Clinical trial · Interventional
Clofarabine and Daunorubicin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
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
NCT00814164CI-TRIAL-00023513terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor withdrew support
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| clofarabine | Drug | Clofarabine | ALIAS |
| cytogenetic analysis | Genetic | — | UNRESOLVED |
| daunorubicin hydrochloride | Drug | Daunorubicin | ALIAS |
| immunologic technique | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| protein expression analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Clorafarbine with daunorubicin
- description
- Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.
- interventionNames
- Drug: clofarabine
- Drug: daunorubicin hydrochloride
- Genetic: cytogenetic analysis
- Genetic: protein expression analysis
- Other: immunologic technique
- Other: pharmacological study
Primary outcomes (1)
- measure
- Complete Remission (CR)
- timeFrame
- 2 years
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Newly diagnosed acute myeloid leukemia * At least 10% blasts in the peripheral blood * De novo or secondary disease * No acute promyelocytic leukemia with t\[15;17\] or any other variant * No clinical evidence of CNS disease PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Serum bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST and ALT ≤ 2.5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN * LVEF ≥ 45% * Estimated glomerular filtration rate ≥ 50 mL/min * Not pregnant or nursing * Fertile patients must use effective barrier contraception during and for at least 6 months following study treatment * No known HIV positivity * Able to comply with study procedures and follow-up examinations * No psychiatric disorders that would interfere with consent, study participation, or follow-up * No uncontrolled systemic fungal, bacterial, viral, or other infection (i.e., exhibiting ongoing signs/symptoms related to the infection and without improvement despite appropriate antibiotics or other treatment) * No history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo induction therapy with both agents * No other malignancy, unless disease-free for at least 3 years following curative intent therapy * Nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are allowed if definitive treatment for the condition has been completed * Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed * No other severe concurrent disease PRIOR CONCURRENT THERAPY: * No other concurrent systemic antileukemic therapy (standard or investigational) * No concurrent cytotoxic therapy or investigational therapy * No concurrent alternative medications (e.g., herbal or botanical for anticancer purposes) * No prior chemotherapy * Prior hydroxyurea allowed
References
Publications (0)
Data not yet available
No reference posted for this study.