Clinical trial · Observational
Myeloablative Hematopoietic Progenitor Cell Transplantation (HPCT) for Pediatric Malignancies
NCT00619879CI-TRIAL-00086891completedClinicalTrials.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)
The purpose of this study is to show that myeloablative hematopoietic progenitor cell transplantation (HPCT) continues to offer acceptable disease-free survival for select patients requiring HPCT.
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 |
|---|---|---|---|
| Leukemia, Lymphoblastic, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Leukemia, Myelogenous, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Leukemia, Myelogenous, Chronic | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Lymphoma, Malignant | Lymphoma | ALIAS | 0.90 |
| Myeloproliferative-Myelodysplastic Diseases | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CNS radiation treatment for ALL with prior CNS disease patients | Radiation | — | UNRESOLVED |
| Hematopoietic Progenitor Cell Transplantation (HPCT) | Other | — | UNRESOLVED |
| Myeloablative Chemotherapy Regimen for Lymphoid Malignancies or Cord Blood Unit Recipients | Drug | — | UNRESOLVED |
| Myeloablative Chemotherapy Regimen for Non-Cord Blood Unit Recipients with Myeloid Malignancies | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Evaluate the morbidity and mortality of hematopoietic progenitor cell transplantation (HPCT) at Children's Memorial Hospital.
- timeFrame
- To study end
Secondary outcomes (3)
- measure
- Evaluate the effectiveness of graft versus host disease prevention with a combination of anti-thymocyte globulin, continuous infusion cyclosporine, and short course methotrexate for transplants.
- timeFrame
- To study end
- measure
- Determine the toxicity of a single conditioning regimen consisting of total body irradiation, etoposide, and Cyclophosphamide for patients with transplant eligible lymphoid malignant conditions or myeloid malignant conditions receiving cord blood units.
- timeFrame
- To study end
- measure
- Determine the toxicity of a single conditioning regimen consisting of Busulfan and Cyclophosphamide for patients with transplant eligible myeloid malignant conditions who are not receiving cord blood units.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria:
* Malignant Disease
* Chronic myleogenous leukemia in chronic or accelerated phase
* Acute lymphoblastic leukemia (ALL)
* First remission high-risk ALL (Ph+, t( 4-11) infants).
* Second remission ALL, after a short first remission (\<36 mos from Dx).
* 3rd or greater remission ALL.
* Acute myelogenous leukemia (AML)
* First remission high risk acute nonlymphoblastic (ANLL) (as defined by cytogenetics), if a matched sibling donor is available.
* Initial partial remission AML (\<20% blasts in the bone marrow).
* AML that is refractory to two cycles of induction therapy.
* Second or greater remission AML
* Myelodysplastic/Myeloproliferative Disease
* Juvenile Myelomonocytic Leukemia (JMML)
* Myelosplastic syndrome and/or pre-leukemia at any stage
* Lymphoma
* Relapsed lymphoma with residual disease that appears to be chemo-sensitive and non-bulky (\<5 cm at largest diameter)
* Venous Access: Three lumens of central vascular access will be required for all patients entered on protocol due to the need for a dedicated line for continuous infusion cyclosporine.
* Informed Consent: The patient and/or the patient's legally authorized guardian must acknowledge in writing that consent to become a study subject has been obtained in accordance with the institutional policies approved by the U.S. Department of Health and Human Services.
* Patient organ function requirements:
* Adequate renal function: Serum Creatinine \<\~1.5 x normal, or Creatinine clearance of 70 mL/min/1.73 mE2 or an equivalent GFR as determined by the institutional normal range
* Adequate liver function: Total bilirubin \<1.5 x normal; and SGOT (AST) or SGPT (ALT) \<\~2.5 x normal
* Adequate cardiac function: Shortening fraction of \>/=27% by echocardiogram
* Adequate pulmonary function: FEV1/FVC \>/=60% by pulmonary function test; for children who are uncooperative, no evidence of dysnpea at rest, or exercise intolerance, and must have a pulse oximetry \>94% in room air
* Performance status: Lansky for children \</= 16 years \>/= 60; Karnofsky status for those \> 16 years of age \>/= 70
* Effective Contraceptive Use: Women of childbearing potential and sexually active males should use effective contraception while on study.
Exclusion Criteria:
* Patients who are pregnant or lactating
* Inability to find a suitable donor for the patient
* Patient is HIV-positive
* Patient has active Hepatitis B
* Disease progression or relapse prior to HPC infusionReferences
Publications (0)
Data not yet available
No reference posted for this study.