Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies

Overview

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, we'll continue the study, but only accrue patients with peripheral T-Cell lymphoma (PTCL).
SparkCures ID 88
Trial Phase Phase 1/2
Enrollment 57 Patients
Treatments
  • Pralatrexate
  • Romidepsin
Trial Sponsors
  • Herbert Irving Comprehensive Cancer Center (Columbia University)
Trial Collaborators
  • Northwestern University
NCT Identifier

NCT01947140

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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