Clinical trial · Interventional
Decitabine in Treating Children With Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
A Phase I Study Of Decitabine (DAC) (IND # 50733) In Children With Relapsed Or Refractory Acute Leukemia
NCT00042796CI-TRIAL-00009037terminatedPhase 1ClinicalTrials.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): Administratively complete.
Summary
Brief summary (as posted)
Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. This phase I trial is studying the side effects and best dose of decitabine in treating children with relapsed or refractory acute myeloid leukemia or acute lymphoblastic leukemia
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Acute Myeloblastic Leukemia With Maturation (M2) | Childhood Acute Myeloid Leukemia with Maturation | ALIAS | 0.90 |
| Childhood Acute Promyelocytic Leukemia (M3) | Childhood Acute Promyelocytic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Recurrent Childhood Acute Lymphoblastic Leukemia | Childhood Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Recurrent Childhood Acute Myeloid Leukemia | Childhood Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Secondary Acute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| decitabine | Drug | Decitabine | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (decitabine)
- description
- Patients receive decitabine IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 4-6 weeks for a minimum of 4 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: decitabine
- Other: pharmacological study
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- MTD defined as the highest dose at which fewer than one-third of patients experience DLT assessed using CTC version 2.0
- timeFrame
- 4 weeks
Secondary outcomes (6)
- measure
- CR rate
- timeFrame
- Up to 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed acute myeloid leukemia (AML) or acute lymphoblastic leukemia that is considered refractory to conventional therapy or for which no conventional therapy exists * For patients with AML: * M3 marrow * M2 marrow with at least 15% blasts * Secondary AML allowed * CNS involvement allowed * Performance status - Karnofsky 50-100% (age 17 to 21) * Performance status - Lansky 50-100% (age 16 and under) * At least 8 weeks * See Chemotherapy * WBC no greater than 30,000/mm\^3 * Patients with granulocytopenia, anemia, and/or thrombocytopenia are eligible but are not evaluable for hematological toxicity * Bilirubin no greater than 1.5 times normal * ALT no greater than 5 times normal * Albumin at least 2 g/dL * Creatinine no greater than 1.5 times normal * Creatinine clearance or radioisotope glomerular filtration rate at least lower limit of normal * Shortening fraction at least 27% by echocardiogram * Ejection fraction at least 50% by MUGA scan * No evidence of dyspnea at rest * No exercise intolerance * Oxygen saturation greater than 94% by pulse oximetry * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Concurrent seizure disorder allowed if well controlled on anticonvulsants * No grade 2 or greater CNS toxicity * No uncontrolled infection (i.e., infections associated with fever, dissemination, hemodynamic instability \[requiring pressor support\], and progression while on therapy) * No active graft-versus-host disease (GVHD) * GVHD well controlled on cyclosporine allowed * Recovered from prior immunotherapy * At least 1 week since prior biologic agents * At least 6 months since prior allogeneic bone marrow transplantation (BMT) * At least 3 months since prior autologous BMT * No concurrent sargramostim (GM-CSF) * No concurrent prophylactic filgrastim (G-CSF) during the first course of therapy * Recovered from prior chemotherapy * At least 4 weeks since prior cytarabine * At least 24 hours since prior cytoreductive therapy with hydroxyurea (20-30 mg/kg/day for no more than 7 days) to lower the WBC to no greater than 30,000/mm\^3 * No concurrent intrathecal therapy during the first course of decitabine * Recovered from prior radiotherapy * At least 2 weeks since prior local palliative radiotherapy (small port) * At least 6 weeks since prior cranial or craniospinal radiotherapy * No concurrent medications that induce cytidine deaminase or deoxycytidine kinase (e.g., cytarabine) * No concurrent medications that mask poor or deteriorating organ function * No concurrent CNS prophylaxis during the first course of decitabine * Concurrent anticonvulsants with no known interactions with decitabine allowed * Concurrent antibacterial or antifungal therapies for controlled infections allowed
References
Publications (0)
Data not yet available
No reference posted for this study.