Status:
COMPLETED
Phase II Study of RT-PEPC in Relapsed Mantle Cell Lymphoma
Lead Sponsor:
Weill Medical College of Cornell University
Conditions:
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 mant...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 7 2011
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00151281
Start Date
November 1 2004
End Date
April 7 2011
Last Update
June 28 2018
Active Locations (1)
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1
Weill Medical College of Cornell University
New York, New York, United States, 10021