Idarubicin and High-Dose Cytarabine in Treating Patients With Acute Myeloid Leukemia
- Registration Number
- NCT00528398
- Lead Sponsor
- City of Hope Medical Center
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, 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.
PURPOSE: This phase II trial is studying how well giving idarubicin together with high-dose cytarabine works in treating patients with acute myeloid leukemia.
- Detailed Description
OBJECTIVES:
* Determine the complete remission rate (CR).
* Determine the proportion of patients who are bone marrow-positive at day 7 post-induction chemotherapy.
* Further evaluate the toxicity of this regimen.
OUTLINE: Patients receive cytarabine IV over 3 hours every 12 hours on days 1-4 and idarubicin IV over 5-10 minutes on days 1-3. Patients undergo bone marrow aspirate and biopsy 7 days after completion of induction chemotherapy. Patients with \> 25% cellular biopsy or \> 10% abnormal cells on aspirate receive 4 more doses of cytarabine and 1 dose of idarubicin.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 111
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment (idarubicin, cytarabine) cytarabine Patients receive cytarabine IV over 3 hours every 12 hours on days 1-4 and idarubicin IV over 5-10 minutes on days 1-3. Patients undergo bone marrow aspirate and biopsy 7 days after completion of induction chemotherapy. Patients with \> 25% cellular biopsy or \> 10% abnormal cells on aspirate receive 4 more doses of cytarabine and 1 dose of idarubicin. Treatment (idarubicin, cytarabine) idarubicin Patients receive cytarabine IV over 3 hours every 12 hours on days 1-4 and idarubicin IV over 5-10 minutes on days 1-3. Patients undergo bone marrow aspirate and biopsy 7 days after completion of induction chemotherapy. Patients with \> 25% cellular biopsy or \> 10% abnormal cells on aspirate receive 4 more doses of cytarabine and 1 dose of idarubicin.
- Primary Outcome Measures
Name Time Method Complete Remission (CR) 7 days post completion of induction chemotherapy The peripheral blood neutrophil count is \>= 1.5 x 10\^9 / L and platelets more than 100 x 10\^9 / L. Leukemia blast cells are not present in the peripheral blood. The cellularity of the bone marrow is more than 20% with maturation of all cell lines. The bone marrow contains less than 5% blast cells, and Auer rods is not detectable.
- Secondary Outcome Measures
Name Time Method Bone Marrow at Day 7 Post-Induction Chemotherapy 7 days post completion of induction chemotherapy Bone marrow positive, negative cells at day 7 post-induction chemotherapy for leukemia (%)
Trial Locations
- Locations (2)
Banner Good Samaritan Medical Center
🇺🇸Phoenix, Arizona, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States