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Bone Marrow Transplant Plus Cyclophosphamide and Total-Body Irradiation in Treating Patients With Hematologic Cancer

This study has been completed.
Information provided by:
Temple University Identifier:
First received: November 1, 1999
Last updated: September 30, 2010
Last verified: September 2010

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy and radiation therapy together with bone marrow transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving bone marrow transplant from an unrelated donor together with cyclophosphamide and total-body irradiation works in treating patients with hematologic cancer.

Condition Intervention Phase
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Biological: anti-thymocyte globulin
Biological: filgrastim
Biological: sargramostim
Biological: therapeutic immune globulin
Drug: cyclophosphamide
Drug: methotrexate
Drug: tacrolimus
Procedure: allogeneic bone marrow transplantation
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Unrelated Bone Marrow Transplantation With Cyclophosphamide and Total Body Irradiation For Hematologic Malignancies and Bone Marrow Failure States

Resource links provided by NLM:

Further study details as provided by Temple University:

Estimated Enrollment: 10
Study Start Date: August 1996
Study Completion Date: December 2003
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Detailed Description:


  • Study the curative potential of high-dose cyclophosphamide and total-body irradiation followed by rescue with bone marrow from volunteer HLA-matched donors in patients with a variety of hematologic malignancies and bone marrow failure states.
  • Study the toxic effects associated with matched unrelated bone marrow transplantation in this patient population.
  • Participate in collaborative research studies with the National Marrow Donor Program.

OUTLINE: All patients receive myeloablative therapy with high-dose cyclophosphamide and total body irradiation over 4 days; patients with severe aplastic anemia also receive antithymocyte globulin. Patients then undergo allogeneic bone marrow transplantation. Filgrastim (G-CSF) is given after transplant to accelerate engraftment. Sargramostim (GM-CSF) may be given in case of graft failure.

All patients receive graft-versus-host-disease (GVHD) prophylaxis with tacrolimus, methotrexate, and gamma globulin. Established GVHD is treated with corticosteroids and, as necessary, antithymocyte globulin.

Patients are followed at 100 days, 6 months, and 1 year after transplant, then annually thereafter.

PROJECTED ACCRUAL: A total of 10 patients per year will be accrued for this study over 5 years.


Ages Eligible for Study:   17 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • One of the following hematologic malignancies/disorders:

    • Acute lymphoblastic leukemia

      • In second or subsequent complete remission (CR)
      • In first CR with high-risk features (e.g., Philadelphia chromosome-positive)
      • In first relapse and failed conventional salvage therapy
    • Acute myelogenous leukemia (AML)

      • In second or subsequent CR
      • In early first relapse
      • In full first relapse and failed conventional salvage therapy
      • In first CR with high-risk features, e.g., trisomy 8 or FAB 6/7

        • Standard-risk AML offered conventional-dose consolidation chemotherapy or autologous bone marrow transplantation
    • Chronic myelogenous leukemia in chronic, accelerated, or second chronic phase

      • No blast crisis
    • Severe aplastic anemia that has failed at least 1 course of immunosuppressive therapy
    • Paroxysmal nocturnal hemoglobinuria with high-risk features (e.g., disseminated intravascular coagulation, thrombotic events)
    • Myelodysplastic syndrome, i.e.:

      • Symptomatic, transfusion-dependent refractory anemia with excess blasts
      • (RAEB) or RAEB in transformation
    • Secondary leukemia in CR following conventional-dose induction chemotherapy
  • Unrelated marrow donor available who is 8 out of 10-, 9 out of 10-, or 10 out of 10-antigen serologically HLA-matched at A, B, C, DRb, and DQB loci by molecular typing
  • No CNS malignancy



  • 17 to 60

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • No reduction due to other serious illness


  • Not specified


  • Bilirubin less than 3 mg/dL
  • AST/ALT no greater than twice normal


  • Creatinine no greater than 2.0 mg/dL
  • Creatinine clearance greater than 60 mL/min


  • Left ventricular ejection fraction at least 45%
  • No severe hypertension


  • DLCO, FEV_1, and FVC at least 50%


  • HIV negative
  • No active infection at time of transplant
  • No advanced diabetes
  • No significant neurologic deficit
  • No active drug or substance abuse
  • No emotional disorders
  • Able to participate in frequent medical care for at least 1-2 years
  • Willing to comply with National Marrow Donor Program policies


Biologic therapy

  • See Disease Characteristics


  • See Disease Characteristics

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified
  Contacts and Locations
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Please refer to this study by its identifier: NCT00002809

United States, Pennsylvania
Fox Chase-Temple Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2442
Sponsors and Collaborators
Temple University
Study Chair: Kenneth F. Mangan, MD, FACP Fox Chase Cancer Center
  More Information

Responsible Party: Temple University Bone Marrow Transplant Program, Temple University Health Systems Identifier: NCT00002809     History of Changes
Other Study ID Numbers: CDR0000064937
Study First Received: November 1, 1999
Last Updated: September 30, 2010

Keywords provided by Temple University:
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
refractory chronic lymphocytic leukemia
chronic phase chronic myelogenous leukemia
accelerated phase chronic myelogenous leukemia
adult acute myeloid leukemia in remission
adult acute lymphoblastic leukemia in remission
refractory anemia
refractory anemia with excess blasts
refractory anemia with excess blasts in transformation
secondary acute myeloid leukemia
previously treated myelodysplastic syndromes
atypical chronic myeloid leukemia
myelodysplastic/myeloproliferative disease, unclassifiable
adult acute myeloid leukemia with t(8;21)(q22;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with t(15;17)(q22;q12)

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Antilymphocyte Serum
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Abortifacient Agents, Nonsteroidal
Abortifacient Agents processed this record on April 21, 2017