Clofarabine and Daunorubicin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT00814164|
Recruitment Status : Terminated (Sponsor withdrew support)
First Posted : December 24, 2008
Results First Posted : August 17, 2016
Last Update Posted : August 17, 2016
RATIONALE: Drugs used in chemotherapy, such as clofarabine and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving clofarabine together with daunorubicin may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving clofarabine together with daunorubicin works in treating older patients with newly diagnosed acute myeloid leukemia.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: clofarabine Drug: daunorubicin hydrochloride Genetic: cytogenetic analysis Genetic: protein expression analysis Other: immunologic technique Other: pharmacological study||Phase 2|
- Study complete response (CR) and CR without platelet recovery (CRp) following treatment with clofarabine and daunorubicin hydrochloride in older patients with newly diagnosed acute myeloid leukemia.
- Study disease-free and overall survival of these patients following treatment with this regimen.
- Compare disease-free and overall survival of patients whose cells do or do not demonstrate apoptosis following treatment with this regimen.
- Induction therapy: Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5. Patients are assessed after induction course 1. Patients with ≥ 5% blasts in bone marrow may receive another course of induction therapy beginning between 28-84 days after initiation of course 1. Patients who achieve complete remission (CR) or CR without platelet recovery (CRp) (after 1 or 2 courses of induction therapy) proceed to consolidation therapy.
- Consolidation therapy: Beginning between 28 -84 days after initiation of last course of induction therapy, patients receive clofarabine IV over 1 hour on days 1-3 and daunorubicin hydrochloride IV over 5 minutes on days 1 and 3. Patients may receive a second course of consolidation therapy beginning between 28-84 days of consolidation course 1.
Blood and bone marrow samples are collected periodically to assess response and for pharmacokinetic, cytogenetic, immunophenotyping, and molecular analyses.
After completion of study treatment, patients are followed for at least 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Evaluating Mechanisms of Resistance Following Treatment With Clofarabine and Daunorubicin in Newly Diagnosed Adult Acute Myeloid Leukemia Patients > or = to 60 Years Old|
|Study Start Date :||December 2008|
|Primary Completion Date :||June 2013|
|Study Completion Date :||August 2013|
Experimental: Clorafarbine with daunorubicin
Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.
IVDrug: daunorubicin hydrochloride
IVGenetic: cytogenetic analysis
Correlative studyGenetic: protein expression analysis
Correlative StudyOther: immunologic technique
Correlative StudyOther: pharmacological study
- Complete Remission (CR) [ Time Frame: 2 years ]Complete Response/Remission (CR) was defined on morphologic criteria at a single response assessment as follows: A bone marrow aspirate or biopsy of < 5% blasts, with evidence of normal hematopoiesis; Absence of Auer rods in the blast that are present; Absence of extramedullary disease [imaging required only if obtained pretreatment for known site(s) of disease]; If applicable and available, absence of a unique phenotype determined at the pretreatment specimen, as assessed by immunophenotyping; Recovery of peripheral counts (platelets ≥100x109/L, and ANC ≥1.0x109/L). Peripheral count recovery must be documented no earlier than 7 days prior to, and no later than 14 days following, the bone marrow assessment that provides evidence of the CR. Complete Response/Remission without platelet recovery (CRp) was defined as all criteria for CR except for thrombocytopenia (platelet count ≥75x109/L).
- Disease-free Survival [ Time Frame: 5 years ]Disease-free survival was defined as time from first objective documentation of CR or CRp until the date of first objective documentation of disease relapse or death due to any cause, whichever occurs first.
- Overall Survival [ Time Frame: 4 years ]Overall survival was defined as time from date of treatment initiation until date of death due to any cause.
- Differences in Disease-free and Overall Survival Between Patients Whose Cells do or do Not Demonstrate Apoptosis Following Clofarabine and Daunorubicin Hydrochloride Therapy [ Time Frame: 4 years ]
- Difference in Disease-free and Overall Survival According to p53R2 Protein Sizes [ Time Frame: 4 years ]
- Difference in Disease-free and Overall Survival According to Multi-drug Resistance Protein Expression [ Time Frame: 4 years ]
- Difference in Disease-free and Overall Survival Based on Clofarabine Triphosphate Levels [ Time Frame: 4 years ]
- A Preliminary Relationship Between Treatment Outcome and Biologic Parameters [ Time Frame: 4 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00814164
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||Meir Wetzler, MD||Roswell Park Cancer Institute|