Chicago, Illinois 60614


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.


Study summary:

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.


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


Study is Available At:


Original ID:

SCT 0307


NCT ID:

NCT00619879


Secondary ID:


Study Acronym:


Brief Title:

Myeloablative Hematopoietic Progenitor Cell Transplantation (HPCT) for Pediatric Malignancies


Official Title:

Myeloablative Hematopoietic Progenitor Cell Transplantation (HPCT) for Pediatric Malignancies


Overall Status:

Recruiting


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

N/A


Maximum Age:

21 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Children's Memorial Hospital


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

200


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Morris Kletzel, MD
Principal Investigator
Children's Memorial Hospital
Primary Contact:Morris Kletzel, MD
773-880-4562
mkletzel@northwestern.edu
Backup Contact:Terriss Conterato
773-880-8153
TConterato@childrensmemorial.org

Study Dates

Start Date:March 2007
Completion Date:January 2020
Completion Type:Anticipated
Primary Completion Date:January 2020
Primary Completion Type:Anticipated
Verification Date:March 2011
Last Changed Date:March 29, 2011
First Received Date:January 8, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Evaluate the morbidity and mortality of hematopoietic progenitor cell transplantation (HPCT) at Children's Memorial Hospital.
Time Frame:To study end
Safety Issues:True
Outcome Type:Secondary Outcome
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 Issues:True
Outcome Type:Secondary Outcome
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 Issues:True
Outcome Type:Secondary Outcome
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 Issues:True

Study Interventions

Intervention Type:Drug
Name:Myeloablative Chemotherapy Regimen for Lymphoid Ma
Description:Total Body Irradiation (TBI) 1200 cGy will be given on days -8,-7,-6 and -5 in eight sessions, delivering 150cGy in each session. Etoposide 1000 mg/m2 as a 24 hour continuous infusion started on day -4. Cyclophosphamide 60 mg/kg/day IV given over 1 hour daily on days -3, -2.
Intervention Type:Drug
Name:Myeloablative Chemotherapy Regimen for Non-Cord Bl
Description:Busulfan administration: For children >/= 4 years of age, Busulfan 0.8 mg/kg/dose will be given every 6 hours over days -8,-7, -6, and -5 for a total of 16 doses. For children < 4 years of age, Busulfan 1 mg/kg/dose will be given every 6 hours over days -8, -7, -6, -5 for a total of 16 doses. Pharmacokinetic analysis will guide dose modifications targeted to receive an average AUC of 800-1200 microMols*min for the 16 doses. Lorazepam (0.05 mg/kg) IV will be administered one half hour b
Intervention Type:Other
Name:Hematopoietic Progenitor Cell Transplantation (HPC
Description:Hematopoietic progenitor cells (HPCs) will be infused on day 0. Source of cells may be bone marrow, peripheral blood cells, or cord blood units, from matched related or unrelated donors.
Intervention Type:Radiation
Name:CNS radiation treatment for ALL with prior CNS dis
Description:Patients with prior CNS disease over the age of 1 year will be treated with 600 cGy of cranial irradiation in addition to 1200 cGy of TBI. Patients diagnosed with ALL with CNS disease (at the time of diagnosis or relapse) < 1 year of age will receive CNS treatment as Intrathecal Methotrexate as follows: Infants ≤ 1 year of age at the time of Intrathecal Therapy will receive a dosing of 7.5 mg once a month for 6 months after transplant beginning at day +30 with an adequate white count Chil

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Children's Memorial Hospital

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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