Azacitidine With Rituximab, Vincristine, and Cyclophosphamide in Refractory Lymphoma
Information source: University of Kentucky
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphoma
Intervention: Azacitidine with rituximab, vincristine, and cyclophosphamide (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: University of Kentucky Overall contact:
John W Hayslip, M.D., MSCR, Phone: 859-323-8718, Email: jhays2@uky.edu
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.
Clinical Details
Official title: Azacitidine With Rituximab, Vincristine, and Cyclophosphamide in Refractory Lymphoma: A Phase I Trial
Study design: Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Determine the maximal tolerated dose (MTD) of azacitidine in combination with rituximab, vincristine, and cyclophosphamide in patients with lymphoma
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
John W Hayslip, M.D., MSCR, Phone: 859-323-8718, Email: jhays2@uky.edu
University of Kentucky, Lexington, Kentucky 40536, United States; Recruiting
Additional Information
Starting date: May 2009
Last updated: September 13, 2010
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