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| Sponsor: | Weill Medical College of Cornell University |
|---|---|
| Collaborator: |
Celator Pharmaceuticals |
| Information provided by: | Weill Medical College of Cornell University |
| ClinicalTrials.gov Identifier: | NCT00875693 |
Purpose
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 |
|---|---|---|
|
Acute Myelogenous Leukemia Myelodysplastic Syndrome |
Drug: CPX-351 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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: | June 2009 |
| Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Dose level 1
60 units/m2 days -28, -26 and -24
|
Drug: CPX-351
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.
|
|
Experimental: Dose Level 2
80 units/m2 days -28, -26 and -24
|
Drug: CPX-351
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.
|
|
Experimental: Dose level 3
100 units/m2 days -28, -26 and -24
|
Drug: CPX-351
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.
|
|
Experimental: Dose Level 4
120 units/m2 days -28, -26 and -24
|
Drug: CPX-351
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.
|
|
Experimental: Dose Level 5
140 units/m2 days -28, -26 and -24
|
Drug: CPX-351
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.
|
|
Experimental: Dose Level 6
160 units/m2 days -28, -26 and -24
|
Drug: CPX-351
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.
|
Eligibility| 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.
Contacts and Locations| Contact: Usama Gergis, MD | usg2001@med.cornell.edu |
| United States, New York | |
| Weill Cornell Medical College | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Usama Gergis, MD usg2001@med.cornell.edu | |
| Principal Investigator: Usama Gergis, MD | |
| Principal Investigator: | Usama Gergis, MD | Weill Medical College of Cornell University |
More Information
| Responsible Party: | Usama Gergis, MD, Weill Cornell Medical College |
| ClinicalTrials.gov Identifier: | NCT00875693 History of Changes |
| Other Study ID Numbers: | 0812010140 |
| Study First Received: | April 2, 2009 |
| Last Updated: | January 3, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
AML leukemia MDS |
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Myelodysplastic Syndromes Preleukemia |
Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases Hematologic Diseases Precancerous Conditions |