This trial is active, not recruiting.

Condition non-hodgkin's lymphoma
Treatment rituximab, thalidomide, prednisone, etoposide, procarbazine, cyclophosphamide
Phase phase 2
Sponsor Weill Medical College of Cornell University
Start date November 2004
End date December 2009
Trial size 46 participants
Trial identifier NCT00151281, 047080073974


Primary Objective:

Evaluate the clinical activity of the RT-PEPC combination regimen (rituximab, thalidomide, and prednisone, etoposide, procarbazine, cyclophosphamide) in patients with relapsed mantle cell lymphoma. Specifically, response rate (RR) and time to disease progression (TTP) will be assessed.

Secondary Objectives:

1. Assess the toxicity profiles of RT-PEPC treatment in patients with relapsed mantle cell lymphoma.

2. Prospectively characterize the angiogenic profile of patients with mantle cell lymphoma during treatment with RT-PEPC. The dynamics of the angiogenic profile will be correlated with clinical response to RT-PEPC therapy.

3. Assess the quality of life of patients receiving RT-PEPC treatment

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

effect of drug combination on mantle cell lymphoma
time frame: duration of study

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histologically confirmed diagnosis of mantle cell Non-Hodgkin's Lymphoma with characteristic immunophenotypic profiles: CD5(+),CD23(-), CD19(+) or CD20(+), cyclin D1(+), and CD10(-) - Patient has persistent / recurrent disease after standard chemotherapy - Patient has not received either standard or investigational drugs within the last 3 weeks - Available frozen tumor tissue obtained since completion of last prior therapy (rebiopsy if needed) - Patient has measurable disease as defined by a tumor mass > 1.5 cm in one dimension - Age > 18 years - Absolute granulocyte count > 1000 cells/mm3 - Platelet count > 50,000 cells/mm3 - Creatinine < 2.0 x ULN - Total bilirubin < 2.0 x ULN - Patient has KPS > 50% - Patient agrees to use birth control if of reproductive potential Exclusion Criteria: - Known central nervous system (CNS) involvement by lymphoma - Known HIV disease - Known peripheral neuropathy > grade 2 - Patient is pregnant or nursing - Patient has had major surgery within the last 3 weeks - Patient is receiving other investigational drugs

Additional Information

Official title Phase II Trial of Anti-Angiogenic Therapy With RT-PEPC in Patients With Relapsed Mantle Cell Lymphoma
Principal investigator John P Leonard, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2010.
Information provided to ClinicalTrials.gov by Weill Medical College of Cornell University.