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

This study is currently recruiting participants.
See Contacts and Locations
Verified February 2017 by Jennifer Amengual, Columbia University
Sponsor:
Information provided by (Responsible Party):
Jennifer Amengual, Columbia University
ClinicalTrials.gov Identifier:
NCT01947140
First received: September 9, 2013
Last updated: February 14, 2017
Last verified: February 2017
  Purpose
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).

Condition Intervention Phase
Lymphoid Malignancies Multiple Myeloma Lymphoma Hodgkin Lymphoma Non-hodgkin Lymphoma Drug: Pralatrexate Drug: Romidepsin Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Phase I/IIA Study of the Novel Antifolate Agent Pralatrexate in Combination With the Histone Deacetylase Inhibitor Romidepsin for the Treatment of Patients With Relapsed and Refractory Lymphoid Malignancies and Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Jennifer Amengual, Columbia University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 93
Actual Study Start Date: September 9, 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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
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
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
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

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01947140

Contacts
Contact: Renee Lichtenstein 212-326-5720 rl2619@cumc.columbia.edu

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10019
Contact: Renee Lichtenstein    212-326-5720    rl2619@cumc.columbia.edu   
Principal Investigator: Jennifer E Amengual, MD         
Sponsors and Collaborators
Jennifer Amengual
Investigators
Principal Investigator: Jennifer E Amengual, MD Columbia University
  More Information

Responsible Party: Jennifer Amengual, Assistant Professor of Medicine & Experimental Therapeutics, Columbia University
ClinicalTrials.gov Identifier: NCT01947140     History of Changes
Other Study ID Numbers: AAAJ5656
Study First Received: September 9, 2013
Last Updated: February 14, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

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:
Lymphoid Malignancies
Multiple Myeloma
Lymphoma
Hodgkin Lymphoma
Non-hodgkin Lymphoma
Follicular Lymphoma
Diffuse Large B-Cell Lymphoma
Anaplastic Large Cell Lymphoma
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Mantle Cell Lymphoma
Marginal Zone Lymphoma
Burkitt Lymphoma
Waldenstrom Macroglobulinemia
Peripheral T-cell Lymphoma
Cutaneous T-cell Lymphoma

Additional relevant MeSH terms:
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms
Lymphoma, Non-Hodgkin
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Aminopterin
Romidepsin
Histone Deacetylase Inhibitors
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 26, 2017