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Myeloablative Hematopoietic Progenitor Cell Transplantation (HPCT) for Pediatric Malignancies
This study is currently recruiting participants.
Study NCT00619879   Information provided by Children's Memorial Hospital
First Received: January 8, 2008   Last Updated: August 26, 2008   History of Changes

January 8, 2008
August 26, 2008
March 2007
January 2020   (final data collection date for primary outcome measure)
Evaluate the morbidity and mortality of hematopoietic progenitor cell transplantation (HPCT) at Children's Memorial Hospital. [ Time Frame: To study end ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00619879 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • Determine the toxicity of a single conditioning regimen consisting of total body irradiation, etoposide, and cyclophosphamide for patients with transplant eligible lymphoid malignant conditions. [ Time Frame: To study end ] [ Designated as safety issue: Yes ]
  • Determine the toxicity of a single conditioning regimen consisting of busulfan and cyclophosphamide for patients with transplant eligible myeloid malignant conditions. [ Time Frame: To study end ] [ Designated as safety issue: Yes ]
Same as current
 
Myeloablative Hematopoietic Progenitor Cell Transplantation (HPCT) for Pediatric Malignancies
Myeloablative Hematopoietic Progenitor Cell Transplantation (HPCT) for Pediatric Malignancies

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.

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.

Phase III
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
  • Leukemia, Myelogenous, Chronic
  • Leukemia, Lymphoblastic, Acute
  • Leukemia, Myelogenous, Acute
  • Juvenile Myelomonocytic Leukemia
  • Dysmyelopoietic Syndromes
  • Drug: Myeloablative Chemotherapy Regimen for Lymphoid Malignancies
  • Drug: Myeloablative Chemotherapy Regimen for Myeloid Malignancies
  • Other: Hematopoietic Progenitor Cell Transplanation (HPCT)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
200
January 2020
January 2020   (final data collection date for primary outcome measure)

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
Both
up to 21 Years
No
Contact: Morris Kletzel, MD 773-880-4562 mkletzel@northwestern.edu
Contact: Terriss Conterato 773-880-8153 TConterato@childrensmemorial.org
United States
 
NCT00619879
Morris Kletzel, MD, Children's Memorial Hospital
SCT 0307
Children's Memorial Hospital
 
Principal Investigator: Morris Kletzel, MD Children's Memorial Hospital
Children's Memorial Hospital
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP