Description:
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.
Title
- Brief Title: Myeloablative Hematopoietic Progenitor Cell Transplantation (HPCT) for Pediatric Malignancies
- Official Title: Myeloablative Hematopoietic Progenitor Cell Transplantation (HPCT) for Pediatric Malignancies
Clinical Trial IDs
- ORG STUDY ID:
SCT 0307
- NCT ID:
NCT00619879
Conditions
- Leukemia, Myelogenous, Chronic
- Leukemia, Lymphoblastic, Acute
- Leukemia, Myelogenous, Acute
- Myeloproliferative-Myelodysplastic Diseases
- Lymphoma, Malignant
Interventions
Drug | Synonyms | Arms |
---|
Myeloablative Chemotherapy Regimen for Lymphoid Malignancies or Cord Blood Unit Recipients | | |
Myeloablative Chemotherapy Regimen for Non-Cord Blood Unit Recipients with Myeloid Malignancies | | |
Purpose
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.
Detailed Description
Myeloablative hematopoietic progenitor cell transplantation (HPCT) remains the standard of
care for patients requiring HPCT. The purpose of this study is to evaluate the morbidity and
mortality of myeloablative HPCT at Children's Memorial Hospital. It will also look to
determine the toxicity of a single conditioning regimen consisting of total body irradiation
(TBI), etoposide (VP-16), and Cyclophosphamide for patients with transplant eligible lymphoid
malignant conditions or with transplant eligible myeloid malignant conditions who are
receiving cord blood units, or to 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.
Trial Arms
Name | Type | Description | Interventions |
---|
Eligibility Criteria
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 infusion
Maximum Eligible Age: | 21 Years |
Minimum Eligible Age: | N/A |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Evaluate the morbidity and mortality of hematopoietic progenitor cell transplantation (HPCT) at Children's Memorial Hospital. |
Time Frame: | To study end |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
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. |
Time Frame: | To study end |
Safety Issue: | |
Description: | |
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. |
Time Frame: | To study end |
Safety Issue: | |
Description: | |
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. |
Time Frame: | To study end |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Unknown status |
Lead Sponsor: | Ann & Robert H Lurie Children's Hospital of Chicago |
Trial Keywords
- Leukemia, Myelogenous, Chronic
- Leukemia, Lymphoblastic, Acute
- Leukemia, Myelogenous, Acute
- Myeloproliferative-Myelodysplastic Diseases
- Juvenile Myelomonocytic Leukemia
- Dysmyelopoietic Syndromes
- Lymphoma, Malignant
- Stem Cell Transplantation, Hematopoietic
- Allogeneic Transplantation
- Human Leukocyte Antigens
- Busulfan
- Total Body Irradiation
- VP-16
- Etoposide
- Cyclophosphamide
- Graft-Versus-Host Disease
Last Updated
March 30, 2011