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Azacitidine With Rituximab, Vincristine, and Cyclophosphamide in Refractory Follicular Lymphoma
This study is currently recruiting participants.
Verified by University of Kentucky, May 2009
First Received: May 11, 2009   Last Updated: May 12, 2009   History of Changes
Sponsor: University of Kentucky
Collaborator: Celgene Corporation
Information provided by: University of Kentucky
ClinicalTrials.gov Identifier: NCT00901069
  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 follicular lymphoma (FL). The investigators expect to enroll 12-24 patients in this trial over a 2 year accrual period.


Condition Intervention Phase
Refractory Follicular Lymphoma
Drug: Azacitidine with rituximab, vincristine, and cyclophosphamide
Phase I

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: Azacitidine With Rituximab, Vincristine, and Cyclophosphamide in Refractory Follicular Lymphoma: A Phase I Trial

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Estimated Enrollment: 24
Study Start Date: May 2009
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   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 or refractory follicular lymphoma or transformed follicular 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

Contacts
Contact: John W Hayslip, M.D., MSCR 859-323-8718 jhays2@uky.edu
Contact: Nicole M Cropper 859-323-8528 nmcr222@uky.edu

Locations
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
University of Kentucky
Celgene Corporation
  More Information

No publications provided

Responsible Party: University of Kentucky ( John Hayslip, MD, MSCR )
Study ID Numbers: 07-NHL-06-UK/CC
Study First Received: May 11, 2009
Last Updated: May 12, 2009
ClinicalTrials.gov Identifier: NCT00901069     History of Changes
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 20, 2009