Myeloablative Hematopoietic Progenitor Cell Transplantation (HPCT) for Pediatric Malignancies
Information source: Children's Memorial Hospital
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leukemia, Myelogenous, Chronic; Leukemia, Lymphoblastic, Acute; Leukemia, Myelogenous, Acute; Juvenile Myelomonocytic Leukemia; Dysmyelopoietic Syndromes
Intervention: Myeloablative Chemotherapy Regimen for Lymphoid Malignancies (Drug); Myeloablative Chemotherapy Regimen for Myeloid Malignancies (Drug); Hematopoietic Progenitor Cell Transplanation (HPCT) (Other)
Phase: Phase 3
Status: Recruiting
Sponsored by: Children's Memorial Hospital Official(s) and/or principal investigator(s):
Morris Kletzel, MD, Principal Investigator, Affiliation: Children's Memorial Hospital
Overall contact:
Morris Kletzel, MD, Phone: 773-880-4562, Email: mkletzel@northwestern.edu
Summary
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.
Clinical Details
Official title: Myeloablative Hematopoietic Progenitor Cell Transplantation (HPCT) for Pediatric Malignancies
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Evaluate the morbidity and mortality of hematopoietic progenitor cell transplantation (HPCT) at Children's Memorial Hospital.
Secondary outcome: 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.Determine the toxicity of a single conditioning regimen consisting of total body irradiation, etoposide, and cyclophosphamide for patients with transplant eligible lymphoid malignant conditions. Determine the toxicity of a single conditioning regimen consisting of busulfan and cyclophosphamide for patients with transplant eligible myeloid malignant conditions.
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 either total body
irradiation, etoposide, and cyclophosphamide, or busulfan and cyclophosphamide, for patients
with transplant eligible lumphoid malignant conditions. The study will accrue patients until
a superior method of HPCT is determined and set forth as the new standard of care.
Eligibility
Minimum age: N/A.
Maximum age: 21 Years.
Gender(s): Both.
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)
- Acute nonlymphoblastic leukemia (ANLL) in 2nd remission/early relapse or
with other high risk features and the approval of the PI.
- Myelodysplastic/Myeloproliferative Disease
- Juvenile Myelomonocytic Leukemia (JMML)
- Myelosplastic syndrome and/or pre-leukemia at any stage
- 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; Karnofsy status for those >
16 years of age >/= 70
Exclusion Criteria:
- Patients who are pregnant
- 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
Locations and Contacts
Morris Kletzel, MD, Phone: 773-880-4562, Email: mkletzel@northwestern.edu
Children's Memorial Hospital, Chicago, Illinois 60614, United States; Recruiting
Morris Kletzel, MD, Principal Investigator
Additional Information
Starting date: March 2007
Ending date: January 2020
Last updated: August 26, 2008
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