This trial is active, not recruiting.

Conditions lymphoma, hodgkin disease, lymphoma, non-hodgkin
Treatment azacitidine with rituximab, vincristine, and cyclophosphamide
Phase phase 1
Sponsor John Haslip
Collaborator Celgene Corporation
Start date May 2009
End date January 2012
Trial size 24 participants
Trial identifier NCT00901069, 07-NHL-06-UK/CC, NCT00589160


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
(Active Comparator)
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^

Primary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. 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. 2. Age ≥ 18 years and without a maximum age. 3. 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. 4. Women of childbearing potential must have a negative serum pregnancy test within 2 weeks of beginning treatment. 5. Patients must have relapsed lymphoma. 6. ECOG performance status of 2 or better. Exclusion Criteria: 1. Pregnant or breast-feeding at the time of proposed study entry 2. Clinical AIDS or ARS or known positive HIV serology 3. 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 4. Psychiatric or additive disorders that would preclude obtaining informed consent 5. 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 6. Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) levels > 2 times ULN 7. Serum creatinine levels > 1.5 times ULN 8. Platelets < 75,000/mm3 9. Absolute neutrophil count < 1500/mm3 10. Active infection including viral hepatitis 11. Known or suspected hypersensitivity to mannitol, azacitidine, or rituximab 12. Grade 3 or 4 neuropathy 13. Advanced hepatic tumors 14. Uncompensated heart failure

Additional Information

Official title Azacitidine With Rituximab, Vincristine, and Cyclophosphamide in Refractory Lymphoma: A Phase I Trial
Principal investigator Hayslip W John, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by University of Kentucky.