Azacitidine With Rituximab, Vincristine, and Cyclophosphamide in Refractory Lymphoma
NCT00901069 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2016-10-17
Summary
This is a phase I, prospective, open label, dose escalation study of azacitidine in combination with rituximab, vincristine, and cyclophosphamide for the treatment of refractory lymphoma. The investigators expect to enroll 12-24 patients in this trial over a 2 year accrual period.
Conditions
- Lymphoma
- Hodgkin Disease
- Lymphoma, Non-Hodgkin
Interventions
- DRUG
-
Azacitidine with rituximab, vincristine, and cyclophosphamide
Azacitidine cycle days 1-5 Cyclophosphamide cycle days 6-9 Vincristine cycle day 8 Rituximab cycle day 8 Rituximab is only for those patients with CD20+ lymphoma. Azacitidine 25 mg/m2\^ Azacitidine 50 mg/m2\^ Azacitidine 75 mg/m2\^ Azacitidine 100 mg/m2\^
Sponsors & Collaborators
-
Celgene
collaborator INDUSTRY -
Shams Shakil
lead OTHER
Principal Investigators
-
Shams Shakil, MD · Lucille P. Markey Cancer Center at University of Kentucky
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-05-31
- Primary Completion
- 2012-01-31
- Completion
- 2012-11-30
Countries
- United States
Study Locations
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