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Sponsors and Collaborators: |
Yale University Genzyme |
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Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00338494 |
Clofarabine is a new chemotherapy drug which was FDA approved for the treatment of acute lymphocytic leukemia in children. This study is being done to see if Clofarabine works in adult patients with B-cell types of lymphoma.
This research is being done to develop new treatments for patients with lymphoma whose cancer has returned or resisted treatment with previous chemotherapy.
Condition | Intervention | Phase |
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B-Cell Lymphoma |
Drug: Clofarabine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Dose Escalation Study of Clofarabine in Patients With Relapsed or Refractory Low Grade or Intermed.Grade B-Cell/T-Cell Lymphoma |
Estimated Enrollment: | 21 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Clofarabine
The starting dose of clofarabine will be 10 mg/m2 once a week for 3 weeks repeated every 4 weeks with dose escalations to 15, 20 , 30 and 40 mg/m2/week.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Laboratory values obtained ≤2 weeks prior to entry
Exclusion Criteria:
The patient must have recovered from all acute toxicities from any previous therapy.
Contact: Noelle Sowers, R.N. | 203-785-2442 | noelle.sowers@yale.edu |
Contact: Donna LaCivita | 203-737-2579 | donna.lacivita@yale.edu |
United States, Connecticut | |
Yale Comprehensive Cancer Center at Yale University School of Medicine | Recruiting |
New Haven, Connecticut, United States, 06520 |
Principal Investigator: | Francine Foss, M.D. | Yale University |
Responsible Party: | Yale University School of Medicine ( Francine Foss, M.D. ) |
Study ID Numbers: | 0506000158 |
Study First Received: | June 15, 2006 |
Last Updated: | June 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00338494 History of Changes |
Health Authority: | United States: Institutional Review Board |
Clofarabine Lymphoma, B-Cell Lymphatic Diseases Vidarabine Immunoproliferative Disorders B-cell Lymphomas |
Lymphoma, T-Cell Fludarabine Fludarabine monophosphate Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |
Clofarabine Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Antineoplastic Agents Pharmacologic Actions Lymphoma, B-Cell |
Lymphatic Diseases Neoplasms Therapeutic Uses Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |