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

NCT ID: NCT00521430

Last Updated: 2013-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2008-09-30

Brief Summary

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.

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.

Conditions

Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Nonmalignant Neoplasm; Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

anti-thymocyte globulin

Intervention Type: BIOLOGICAL

busulfan

Intervention Type: DRUG

cyclosporine

Intervention Type: DRUG

fludarabine phosphate

Intervention Type: DRUG

methotrexate

Intervention Type: DRUG

methylprednisolone

Intervention Type: DRUG

allogeneic hematopoietic stem cell transplantation

Intervention Type: PROCEDURE

peripheral blood stem cell transplantation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Principal Investigators

Kyoo H. Lee, MD

Role: STUDY_CHAIR

Asan Medical Center

Locations

Asan Medical Center - University of Ulsan College of Medicine

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: RESULT

PMID: 21715313 (View on PubMed)

Other Identifiers

AMC-UUCM-2004-0029

Identifier Type: -

Identifier Source: secondary_id

CDR0000561542

Identifier Type: -

Identifier Source: org_study_id