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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
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - 21 Years (Child, Adult)MaleDoes not accept healthy volunteers

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

    First Posted
    April 20, 2011
    Last Updated
    April 20, 2011
    Sponsor
    Tel-Aviv Sourasky Medical Center
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    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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