Romidepsin and Lenalidomide in Treating Patients With Previously Untreated Peripheral T-Cell Lymphoma
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Hepatosplenic T Cell Lymphoma
- Adult Nasal Type Extranodal NK/T-cell Lymphoma
- Anaplastic Large Cell Lymphoma
- Angioimmunoblastic T Cell Lymphoma
- Stage IIIB Mycosis Fungoides/Sezary Syndrome
- Peripheral T Cell Lymphoma
- Stage I Cutaneous T-cell Non-Hodgkin Lymphoma
- Stage IVB Mycosis Fungoides/Sezary Syndrome
- Stage IIIA Mycosis Fungoides/Sezary Syndrome
- Stage IA Mycosis Fungoides/Sezary Syndrome
- Stage III Cutaneous T-cell Non-Hodgkin Lymphoma
- Stage IB Mycosis Fungoides/Sezary Syndrome
- Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma
- Stage II Cutaneous T-cell Non-Hodgkin Lymphoma
- Stage IIA Mycosis Fungoides/Sezary Syndrome
- Stage IVA Mycosis Fungoides/Sezary Syndrome
- Stage IIB Mycosis Fungoides/Sezary Syndrome
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To evaluate the efficacy of the combination of romidepsin plus lenalidomide in patients with previously untreated peripheral T-cell lymphoma (PTCL). SECONDARY OBJECTIVES: I. Evaluate the safety of the combination of romidepsin and lenalidomide. II. Further evaluate efficacy of...
PRIMARY OBJECTIVES: I. To evaluate the efficacy of the combination of romidepsin plus lenalidomide in patients with previously untreated peripheral T-cell lymphoma (PTCL). SECONDARY OBJECTIVES: 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. TERTIARY OBJECTIVES: 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. OUTLINE: 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.
Tracking Information
- NCT #
- NCT02232516
- Collaborators
- Celgene
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Barbara Pro, MD Northwestern University
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