Trial record 1 of 1 for:    NCT01027000
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Donor Stem Cell Transplant in Treating Patients With High-Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

This study is currently recruiting participants.
Verified February 2013 by National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: December 4, 2009
Last updated: February 15, 2013
Last verified: February 2013

RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. Also, monoclonal antibodies, such as rituximab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus, sirolimus, and methotrexate after the transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well donor stem cell transplant works in treating patients with high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma.

Condition Intervention Phase
Biological: anti-thymocyte globulin
Biological: rituximab
Drug: busulfan
Drug: cyclophosphamide
Drug: fludarabine phosphate
Drug: methotrexate
Drug: sirolimus
Drug: tacrolimus
Other: laboratory biomarker analysis
Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Reduced-Intensity Allogeneic Stem Cell Transplant for High-Risk Chronic Lymphocytic Leukemia (CLL)

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 2-year progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response [ Designated as safety issue: No ]
  • Acute graft-vs-host disease (GVHD) [ Designated as safety issue: No ]
  • Chronic GVHD [ Designated as safety issue: No ]
  • Treatment-related mortality [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Chimerism for CD3 [ Designated as safety issue: No ]

Estimated Enrollment: 86
Study Start Date: February 2010
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
  Show Detailed Description


Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Diagnosis of B-cell chronic lymphocytic leukemia or B-cell small lymphocytic lymphoma according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria
  • Meets 1 of the following criteria:

    • Early disease cohort:

      • Meets ≥ 1 of the following criteria:

        • FISH showing deletion 17p in ≥ 20% of cells (either at diagnosis or any time before study entry) either alone or in combination with other cytogenetic abnormalities
        • FISH showing deletion 11q in ≥ 20% of cells (either at diagnosis or any time before study entry) either alone or in combination with other cytogenetic abnormalities, unless the patient has achieved a complete remission, according to IWCLL 2008 criteria which includes CT scan, bone marrow morphology, and flow cytometry
        • Failed to achieve a partial response to initial therapy but lack of disease progression (may receive a second therapy to improve response before transplant)
      • Received ≥ 2 courses of induction therapy (it is expected that patients will receive ≥ 4 months of therapy prior to enrollment, but this is not required)

        • Suggested regimens include, but are not limited to, the following:

          • Fludarabine phosphate and rituximab
          • Fludarabine phosphate, cyclophosphamide, and rituximab
          • Pentostatin, cyclophosphamide, and rituximab
          • Bendmustine and rituximab
          • Alemtuzumab alone or in combination with other agents
      • Stable disease or better after most recent therapy (i.e., no prior progression), according to the revised IWCLL 2008 criteria
      • Nodes ≤ 5 cm
    • Advanced disease cohort:

      • Meets ≥ 1 of the following criteria:

        • First disease progression < 24 months after completing (this includes progression on initial therapy)
        • Second or subsequent progression
      • Stable disease or better after most recent chemotherapy, according to the revised IWCLL 2008 criteria
      • Nodes ≤ 5 cm
      • FISH showing deletion of 17p in ≥ 20% of cells (regardless of interval from initial therapy) either alone or in combination with other cytogenetic abnormalities
  • Has an HLA-matched related or unrelated donor available

    • 6/6 HLA-matched related donor by low-resolution typing at HLA A, B, C, and DR
    • 8/8 HLA-matched unrelated donor by molecular typing at both HLA class I and class II (A, B, C, and DR loci)
    • No syngeneic donors


  • ECOG performance status 0-2
  • Serum creatinine < 2 mg/dL
  • Calculated creatinine clearance ≥ 40 mL/min
  • AST < 3 times upper limit of normal
  • Total bilirubin < 2 mg/dL (except for patients with Gilbert syndrome)
  • DLCO ≥ 40% predicted
  • LVEF ≥ 30% by ECHO or MUGA
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • Hepatitis B surface antigen negative
  • Anti-hepatitis B core antigen negative
  • Hepatitis C antibody negative
  • No uncontrolled diabetes mellitus or active uncontrolled serious infections
  • No history of Richter transformation


  • See Disease Characteristics
  • At least 4 weeks after day 1 of the last course since prior cytotoxic chemotherapy or alemtuzumab
  Contacts and Locations
Please refer to this study by its identifier: NCT01027000

  Show 25 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
Study Chair: Edwin P. Alyea, MD Dana-Farber Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Monica M. Bertagnolli, Cancer and Leukemia Group B Identifier: NCT01027000     History of Changes
Other Study ID Numbers: CDR0000660555, CALGB-100701
Study First Received: December 4, 2009
Last Updated: February 15, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
refractory chronic lymphocytic leukemia
stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
B-cell chronic lymphocytic leukemia
contiguous stage II small lymphocytic lymphoma
noncontiguous stage II small lymphocytic lymphoma
recurrent small lymphocytic lymphoma
stage I small lymphocytic lymphoma
stage III small lymphocytic lymphoma
stage IV small lymphocytic lymphoma

Additional relevant MeSH terms:
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antilymphocyte Serum
Fludarabine monophosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses processed this record on April 17, 2014