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Busulfan and Cyclophosphamide Instead of Total Boby Irradiation (TBI) and Cyclophosphamide for Hematological Malignancies Hematocrit (HCT)

Information source: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Leukemias; Chronic Leukemias; Myelodysplastic Syndrome; Juvenile Myelomonocytic Leukemia

Intervention: Busulfan/Cyclophosphamide (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Tel-Aviv Sourasky Medical Center

Summary

Long-term follow-up studies have demonstrated significant late toxicities of total body irradiation (TBI), which are most marked in children radiated at a young age. Growth failure, decline in cognitive function, and endocrine abnormalities have all been described. Good outcomes can be achieved with alkylating agents only as a preparative regimen. This plan will use a combination of busulfan and cyclophosphamide (Bu/Cy) with or without antithymocyte globulin (ATG) to reduce the late toxicities of therapy that includes TBI.

Clinical Details

Official title: Treatment Plan for Hematologic Malignancies Using Intravenous Busulfan and Cyclophosphamide Instead of Total Boby Irradiation (TBI) and Cyclophosphamide to Examine Results, Success and Side Effects of Treatment With Chemotherapy Only, as a Preparative Therapy for Patients With Cord Blood Transplants

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Overall survival

Secondary outcome: Disease free survival

Eligibility

Minimum age: N/A. Maximum age: 21 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Suitable cord blood from matched unrelated or related donor.

- Cardiac (Echo/EKG): shortening fraction ≥ 27%

- Electrolytes within normal CCHMC limits.

- Pulmonary function tests: DLCO ≥ 50%

- Renal: creatinine clearance/GFR ≥ 60 ml/minute/1. 73m2

- Lumbar puncture: no leukemic infiltrate.

- CBC: ANC ≥ 1000ml and unsupported platelet count of ≥ 50,000/ml

- Documented HSV and CMV titers, Hepatitis B surface antigen, Hepatitis C by serology,

HIV by serology: all negative.

- Hepatic transaminases < 2. 5x normal; Total bilirubin < 2 mg/dl Patients who do not

meet above organ function criteria (liver, cardiac, renal), due to the presence of a tumor compromising these organs, may have exception made for these criteria and remain eligible for treatment plan after consultation with Program Director of Blood and Marrow Transplant Exclusion Criteria:

- Patients with neoplastic or non-neoplastic disease of any major organ system that

would compromise their ability to withstand the pre-transplant conditioning regimen.

- Patients with uncontrolled (culture or biopsy positive) infections requiring

intravenous antivirals, antibiotics, or antifungals. Patients on prolonged antifungal therapy with a history of fungal infection should be considered for a non-myeloablative protocol.

- Patients who are pregnant or lactating. Patients of childbearing potential must

practice an effective method of birth control while participating on this treatment plan.

- HIV seropositive patients

Locations and Contacts

Additional Information

Starting date: June 2011
Last updated: April 20, 2011

Page last updated: August 23, 2015

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