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Trial record 42 of 57 for:    Romidepsin | Phase 2

Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies (PDX+Romi)

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ClinicalTrials.gov Identifier: NCT01947140
Recruitment Status : Recruiting
First Posted : September 20, 2013
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Jennifer Amengual, Columbia University

Tracking Information
First Submitted Date  ICMJE September 9, 2013
First Posted Date  ICMJE September 20, 2013
Last Update Posted Date May 9, 2019
Actual Study Start Date  ICMJE September 9, 2013
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2017)
  • Maximum tolerated dose (MTD) of the combination of pralatrexate and romidepsin [ Time Frame: Up to 1.5 years ]
    For Phase I
  • Overall response rate (ORR) (complete + partial response) of the combination of pralatrexate and romidepsin in patients with relapsed/refractory T-Cell Lymphoma [ Time Frame: Up to 3 years ]
    For Phase II
Original Primary Outcome Measures  ICMJE
 (submitted: September 17, 2013)
  • Phase I: Maximum tolerated dose (MTD) of the combination of pralatrexate and romidepsin. [ Time Frame: Up to 1.5 years ]
  • Phase II: Overall response rate (ORR) (complete + partial response) of the combination of pralatrexate and romidepsin in patients with relapsed/refractory T-Cell Lymphoma. [ Time Frame: Up to 3 years ]
Change History Complete list of historical versions of study NCT01947140 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2017)
  • Maximum number of cycles received [ Time Frame: Up to 1.5 years ]
    For Phase II
  • Number of dose delays at the MTD [ Time Frame: Up to 1.5 years ]
    For Phase I
  • Overall response rate (ORR) of the study population [ Time Frame: Up to 1.5 years ]
    For Phase I
  • Duration of response (DOR) of the combination in patients with T-Cell Lymphoma [ Time Frame: Up to 3 years ]
    For Phase II
  • Overall survival (OS) of patients with T-Cell Lymphoma on study [ Time Frame: Up to 3 years ]
    For Phase II
  • Progression free survival (PFS) of the combination in patients with T-Cell Lymphoma [ Time Frame: Up to 3 years ]
    For Phase II
  • Number of dose reductions at the MTD [ Time Frame: Up to 1.5 years ]
    For Phase I
  • Progression free survival (PFS) of the study population [ Time Frame: Up to 1.5 years ]
    For Phase I
  • Duration of response (DOR) of the study population. [ Time Frame: Up to 1.5 years ]
    For Phase I
Original Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2013)
  • Phase II: Maximum number of cycles received [ Time Frame: Up to 1.5 years ]
  • Phase I: Number of dose delays at the MTD [ Time Frame: Up to 1.5 years ]
  • Phase I: Overall response rate (ORR) of the study population. [ Time Frame: Up to 1.5 years ]
  • Phase II: Duration of response (DOR) of the combination in patients with T-Cell Lymphoma [ Time Frame: Up to 3 years ]
  • Phase II: Overall survival (OS) of patients with T-Cell Lymphoma on study [ Time Frame: Up to 3 years ]
  • Phase II: Progression free survival (PFS) of the combination in patients with T-Cell Lymphoma [ Time Frame: Up to 3 years ]
  • Phase I: Number of dose reductions at the MTD. [ Time Frame: Up to 1.5 years ]
  • Phase I: Progression free survival (PFS) of the study population. [ Time Frame: Up to 1.5 years ]
  • Phase I: Duration of response (DOR) of the study population. [ Time Frame: Up to 1.5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies
Official Title  ICMJE 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
Brief 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lymphoid Malignancies
  • Multiple Myeloma
  • Lymphoma
  • Hodgkin Lymphoma
  • Non-hodgkin Lymphoma
Intervention  ICMJE
  • Drug: Pralatrexate

    Phase I - Schedule A: Intravenous drug given on days 1 and 8 of each 21 day cycle Schedule B: Intravenous drug given on days 1 and 15 of each 28 day cycle Dose escalation from 10 mg/m2 to 25 mg/m2

    Phase II - 25 mg/m2 will be given intravenously once weekly on days 1 and 15 on a 28 day cycle.

    Other Name: Folotyn
  • Drug: Romidepsin

    Phase I - Schedule A: Intravenous drug given on days 1 and 8 of each 21 day cycle Schedule B: Intravenous drug given on days 1 and 15 of each 28 day cycle Dose escalation from 12 mg/m2 to 14 mg/m2.

    Phase II - 12 mg/m2 will be given intravenously once weekly on days 1 and 15 on a 28 day cycle.

    Other Name: Istodax
Study Arms  ICMJE
  • Experimental: Phase I: Schedule A
    Subjects will receive dose escalation of pralatrexate and romidepsin, receiving both infusions on days 1 and 8 of each 21 day cycle
    Interventions:
    • Drug: Pralatrexate
    • Drug: Romidepsin
  • Experimental: Phase I: Schedule B
    Subjects will receive dose escalation of pralatrexate and romidepsin, receiving both infusions on days 1 and 15 of each 28 day cycle
    Interventions:
    • Drug: Pralatrexate
    • Drug: Romidepsin
  • Experimental: Phase II
    Subjects will receive Pralatrexate 25 mg/m2 and Romidepsin 12 mg/m2 will be given intravenously once weekly on days 1 and 15 on a 28 day cycle
    Interventions:
    • Drug: Pralatrexate
    • Drug: Romidepsin
Publications * Amengual JE, Lichtenstein R, Lue J, Sawas A, Deng C, Lichtenstein E, Khan K, Atkins L, Rada A, Kim HA, Chiuzan C, Kalac M, Marchi E, Falchi L, Francescone MA, Schwartz L, Cremers S, O'Connor OA. A phase 1 study of romidepsin and pralatrexate reveals marked activity in relapsed and refractory T-cell lymphoma. Blood. 2018 Jan 25;131(4):397-407. doi: 10.1182/blood-2017-09-806737. Epub 2017 Nov 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 24, 2015)
93
Original Estimated Enrollment  ICMJE
 (submitted: September 17, 2013)
57
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • Inclusion Criteria for Multiple Myeloma patients specified in the protocol

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
  • Patient known to be Human Immunodeficiency Virus (HIV)-positive
  • Active Hepatitis A, Hepatitis B, or Hepatitis C infection
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michelle Malanga, MPA 212-326-5731 mm4629@cumc.columbia.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01947140
Other Study ID Numbers  ICMJE AAAJ5656
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jennifer Amengual, Columbia University
Study Sponsor  ICMJE Jennifer Amengual
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jennifer Amengual, MD Columbia University
PRS Account Columbia University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP