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Sponsors and Collaborators: |
Weill Medical College of Cornell University Celator Pharmaceuticals |
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Information provided by: | Weill Medical College of Cornell University |
ClinicalTrials.gov Identifier: | NCT00875693 |
This open-label Phase I study is designed to determine the maximum tolerated dose (MTD) for CPX-351 followed by a reduced intensity conditioning regimen and incorporates a dose-escalation schedule that sequentially enrolls 6 dosing cohorts. After the determination of the MTD, the investigator reserves the option to enroll up to 10 additional subjects in an expanded safety cohort(s) at the MTD. Refractory and relapsed AML patients who meet standard institutional criteria to undergo sequential induction/reduced intensity conditioning allogeneic transplants will be offered a transplant from a related or unrelated donor (full match or 1 antigen mismatch). Cord blood transplants will not be used in this study.
Condition | Intervention | Phase |
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Acute Myelogenous Leukemia Myelodysplastic Syndrome |
Drug: CPX-151 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment |
Official Title: | A Novel Sequential Treatment of Salvage and Reduced Intensity Conditioning RIC) Chemotherapy for Allogeneic Stem-Cell Transplantation (SCT)for Primary Refractory and Relapsed Acute Myelogenous Leukemia |
Estimated Enrollment: | 30 |
Study Start Date: | April 2009 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Dose level 1: Experimental
60 units/m2 days -28, -26 and -24
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Drug: CPX-151
CPX-351 is a liposomal formulation of a fixed combination of the antineoplastic drugs cytarabine and daunorubicin. The two drugs are present inside the liposome in a 5:1 molar ratio.
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Dose Level 2: Experimental
80 units/m2 days -28, -26 and -24
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Drug: CPX-151
CPX-351 is a liposomal formulation of a fixed combination of the antineoplastic drugs cytarabine and daunorubicin. The two drugs are present inside the liposome in a 5:1 molar ratio.
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Dose level 3: Experimental
100 units/m2 days -28, -26 and -24
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Drug: CPX-151
CPX-351 is a liposomal formulation of a fixed combination of the antineoplastic drugs cytarabine and daunorubicin. The two drugs are present inside the liposome in a 5:1 molar ratio.
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Dose Level 4: Experimental
120 units/m2 days -28, -26 and -24
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Drug: CPX-151
CPX-351 is a liposomal formulation of a fixed combination of the antineoplastic drugs cytarabine and daunorubicin. The two drugs are present inside the liposome in a 5:1 molar ratio.
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Dose Level 5: Experimental
140 units/m2 days -28, -26 and -24
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Drug: CPX-151
CPX-351 is a liposomal formulation of a fixed combination of the antineoplastic drugs cytarabine and daunorubicin. The two drugs are present inside the liposome in a 5:1 molar ratio.
|
Dose Level 6: Experimental
160 units/m2 days -28, -26 and -24
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Drug: CPX-151
CPX-351 is a liposomal formulation of a fixed combination of the antineoplastic drugs cytarabine and daunorubicin. The two drugs are present inside the liposome in a 5:1 molar ratio.
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have adequate physical function measured by:
Exclusion Criteria:
Prior daunorubicin therapy with a cumulative dose of more than 368 mg/m2 or equivalent. The anthracycline agents commonly used in treating myeloid malignancies are doxorubicin, idarubicin and mitoxantron.
For example, a patient who receives 7 + 3 (daunorubicin 180 mg/m2) for induction and MEC (mitoxantrone 48 mg/m2) for salvage. The cumulative daunorubicin equivalent is 180 + (48x2) = 278 mg/m2.
Contact: Usama Gergis, MD | usg2001@med.cornell.edu |
United States, New York | |
Weill Cornell Medical College | |
New York, New York, United States, 10021 |
Principal Investigator: | Usama Gergis, MD | Weill Cornell Medical College |
Responsible Party: | Weill Cornell Medical College ( Usama Gergis, MD ) |
Study ID Numbers: | 0812010140 |
Study First Received: | April 2, 2009 |
Last Updated: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00875693 History of Changes |
Health Authority: | United States: Food and Drug Administration |
AML leukemia MDS |
Daunorubicin Leukemia Acute Myelocytic Leukemia Preleukemia Acute Myeloid Leukemia, Adult Precancerous Conditions |
Hematologic Diseases Myelodysplastic Syndromes Leukemia, Myeloid Bone Marrow Diseases Leukemia, Myeloid, Acute Cytarabine |
Neoplasms by Histologic Type Disease Precancerous Conditions Hematologic Diseases Myelodysplastic Syndromes Leukemia, Myeloid Leukemia, Myeloid, Acute |
Leukemia Preleukemia Neoplasms Pathologic Processes Syndrome Bone Marrow Diseases |