Clinical Trial ECOG 2906
- Phase III Randomized Trial of Clofarabine as Induction and Post-Remission Therapy vs. Standard Daunorubicin & Cytarabine Induction and Intermediate Dose Cytarabine Post-Remission Therapy, Followed by Decitabine Maintenance vs. Observation in Newly-Diagnosed Acute Myeloid Leukemia in Older Adults (Age = 60 Years)
- Principal Investigator
- Jessica Altman
- Status: CLOSED
- Study Type: Therapeutic, Treatment
- Protocol No:.ECOG 2906
- The primary purpose of this research is to find out the best treatment for older patients with newly diagnosed acute myeloid leukemia (AML).
- This study is for older adults (aged 60 or older) with AML. Unfortunately, AML in this group of patients has worse outcomes despite therapy. Therefore, there is a clear need for AML therapy that is less toxic and more effective. This study has three parts. One of the drug used in this study is clofarbine. The drug clofarbine is not approved for use in treating AML and is considered the experimental treatment in this research study.
Some of the eligibility criteria include:
- Participants must be 60 years old or older.
- Participants must be diagnosed with acute myeloid leukemia (AML).
- Participants may not have received prior chemotherapy for AML.
- Description of Treatment
- In part I of this study participants are treated with one of two different chemotherapy regimens. Participants in Arm A will receive daunorubicin and cytarabine. These drugs are given through a vein. Participants in Arm B will receive clofarabine, also given through the vein. A bone marrow biopsy will be done at about 2 weeks after the chemotherapy. If the bone marrow biopsy shows that there are still signs of leukemia, participants will receive a second course of treatment. If there is no AML in the bone marrow, participants will receive GM-CSF once a day as an injection underneath the skin or through a vein. Participants will continue to receive GM-CSF for approximately 4-5 weeks until their blood counts recover from the effects of chemotherapy. In part II of this study participants will receive either an allogeneic transplant or consolidation chemotherapy to prevent relapse. An allogeneic bone marrow transplant is a transplant of healthy bone marrow cells that have been removed from another person. Participants who will not be having the transplant will begin consolidation treatment. Participants from Arm A will receive 2 consolidation treatments approximately 1 month apart.. The drug given will be cytarabine, which is given by vein. Participants who were in Arm B will receive 2 further consolidation treatments approximately 1 month apart. These participants will get clofarabine through the vein. In part III of this study, participants will be either observed closely for 12 months or will get decitabine through the vein for 3 consecutive days each month for 12 months. The treatment received in Part III will be decided by chance. Neither participant, nor doctor will be able to choose which treatment is received. Participants who received an allogeneic transplant (a transplant from another donor) in the part II of the study will not be included in the third part of the study.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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- A Phase I Study of Metformin and Cytarabine for the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
- A Phase II Study of the BRAF Inhibitor, Vemurafenib, in Patients with Relapsed or Refractory Hairy Cell Leukemia
- A Randomized Phase III Study of Standard Cytarabine plus Daunorubicin (7+3) Therapy or Idarubicin with High Dose Cytarabine (IA) versus IA with Vorinostat (IA+V) in Younger Patients with Previously Untreated Acute Myeloid Leukemia (AML)
last updated: 03-Sep-15 01:49 AM
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