Clinical Trials /

Myeloablative Hematopoietic Progenitor Cell Transplantation (HPCT) for Pediatric Malignancies

NCT00619879

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.

Related Conditions:
  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Juvenile Myelomonocytic Leukemia
  • Lymphoma
  • Myelodysplastic Syndromes
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

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

DrugSynonymsArms
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

NameTypeDescriptionInterventions

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:Recruiting
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

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