Status:
COMPLETED
Azacitidine With Rituximab, Vincristine, and Cyclophosphamide in Refractory Lymphoma
Lead Sponsor:
Shams Shakil
Collaborating Sponsors:
Celgene
Conditions:
Lymphoma
Hodgkin Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 investig...
Eligibility Criteria
Inclusion
- Patient or their authorized legally acceptable representative must consent to be in the study and must have signed and dated an approved consent form which conforms to federal and institutional guidelines.
- Age ≥ 18 years and without a maximum age.
- All patients of reproductive potential should not plan on conceiving children during the treatment program and must agree to use a medically accepted form of contraception.
- Women of childbearing potential must have a negative serum pregnancy test within 2 weeks of beginning treatment.
- Patients must have relapsed lymphoma.
- ECOG performance status of 2 or better.
Exclusion
- Pregnant or breast-feeding at the time of proposed study entry
- Clinical AIDS or ARS or known positive HIV serology
- History of malignant neoplasm, other than lymphoma, treated within two years prior to study entry (other than non-melanoma skin cancer or in situ cervical cancer) or where there is current evidence of recurrent or metastatic disease
- Psychiatric or additive disorders that would preclude obtaining informed consent
- Serum bilirubin \> 1.5 times the upper limit of the normal range for the laboratory (ULN). Higher levels are acceptable if these are attributed to active hemolysis
- Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) or serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase \[ALT\]) levels \> 2 times ULN
- Serum creatinine levels \> 1.5 times ULN
- Platelets \< 75,000/mm3
- Absolute neutrophil count \< 1500/mm3
- Active infection including viral hepatitis
- Known or suspected hypersensitivity to mannitol, azacitidine, or rituximab
- Grade 3 or 4 neuropathy
- Advanced hepatic tumors
- Uncompensated heart failure
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00901069
Start Date
May 1 2009
End Date
November 1 2012
Last Update
October 17 2016
Active Locations (1)
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1
University of Kentucky
Lexington, Kentucky, United States, 40536