Idarubicin and High-Dose Cytarabine in Treating Patients With Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT00528398|
Recruitment Status : Completed
First Posted : September 12, 2007
Results First Posted : February 6, 2017
Last Update Posted : February 6, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: cytarabine Drug: idarubicin||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||111 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial Utilizing Idarubicin in Combination With High Dose Ara-C for Induction Therapy for Adult Acute Myelogenous Leukemia (AML)|
|Study Start Date :||September 1994|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Experimental: Treatment (idarubicin, 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.
- Complete Remission (CR) [ Time Frame: 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.
- Bone Marrow at Day 7 Post-Induction Chemotherapy [ Time Frame: 7 days post completion of induction chemotherapy ]Bone marrow positive, negative cells at day 7 post-induction chemotherapy for leukemia (%)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00528398
|United States, Arizona|
|Banner Good Samaritan Medical Center|
|Phoenix, Arizona, United States, 85006|
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010-3000|
|Principal Investigator:||Anthony S. Stein, MD||City of Hope Comprehensive Cancer Center|