Oral Clofarabine for Relapsed/Refractory Non-Hodgkin Lymphoma
NCT ID: NCT00644189
Last Updated: 2023-03-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2008-06-30
2021-07-31
Brief Summary
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This trial studies the efficacy of oral clofarabine in the treatment of relapsed non-Hodgkin lymphomas.
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Detailed Description
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* Clofarabine is a tablet that will be taken orally in the morning once daily on days 1 through 21 of each 28-day cycle. Participants can receive up to a total of 6 cycles if they do not experience any unacceptable side effects and if their cancer does not get worse.
* The following tests and procedures will be performed at specified intervals through out the treatment period: blood tests, physical examinations, vital signs, radiological exams and urine tests.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Clofarabine
Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
Clofarabine
Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
Interventions
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Clofarabine
Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* One or more prior line of chemotherapy, immunotherapy, or radioimmunotherapy.
* Measurable disease on cross sectional imaging of at least 2cm.
* ECOG Performance Status 0-2
* 18 years of age or older
* Life expectancy of greater than 3 months
* Normal organ and marrow function as outlined in the protocol
* Must agree to use adequate contraception prior to study entry and for the duration of study participation
Exclusion Criteria
* Receiving any other investigational agent
* Known brain metastases
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Clofarabine
* Systemic fungal, bacterial, viral, or other infection not controlled
* Pregnant or lactating
* Prior history of another malignancy (except for non-melanoma skin cancer or in situ cervical or breast cancer) unless disease free for over one year
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Prior allogeneic stem cell transplantation
18 Years
ALL
No
Sponsors
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Dana-Farber Cancer Institute
OTHER
Brigham and Women's Hospital
OTHER
Genzyme, a Sanofi Company
INDUSTRY
Massachusetts General Hospital
OTHER
Responsible Party
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Jeremy Abramson, MD
Director, Lymphoma Program
Principal Investigators
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Jeremy Abramson, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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Other Identifiers
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07-401
Identifier Type: -
Identifier Source: org_study_id
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