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Allogeneic Peripheral Stem Cell Transplantation Followed By Donor Lymphocyte Infusions in Treating Patients With Hematologic Cancer
This study is ongoing, but not recruiting participants.
Study NCT00066300   Information provided by National Cancer Institute (NCI)
First Received: August 6, 2003   Last Updated: February 6, 2009   History of Changes

August 6, 2003
February 6, 2009
May 2003
 
 
 
Complete list of historical versions of study NCT00066300 on ClinicalTrials.gov Archive Site
 
 
 
Allogeneic Peripheral Stem Cell Transplantation Followed By Donor Lymphocyte Infusions in Treating Patients With Hematologic Cancer
Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation Followed By T Cell Add-Back For Hematological Malignancies - Effect Of Irradiated Donor Lymphocytes On Chimerism

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. Sometimes the transplanted cells from a donor are rejected by the body's normal cells. Eliminating the T cells from the donor cells before transplanting them may prevent this from happening. Infusions of donor lymphocytes may decrease the body's rejection of the transplanted peripheral stem cells.

PURPOSE: Phase II trial to study the effectiveness of allogeneic stem cell transplantation followed by donor lymphocyte infusions in treating patients who have hematologic cancer.

OBJECTIVES:

  • Determine the effect of irradiated donor T-cell infusion on donor T-cell chimerism 6 weeks after hematopoietic stem cell transplantation in patients with hematologic malignancies.
  • Determine the infusional toxic effects of irradiated donor lymphocytes in these patients.
  • Determine the risk of acute and chronic graft-versus-host disease from donor lymphocyte infusions on day 45 and day 100 posttransplantation in HLA 6/6 matched transplantations from a related donor in these patients.
  • Determine disease-free survival, cytomegalovirus reactivation, and relapse in patients treated with this regimen.
  • Determine transplant-related mortality and death from all causes in patients treated with this regimen.

OUTLINE:

  • Preparative regimen: Patients receive fludarabine IV over 30 minutes on days -8 to -4 and cyclophosphamide IV over 1 hour on days -3 and -2. Patients undergo total body irradiation on days -7 to -4.
  • Pretransplantation irradiated donor lymphocyte infusion (DLI): Patients receive irradiated DLI on day -4.
  • Hematopoietic stem cell transplantation (HSCT): Patients undergo allogeneic HSCT on day 0.
  • Graft-versus-host disease prophylaxis: Patients receive oral cyclosporine on days 44-120.
  • Posttransplantation DLI: Patients receive DLI on days 45 and 100. Patients with chronic myelogenous leukemia in chronic phase who are polymerase chain reaction negative for bcr/abl receive DLI on day 45 only.

Patients are followed at 3, 6, and 12 months and then annually thereafter.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Phase II
Interventional
Treatment, Open Label
  • Chronic Myeloproliferative Disorders
  • Leukemia
  • Lymphoma
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Diseases
  • Biological: graft-versus-tumor induction therapy
  • Biological: therapeutic allogeneic lymphocytes
  • Drug: cyclophosphamide
  • Drug: cyclosporine
  • Drug: fludarabine phosphate
  • Procedure: allogeneic bone marrow transplantation
  • Procedure: peripheral blood stem cell transplantation
  • Radiation: radiation therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

DISEASE CHARACTERISTICS:

  • Diagnosis of any of the following hematologic malignancies:

    • Chronic myelogenous leukemia (CML) in chronic phase meeting 1 of the following criteria:

      • Under 41 years of age with no prior imatinib mesylate therapy
      • 10 to 55 years of age and failed prior imatinib mesylate therapy
      • 41 to 55 years of age for whom imatinib mesylate is not the treatment of choice
    • CML in accelerated phase or blast transformation
    • Acute lymphoblastic leukemia meeting any of the following criteria:

      • Over 18 years of age and in first remission with high-risk features (e.g., WBC greater than 100,000/mm^3, karyotypes t[9;22], t[4], t[19], t[11], and biphenotypic leukemia)
      • Second or subsequent remission
      • Primary induction failure
      • Partially responding or untreated relapse
    • Acute myeloid leukemia meeting any of the following criteria:

      • First remission, except with good-risk karyotypes (e.g., M3 t[15;17], M4E0 inv[16], t[8;21])
      • Second or subsequent remission
      • Primary induction failure
      • Resistant relapse
    • Myelodysplastic syndromes of any of the following types:

      • Refractory anemia (RA) with transfusion dependence
      • RA with excess blasts
      • In transformation to acute leukemia
      • Chronic myelomonocytic leukemia
    • Myeloproliferative disorders in transformation to acute leukemia, of any of the following types:

      • Myelofibrosis
      • Polycythemia vera
      • Essential thrombocythemia
    • Chronic lymphocytic leukemia that is refractory to fludarabine with 1 of the following:

      • Bulky progressive disease
      • Thrombocytopenia (WBC no greater than 100,000/mm^3)*
      • Anemia (hemoglobin no greater than 10 g/dL)* NOTE: *Not due to recent chemotherapy
    • Non-Hodgkin's lymphoma, including mantle cell lymphoma, relapsing or refractory to current chemotherapy and monoclonal antibody therapy and unsuitable for autologous stem cell transplantation
  • Availability of a HLA-identical (6/6) family donor

PATIENT CHARACTERISTICS:

Age

  • 10 to 55

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • See Disease Characteristics

Hepatic

  • Bilirubin no greater than 4 mg/dL
  • Transaminases no greater than 3 times upper limit of normal

Renal

  • Creatinine no greater than 3 mg/dL

Cardiovascular

  • LVEF at least 40% of predicted

Pulmonary

  • DLCO at least 60% of predicted

Other

  • Not pregnant
  • Negative pregnancy test
  • HIV negative
  • No severe psychiatric illness or mental deficiency that would preclude giving informed consent or complying with study treatment
  • No major illness or organ dysfunction that would preclude transplantation
  • No other prior malignancy except basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics

Chemotherapy

  • See Disease Characteristics
  • No prior continuous busulfan for more than 6 months duration

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified
Both
10 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00066300
 
CDR0000315460, NHLBI-03-H-0192
National Heart, Lung, and Blood Institute (NHLBI)
 
Study Chair: Austin J. Barrett, MD, FRCP NHLBI - Bone Marrow Transplantation Unit
National Cancer Institute (NCI)
April 2004

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