Azacitidine With Rituximab, Vincristine, and Cyclophosphamide in Refractory Lymphoma

NCT00901069 | Completed Phase 1 DMC

• 1 other identifier: 07-NHL-06-UK/CC
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Determine the maximal tolerated dose (MTD) of azacitidine in combination with rituximab, vincristine, and cyclophosphamide in patients with lymphoma

  Eight 21 day cycles

Study Arms (1)

Azacitidine

OTHER

Drug: Azacitidine with rituximab, vincristine, and cyclophosphamide

Interventions

Azacitidine with rituximab, vincristine, and cyclophosphamide 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\^

Azacitidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Age ≥ 18 years and without a maximum age.
• 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.
• Women of childbearing potential must have a negative serum pregnancy test within 2 weeks of beginning treatment.
• Patients must have relapsed lymphoma.
• ECOG performance status of 2 or better.

You may not qualify if:

• Pregnant or breast-feeding at the time of proposed study entry
• Clinical AIDS or ARS or known positive HIV serology
• 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
• Psychiatric or additive disorders that would preclude obtaining informed consent
• 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
• Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) or serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase \[ALT\]) levels \> 2 times ULN
• Serum creatinine levels \> 1.5 times ULN
• Platelets \< 75,000/mm3
• Absolute neutrophil count \< 1500/mm3
• Active infection including viral hepatitis
• Known or suspected hypersensitivity to mannitol, azacitidine, or rituximab
• Grade 3 or 4 neuropathy
• Advanced hepatic tumors
• Uncompensated heart failure

Sponsors & Collaborators

• Shams Shakil: lead
• Celgene: collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease; Lymphoma, Non-Hodgkin

Interventions

Azacitidine; Rituximab; Vincristine; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds

Study Officials

• Shams Shakil, MD

  Lucille P. Markey Cancer Center at University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 11, 2009
• First Posted: May 13, 2009
• Study Start: May 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: November 1, 2012
• Last Updated: October 17, 2016

Record last verified: 2016-10

Locations

US (1)