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 — DRUG
    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\^

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)

FacilityCityStateZIPSite coordinators
University of KentuckyLexingtonKentucky40536-

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