Total-Body Irradiation, Cyclophosphamide, and Stem Cell Transplantation in Treating Patients With Hematologic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00062140
Recruitment Status : Completed
First Posted : June 6, 2003
Last Update Posted : September 21, 2010
National Cancer Institute (NCI)
Information provided by:
Fred Hutchinson Cancer Research Center

June 5, 2003
June 6, 2003
September 21, 2010
April 2003
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Complete list of historical versions of study NCT00062140 on Archive Site
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Total-Body Irradiation, Cyclophosphamide, and Stem Cell Transplantation in Treating Patients With Hematologic Cancer
A Phase I Trial Of Total Body Irradiation, Cyclophosphamide Dose-Adjustment Based On Its Metabolism, And Hematopoietic Stem Cell Transplantation For Patients With Hematological Malignancy

RATIONALE: Adjusting the dose of drugs used in chemotherapy such as cyclophosphamide may decrease side effects while stopping cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill cancer cells.

PURPOSE: Phase I trial to study the effect on the body of dose-adjusted cyclophosphamide combined with total-body irradiation and donor stem cell transplantation in treating patients who have hematologic cancer.


  • Determine a safe and reproducible method of adjusting the dose of cyclophosphamide based on its metabolism when given in combination with total body irradiation and hematopoietic stem cell transplantation in patients with hematologic malignancy.


  • Preparative regimen: Patients undergo total body irradiation twice daily on days -6 to -4. Patients then receive dose-adjusted (based on metabolism) cyclophosphamide IV over 1 hour on days -3 and -2.
  • Hematopoietic stem cell (HSC) infusion: Patients undergo allogeneic HSC transplantation on day 0.

Patients receive graft-versus-host disease prophylaxis, CNS prophylaxis, and testicular irradiation as per institutional standard practices.

Patients are followed daily until day 80 after transplantation and then regularly thereafter for survival.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Phase 1
Masking: None (Open Label)
Primary Purpose: Treatment
  • Leukemia
  • Lymphoma
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Diseases
  • Drug: cyclophosphamide
  • Procedure: allogeneic bone marrow transplantation
  • Procedure: peripheral blood stem cell transplantation
  • Radiation: radiation therapy
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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July 2004
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  • Diagnosis of hematological malignancy, including any of the following:

    • Chronic myeloid leukemia
    • Acute myeloid leukemia
    • Acute lymphocytic leukemia
    • Myelodysplastic syndromes
    • Lymphoma
  • Unlikely to respond to conventional treatment and would benefit from hematopoietic stem cell transplantation
  • No bulky tumor mass requiring additional involved field radiotherapy
  • No large body burden of tumor cells requiring cytoreductive chemotherapy before total body irraditation and cyclophosphamide
  • Undergoing conditioning for transplantation at the University of Washington Medical Center
  • Availability of 1 of the following types of allogeneic donors:

    • HLA-identical family members
    • Unrelated donors

      • Allele match (match grade 1)
      • One allele mismatch for A, B, C, DRB1 or DQB1 (match grades 2.1 or 2.2)



  • 18 to 65

Performance status

  • Not specified

Life expectancy

  • Not severely limited by diseases other than malignancy
  • Not moribund


  • Not specified


  • Bilirubin no greater than 1.2 mg/dL
  • No cirrhosis
  • No hepatic fibrosis with bridging


  • Creatinine no greater than 1.2 mg/dL


  • No coronary artery disease
  • No congestive heart failure requiring therapy


  • Oxygen saturation at least 93% (on room air)


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • HIV negative
  • No concurrent infection requiring systemic antibiotic or antifungal therapy


Biologic therapy

  • No prior hematopoietic stem cell transplantation


  • See Disease Characteristics

Endocrine therapy

  • Not specified


  • See Disease Characteristics
  • No prior radiotherapy to the liver or adjacent organs


  • Not specified


  • No concurrent aspirin or nonsteroidal anti-inflammatory medications such as ibuprofen (e.g., Motrin® or Advil®)
  • No other concurrent phase I study enrollment
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000304522 ( Registry Identifier: PDQ )
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Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Study Chair: George B. McDonald, MD Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP