Oral Clofarabine for Relapsed/Refractory Indolent B-cell NHL and Mantle Cell Lymphoma

This study is currently recruiting participants.
Verified June 2012 by Massachusetts General Hospital

First Received on March 24, 2008.  
Last Updated on June 12, 2012  
History of Changes
This Clinical Trial Sponsored By: 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
 

Purpose for Clinical Trial

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 and will determine efficacy of oral clofarabine in the treatment of low-grade non-Hodgkin lymphomas and mantle cell lymphoma.

Condition Study Intervention Clinical Trial Phase
Follicular Lymphoma
Marginal Zone Lymphoma
Mantle Cell Lymphoma
Small Lymphocytic Lymphoma
Lymphoplasmacytic Lymphoma
Low Grade B-cell Lymphoma, Not Otherwise Specified
Drug: Clofarabine Phase 1
Phase 2

Study Type: Study Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
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 Indolent B-cell Lymphomas and Mantle Cell Lymphoma

Resource links provided by NLM:

Genetics Home Reference related topics:
aceruloplasminemia
hemophilia
MedlinePlus related topics:
Cancer
Lymphoma
Drug Information available for:
Clofarabine

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures For Clinical Trial:

  • 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 For Clinical Trial:

  • 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: June 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Study Intervention Details:

    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.

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.
  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.
  • 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

Contacts
Contact: Christine Connolly 617-726-5131 cconnolly1@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Sharon Fee     617-643-3621    

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