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Azacitidine With Rituximab, Vincristine, and Cyclophosphamide in Refractory Lymphoma: A Phase I Trial

Phase 1
18 Years
Open (Enrolling)
Lymphoma, Hodgkin Disease, Lymphoma, Non-Hodgkin

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Trial Information

Azacitidine With Rituximab, Vincristine, and Cyclophosphamide in Refractory Lymphoma: A Phase I Trial

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the maximal tolerated dose (MTD) of azacitidine in combination with rituximab, vincristine, and cyclophosphamide in patients with lymphoma

Outcome Time Frame:

Eight 21 day cycles

Safety Issue:


Principal Investigator

Hayslip W John, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Lucille P. Markey Cancer Center at University of Kentucky


United States: Institutional Review Board

Study ID:




Start Date:

May 2009

Completion Date:

August 2013

Related Keywords:

  • Lymphoma
  • Hodgkin Disease
  • Lymphoma, Non-Hodgkin
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin



University of Kentucky Lexington, Kentucky  40536-0098