Romidepsin and Lenalidomide in Treating Patients With Previously Untreated Peripheral T-Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT02232516|
Recruitment Status : Recruiting
First Posted : September 5, 2014
Last Update Posted : February 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Adult Nasal Type Extranodal NK/T-cell Lymphoma Anaplastic Large Cell Lymphoma Angioimmunoblastic T-cell Lymphoma Hepatosplenic T-cell Lymphoma Peripheral T-cell Lymphoma Stage I Cutaneous T-cell Non-Hodgkin Lymphoma Stage IA Mycosis Fungoides/Sezary Syndrome Stage IB Mycosis Fungoides/Sezary Syndrome Stage II Cutaneous T-cell Non-Hodgkin Lymphoma Stage IIA Mycosis Fungoides/Sezary Syndrome Stage IIB Mycosis Fungoides/Sezary Syndrome Stage III Cutaneous T-cell Non-Hodgkin Lymphoma Stage IIIA Mycosis Fungoides/Sezary Syndrome Stage IIIB Mycosis Fungoides/Sezary Syndrome Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma Stage IVA Mycosis Fungoides/Sezary Syndrome Stage IVB Mycosis Fungoides/Sezary Syndrome||Drug: romidepsin Drug: lenalidomide Other: laboratory biomarker analysis||Phase 2|
I. To evaluate the efficacy of the combination of romidepsin plus lenalidomide in patients with previously untreated peripheral T-cell lymphoma (PTCL).
I. Evaluate the safety of the combination of romidepsin and lenalidomide. II. Further evaluate efficacy of the combination of romidepsin and lenalidomide.
III. Evaluate the delay to cytotoxic chemotherapy.
I. Evaluate the use of Northwestern Medicine (NM) positron emission tomography (PET)/computed tomography (CT) vs CT imaging in PTCL.
II. Validate a new prognostic model for newly diagnosed PTCL. III. Investigate the tumor immunohistochemical profile to identify potential biomarkers associated with prognosis and treatment response.
Patients receive romidepsin intravenously (IV) over 4 hours on days 1, 8, and 15 and lenalidomide orally (PO) once daily (QD) on days 1-21. Treatment repeats every 28 days for up to 1 year in the absence of disease progression, inter-current illness that prevents further administration of treatment, unacceptable toxicity, patient decides to withdraw from study treatment (or study as a whole), or general or specific changes in the patient's condition render the patient unacceptable for further treatment in the judgment of the treating investigator.
After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months for 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Romidepsin Plus Lenalidomide for Patients With Previously Untreated PTCL|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||July 2022|
|Estimated Study Completion Date :||August 2023|
Experimental: Treatment (romidepsin, lenalidomide)
Patients receive romidepsin IV over 4 hours on days 1, 8, and 15 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
- Objective response rate (ORR), as defined per Cheson criteria [ Time Frame: Assessed after cycles 3 and 6, then every 6 months up to 3 years ]ORR will be assessed by imaging after cycles 3 and 6, and then every 6 months up to 3 years.
- Incidence of toxicity assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Evaluated once per cycle (1 cycle=28 days) up to 1 year ]The frequency and severity of toxicity events will be evaluated. All adverse events will be summarized as to type, severity, frequency, timing and attribution.
- Progression-free survival (PFS) [ Time Frame: Reported at 1 and 3 years after the start of treatment ]PFS will be evaluated at 1 and 3 years after treatment has begun.
- Overall survival (OS) [ Time Frame: Reported at 1 and 3 years after the start of treatment ]OS will be assessed at 1 and 3 years after treatment has begun.
- Duration of response, defined per Cheson criteria [ Time Frame: Assessed from start of therapy for up to 3 years ]The duration of overall response is measured from the time measurement criteria are met for Complete Remission or Partial Response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.
- Delay to cytotoxic chemotherapy [ Time Frame: Up to 1 year ]Time to first cytotoxic chemotherapy is defined as the time (in months) from start of study treatment to time of first dose of anti-neoplastic cytotoxic chemotherapy that is administered to treat lymphoma.
- NM PET/CT vs. CT imaging in PTCL [ Time Frame: Up to 3 years ]To evaluate the use of NM PET/CT vs CT imaging in PTCL, a review of the utilized imaging modalities during treatment as a tool of response assessment will be done. When both imaging modalities are chosen for a patient, response assessment will be compared.
- Validate a new prognostic model for newly diagnosed PTCL [ Time Frame: Up to 3 years ]Clinical biomarkers including age, race, histology, and stage as an assessment of prognosis. A points based system will be used to correlate with recently developed prognostic model.
- Immunohistochemistry profile [ Time Frame: Baseline ]To investigate the tumor immunohistochemical profile to identify potential biomarkers associated with prognosis and treatment response. Archived tissue samples collected at baseline will be evaluated in order to determine how marker expression correlates with clinical outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02232516
|Contact: Study Coordinator||(312)email@example.com|
|United States, California|
|City of Hope||Recruiting|
|Duarte, California, United States, 91010|
|Contact: Jasmine Zain, MD 626-256-4673|
|Principal Investigator: Jasmine Zain, MD|
|United States, Connecticut|
|Yale University||Not yet recruiting|
|New Haven, Connecticut, United States, 06520|
|Contact: Francine M. Foss, MD 203-200-4363|
|Principal Investigator: Francine M. Foss, MD|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Contact: Adam M. Petrich, MD 312-695-4537|
|Principal Investigator: Adam M. Petrich, MD|
|United States, New York|
|Weill Cornell Medicine||Recruiting|
|New York, New York, United States, 10021|
|Contact: Jia Ruan, MD 646-962-2064|
|Principal Investigator: Jia Ruan, MD|
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Not yet recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Andrei R. Shustov 206-288-6739|
|Principal Investigator: Andrei R. Shustov, MD|
|Principal Investigator:||Barbara Pro, MD||Northwestern University|