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NCT Number: NCT00521430

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

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.

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Key information

Conditions

Leukemia Anemia Anemia, Aplastic Anemia, Refractory Anemia, Refractory, with Excess of Blasts Blast Crisis Blood Protein Disorders Bone Marrow Diseases Bone Marrow Failure Disorders Burkitt Lymphoma Carcinogenesis Cardiovascular Diseases Cell Transformation, Neoplastic Chronic Disease Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities DNA Virus Infections Dendritic Cell Sarcoma, Interdigitating Disease Attributes Epstein-Barr Virus Infections Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Herpesviridae Infections Histiocytic Disorders, Malignant Histiocytosis Hodgkin Disease Immune System Diseases Immunoblastic Lymphadenopathy Immunoproliferative Disorders Infections Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Accelerated Phase Leukemia, Myeloid, Acute Leukemia, Myeloid, Chronic-Phase Leukemia, Myelomonocytic, Chronic Lymphadenopathy Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Extranodal NK-T-Cell Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Anaplastic Lymphoma, Large-Cell, Immunoblastic Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Multiple Myeloma Multiple Myeloma and Plasma Cell Neoplasm Mycosis Fungoides Myelodysplastic Syndromes Myelodysplastic-Myeloproliferative Diseases Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Neoplastic Processes Nonmalignant Neoplasm Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Precursor T-Cell Lymphoblastic Leukemia-Lymphoma Recurrence Sezary Syndrome Tumor Virus Infections Unspecified Adult Solid Tumor, Protocol Specific Vascular Diseases Virus Diseases Waldenstrom Macroglobulinemia

Age range

Up to 65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asan Medical Center - University of Ulsan College of Medicine

Seoul, 138-736, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

anti-thymocyte globulin

Biological

busulfan

Drug

cyclosporine

Drug

fludarabine phosphate

Drug

methotrexate

Drug

methylprednisolone

Drug

allogeneic hematopoietic stem cell transplantation

Procedure

peripheral blood stem cell transplantation

Procedure

Primary outcomes

  1. Engraftment (neutrophil, platelet, and red blood cells)

  2. Frequency and kinetics of mixed chimerism as assessed by polymerase chain reaction

  3. Frequency and severity of regimen-related toxicities

  4. Frequency of acute and chronic graft-versus-host disease

  5. Immune reconstitution

Secondary outcomes

  1. Tumor response rate

  2. Duration of tumor response

  3. Survival

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

NON-T-CELL DEPLETED HLA-HAPLOIDENTICAL FAMILIAL DONOR HEMATOPOIETIC CELL TRANSPLANTATION AFTER REDUCED INTENSITY CONDITIONING

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Aug 27, 2007
Registry last updated
Mar 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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