Phase III Randomized Trial of Clofarabine as Induction and Post-Remission Therapy vs. Standard Daunorubicin &Amp; 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)
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 727
- Locations
- 269
- Primary Endpoint
- Overall Survival
Study Overview
Brief Summary
This randomized phase III trial studies clofarabine to see how well it works compared with daunorubicin hydrochloride and cytarabine when followed by decitabine or observation in treating older patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as clofarabine, daunorubicin hydrochloride, cytarabine, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which chemotherapy regimen is more effective in treating acute myeloid leukemia.
Detailed Description
PRIMARY OBJECTIVES:
I. To evaluate the effect of clofarabine induction and consolidation therapy on overall survival in comparison with standard therapy (daunorubicin [daunorubicin hydrochloride] & cytarabine) in newly-diagnosed acute myeloid leukemia (AML) patients age >= 60 years.
SECONDARY OBJECTIVES:
I. To evaluate complete remission (CR) rates, duration of remission, and toxicity/treatment-related mortality of clofarabine in comparison with standard therapy (daunorubicin & cytarabine) in newly-diagnosed AML patients age >= 60 years.
II. To evaluate the feasibility of consolidation with reduced-intensity conditioning and allogeneic hematopoietic stem cell transplantation from human leukocyte antigen (HLA)-identical donors in patients who achieve a response to induction therapy, including the incidence of successful engraftment, acute and chronic graft-versus-host disease, transplant-related mortality, and its impact on overall survival in comparison to patients receiving chemotherapy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
A (Induction:daunorubicin/cytarabine; consolidation:cytarabine; maintenance:observation/transplant)
See Detailed Description
Intervention: Daunorubicin (Drug)
A (Induction:daunorubicin/cytarabine; consolidation:cytarabine; maintenance:observation/transplant)
See Detailed Description
Intervention: Cytarabine (Drug)
A (Induction:daunorubicin/cytarabine; consolidation:cytarabine; maintenance:observation/transplant)
See Detailed Description
Intervention: Observation (Other)
A (Induction:daunorubicin/cytarabine; consolidation:cytarabine; maintenance:observation/transplant)
See Detailed Description
Intervention: Allogeneic hematopoietic stem cell transplantation (Procedure)
B (Induction: clofarabine; Consolidation: clofarabine; Maintenance: decitabine or transplant)
See Detailed Description
Intervention: Clofarabine (Drug)
B (Induction: clofarabine; Consolidation: clofarabine; Maintenance: decitabine or transplant)
See Detailed Description
Intervention: Decitabine (Drug)
B (Induction: clofarabine; Consolidation: clofarabine; Maintenance: decitabine or transplant)
See Detailed Description
Intervention: Allogeneic hematopoietic stem cell transplantation (Procedure)
Outcomes
Primary Outcomes
Overall Survival
Time Frame: Assessed every 3 months for 4 years and then every 6 months for 1 year
Overall survival is defined as the time from randomization to death or date last known alive.
Secondary Outcomes
- Proportion of Patients With Complete Remission(Assessed every 3 months for 4 years and then every 6 months for 1 year)
- Overall Survival by Donor Status(Assessed every 3 months for 4 years and then every 6 months for 1 year)
- Disease-free Survival for Maintenance(Assessed every 3 months for 4 years and then every 6 months for 1 year)