Clinical Trial: Cancer

Newly Diagnosed Acute Myeloid Leukemia Study for Older Adults

Full Name

Acute Myeloid Leukemia (ECOG #E2906): 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 greater than or equal to 60 Years) (1_PRO00000519 - CIRB)

Description

Participants will have blood tests, physical exams, bone marrow aspirate & biopsy and cytogenetics analysis (cytogenetics is the study of the structure and function of cells), and evaluation of heart function to determine if they can be in the study. Eligible patients will be randomly assigned to one of two groups (often called "Arms"). This study is divided into three parts. The first part is called induction. Participants will receive one of two different chemotherapy regimens. Those on Arm A will receive daunorubicin and cytarabine. Those on Arm B will receive clofarabine. Clofarabine is not approved for use in treating AML, and is considered experimental in this research study. Two weeks following the first administration of chemotherapy a bone marrow biopsy will be done. If the bone marrow biopsy shows that there is still some residual leukemia, the participant will receive a second course of treatment at either the same dose (if you were assigned to Arm A) or a lower dose (if you were assigned to Arm B). If there is no AML in the bone marrow, you will receive GM-CSF once a day for approximately 4-5 weeks. In the second part of the study, participants will receive either an allogenic transplant (transplant of healthy bone marrow cells removed from another person) or consolidation chemotherapy. Those who were assigned to receive standard daunorubicin and cytarabine will receive 2 consolidation treatments approximately one month apart. The treatment used will depend on the participant’s age. In the third part of the study, participants will either be closely monitored for 12 months with a physical examination and complete blood count, or they will be treated with decitabine (an FDA approved drug, but is considered experimental for this disease) through the vein over 1 hour for 3 consecutive days each month for 12 months. In addition to the above, participants will also complete questionnaires and have blood tests throughout the study.

Eligibility

Inclusion Criteria

o Must be ≥ 60 years old
o Must not have an active, uncontrolled infection
o Must not have another malignancy for which treatment is being received

Doctor(s) Running This Study

Specialties

  • Hematology/Medical Oncology

Area of focus i

  • Lung Cancer
  • Lymphoma
  • Gastrointestinal Cancer
  • Testicular Cancer

Affiliated with

LVPG Cliniciani

Accepting New Patients