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)
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01027000
First received: December 4, 2009
Last updated: February 15, 2013
Last verified: February 2013
  Purpose

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
Leukemia
Lymphoma
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

  Eligibility

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

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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 ClinicalTrials.gov identifier: NCT01027000

  Hide Study Locations
Locations
United States, California
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010-3000
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen    800-826-4673    becomingapatient@coh.org   
United States, Delaware
Tunnell Cancer Center at Beebe Medical Center Recruiting
Lewes, Delaware, United States, 19958
Contact: Clinical Trials Office - Tunnell Cancer Center    302-645-3171      
CCOP - Christiana Care Health Services Recruiting
Newark, Delaware, United States, 19713
Contact: Clinical Trial Office - CCOP - Christiana Care Health Services    302-623-4450      
United States, Florida
Florida Hospital Cancer Institute at Florida Hospital Orlando Recruiting
Orlando, Florida, United States, 32803-1273
Contact: Clinical Trials Office - Florida Hospital Cancer Institute    407-303-5623      
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida Recruiting
Tampa, Florida, United States, 33612-9497
Contact: Clinical Trials Office - H. Lee Moffitt Cancer Center and Rese    800-456-7121    canceranswers@moffitt.org   
United States, Illinois
University of Chicago Cancer Research Center Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Clinical Trials Office - University of Chicago Cancer Research    773-834-7424      
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa Recruiting
Iowa City, Iowa, United States, 52242-1002
Contact: Cancer Information Service    800-237-1225      
United States, Maryland
Union Hospital of Cecil County Recruiting
Elkton MD, Maryland, United States, 21921
Contact: Frank Beardell, MD    302-737-7700      
United States, Massachusetts
Dana-Farber/Brigham and Women's Cancer Center Recruiting
Boston, Massachusetts, United States, 02115
Contact: Clinical Trials Office    617-724-5200      
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Edwin P. Alyea, MD    617-632-3465      
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Clinical Trials Office - Massachusetts General Hospital    877-726-5130      
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Ravi Vij, MD    314-454-8323      
United States, Nebraska
UNMC Eppley Cancer Center at the University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198-6805
Contact: Clinical Trials Office - UNMC Eppley Cancer Center at the Univ    800-999-5465      
United States, New Jersey
Cancer Institute of New Jersey at Cooper - Voorhees Recruiting
Voorhees, New Jersey, United States, 08043
Contact: Clinical Trials Office - Cancer Institute of New Jersey at Coo    856-325-6757      
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263-0001
Contact: Clinical Trials Office - Roswell Park Cancer Institute    877-275-7724      
Monter Cancer Center of the North Shore-LIJ Health System Recruiting
Lake Success, New York, United States, 11042
Contact: Alla Keyzner    516-734-8959      
CCOP - North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Contact: Alla Keyzner    516-734-8954      
Don Monti Comprehensive Cancer Center at North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Contact: Clinical Trials Office - Don Monti Comprehensive Cancer Center    516-734-8900      
Long Island Jewish Medical Center Recruiting
New Hyde Park, New York, United States, 11040
Contact: Alla Keyzner    718-470-7000      
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Miguel-Angel Perales    212-639-8895      
New York Weill Cornell Cancer Center at Cornell University Recruiting
New York, New York, United States, 10021
Contact: Clinical Trials Office - New York Weill Cornell Cancer Center    212-746-1848      
United States, North Carolina
Wake Forest University Comprehensive Cancer Center Recruiting
Winston-Salem, North Carolina, United States, 27157-1096
Contact: Clinical Trials Office - Wake Forest University Comprehensive    336-713-6771      
United States, Ohio
Cleveland Clinic Taussig Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente    866-223-8100      
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210-1240
Contact: Ohio State University Cancer Clinical Trial Matching Service    866-627-7616    Jamesline@osumc.edu   
United States, Oklahoma
Oklahoma University Cancer Institute Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Carla Kurkjian    405-271-6822      
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
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
ClinicalTrials.gov 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
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antilymphocyte Serum
Busulfan
Cyclophosphamide
Methotrexate
Fludarabine monophosphate
Sirolimus
Tacrolimus
Rituximab
Fludarabine
Vidarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014