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

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ClinicalTrials.gov Identifier: NCT01339988
Recruitment Status : Not yet recruiting
First Posted : April 21, 2011
Last Update Posted : April 21, 2011
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center

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.

Condition or disease Intervention/treatment Phase
Acute Leukemias Chronic Leukemias Myelodysplastic Syndrome Juvenile Myelomonocytic Leukemia Drug: Busulfan/Cyclophosphamide Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2011
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2019


Arm Intervention/treatment
Experimental: Busulfan/Cyclophosphamide Drug: Busulfan/Cyclophosphamide

Conditioning regimen:

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

Other Name: Cytoxan



Primary Outcome Measures :
  1. Overall survival [ Time Frame: Five years ]

Secondary Outcome Measures :
  1. Disease free survival [ Time Frame: Five years ]


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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Responsible Party: Menachem Bitan, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01339988     History of Changes
Other Study ID Numbers: TASMC-11-MB-442-CTIL
First Posted: April 21, 2011    Key Record Dates
Last Update Posted: April 21, 2011
Last Verified: April 2011

Keywords provided by Tel-Aviv Sourasky Medical Center:
Stem-cells
Transplantation
Busulfex
Cyclophosphamide
Total-Body-Ittadiation

Additional relevant MeSH terms:
Leukemia
Myelodysplastic Syndromes
Preleukemia
Leukemia, Myelomonocytic, Juvenile
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Leukemia, Myeloid
Myelodysplastic-Myeloproliferative Diseases
Cyclophosphamide
Busulfan
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists