NCT02232516

Romidepsin and Lenalidomide in Treating Patients With Previously Untreated Peripheral T-Cell Lymphoma

Phase II Study of Romidepsin Plus Lenalidomide for Patients With Previously Untreated PTCL

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate how safe and effective the combination of the study drugs romidepsin and lenalidomide is for treating patients with peripheral t-cell lymphoma (PTCL) who have not been previously treated for this cancer. Currently, there is no standard treatment for patients with PTCL; the most common treatment used is a combination of drugs called CHOP, but this can be a difficult treatment to tolerate because of side effects, and is not particularly effective for most patients with PTCL. Romidepsin (Istodax®) is a type of drug called an HDAC inhibitor. It interacts with DNA (genetic material in cells) in ways that can stop tumors from growing. It is given as an infusion through the veins. Lenalidomide (Revlimid®) is a type of drug known as an immunomodulatory drug, or IMID for short. This drug affects how tumor cells grow and survive, including affecting blood vessel growth in tumors. It is given as an oral tablet (by mouth).

Detailed 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 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.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	romidepsin	Given IV
DRUG	lenalidomide	Given PO
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2015-06-11
• Primary completion: 2020-08-11
• Completion: 2024-08-01
• First posted: 2014-09-05
• Last updated: 2024-04-10
• Results posted: 2024-04-10

Locations

5 sites across 1 country: United States