NCT02561273

Combination Chemotherapy & Lenalidomide in Newly Diagnosed Stage II-IV Peripheral T-cell Non-Hodgkin's Lymphoma

A Phase I/II Trial of CHOEP Chemotherapy Plus Lenalidomide as Front Line Therapy for Patients With Stage II, III and IV Peripheral T-Cell Non-Hodgkin's Lymphoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I/II trial studies the side effects and best dose of lenalidomide when given together with combination chemotherapy and to see how well they work in treating patients with newly diagnosed stage II-IV peripheral T-cell non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and etoposide, 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. Lenalidomide may stop the growth of peripheral T-cell non-Hodgkin's lymphoma by blocking the growth of new blood vessels necessary for cancer growth. Giving combination chemotherapy with lenalidomide may be a better treatment for peripheral T-cell non-Hodgkin's lymphoma.

Detailed description

PRIMARY OBJECTIVES: I. To assess the safety and efficacy of lenalidomide in combination with standard induction therapy (CHOEP- cyclophosphamide, doxorubicin \[doxorubicin hydrochloride\], etoposide, vincristine \[vincristine sulfate\] and prednisone) in patients with newly diagnosed stage II, III and IV peripheral T-cell lymphoma not otherwise specified (NOS), anaplastic large cell lymphoma (anaplastic lymphoma receptor tyrosine kinase \[ALK\] negative) (ALK positive if International Prognostic Index \[IPI\] 3, 4, or 5), angioimmunoblastic T-cell lymphoma, enteropathy associated T-cell lymphoma or hepatosplenic gamma delta T-cell lymphoma. II. To establish the maximum tolerated dose of lenalidomide in combination with CHOEP chemotherapy. (Phase I) III. To assess the efficacy (complete response rate) of this combination. (Phase II) SECONDARY OBJECTIVES: I. To evaluate overall response rate (complete response \[CR\] + partial response \[PR\]) of the combination of lenalidomide and CHOEP chemotherapy. II. To evaluate the safety and tolerability of the regimen. III. To assess the 2 year progression free survival (PFS) and overall survival (OS) using this regimen. OUTLINE: This is a phase I, dose-escalation study of lenalidomide, followed by a phase II study. Patients receive cyclophosphamide intravenously (IV), doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone orally (PO) on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows: TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care. MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year.

Conditions

• Anaplastic Large Cell Lymphoma, ALK-Negative
• Anaplastic Large Cell Lymphoma, ALK-Positive
• Hepatosplenic T-Cell Lymphoma
• Peripheral T-Cell Lymphoma, Not Otherwise Specified
• Stage II Angioimmunoblastic T-cell Lymphoma
• Stage II Enteropathy-Associated T-Cell Lymphoma
• Stage III Angioimmunoblastic T-cell Lymphoma
• Stage III Enteropathy-Associated T-Cell Lymphoma
• Stage IV Angioimmunoblastic T-cell Lymphoma
• Stage IV Enteropathy-Associated T-Cell Lymphoma

Interventions

Type	Name	Description
PROCEDURE	Autologous Hematopoietic Stem Cell Transplantation	Undergo autologous stem cell transplant
DRUG	Cyclophosphamide	Given IV
DRUG	Doxorubicin Hydrochloride	Given IV
DRUG	Etoposide	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Lenalidomide	Given PO
PROCEDURE	Peripheral Blood Stem Cell Transplantation	Undergo peripheral blood stem cell transplant
DRUG	Prednisone	Given PO
DRUG	Vincristine Sulfate	Given IV

Timeline

• Start date: 2015-09-28
• Primary completion: 2019-11-01
• Completion: 2020-11-01
• First posted: 2015-09-28
• Last updated: 2023-12-13
• Results posted: 2021-06-18

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study