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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2011 by Tel-Aviv Sourasky Medical Center
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01339988
First received: April 20, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted
  Purpose

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Five years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Disease free survival [ Time Frame: Five years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: June 2011
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

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
Study First Received: April 20, 2011
Last Updated: April 20, 2011
Health Authority: Israel: Ethics Commission

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, Acute
Leukemia, Myelomonocytic, Chronic
Leukemia, Myelomonocytic, Juvenile
Hematologic Neoplasms
Chronic Disease
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Leukemia, Myeloid
Myelodysplastic-Myeloproliferative Diseases
Neoplasms by Site
Disease Attributes
Pathologic Processes
Busulfan
Cyclophosphamide
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Antineoplastic Agents
Therapeutic Uses
Myeloablative Agonists

ClinicalTrials.gov processed this record on August 28, 2014