Clinical trial · Interventional
Autologous Bone Marrow Transplant for Children With Acute Myelogenous Leukemia (AML) in First Complete Remission
Autologous Bone Marrow Transplant for Children With AML in First Complete Remission: Use of Marker Genes to Investigate the Biology of Marrow Reconstitution and the Mechanism of Relapse
NCT00667927CI-TRIAL-00001429completedPhase 1ClinicalTrials.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)
This study proposes to transfer marker genes (detectable genetic traits or segments of DNA that can be identified and tracked) into aliquots of marrow obtained for Bone Marrow Transplant (BTM) in patients in remission of Acute Myelogenous Leukemia (AML).
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 |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Busulfan | Drug | Busulfan | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Mesna | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- 1
- interventionNames
- Drug: Busulfan
- Drug: Cyclophosphamide
- Drug: Mesna
Primary outcomes (1)
- measure
- To estimate the continuous complete remission rate at 2 years for children with AML in first complete remission treated with Autologous Bone Marrow Transplant (ABMT).
- timeFrame
- 2 years post transplant
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged between 1 and 18 years at diagnosis with acute nonlymphocytic leukemia in first remission are eligible for this protocol. * Patients enrolled on the AML-87 study in second or subsequent remission are eligible for this protocol. Exclusion Criteria: * Has an HLA-matched, MLC-compatible donor(unless parents and/or patient refuses transplant. * Diagnosis of FAB M3 or FAB M3v (acute progranulocytic leukemia) * Life expectancy limited by disease other than leukemia * Significant cardiac disease (echo shortening fraction \<25% or MUGA scan \<50%) * Severe renal dysfunction, i.e., creatinine clearance less than 60cc/1.73 m2/min * Severe restrictive pulmonary disease (FCV less than 40% of predicted) * Severe hepatic disease (bilirubin greater than 3 mg/dl or SGPT greater than 500IU) * Severe personality disorder or mental illness * Previous severe cystitis from cyclophosphamide * Previous total dose of anthracyclines of \>450 mg/m2 * Sever infection that on evaluation by the PI precludes ablative chemotherapy or successful transplantation * Previous autologous transplant * HIV reactivity * Karnofsky score \<70%
References
Publications (0)
Data not yet available
No reference posted for this study.