Clinical Trials Using Romidepsin

Clinical trials are research studies that involve people. The clinical trials on this list are studying Romidepsin. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 1-8 of 8
  • Duvelisib and Romidepsin or Bortezomib in Treating Patients with Relapsed or Refractory T-cell Lymphoma

    This phase I trial studies the side effects and best dose of duvelisib when given together with romidepsin or bortezomib in treating patients with T-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Duvelisib, romidepsin, and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
    Location: 10 locations

  • Romidepsin and Brentuximab Vedotin in Treating Patients with Cutaneous T-Cell Lymphoma

    This phase I trial studies the best dose and side effects of romidepsin when given together with brentuximab vedotin in treating patients with cutaneous T-cell lymphoma. Romidepsin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to CD30 positive cancer cells in a targeted way and delivers vedotin to kill them. Giving romidepsin and brentuximab vedotin together may work better in treating patients with cutaneous T-cell lymphoma.
    Location: 3 locations

  • Romidepsin in Conditioning and Maintenance in Patients with T-cell Leukemia or Lymphoma Undergoing Donor Stem Cell Transplant

    This phase I / II trial studies the side effects and best dose of romidepsin when given together with busulfan and fludarabine phosphate before donor stem cell transplant (SCT) (conditioning) and alone after SCT (maintenance) in treating patients with T-cell leukemia or lymphoma. Drugs used in chemotherapy, such as romidepsin, busulfan, and fludarabine phosphate, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving romidepsin together with busulfan and fludarabine phosphate may help prevent the patient's body from rejecting transplanted cells, and help kill any cancer cells that are in the body. Maintenance romidepsin may keep the cancer cells from coming back after the transplant.
    Location: Ohio State University Comprehensive Cancer Center, Columbus, Ohio

  • A Phase 1 Study of Romidepsin, CC-486 (5-azacitidine), Dexamethasone, and Lenalidomide (RAdR) for Relapsed / Refractory T-cell Malignancies

    Background: - Mature T-cell malignancies (TCM) are rare and heterogeneous group of leukemias and lymphomas accounting for 5 to 10% of all lymphomas in the US - Patients with systemic TCM are most commonly treated with a CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone)-like regimens, that produce long-term progression-free survival in about 30% of these cases - Patients with relapsed / refractory (R / R) TCM have very poor prognosis with median overall survival of less than 1 year. Treatment options for R / R TCM are very few and of limited efficacy, thus novel treatment strategies are urgently needed. - Mutations in epigenetic regulators are common in aggressive TCMs and standard treatment with histone deacetylase inhibitors (HDACi) such as romidepsin show modest clinical activity with single agent the overall response (ORR) around 25% - Combination of romidepsin and 5-azacitidine (hypomethylating agents) was synergistic in preclinical models, and has demonstrated high clinical activity with an ORR of 79% - Many TCMs rely on The Ikaros-dependent NF-kB / IRF4 signaling pathway to maintain proliferation, which is why lenalidomide, which induces degradation of Ikaros and downregulates IRF4, has single agent activity in R / R TCM with ORR of 26% to 42%, depending on the subtype. - Lenalidomide synergizes with romidepsin and enhances tumor cell death in TCM cell lines, predicting that the addition of lenalidomide to the established romidepsin / CC-486 (5- azacitidine) combination will further improve efficacy. Objectives: To determine the safety and toxicity profile and the maximum tolerated dose (MTD) of the four-drug combination of CC-486 (5-azacitidine), romidepsin, lenalidomide and dexamethasone in patients with TCM Eligibility: - Refractory / relapsed TCM defined as follows: - Patients with systemic disease - Have received at least one line of prior therapy - Must have received brentuximab vedotin if the disease is anaplastic large cell lymphoma or CD30-positive cutaneous T-cell lymphoma - Age greater than or equal to 18 years of age - ECOG performance status of less than or equal to 2 (or less than or equal to 3 if decrease is due to the disease) - Histologically or cytologically confirmed relapsed and / or refractory mature TCM - Adequate organ and marrow function Design: - Open-label, single-center, uncontrolled Phase 1 study - '3 + 3' design will be used to determine the MTD of dose-escalated lenalidomide with fixed dose of romidepsin and CC-486 (5-azacitidine) - An expansion cohort of 9 patients will be evaluated at the MTD - Maximum 6 cycles (21-day cycle) of combination therapy - To explore all dose levels, including further evaluation in a dose expansion cohort, the accrual ceiling will be set at 30 patients
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • Doxorubicin, CC-(486) (5-azacitidine), Romidepsin, and Duvelisib (hARD) for T-cell Lymphoma

    Background: T-cell lymphomas (TCLs) are rare cancers. Many types of TCLs do not develop in the lymph nodes but in places like the skin, spleen, and bone marrow. Researchers want to see if a mix of 4 drugs can help people with TCL. Objective: To test if the combination of romidepsin, CC-486 (5-azacitidine), duvelisib, and doxorubicin can be used safely in people with TCL. Eligibility: Adults 18 and older with TCL that is newly diagnosed or that returned after or did not respond to standard treatments. Design: Participants will be screened on a separate protocol. They may have a tumor biopsy. Participants will have medical histories, medicine reviews, and physical exams. Their ability to do daily activities will be assessed. They will have blood and urine tests. Participants will take duvelisib and CC-486 (5-azacitidine) by mouth. They will get romidepsin and doxorubicin by intravenous infusion. They will take the drugs for up to eight 21-day cycles. They will keep a medicine diary. Participants will have a bone marrow aspiration and / or biopsy. Bone marrow will be taken through a needle inserted in the hip. Participants will have tumor imaging scans. Some may have a brain MRI and lumbar puncture. Some may have skin assessments. Participants will give blood, saliva, and tumor samples for research. Participants will have a safety visit 30 days after treatment ends. Then they will have follow-up visits every 60 days for 6 months, then every 90 days for 2 years, and then every 6 months for 2 years. Then they will have yearly visits until their disease gets worse or they start a new treatment....
    Location: National Institutes of Health Clinical Center, Bethesda, Maryland

  • Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients with Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer

    This pilot phase I trial studies the side effects of direct tumor microinjection and fludeoxyglucose F-18 positron emission tomography (FDG-PET) in testing drug sensitivity in patients with non-Hodgkin lymphoma, Hodgkin lymphoma, or stage IV breast cancer that has returned after a period of improvement or does not respond to treatment. Injecting tiny amounts of anti-cancer drugs directly into tumors on the skin or in lymph nodes and diagnostic procedures, such as FDG-PET, may help to show which drugs work better in treating patients with non-Hodgkin lymphoma, Hodgkin lymphoma, or breast cancer.
    Location: Mayo Clinic in Rochester, Rochester, Minnesota

  • Pembrolizumab and Romidepsin in Treating Participants with Recurrent or Refractory Peripheral T-Cell Lymphoma

    This phase I / II trial studies the side effects of pembrolizumab and romidepsin and to see how well they work in treating participants with peripheral T-cell lymphoma that has come back (recurrent) or that does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Romidepsin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and romidepsin may work better than pembrolizumab alone in treating participants with recurrent or refractory peripheral T-cell lymphoma.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Microdevice for In Situ Candidate Drug Screening in Skin Lesions of T-Cell Lymphoma

    This pilot trial studies the side effects and feasibility of microdevice for in situ candidate drug screening in skin lesions of T-cell lymphoma. Implanting and retrieving a microdevice that releases up to 19 drugs directly within a skin lesion may be a possible tool to evaluate the effectiveness of several approved cancer drugs against cutaneous T cell lymphoma or peripheral T cell lymphoma.
    Location: 2 locations