Brief Title
Oral Clofarabine for Relapsed/Refractory Non-Hodgkin Lymphoma
Official Title
A Phase II Study of Oral Clofarabine in Patients With Relapsed/Refractory Non-Hodgkin Lymphoma
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 cancer cells need to reproduce. When these enzymes are blocked, the cancer call
can no longer prepare the DNA needed to make new cells. Clofarabine also encourages existing
cancer cells to die by disturbing components within the cancer cell. This causes the release
of a substance that is fatal to the cell.
This trial studies the efficacy of oral clofarabine in the treatment of relapsed non-Hodgkin
lymphomas.
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 calendar for each treatment cycle.
- 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.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
All Phase I-II Participants: Overall Response Rate (ORR)
Secondary Outcome
Phase I-II Participants Treated at the RP2D (3mg): Overall Response Rate (ORR)
Condition
Follicular Lymphoma
Intervention
Clofarabine
Study Arms / Comparison Groups
Clofarabine
Description: Taken orally once a day (in the AM) on days 1 through 21 of a 28-day cycle for a maximum of 6 cycles.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
50
Start Date
June 2008
Completion Date
July 2022
Primary Completion Date
December 2013
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Jeremy Abramson, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00644189
Organization ID
07-401
Responsible Party
Principal Investigator
Study Sponsor
Massachusetts General Hospital
Collaborators
Dana-Farber Cancer Institute
Study Sponsor
Jeremy Abramson, MD, Principal Investigator, Massachusetts General Hospital
Verification Date
January 2021