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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01339988

Enrollment

Registered

2011-04-21

Start date

2011-06-30

Completion date

2019-06-30

Last updated

2011-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Leukemias, Chronic Leukemias, Juvenile Myelomonocytic Leukemia, Myelodysplastic Syndrome

Keywords

Stem-cells, Transplantation, Busulfex, Cyclophosphamide, Total-Body-Ittadiation

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.

Interventions

DRUGBusulfan/Cyclophosphamide

Conditioning regimen: Cyclophosphamide 50mg/kg/day for 4 days + Busulfan 0.8-1.0mg/kg/day for 4 days.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

No minimum to 21 Years

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

Design outcomes

Primary

Measure	Time frame
Overall survival	Five years

Secondary

Measure	Time frame
Disease free survival	Five years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026