Azacitidine With Rituximab, Vincristine, and Cyclophosphamide in Refractory Lymphoma

NCT ID: NCT00901069

Last Updated: 2016-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2012-11-30

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.

Conditions

Lymphoma; Hodgkin Disease; Lymphoma, Non-Hodgkin

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Azacitidine

Group Type: OTHER

Azacitidine with rituximab, vincristine, and cyclophosphamide

Intervention Type: DRUG

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\^

Interventions

Azacitidine 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\^

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: collaborator

Shams Shakil

OTHER

Sponsor Role: lead

Responsible Party

Shams Shakil

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Shams Shakil, MD

Role: PRINCIPAL_INVESTIGATOR

Lucille P. Markey Cancer Center at University of Kentucky

Locations

University of Kentucky

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

07-NHL-06-UK/CC

Identifier Type: -

Identifier Source: org_study_id

NCT00589160

Identifier Type: -

Identifier Source: nct_alias