Columbia University:
Romidepsin
Pralatrexate
PTCL
Peripheral T-cell Lymphoma

Additional relevant MeSH terms:
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Lymphoma
Lymphoma, T-Cell, Peripheral
Lymphoma, T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Romidepsin
Aminopterin
Antibiotics, Antineoplastic
Antineoplastic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action