Azacitidine With Rituximab, Vincristine, and Cyclophosphamide in Refractory Lymphoma
Part of paid clinical trials in Lexington, Kentucky.
- Sponsor
- Shams Shakil
- Study ID
- NCT00901069
- Phase
- PHASE1
- Status
- Completed
Conditions
- Hodgkin Disease
- Lymphoma
- Lymphoma, Non-Hodgkin
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Azacitidine with rituximab, vincristine, and cyclophosphamide — DRUGAzacitidine 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\^
Study Details
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.
Key Dates
- Start date
- May 31, 2009
- Status verified
- Oct 2016
- Primary completion
- Jan 31, 2012
- Completion
- Nov 30, 2012
Study Design
- Enrollment
- 12 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Other: Azacitidine
Primary Outcome Measure
Determine the maximal tolerated dose (MTD) of azacitidine in combination with rituximab, vincristine, and cyclophosphamide in patients with lymphoma [ Time Frame: Eight 21 day cycles ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40536 | - |
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