Azacitidine With Rituximab, Vincristine, and Cyclophosphamide in Refractory Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
John Haslip, University of Kentucky
ClinicalTrials.gov Identifier:
NCT00901069
First received: May 11, 2009
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Lymphoma
Hodgkin Disease
Lymphoma, Non-Hodgkin
Drug: Azacitidine with rituximab, vincristine, and cyclophosphamide
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Azacitidine With Rituximab, Vincristine, and Cyclophosphamide in Refractory Lymphoma: A Phase I Trial

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • Determine the maximal tolerated dose (MTD) of azacitidine in combination with rituximab, vincristine, and cyclophosphamide in patients with lymphoma [ Time Frame: Eight 21 day cycles ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: May 2009
Estimated Study Completion Date: August 2014
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Azacitidine 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^

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00901069

Locations
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
John Haslip
Celgene Corporation
Investigators
Principal Investigator: Hayslip W John, MD Lucille P. Markey Cancer Center at University of Kentucky
  More Information

No publications provided

Responsible Party: John Haslip, Director, Clinical Research and Data Management Shared Resource Facility, University of Kentucky
ClinicalTrials.gov Identifier: NCT00901069     History of Changes
Obsolete Identifiers: NCT00589160
Other Study ID Numbers: 07-NHL-06-UK/CC
Study First Received: May 11, 2009
Last Updated: November 14, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Azacitidine
Rituximab
Cyclophosphamide
Vincristine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on April 17, 2014