Clinical Trial DRUG CLTR0310-301
- Phase III, Multicenter, Randomized, Trial Of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection Versus Cytarabine and Daunorubicin in Patients 60-75 Years Of Age with Untreated High Risk (Secondary) AML
- Principal Investigator
- Olga Frankfurt
- Status: CLOSED
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG CLTR0310-301
- The purpose of this study is find out what effects (good and/or bad) the study drug CPX-351 has on untreated high risk secondary leukemia (it was a consequence of another disease) versus the standard combination treatment of Cytarabine and Daunorubicin.
- The standard treatment for secondary leukemia is a combination of Cytarabine and Daunorubicin. Cytarabine is given by IV (through the vein)continuously for 7 days with Danunorubin being given for the first 3 days. CPX-351 is a combination of these two anti-tumor drugs, Cytarabine and Daunorubicin. CPX-351 is given as an liposome injection (slow infusion). Liposome is a special fat that surrounds the drugs and protects them from being destroyed by the body and better able to work against the cancer. The fixed combination (amount of each drug)and the way CPX-351 is given is experimental.
Some of the eligibility criteria include:
- Participants must be age 60-75 at the time of Acute myeloid leukemia (AML) diagnosis.
- Participants must have high-risk secondary AML.
- Description of Treatment
- Participants will be randomized (like flipping a coin) into one of two groups, called Arms, for treatment. After participants have been randomized into an Arm they will know what treatment group they belong to. Both Arms may be treated with up to 2 cycles of treatment called induction. The purpose of the induction cycle(s) is to control the disease by causing remission (signs of the disease cannot be detected). Participants in Arm A will receive the experimental drug CPX-351 by slow infusion (90 minutes) on day 1, 3 and 5 of a 5 day induction cycle. Arm B participants will be given a continuous infusion of cytarabine for 7 days and daunorubicin will be given as a 90 minute infusion on days 1,2 and 3 of a 7 day induction therapy. Participants in both Arms may receive another cycle of induction and then possibly 2 more cycles of consolidation therapy (it is a maintenance therapy to keep the disease in remission). Consolidation therapy cycles are for less days than induction cycles.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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last updated: 04-May-16 11:50 PM
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