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Busulfan, Etoposide, and Total-Body Irradiation in Treating Patients Undergoing Donor Stem Cell or Bone Marrow Transplant for Advanced Hematologic Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00534430
First received: September 20, 2007
Last updated: December 16, 2013
Last verified: December 2013

September 20, 2007
December 16, 2013
January 2000
June 2014   (final data collection date for primary outcome measure)
  • Efficacy [ Designated as safety issue: No ]
  • Disease-free survival at 2 years and 5 years [ Designated as safety issue: No ]
  • Prognostic factors for relapse, disease-free survival, and overall survival evaluated by cytogenetics, WBC at presentation, targeted busulfan dose, and number of courses of induction therapy to achieve remission [ Designated as safety issue: No ]
  • Efficacy
  • Disease-free survival at 2 years and 5 years
  • Prognostic factors for relapse, disease-free survival, and overall survival evaluated by cytogenetics, WBC at presentation, targeted busulfan dose, and number of courses of induction therapy to achieve remission
Complete list of historical versions of study NCT00534430 on ClinicalTrials.gov Archive Site
Early and late toxicities [ Designated as safety issue: Yes ]
Early and late toxicities
Not Provided
Not Provided
 
Busulfan, Etoposide, and Total-Body Irradiation in Treating Patients Undergoing Donor Stem Cell or Bone Marrow Transplant for Advanced Hematologic Cancer
Phase II Study of IV Busulfan Combined With 12 cGy of Fractionated Total Body Irradiation (FTBI) and Etoposide (VP-16) as a Preparative Regimen for Allogeneic Bone Marrow Transplantation for Patients With Advanced Hematological Malignancies

RATIONALE: Giving chemotherapy and total-body irradiation before a donor stem cell transplant or a donor bone marrow transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving mycophenolate mofetil and cyclosporine before and after transplant may stop this from happening.

PURPOSE: This phase II trial is studying the side effects and best way to give busulfan together with etoposide and total-body irradiation and to see how well they work in treating patients who are undergoing a donor stem cell or bone marrow transplant for advanced hematologic cancer.

OBJECTIVES:

  • To determine the efficacy of a preparative regimen comprising dose targeted busulfan, etoposide, and fractionated total-body irradiation followed by allogeneic hematopoietic stem cell or bone marrow transplantation in patients with advanced hematologic malignancies.
  • To determine the efficacy of this regimen in patients with acute myeloid leukemia in first remission with unfavorable cytogenetics.
  • To evaluate the early and late toxicities of this regimen.

OUTLINE:

  • Preparative chemotherapy regimen: Patients receive busulfan IV over 2 hours once every 6 hours on days -14 to -8 for a total of 16 doses and etoposide IV on day -3.* NOTE: *Patients also receive oral or IV dilantin 1-3 times daily on days -18 to -5 for prophylaxis of grand mal seizures.
  • Fractionated total-body irradiation (FTBI): Patients undergo FTBI on days -7 to -4 for a total of 10 fractions.
  • Allogeneic transplantation: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0.
  • Graft-versus-host disease (GVHD) prophylaxis: Patients receive cyclosporine IV or orally on days -1 to 50 followed by a taper to day 180 in the absence of GVHD. Patients also receive mycophenolate mofetil orally or IV over 2 hours twice daily on days 0-27, followed by a taper until day 56.

After completion of study treatment, patients are followed annually for 2 years.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
  • Leukemia
  • Myelodysplastic Syndromes
  • Drug: busulfan
  • Drug: cyclosporine
  • Drug: etoposide
  • Drug: mycophenolate mofetil
  • Procedure: allogeneic bone marrow transplantation
  • Procedure: allogeneic hematopoietic stem cell transplantation
  • Procedure: peripheral blood stem cell transplantation
  • Radiation: total-body irradiation
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
Not Provided
June 2014   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosis of 1 of the following:

    • Acute myeloid leukemia (AML)

      • Failed remission induction therapy or in relapse beyond second remission
      • In first remission with poor risk cytogenetics (e.g., 11q abnormalities, -7, -5, complex abnormalities [i.e., > 3 abnormalities, 6;9 translocation and 3q abnormalities del (7q), del (5q), complex abnormalities ≥ abnormalities, 9q, 20q, 21q, 17q, t(9;21)])
    • Acute lymphoblastic leukemia (ALL)

      • Failed remission induction therapy or in relapse beyond second remission
    • Blastic phase chronic myelogenous leukemia
    • Refractory anemia with excess blasts
    • Refractory anemia with excess blasts in transformation
  • HLA -A, -B, -C, -DR identical sibling donor match available
  • No relapse after prior bone marrow transplantation

PATIENT CHARACTERISTICS:

  • Cardiac ejection fraction ≥ 50%
  • Serum creatinine ≤ 1.2 times upper limit of normal (ULN) or creatinine clearance > 80 mL/min
  • Bilirubin ≤ 1.5 times ULN
  • AST and ALT < 5 times ULN
  • FEV_1 ≥ 50% of predicted normal
  • DLCO ≥ 50% of predicted normal
  • No psychological or medical condition that would preclude allogeneic transplantation (in the opinion of the treating physician)
  • Not pregnant
  • Negative pregnancy test

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 28 days since prior induction or reinduction therapy
  • Prior etoposide and busulfan allowed
  • No prior radiation therapy that would exclude total-body irradiation
Both
16 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00534430
99041, P30CA033572, CHNMC-99041, CDR0000564777
Not Provided
City of Hope Medical Center
City of Hope Medical Center
National Cancer Institute (NCI)
Study Chair: Anthony S. Stein, MD Beckman Research Institute
City of Hope Medical Center
December 2013

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