Azacitidine With Rituximab, Vincristine, and Cyclophosphamide in Refractory Lymphoma
This trial is active, not recruiting.
|Conditions||lymphoma, hodgkin disease, lymphoma, non-hodgkin|
|Treatment||azacitidine with rituximab, vincristine, and cyclophosphamide|
|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.
|Endpoint classification||safety study|
|Intervention model||single group assignment|
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
Male or female participants at least 18 years old.
- 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.
- 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
|Official title||Azacitidine With Rituximab, Vincristine, and Cyclophosphamide in Refractory Lymphoma: A Phase I Trial|
|Principal investigator||Hayslip W John, MD|
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