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

March 25, 2013 updated by: Asan Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center - University of Ulsan College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Immune reconstitution
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

Secondary Outcome Measures

Outcome Measure
Survival
Duration of tumor response
Tumor response rate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Study Chair: Kyoo H. Lee, MD, Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

August 24, 2007

First Submitted That Met QC Criteria

August 24, 2007

First Posted (Estimate)

August 27, 2007

Study Record Updates

Last Update Posted (Estimate)

March 26, 2013

Last Update Submitted That Met QC Criteria

March 25, 2013

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000561542
  • AMC-UUCM-2004-0029

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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