Double-Drug attack on Hard-to-Treat lymphomas
NCT ID NCT01947140
First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time
Summary
Researchers are testing whether combining two chemotherapy drugs, pralatrexate and romidepsin, is safe and effective for people with lymphoid cancers that have returned or stopped responding to treatment. The trial first finds the highest dose people can tolerate, then gives that dose to patients with peripheral T-cell lymphoma to see how many respond. Participants receive both drugs intravenously on scheduled days, and researchers track side effects and tumor shrinkage.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a combination of two chemotherapy drugs, pralatrexate and romidepsin
- What this could lead to
- If the combination works, it could offer a new treatment option for people with T-cell lymphoma that has come back or stopped responding to standard therapy.
- What could go wrong
- This is an early-phase trial with a small number of participants, so safety and effectiveness are still uncertain. Combining two drugs may cause stronger side effects than either alone, and the treatment may not shrink tumors for everyone.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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57 people
The number who actually took part.
- Started
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Sep 2013
- Finished
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Sep 2022
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
-
Columbia University Irving Medical Center
New York, New York, 10019, United States
-
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
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