Busulfan and Cyclophosphamide Instead of Total Boby Irradiation (TBI) and Cyclophosphamide for Hematological Malignancies Hematocrit (HCT)
This study is not yet open for participant recruitment.
Verified April 2011 by Tel-Aviv Sourasky Medical Center
Information provided by:
Tel-Aviv Sourasky Medical Center
First received: April 20, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted
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.
Juvenile Myelomonocytic Leukemia
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Overall survival [ Time Frame: Five years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Disease free survival [ Time Frame: Five years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2014 (Final data collection date for primary outcome measure)
Cyclophosphamide 50mg/kg/day for 4 days + Busulfan 0.8-1.0mg/kg/day for 4 days.
Other Name: Cytoxan
|Ages Eligible for Study:
||up to 21 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
No Contacts or Locations Provided
No publications provided
||Menachem Bitan, Tel-Aviv Sourasky Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 20, 2011
||April 20, 2011
||Israel: Ethics Commission
Keywords provided by Tel-Aviv Sourasky Medical Center:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 11, 2013
Leukemia, Myelomonocytic, Acute
Leukemia, Myelomonocytic, Chronic
Leukemia, Myelomonocytic, Juvenile
Neoplasms by Histologic Type
Bone Marrow Diseases
Neoplasms by Site
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action