Phase I/II Trial of R-CHOP + Azacytidine in Diffuse Large B Cell Lymphoma
Phase I/II Trial of Azacytidine + R-CHOP in Diffuse Large B-Cell Lymphoma
1 other identifier
interventional
14
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2010
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2009
CompletedFirst Posted
Study publicly available on registry
October 30, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedResults Posted
Study results publicly available
April 10, 2017
CompletedApril 10, 2017
February 1, 2017
3.7 years
October 29, 2009
February 23, 2017
February 23, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Complete Response
Complete Response
13 months
Study Arms (1)
All patients
EXPERIMENTALsubjects will receive azacytidine dose dependent on dose-escalation schedule at time of enrollment - all will receive standard dose RCHOP
Interventions
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 Criteria
You may qualify if:
- 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.
- +2 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Weill Medical College of Cornell Universitylead
- Celgenecollaborator
Study Sites (1)
Weill Cornell Medical College
New York, New York, 10065, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Peter Martin, MD
- Organization
- Weill Cornell Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Martin, MD
Weill Medical College of Cornell University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2009
First Posted
October 30, 2009
Study Start
January 1, 2010
Primary Completion
September 1, 2013
Study Completion
February 1, 2016
Last Updated
April 10, 2017
Results First Posted
April 10, 2017
Record last verified: 2017-02