Myeloablative Hematopoietic Progenitor Cell Transplantation (HPCT) for Pediatric Malignancies

• Status: Unknown status
• Trial end date: 2020-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
• Treatments: Busulfan; Cyclophosphamide; Etoposide

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/= 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