Clinical trial · Interventional
Chemotherapy in Treating Children With Recurrent Acute Myeloid Leukemia
Idarubicin and Cladribine in Recurrent and Refractory Acute Myeloid Leukemia: A POG Phase II Study
NCT00003178CI-TRIAL-00015210completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of idarubicin and cladribine in treating children who have recurrent 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cladribine | Drug | Cladribine | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| idarubicin | Drug | Idarubicin | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 1st Untreated Relapse for AML
- description
- Patients receive idarubicin IV over 15 minutes on days 1-3, cladribine IV over 2 hours on days 1-5, and filgrastim (G-CSF) subcutaneously beginning on day 6 and continuing until blood counts have recovered for 2 days. Treatment repeats every 3 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response after completion of course 1 may proceed to other chemotherapy or bone marrow transplantation at the discretion of the protocol investigator. Patients with extramedullary disease may receive intrathecal chemotherapy or radiotherapy to symptomatic sites.
- interventionNames
- Biological: filgrastim
- Drug: cladribine
- Drug: idarubicin
- type
- EXPERIMENTAL
- label
- Primary Refractory AML
- description
- Patients receive idarubicin IV over 15 minutes on days 1-3, cladribine IV over 2 hours on days 1-5, and filgrastim (G-CSF) subcutaneously beginning on day 6 and continuing until blood counts have recovered for 2 days. Treatment repeats every 3 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response after completion of course 1 may proceed to other chemotherapy or bone marrow transplantation at the discretion of the protocol investigator. Patients with extramedullary disease may receive intrathecal chemotherapy or radiotherapy to symptomatic sites.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * One of the following diagnoses: * Acute myeloid leukemia (AML) (FAB M0-M7) * Secondary AML in first relapse (Secondary AML stratum closed as of 04/02/02) * AML in primary induction failure (Refractory AML stratum closed as of 04/03/01) * Myelodysplastic syndromes (MDS) (not related to Down syndrome) (MDS stratum closed as of 04/03/01) * Extramedullary disease allowed * Relapse more than 6 months after allogeneic or autologous bone marrow transplantation allowed PATIENT CHARACTERISTICS: Age: * Under 21 at diagnosis Performance status: * Karnofsky 50-100% (over 10 years) * Lansky 50-100% (10 years and under) Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin less than 1.5 mg/dL * ALT less than 3 times normal Renal: * Creatinine less than 2 times normal Cardiovascular: * Shortening fraction greater than 29% * Ejection fraction greater than 55% with normal wall motion Other: * No uncontrolled infection * Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics Chemotherapy: * At least 12 weeks since prior idarubicin and recovered * At least 2 weeks since other prior chemotherapy and recovered Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified
References
Publications (1)
- RESULTChaleff S, Hurwitz CA, Chang M, Dahl G, Alonzo TA, Weinstein H. Phase II study of 2-chlorodeoxyadenosine plus idarubicin for children with acute myeloid leukaemia in first relapse: a paediatric oncology group study. Br J Haematol. 2012 Mar;156(5):649-55. doi: 10.1111/j.1365-2141.2011.08976.x. PMID 22512017