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Last Updated: December 16, 2019

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CLINICAL TRIALS PROFILE FOR CLOFARABINE

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505(b)(2) Clinical Trials for CLOFARABINE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT01643668 Busulfan/Clofarabine + Allogeneic Stem Cell Transplantation Completed Massachusetts General Hospital Phase 2 2012-07-01 This research is a phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational intervention to learn whether it works in treating a specific cancer. "Investigational" means that the study intervention is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not yet approved this study intervention for your type of cancer. All participants on this study are treated in an identical manner. The investigators are doing this study because there continues to be a significant risk of relapse of disease after reduced intensity transplantation. In studies which have compared transplants using high-doses of chemotherapy and/or radiation versus reduced intensity transplants, patients undergoing reduced intensity transplants appear to have higher rates of relapse, but lower rates of toxicity and complication. This study attempts to utilize clofarabine, a newer chemotherapy agent shown to be quite active in AML, ALL, and MDS, to increase the anti-tumor effects of the conditioning regimen without accumulating unacceptable toxicity. The reduced intensity allogeneic stem cell transplantation procedure involves giving you chemotherapy in relatively less intense doses to suppress your immune system. This is followed by an infusion of healthy blood stem cells from a matched related donor or a matched unrelated volunteer donor. It is hoped that these donor cells can eventually then attack any cancer cells which remain. In this research study, the investigators are looking to see how well this new combination of busulfan and clofarabine works in reduced intensity allogeneic stem cell transplantation. By "works" the investigators mean to analyze safety, ability of donor cells to engraft (take hold), as well as measures of complications including toxicity, infections, graft-vs-host disease (GVHD), and relapse.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for CLOFARABINE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00028418 Clofarabine in Chronic Lymphocytic Leukemia Completed M.D. Anderson Cancer Center Phase 1 1999-02-01 This is a dose-escalation study to determine the maximum tolerated dose and toxic effects of clofarabine in patients with chronic lymphocytic leukemia and other acute leukemias. Clofarabine is a synthesized hybrid nucleoside analog, which is believed to possess the better qualities of fludarabine and chlorodeoxyadenosine, the 2 most active agents against lymphoproliferative disorders. Thus, it is hoped that this drug will be more active and less toxic than similar drugs.
NCT00042341 Phase II Study of Clofarabine in Pediatric Acute Lymphoblastic Leukemia (ALL) Completed Genzyme, a Sanofi Company Phase 2 2002-05-01 Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. The purpose of this study is to determine whether Clofarabine is safe and effective in the treatment of Acute Lymphoblastic Leukemia (ALL.)
NCT00042354 Phase II Study of Clofarabine in Pediatric Acute Myelogenous Leukemia (AML) Patients Completed Genzyme, a Sanofi Company Phase 2 2002-05-01 Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. The purpose of this study is to determine whether Clofarabine is safe and effective in the treatment of Acute Myelogenous Leukemia (AML.)
NCT00044889 Phase II Study of Clofarabine in Adult Patients With Refractory or Relapsed Acute Myelogenous Leukemia Completed Genzyme, a Sanofi Company Phase 2 2002-05-01 Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. This is a single arm, open-label, Phase II study of CLOFARABINE in adult patients with refractory or relapsed acute myelogenous leukemia (AML). Qualified patients must be refractory to one or two induction regimens, or have relapsed < one year from the date of confirmation of the initial complete remission (CR). There will be two phases in this study - an Induction phase and a Consolidation phase.
NCT00065143 Clofarabine Plus Cytarabine in Patients With Previously Untreated Acute Myeloid Leukemia and High-risk Myelodysplastic Syndrome Completed Genzyme, a Sanofi Company Phase 2 2003-06-01 The goal of this clinical research study is to learn if clofarabine, when given in combination with ara-C (cytarabine), can help to improve the disease's response to therapy and to increase the duration of response in patients who are 50 years or older with leukemia. The safety of this combination treatment will also be studied.
NCT00065143 Clofarabine Plus Cytarabine in Patients With Previously Untreated Acute Myeloid Leukemia and High-risk Myelodysplastic Syndrome Completed M.D. Anderson Cancer Center Phase 2 2003-06-01 The goal of this clinical research study is to learn if clofarabine, when given in combination with ara-C (cytarabine), can help to improve the disease's response to therapy and to increase the duration of response in patients who are 50 years or older with leukemia. The safety of this combination treatment will also be studied.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for CLOFARABINE

Condition Name

Condition Name for CLOFARABINE
Intervention Trials
Leukemia 41
Acute Myeloid Leukemia 30
Myelodysplastic Syndrome 22
Acute Lymphoblastic Leukemia 22
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Condition MeSH

Condition MeSH for CLOFARABINE
Intervention Trials
Leukemia 111
Leukemia, Myeloid, Acute 74
Leukemia, Myeloid 71
Preleukemia 49
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Clinical Trial Locations for CLOFARABINE

Trials by Country

Trials by Country for CLOFARABINE
Location Trials
United States 458
Canada 20
United Kingdom 9
France 9
Italy 8
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Trials by US State

Trials by US State for CLOFARABINE
Location Trials
Texas 52
Tennessee 28
New York 25
California 24
Illinois 20
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Clinical Trial Progress for CLOFARABINE

Clinical Trial Phase

Clinical Trial Phase for CLOFARABINE
Clinical Trial Phase Trials
Phase 3 7
Phase 2/Phase 3 4
Phase 2 74
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Clinical Trial Status

Clinical Trial Status for CLOFARABINE
Clinical Trial Phase Trials
Completed 73
Recruiting 30
Terminated 21
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Clinical Trial Sponsors for CLOFARABINE

Sponsor Name

Sponsor Name for CLOFARABINE
Sponsor Trials
Genzyme, a Sanofi Company 60
National Cancer Institute (NCI) 30
M.D. Anderson Cancer Center 30
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Sponsor Type

Sponsor Type for CLOFARABINE
Sponsor Trials
Other 168
Industry 82
NIH 33
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