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Clinical Trials (PDQ®)

Donor Stem Cell Transplant in Treating Patients With Relapsed Hematologic Cancer

Basic Trial Information
Trial Description
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentCompletedUnder 70NCI, OtherCDR0000269301
U10CA031946, CALGB-100002, NCT00053196

Trial Description


RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving immunosuppressive therapy after the transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well donor bone marrow or peripheral stem cell transplant works in treating patients with relapsed hematologic cancer after treatment with chemotherapy and autologous stem cell transplant.

Further Study Information


  • Determine the feasibility of non-myeloablative allogeneic hematopoietic stem cell transplantation by demonstrating that the risk of treatment-related mortality during the first 6 months is an acceptable rate of less than 40% in patients with relapsed hematologic malignancies after prior high-dose chemotherapy and autologous stem cell transplantation.
  • Determine the response rates (disease-specific partial and complete response) in patients treated with this regimen.
  • Determine the 6-month and 12-month probabilities of response in patients treated with this regimen.
  • Determine the distribution of time-to-progression in patients responding to this regimen.
  • Determine the percent donor chimerism in patients treated with this regimen.
  • Determine the risk of acute and chronic graft-vs-host disease in patients treated with this regimen.
  • Determine the toxic effects of this regimen in these patients.
  • Determine the disease-free and overall survival of patients treated with this regimen.

OUTLINE: This is an open-label study.

  • Preparative Regimen: Patients receive fludarabine IV over 30 minutes on days -7 to -3 and busulfan IV over 2 hours every 6 hours (for a total of 8 doses) on days -4 and -3.
  • Graft vs Host Disease (GVHD) Prophylaxis: Patients who have an HLA-identical donor receive oral (or IV if unable to tolerate oral administration) tacrolimus twice daily on days -1 to 90 followed by a taper^* until day 150 and methotrexate IV on days 1, 3, and 6. Patients with a matched related or matched unrelated donor receive oral (or IV if unable to tolerate oral administration) tacrolimus twice daily on days -1 to 180 followed by a taper^* as tolerated; methotrexate IV on days 1, 3, 6, and 11; oral mycophenolate mofetil twice daily on days -2 to 60 followed by a taper; and rabbit anti-thymocyte globulin IV over 4-6 hours on days -4 to -1 (for a total of 4 doses).

NOTE: *Tacrolimus may be tapered on days 60-90 if donor chimerism of CD3+ cells is less than 50% at day 60 or patient has progressive disease

  • Allogeneic Stem Cell Transplantation: Patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on days 0 and 1. Patients then receive filgrastim (G-CSF) subcutaneously daily beginning on day 7 and continuing until blood counts recover.
  • Donor Lymphocyte Infusion (DLI): After day 180 (or day 210 for patients without an HLA-identical donor), patients with stable or progressive disease and no active GVHD may receive up to 3 DLIs every 8 weeks.

Patients are followed within 2-3 months, every 3 months for 2 years, and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 20-80 patients will be accrued for this study within 10-40 months.

Eligibility Criteria


  • Histologically confirmed hematologic malignancy, including one of the following:
  • Chronic lymphocytic leukemia (CLL)
  • Absolute lymphocytosis greater than 5,000/mm^3
  • Lymphocytes must appear morphologically mature with less than 55% prolymphocytes
  • Lymphocyte phenotype with expression of CD19 and CD5
  • Prolymphocytic leukemia (PLL)
  • Morphologically confirmed
  • Absolute lymphocytosis greater than 5,000/mm^3
  • More than 55% prolymphocytes
  • Non-Hodgkin's lymphoma or Hodgkin's lymphoma
  • Any WHO histologic subtype allowed except mantle cell lymphoma
  • Core biopsies allowed if they contain adequate tissue for primary diagnosis and immunophenotyping
  • No bone marrow biopsy as the sole diagnostic means for follicular lymphoma
  • Multiple myeloma
  • Active disease requiring treatment
  • Durie-Salmon stage I, II, or III
  • Acute myeloid leukemia
  • Documented control (i.e., less than 10% bone marrow blasts and no circulating blasts)
  • Myelodysplastic syndromes
  • Documented disease by WHO criteria
  • Must have evidence of relapse/progression at least 6 months after prior high-dose chemotherapy with autologous hematopoietic stem cell support
  • Absence of CD23 expression for CLL or PLL allowed provided there is no morphologic evidence of mantle cell lymphoma
  • Availability of any of the following donor types:
  • HLA-identical sibling (6/6)
  • 9/10 matched related donor by high-resolution molecular typing at HLA A, B, C, DRB1, and DQB1 loci
  • Only a single mismatch at one class I or II allele allowed
  • 10/10 matched unrelated donor by high-resolution molecular typing at HLA A, B, C, DRB1, and DQB1 loci
  • No syngeneic donors



  • Under 70

Performance status

  • Not specified

Life expectancy

  • Not specified


  • See Disease Characteristics


  • Bilirubin no greater than 3 times upper limit of normal (ULN)
  • AST no greater than 3 times ULN


  • Creatinine clearance at least 40 mL/min


  • LVEF at least 30% by MUGA


  • DLCO greater than 40%
  • No symptomatic pulmonary disease


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No uncontrolled diabetes mellitus
  • No active serious infection
  • No known hypersensitivity to E. coli-derived products


Biologic therapy

  • See Disease Characteristics


  • See Disease Characteristics
  • More than 4 weeks since prior chemotherapy

Endocrine therapy

  • Not specified


  • More than 4 weeks since prior radiotherapy


  • More than 4 weeks since prior surgery

Trial Contact Information

Trial Lead Organizations/Sponsors

Alliance for Clinical Trials in Oncology

National Cancer Institute

Asad BasheyStudy Chair

Link to the current record.
NLM Identifer NCT00053196 processed this data on November 12, 2014

Note: Information about this trial is from the database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the record to standardize the names of study sponsors, sites, and contacts. only lists sites that are recruiting patients for active trials, whereas lists all sites for all trials. Questions and comments regarding the presented information should be directed to

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