Azacitidine With Rituximab, Vincristine, and Cyclophosphamide in Refractory Lymphoma

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00901069
• Other study ID #: 07-NHL-06-UK/CC
• Status: Completed
• Phase: Phase 1
• First received: May 11, 2009
• Last updated: October 13, 2016
• Start date: May 2009
• Est. completion date: November 2012

Study information

• Verified date: October 2016
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00589160

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• 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^

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Shams Shakil	Celgene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the maximal tolerated dose (MTD) of azacitidine in combination with rituximab, vincristine, and cyclophosphamide in patients with lymphoma		Eight 21 day cycles	Yes