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NCT01947140 · REGISTRY CONDITION SEARCH

Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1, PHASE2
Status at capture
TERMINATED
Registry last update
2026-09-16

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).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Maximum Tolerated Dose (MTD) of the Combination of Pralatrexate and Romidepsin in Phase 1

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outcome · POSTED

Overall Response Rate (ORR) of Subjects Who Received Combination of Pralatrexate and Romidepsin in Phase 2

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outcome · POSTED

Overall Response Rate (ORR) of Subjects Who Received Combination of Pralatrexate and Romidepsin in Phase 1

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outcome · POSTED

Overall Survival (OS) of Subjects in Phase 2

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outcome · POSTED

Progression Free Survival (PFS) of Subjects in Phase 2

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outcome · POSTED

Progression Free Survival (PFS) of Subjects in Phase 1

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility 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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Subjects will receive dose escalation of pralatrexate and romidepsin, receiving both infusions on days 1 and 8 of each 21 day cycle
    intervention Names
    1. Drug: Pralatrexate
    2. Drug: Romidepsin
    label
    Phase I: Schedule A
    type
    EXPERIMENTAL
  2. description
    Subjects will receive dose escalation of pralatrexate and romidepsin, receiving both infusions on days 1 and 15 of each 28 day cycle
    intervention Names
    1. Drug: Pralatrexate
    2. Drug: Romidepsin
    label
    Phase I: Schedule B
    type
    EXPERIMENTAL
  3. description
    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
    intervention Names
    1. Drug: Pralatrexate
    2. Drug: Romidepsin
    label
    Phase II
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Phase I: Schedule A
    2. Phase I: Schedule B
    3. Phase II
    description
    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.
    name
    Pralatrexate
    other Names
    1. Folotyn
    type
    DRUG
  2. arm Group Labels
    1. Phase I: Schedule A
    2. Phase I: Schedule B
    3. Phase II
    description
    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.
    name
    Romidepsin
    other Names
    1. Istodax
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
57
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    The MTD was defined as the dose level at which one-third or fewer patients experienced a dose limiting toxicity. The MTD is determined in clinical trials by testing increasing doses on different groups of people until the highest dose with acceptable side effects is found.
    measure
    Maximum Tolerated Dose (MTD) of the Combination of Pralatrexate and Romidepsin in Phase 1
    time Frame
    Up to 1.5 years
  2. description
    ORR was defined as the number of subjects in a study or treatment group who have a partial response or complete response to the treatment within a certain period of time. A partial response is a decrease in the size of a tumor or in the amount of cancer in the body, and a complete response is the disappearance of all signs of cancer in the body. In a clinical trial, measuring the ORR is one way to see how well a new treatment works.
    measure
    Overall Response Rate (ORR) of Subjects Who Received Combination of Pralatrexate and Romidepsin in Phase 2
    time Frame
    Up to 3 years
secondary Outcomes
  1. description
    ORR was defined as the number of subjects in a study or treatment group who have a partial response or complete response to the treatment within a certain period of time. A partial response is a decrease in the size of a tumor or in the amount of cancer in the body, and a complete response is the disappearance of all signs of cancer in the body. In a clinical trial, measuring the ORR is one way to see how well a new treatment works.
    measure
    Overall Response Rate (ORR) of Subjects Who Received Combination of Pralatrexate and Romidepsin in Phase 1
    time Frame
    Up to 1.5 years
  2. description
    OS was defined as the length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive. In a clinical trial, measuring the OS is one way to see how well a new treatment works.
    measure
    Overall Survival (OS) of Subjects in Phase 2
    time Frame
    Up to 3 years
  3. description
    PFS was defined as the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the PFS is one way to see how well a new treatment works.
    measure
    Progression Free Survival (PFS) of Subjects in Phase 2
    time Frame
    Up to 3 years
  4. description
    PFS is defined as the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the PFS is one way to see how well a new treatment works.
    measure
    Progression Free Survival (PFS) of Subjects in Phase 1
    time Frame
    Up to 1.5 years
Full study description
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.
Source references
references
  1. citation
    Ryu Tiger YK, Jain S, Barta SK, Tolu S, Estrella B, Sawas A, Lue JK, Francescone MM, Pro B, Amengual JE. Phase II study of the novel antifolate agent pralatrexate in combination with the histone deacetylase inhibitor romidepsin for the treatment of patients with mature T-cell lymphoma. Leuk Lymphoma. 2024 Jun;65(6):736-745. doi: 10.1080/10428194.2024.2329996. Epub 2024 Mar 22.
    pmid
    38517235
    type
    DERIVED
  2. citation
    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.
    pmid
    29141948
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice