Status:
COMPLETED
Oral Clofarabine for Relapsed/Refractory Non-Hodgkin Lymphoma
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Conditions:
Follicular Lymphoma
Marginal Zone Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Oral clofarabine is related to two intravenous chemotherapy drugs used for this disease and works in two different ways. It affects the development of new cancer cells by blocking two enzymes that can...
Detailed Description
* Each treatment cycle lasts four weeks during which time the participant will be taking study drug for the first three weeks only. Participants will be supplied with a study medication-dosing calenda...
Eligibility Criteria
Inclusion
- Histologically confirmed relapsed or refractory NHL that includes: follicular lymphoma of any grade; marginal zone lymphoma; small lymphocytic lymphoma/chronic lymphocytic leukemia; mantle cell lymphoma; lymphoplasmacytic lymphoma; low-grade B-cell lymphoma not otherwise specified; diffuse large B-cell lymphoma, anaplastic large cell lymphoma, peripheral T-cell lymphoma, angioimmunoblastic T-cell lymphoma.
- 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
- Patients who have had chemotherapy, rituximab, or radiotherapy within 4 weeks, or radioimmunotherapy within 8 weeks prior to entering the study
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00644189
Start Date
June 1 2008
End Date
July 1 2021
Last Update
March 15 2023
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115