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Azacitidine With Rituximab, Vincristine, and Cyclophosphamide in Refractory Lymphoma

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ClinicalTrials.gov Identifier: NCT00901069
Recruitment Status : Completed
First Posted : May 13, 2009
Last Update Posted : October 17, 2016
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
Shams Shakil, University of Kentucky

May 11, 2009
May 13, 2009
October 17, 2016
May 2009
January 2012   (Final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00901069 on ClinicalTrials.gov Archive Site
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Azacitidine With Rituximab, Vincristine, and Cyclophosphamide in Refractory Lymphoma
Azacitidine With Rituximab, Vincristine, and Cyclophosphamide in Refractory Lymphoma: A Phase I Trial
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.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Lymphoma
  • Hodgkin Disease
  • Lymphoma, Non-Hodgkin
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^
Azacitidine
Intervention: Drug: Azacitidine with rituximab, vincristine, and cyclophosphamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
24
November 2012
January 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00901069
07-NHL-06-UK/CC
Yes
Not Provided
Not Provided
Shams Shakil, University of Kentucky
Shams Shakil
Celgene
Principal Investigator: Shams Shakil, MD Lucille P. Markey Cancer Center at University of Kentucky
University of Kentucky
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP