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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

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

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

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

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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