Busulfan and Cyclophosphamide Instead of Total Boby Irradiation (TBI) and Cyclophosphamide for Hematological Malignancies Hematocrit (HCT)
Primary Purpose
Acute Leukemias, Chronic Leukemias, Myelodysplastic Syndrome
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Busulfan/Cyclophosphamide
Sponsored by
About this trial
This is an interventional treatment trial for Acute Leukemias focused on measuring Stem-cells, Transplantation, Busulfex, Cyclophosphamide, Total-Body-Ittadiation
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Busulfan/Cyclophosphamide
Arm Description
Outcomes
Primary Outcome Measures
Overall survival
Secondary Outcome Measures
Disease free survival
Full Information
NCT ID
NCT01339988
First Posted
April 20, 2011
Last Updated
April 20, 2011
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01339988
Brief Title
Busulfan and Cyclophosphamide Instead of Total Boby Irradiation (TBI) and Cyclophosphamide for Hematological Malignancies Hematocrit (HCT)
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 Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
June 2019 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Leukemias, Chronic Leukemias, Myelodysplastic Syndrome, Juvenile Myelomonocytic Leukemia
Keywords
Stem-cells, Transplantation, Busulfex, Cyclophosphamide, Total-Body-Ittadiation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Busulfan/Cyclophosphamide
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Busulfan/Cyclophosphamide
Other Intervention Name(s)
Cytoxan
Intervention Description
Conditioning regimen:
Cyclophosphamide 50mg/kg/day for 4 days + Busulfan 0.8-1.0mg/kg/day for 4 days.
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
Five years
Secondary Outcome Measure Information:
Title
Disease free survival
Time Frame
Five years
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Learn more about this trial
Busulfan and Cyclophosphamide Instead of Total Boby Irradiation (TBI) and Cyclophosphamide for Hematological Malignancies Hematocrit (HCT)
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