Azacitidine With Rituximab, Vincristine, and Cyclophosphamide in Refractory Lymphoma

Completed · Phase 1

Conditions studied: Lymphoma, Hodgkin Disease, Lymphoma, Non-Hodgkin

In brief

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 facts

Study ID

NCT00901069

Run by

Shams Shakil

People needed

12

Starts

2009-05-01

Expected to finish

2012-11-01

Last updated by the study team

2016-10-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Kentucky — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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