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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


Phase 4
N/A
21 Years
Not Enrolling
Male
Acute Leukemias, Chronic Leukemias, Myelodysplastic Syndrome, Juvenile Myelomonocytic Leukemia

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

Five years

Safety Issue:

Yes

Authority:

Israel: Ethics Commission

Study ID:

TASMC-11-MB-442-CTIL

NCT ID:

NCT01339988

Start Date:

June 2011

Completion Date:

June 2019

Related Keywords:

  • Acute Leukemias
  • Chronic Leukemias
  • Myelodysplastic Syndrome
  • Juvenile Myelomonocytic Leukemia
  • Stem-cells
  • Transplantation
  • Busulfex
  • Cyclophosphamide
  • Total-Body-Ittadiation
  • Leukemia
  • Myelodysplastic Syndromes
  • Preleukemia
  • Leukemia, Myelomonocytic, Acute
  • Leukemia, Myelomonocytic, Chronic
  • Leukemia, Myelomonocytic, Juvenile
  • Hematologic Neoplasms
  • Chronic Disease

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