Hodgkin Disease, Lymphoma, Lymphoma, Non-Hodgkin
Conditions
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 investigators expect to enroll 12-24 patients in this trial over a 2 year accrual period.
Interventions
DRUGAzacitidine 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
Celgene
Shams Shakil
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the maximal tolerated dose (MTD) of azacitidine in combination with rituximab, vincristine, and cyclophosphamide in patients with lymphoma | Eight 21 day cycles |
Countries
United States
Outcome results
None listed