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Myeloablative Hematopoietic Progenitor Cell Transplantation (HPCT) for Pediatric Malignancies


Phase 3
N/A
21 Years
Open (Enrolling)
Both
Leukemia, Myelogenous, Chronic, Leukemia, Lymphoblastic, Acute, Leukemia, Myelogenous, Acute, Myeloproliferative-Myelodysplastic Diseases, Lymphoma, Malignant

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Trial Information

Myeloablative Hematopoietic Progenitor Cell Transplantation (HPCT) for Pediatric Malignancies


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.


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 /= 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate the morbidity and mortality of hematopoietic progenitor cell transplantation (HPCT) at Children's Memorial Hospital.

Outcome Time Frame:

To study end

Safety Issue:

Yes

Principal Investigator

Morris Kletzel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ann & Robert H Lurie Children's Hospital of Chicago

Authority:

United States: Institutional Review Board

Study ID:

SCT 0307

NCT ID:

NCT00619879

Start Date:

March 2007

Completion Date:

January 2020

Related Keywords:

  • Leukemia, Myelogenous, Chronic
  • Leukemia, Lymphoblastic, Acute
  • Leukemia, Myelogenous, Acute
  • Myeloproliferative-Myelodysplastic Diseases
  • Lymphoma, Malignant
  • 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
  • Leukemia
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lymphoma

Name

Location

Children's Memorial HospitalChicago, Illinois  60614