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| Sponsor: | Children's Memorial Hospital |
|---|---|
| Information provided by: | Children's Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT00619879 |
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia, Myelogenous, Chronic Leukemia, Lymphoblastic, Acute Leukemia, Myelogenous, Acute Myeloproliferative-Myelodysplastic Diseases Lymphoma, Malignant |
Drug: Myeloablative Chemotherapy Regimen for Lymphoid Malignancies or Cord Blood Unit Recipients Drug: Myeloablative Chemotherapy Regimen for Non-Cord Blood Unit Recipients with Myeloid Malignancies Other: Hematopoietic Progenitor Cell Transplantation (HPCT) Radiation: CNS radiation treatment for ALL with prior CNS disease patients |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Myeloablative Hematopoietic Progenitor Cell Transplantation (HPCT) for Pediatric Malignancies |
| Estimated Enrollment: | 200 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | January 2020 |
| Estimated Primary Completion Date: | January 2020 (Final data collection date for primary outcome measure) |
Total Body Irradiation (TBI) 1200 cGy will be given on days -8,-7,-6 and -5 in eight sessions, delivering 150cGy in each session.
Etoposide 1000 mg/m2 as a 24 hour continuous infusion started on day -4.
Cyclophosphamide 60 mg/kg/day IV given over 1 hour daily on days -3, -2.
Busulfan administration:
Lorazepam (0.05 mg/kg) IV will be administered one half hour before the initial dose of Busulfan is given and every 6 hours through day -4.
Etoposide 1000 mg/m2 as a 24 hour continuous infusion started on day -4.
Cyclophosphamide 60 mg/kg/day IV given over 1 hour daily on days -3 and -2.
Patients with prior CNS disease over the age of 1 year will be treated with 600 cGy of cranial irradiation in addition to 1200 cGy of TBI.
Patients diagnosed with ALL with CNS disease (at the time of diagnosis or relapse) < 1 year of age will receive CNS treatment as Intrathecal Methotrexate as follows:
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.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Malignant Disease
Acute lymphoblastic leukemia (ALL)
Acute myelogenous leukemia (AML)
Myelodysplastic/Myeloproliferative Disease
Lymphoma
Patient organ function requirements:
Exclusion Criteria:
Contacts and Locations| Contact: Morris Kletzel, MD | 773-880-4562 | mkletzel@northwestern.edu |
| Contact: Terriss Conterato | 773-880-8153 | TConterato@childrensmemorial.org |
| United States, Illinois | |
| Children's Memorial Hospital | Recruiting |
| Chicago, Illinois, United States, 60614 | |
| Principal Investigator: Morris Kletzel, MD | |
| Principal Investigator: | Morris Kletzel, MD | Children's Memorial Hospital |
More Information
| Responsible Party: | Morris Kletzel, MD, Children's Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT00619879 History of Changes |
| Other Study ID Numbers: | SCT 0307 |
| Study First Received: | January 8, 2008 |
| Last Updated: | March 29, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
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 |
|
Neoplasms Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Myeloid, Acute Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Lymphoma Neoplasms by Histologic Type Leukemia, Lymphoid Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Myeloproliferative Disorders |
Bone Marrow Diseases Hematologic Diseases Cyclophosphamide Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists |