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

NCT ID: NCT00151281

Last Updated: 2018-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2011-04-07

Brief Summary

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

Conditions

Non-Hodgkin's Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study Treatment Arm

Group Type: EXPERIMENTAL

PEPC

Intervention Type: DRUG

Induction phase (month 1-3)

• PEPC daily (prednisone 20 mg/day, cyclophosphamide 50 mg/day, etoposide 50 mg/day, and procarbazine 50 mg/day) until expected drop in neutrophil count (ANC < 3000), unless due to disease. After ANC returns to above 2,000/ul, PEPC resumes at alternate day or fractionated weekly basis.

Maintenance phase (month 4-12) • PEPC QOD or fractionated weekly basis.

Post-Month 12 Maintenance phase (post-month 12 until disease progression)

• PEPC QOD or fractionated weekly basis

Thalidomide

Intervention Type: DRUG

Induction phase (month 1-3)

• Daily thalidomide at 50 mg/day for the first 8 weeks, then dose escalated as tolerated to a maximum of 100 mg/day.

Maintenance phase (month 4-12) • Daily low dose thalidomide (50-100 mg/d)

Post-Month 12 Maintenance phase (post-month 12 until disease progression)

• Daily low dose thalidomide (50-100mg/d)

Rituximab

Intervention Type: DRUG

Induction phase (month 1-3)

• Rituximab weekly x 4 (375 mg/m2/week) starting at week 1.

Maintenance phase (month 4-12) • Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months.

Post-Month 12 Maintenance phase (post-month 12 until disease progression)

• Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months

Interventions

PEPC

Induction phase (month 1-3)

• PEPC daily (prednisone 20 mg/day, cyclophosphamide 50 mg/day, etoposide 50 mg/day, and procarbazine 50 mg/day) until expected drop in neutrophil count (ANC < 3000), unless due to disease. After ANC returns to above 2,000/ul, PEPC resumes at alternate day or fractionated weekly basis.

Maintenance phase (month 4-12) • PEPC QOD or fractionated weekly basis.

Post-Month 12 Maintenance phase (post-month 12 until disease progression)

• PEPC QOD or fractionated weekly basis

Intervention Type: DRUG

Thalidomide

Induction phase (month 1-3)

• Daily thalidomide at 50 mg/day for the first 8 weeks, then dose escalated as tolerated to a maximum of 100 mg/day.

Maintenance phase (month 4-12) • Daily low dose thalidomide (50-100 mg/d)

Post-Month 12 Maintenance phase (post-month 12 until disease progression)

• Daily low dose thalidomide (50-100mg/d)

Intervention Type: DRUG

Rituximab

Induction phase (month 1-3)

• Rituximab weekly x 4 (375 mg/m2/week) starting at week 1.

Maintenance phase (month 4-12) • Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months.

Post-Month 12 Maintenance phase (post-month 12 until disease progression)

• Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months

Intervention Type: DRUG

Other Intervention Names

Prednisone, Cyclophosphamide, Etoposide, Procarbazine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John P Leonard, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Medical College of Cornell University

New York, New York, United States

Countries

United States

References

Ruan J, Martin P, Coleman M, Furman RR, Cheung K, Faye A, Elstrom R, Lachs M, Hajjar KA, Leonard JP. Durable responses with the metronomic rituximab and thalidomide plus prednisone, etoposide, procarbazine, and cyclophosphamide regimen in elderly patients with recurrent mantle cell lymphoma. Cancer. 2010 Jun 1;116(11):2655-64. doi: 10.1002/cncr.25055.

Reference Type: RESULT

PMID: 20235190 (View on PubMed)

Other Identifiers

047080073974

Identifier Type: -

Identifier Source: org_study_id