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Oral Clofarabine for Relapsed/Refractory Non-Hodgkin Lymphoma

This study has been completed.
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Jeremy Abramson, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00644189
First received: March 24, 2008
Last updated: March 24, 2014
Last verified: March 2014

March 24, 2008
March 24, 2014
June 2008
December 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00644189 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Phase I: To determine the 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 ]
Not Provided
Not Provided
 
Oral Clofarabine for Relapsed/Refractory Non-Hodgkin Lymphoma
A Phase II Study of Oral Clofarabine in Patients With Relapsed/Refractory Non-Hodgkin Lymphoma

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.

  • 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.
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00644189
07-401
Yes
Jeremy Abramson, MD, Massachusetts General Hospital
Massachusetts General Hospital
  • Dana-Farber Cancer Institute
  • Brigham and Women's Hospital
  • Genzyme, a Sanofi Company
Principal Investigator: Jeremy Abramson, MD Massachusetts General Hospital
Massachusetts General Hospital
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP