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Phase I/II Trial of R-CHOP + Azacytidine in Diffuse Large B Cell Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01004991
First received: October 29, 2009
Last updated: February 23, 2017
Last verified: February 2017
  Purpose
This is a phase I/II open label, multi-center study of azacytidine in combination with standard RCHOP therapy in patients with DLBCL. Patients will be treated with azacytidine at escalating doses on days 1-5, followed by standard dose rituximab plus CHOP chemotherapy on day 8, every 21 days. Patients will be treated for a total 6 cycles. The phase II portion will then evaluate efficacy of the combination at the established MTD.

Condition Intervention Phase
Diffuse Large B Cell Lymphoma Biological: rituximab Drug: cyclophosphamide Drug: vincristine Drug: doxorubicin Drug: prednisone Drug: azacytidine Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Phase I/II Trial of Azacytidine + R-CHOP in Diffuse Large B-Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Complete Response [ Time Frame: 13 months ]
    Complete Response


Enrollment: 14
Actual Study Start Date: January 2010
Study Completion Date: February 2016
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All patients
subjects will receive azacytidine dose dependent on dose-escalation schedule at time of enrollment - all will receive standard dose RCHOP
Biological: rituximab
375 mg/m2 on Day 8 of each of 6 cycles
Drug: cyclophosphamide
750 mg/m2 on Day 8 of each of 6 cycles
Drug: vincristine
1.4 mg/m2 on Day 8 of each of 6 cycles
Drug: doxorubicin
50 mg/m2 on Day 8 of each of 6 cycles
Drug: prednisone
100 mg PO days 8-12 of each of 6 cycles
Drug: azacytidine
Dose level 1: azacytidine 25 mg/m2 days 1-5 Dose level 2: azacytidine 50 mg/m2 days 1-5 Dose level 3: azacytidine 75 mg/m2 days 1-5

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically confirmed DLBCL with characteristic immunophenotypic profiles. Tumor tissue must be confirmed to express the CD20 antigen by flow cytometry or immunohistochemistry.
  • Patients must have at least one site of measurable disease, 1.5 cm in diameter or greater.
  • Patient has not had any previous treatment.
  • Stage II (not appropriate for abbreviated chemoimmunotherapy and radiotherapy), III or IV disease
  • Able to adhere to the study visit schedule and other protocol requirements.
  • Patients must have laboratory test results within these ranges:

    • Absolute neutrophil count > = 1500/mm³
    • Platelet count > = 75,000/mm³
    • Serum creatinine < = 1.5X upper limit of normal (ULN)
    • Total bilirubin < = 1.5X ULN. Higher levels are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis.
    • AST (SGOT) and ALT (SGPT) < = 2 x ULN
  • Disease free of prior malignancies for > = 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
  • Women of childbearing potential must have a negative serum pregnancy test prior to azacitidine treatment.
  • Women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with azacitidine. The effects of azacytidine on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Age >18 years.
  • Ability to understand and the willingness to sign a written informed consent document.
  • ECOG performance status of 0-2

Exclusion Criteria:

  • Patients must not have any serious medical condition, laboratory abnormality,or psychiatric illness that would prevent the subject from signing the informed consent form.
  • Patients must not have any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
  • Use of any other experimental drug or therapy within 28 days of baseline.
  • Concurrent use of other anti-cancer agents or treatments.
  • Known positive for HIV or infectious hepatitis B.
  • Known central nervous system involvement by lymphoma.
  • Known or suspected hypersensitivity to azacitidine or mannitol.
  • Patients must not have advanced malignant hepatic tumors.
  • Pregnant and lactating women are excluded from the study because the risks to an unborn fetus or potential risks in nursing infants are unknown.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01004991

Locations
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Celgene
Investigators
Principal Investigator: Peter Martin, MD Weill Medical College of Cornell University
  More Information

Additional Information:
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01004991     History of Changes
Other Study ID Numbers: 0907010513
Study First Received: October 29, 2009
Results First Received: February 23, 2017
Last Updated: February 23, 2017

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cyclophosphamide
Rituximab
Doxorubicin
Prednisone
Azacitidine
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on June 28, 2017