Oral Clofarabine for Relapsed/Refractory Non-Hodgkin Lymphoma
This study is ongoing, but not recruiting participants.
Sponsor:
Massachusetts General Hospital
Collaborators:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Genzyme
Information provided by (Responsible Party):
Jeremy Abramson, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00644189
First received: March 24, 2008
Last updated: March 11, 2013
Last verified: March 2013
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Purpose
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.
The phase I component of this research study is complete and demonstrated encouraging safety and efficacy in low-grade B-cell lymphomas. The phase II component of the trial is accruing to further study the efficacy of oral clofarabine in the treatment of relapsed non-Hodgkin lymphomas.
| Condition | Intervention | Phase |
|---|---|---|
|
Follicular Lymphoma Marginal Zone Lymphoma Mantle Cell Lymphoma Small Lymphocytic Lymphoma Lymphoplasmacytic Lymphoma Low Grade B-cell Lymphoma, Not Otherwise Specified Diffuse Large B-cell Lymphoma Peripheral T-cell Lymphoma Angioimmunoblastic T-cell Lymphoma Anaplastic Large-cell Lymphoma |
Drug: Clofarabine |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Oral Clofarabine in Patients With Relapsed/Refractory Non-Hodgkin Lymphoma |
Resource links provided by NLM:
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- Phase II: Determine the efficacy of oral clofarabine in patients with relapsed/refractory non-Hodgkin lymphoma using overall response rate (complete and partial). [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Phase I: To determine the MTD and efficacy of oral clofarabine in patients with relapsed/refractory non-Hodgkin lymphoma. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Phase II: Determine the duration of response, progression-free survival and overall survival. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 25 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: 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 Name: Clolar
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00644189
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Genzyme
Investigators
| Principal Investigator: | Jeremy Abramson, MD | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | Jeremy Abramson, MD, Director, Lymphoma Program, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00644189 History of Changes |
| Other Study ID Numbers: | 07-401 |
| Study First Received: | March 24, 2008 |
| Last Updated: | March 11, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Massachusetts General Hospital:
|
clofarabine Clolar lymphoma NHL oral chemotherapy |
Additional relevant MeSH terms:
|
Immunoblastic Lymphadenopathy Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Waldenstrom Macroglobulinemia Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, T-Cell Lymphoma, T-Cell, Peripheral Lymphoma, Large-Cell, Anaplastic Lymphoma, B-Cell, Marginal Zone Lymphoma, Mantle-Cell Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Leukemia, B-Cell Leukemia, Lymphoid Leukemia Neoplasms by Histologic Type Neoplasms Neoplasms, Plasma Cell Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders |
ClinicalTrials.gov processed this record on May 19, 2013