Phase II Study of RT-PEPC in Relapsed Mantle Cell Lymphoma

Weill Cornell Medicine (WCM)

Status and phase: Completed; Phase 2

Conditions: Non-Hodgkin's Lymphoma

Treatments: Drug: Thalidomide; Drug: PEPC; Drug: Rituximab

Study type: Interventional

Funder types: Other

Identifiers

NCT00151281

047080073974

Details and patient eligibility

About

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

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

25 participants in 1 patient group

Study Treatment Arm

Experimental group

Treatment:

Drug: Rituximab

Drug: PEPC

Drug: Thalidomide