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Donor Stem Cell Transplant After Conditioning Therapy in Treating Patients With Hematologic Cancer, Recurrent or Metastatic Solid Tumor, or Other Disease

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00521430
First received: August 24, 2007
Last updated: March 25, 2013
Last verified: October 2007

August 24, 2007
March 25, 2013
April 2004
May 2008   (final data collection date for primary outcome measure)
  • Engraftment (neutrophil, platelet, and red blood cells) [ Designated as safety issue: No ]
  • Frequency and kinetics of mixed chimerism as assessed by polymerase chain reaction [ Designated as safety issue: No ]
  • Frequency and severity of regimen-related toxicities [ Designated as safety issue: Yes ]
  • Frequency of acute and chronic graft-versus-host disease [ Designated as safety issue: No ]
  • Immune reconstitution [ Designated as safety issue: No ]
  • Engraftment (neutrophil, platelet, and red blood cells)
  • Frequency and kinetics of mixed chimerism as assessed by polymerase chain reaction
  • Frequency and severity of regimen-related toxicities
  • Frequency of acute and chronic graft-versus-host disease
  • Immune reconstitution
Complete list of historical versions of study NCT00521430 on ClinicalTrials.gov Archive Site
  • Tumor response rate [ Designated as safety issue: No ]
  • Duration of tumor response [ Designated as safety issue: No ]
  • Survival [ Designated as safety issue: No ]
  • Tumor response rate
  • Duration of tumor response
  • Survival
Not Provided
Not Provided
 
Donor Stem Cell Transplant After Conditioning Therapy in Treating Patients With Hematologic Cancer, Recurrent or Metastatic Solid Tumor, or Other Disease
NON-T-CELL DEPLETED HLA-HAPLOIDENTICAL FAMILIAL DONOR HEMATOPOIETIC CELL TRANSPLANTATION AFTER REDUCED INTENSITY CONDITIONING

RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer or abnormal cells. It also 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 cyclosporine and methotrexate before and after transplant may stop this from happening.

PURPOSE: This clinical trial is studying the side effects and how well donor stem cell transplant works when given after conditioning therapy in treating patients with hematologic cancer, recurrent or metastatic solid tumor, or other disease.

OBJECTIVES:

  • Determine the safety and efficacy of non-T-cell depleted, HLA-haploidentical related donor hematopoietic stem cell transplantation after a reduced-intensity conditioning regimen comprising busulfan, fludarabine phosphate, anti-thymocyte globulin, and methylprednisolone in patients with hematologic cancer, recurrent or metastatic solid tumors, or other diseases.

OUTLINE:

  • Reduced-intensity conditioning regimen: Patients receive busulfan IV 4 times daily on days -7 and -6; fludarabine phosphate IV over 30 minutes on days -7 to -2; and methylprednisolone IV over 30 minutes followed by anti-thymocyte globulin IV over 4 hours on days -4 to -1.
  • Donor hematopoietic stem cell transplantation: Patients receive donor peripheral blood stem cells IV over 1 hour on days 0 and 1.
  • Graft-versus-host disease (GVHD) prophylaxis: Patients receive cyclosporine IV over 2-4 hours or orally twice daily beginning on day -1 and continuing until day 60, followed by a taper in the absence of GVHD. Patients also receive methotrexate IV on days 2, 4, 7, and 12.

After the transplant, patients are followed periodically.

Interventional
Not Provided
Masking: Open Label
Primary Purpose: Treatment
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Nonmalignant Neoplasm
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Biological: anti-thymocyte globulin
  • Drug: busulfan
  • Drug: cyclosporine
  • Drug: fludarabine phosphate
  • Drug: methotrexate
  • Drug: methylprednisolone
  • Procedure: allogeneic hematopoietic stem cell transplantation
  • Procedure: peripheral blood stem cell transplantation
Not Provided
Lee KH, Lee JH, Lee JH, Kim DY, Seol M, Lee YS, Kang YA, Jeon M, Hwang HJ, Jung AR, Kim SH, Yun SC, Shin HJ. Reduced-intensity conditioning therapy with busulfan, fludarabine, and antithymocyte globulin for HLA-haploidentical hematopoietic cell transplantation in acute leukemia and myelodysplastic syndrome. Blood. 2011 Sep 1;118(9):2609-17. doi: 10.1182/blood-2011-02-339838. Epub 2011 Jun 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
September 2008
May 2008   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosis of 1 of the following:

    • High-risk acute leukemia, including any of the following:

      • Refractory acute leukemia
      • Acute leukemia beyond first remission
      • Acute leukemia in first remission with poor prognostic features (e.g., chromosomal changes suggesting poor prognosis)
    • Chronic myelogenous leukemia in second chronic, accelerated, or blastic phase
    • Severe aplastic anemia that is not responsive to immunosuppressive therapy
    • Myelodysplastic syndromes, including any of the following:

      • Refractory anemia (RA) or RA with ringed sideroblasts with severe cytopenia
      • RA with excess blasts (RAEB)
      • RAEB in transformation
      • Chronic myelomonocytic leukemia
    • Refractory or relapsed non-Hodgkin or Hodgkin lymphoma
    • Multiple myeloma
    • Biopsy proven measurable solid tumor meeting 1 of the following criteria:

      • Recurrent disease after primary treatment and deemed incurable to standard treatment
      • Metastatic disease for which no known standard therapy that is potentially curative or definitely capable of extending life expectancy exists
  • Must have a related HLA-haploidentical mismatched (3/6 or fewer loci) donor available

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100%
  • Bilirubin < 2.0 mg/dL
  • AST < 3 times upper limit of normal
  • Creatinine < 2.0 mg/dL
  • Ejection fraction > 40% by MUGA

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Both
up to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00521430
CDR0000561542, AMC-UUCM-2004-0029
Not Provided
Not Provided
Asan Medical Center
Not Provided
Study Chair: Kyoo H. Lee, MD Asan Medical Center
National Cancer Institute (NCI)
October 2007

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