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Fludarabine and Cyclophosphamide Followed by Peripheral Stem Cell Transplant in Treating Patients With Leukemia or Lymphoma

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006252
  Purpose

RATIONALE: Giving chemotherapy drugs, such as fludarabine and cyclophosphamide, before a donor peripheral blood stem cell transplant helps stop the growth of cancer 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.

PURPOSE: This phase II trial is studying how well fludarabine and cyclophosphamide followed by peripheral stem cell transplant works in treating patients with leukemia or lymphoma.


Condition Intervention Phase
Leukemia
Lymphoma
Drug: cyclophosphamide
Drug: filgrastim
Drug: fludarabine phosphate
Drug: therapeutic allogeneic lymphocytes
Procedure: peripheral blood stem cell transplantation
Phase II

MedlinePlus related topics:   Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic    Leukemia, Childhood    Lymphoma   

ChemIDplus related topics:   Cyclophosphamide    Filgrastim    Fludarabine    Fludarabine monophosphate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   Minimal Ablation and Cellular Immune Therapy of Chronic Lymphocytic Leukemia, Prolymphocytic Leukemia, Low-Grade Non-Hodgkin's Lymphoma, and Mantle Cell Lymphoma With Allogeneic Donor Stem Cells

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

Primary Outcome Measures:
  • Treatment-related mortality within the first 6 months post-transplant [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complete response at 1 year [ Designated as safety issue: No ]
  • Percentage of patients achieving complete donor chimerism or mixed donor chimerism at day 90 post-transplant [ Designated as safety issue: No ]
  • Disease control [ Designated as safety issue: No ]

Estimated Enrollment:   45
Study Start Date:   February 2001

Detailed Description:

OBJECTIVES:

  • Determine the feasibility of fludarabine and cyclophosphamide followed by allogeneic peripheral blood stem cell transplantation, in terms of 6-month treatment-related mortality, in patients with chronic lymphocytic leukemia, prolymphocytic leukemia, low-grade non-Hodgkin's lymphoma, or mantle cell lymphoma.
  • Determine the 6-month and 12-month probabilities of response in patients treated with this regimen.
  • Determine the time to disease progression in patients responding to this regimen.
  • Determine the percentage of donor chimerism achieved in patients treated with this regimen.
  • Determine the risk of acute and chronic graft-versus-host disease in patients treated with this regimen.
  • Determine the toxic effects of this regimen in these patients.
  • Determine the overall survival and disease-free survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive fludarabine IV over 30 minutes on days -7 to -3 and cyclophosphamide IV over 1 to 2 hours on days -5 to -3. Patients undergo allogeneic peripheral blood stem cell transplantation on days 0-1. Patients then receive filgrastim (G-CSF) subcutaneously daily beginning on day 5 and continuing until blood counts recover.

Patients with no signs of active graft-versus host disease and stable or progressive disease receive donor lymphocytes IV over 2 hours beginning after day 120. Patients may receive a total of 3 infusions at least 8 weeks apart if disease remains stable or progressive.

Patients are followed every 3 months for 2 years and then every 6 months for 5 years.

PROJECTED ACCRUAL: A maximum of 45 patients will be accrued for this study.

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

Criteria

DISEASE CHARACTERISTICS:

  • One of the following histologically confirmed diagnoses:

    • Chronic lymphocytic leukemia

      • Absolute lymphocytosis greater than 5,000/mm^3
      • Morphologically mature lymphocytes with less than 55% prolymphocytes
      • Lymphocyte phenotypic expression of CD19 and CD5
      • Failed at least 1 prior regimen

        • Progressive lymphocytosis with more than 50% increase in peripheral lymphocytosis or a progressive lymph node or spleen enlargement (at least 25% enlargement or the appearance of new lymph nodes) that persists for at least 4 weeks despite concurrent or prior drug treatment OR
      • At least 1 of the following high-risk factors and not in first complete remission

= 17p deletion = 11q deletion

  • Unmutated VH gene status
  • p53 mutations

    • Prolymphocytic leukemia (PLL)

      • Absolute lymphocytosis greater than 5,000/mm^3
      • Morphologically mature lymphocytes with more than 55% prolymphocytes
    • Low-grade non-Hodgkin's lymphoma

      • Small lymphocytic lymphoma
      • Follicular center lymphoma (grade I or II)
      • Diffuse (predominately small cell type)
      • Marginal zone, B-cell lymphoma
      • No transformed lymphoma
      • Failure of at least 1 prior regimen OR
      • At least 3 of the following risk factors:
  • Over 60 years of age
  • Performance status greater than 1
  • LDH greater than normal
  • More than 1 site of extranodal disease
  • Disease stage III or IV

    • Mantle cell lymphoma

      • Any stage
      • Ineligible for protocol CALGB-59908
      • At least 1 prior treatment regimen
      • At least 1 of the following:
  • Immunophenotypic expression of CD5 and CD19 and absence of CD23
  • Cytogenetic analysis with presence of t(11;14)
  • Overexpression of cyclin D1
  • Rearrangement of BCL1 gene

    • Responsive or stable disease to most recent prior therapy

      • Prior therapy for PLL not required
    • Must have HLA identical sibling (6/6) donor by serologic typing (A, B, DR)

      • No syngeneic donors
      • No age restriction NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age:

  • Under 70

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Granulocyte count at least 500/mm^3*
  • Platelet count at least 50,000/mm^3* NOTE: *Unless attributable to disease

Hepatic:

  • Bilirubin no greater than 3 times upper limit of normal (ULN)*
  • AST no greater than 3 times ULN* NOTE: *Unless attributable to disease

Renal:

  • Creatinine clearance at least 40 mL/min, unless attributable to disease

Cardiovascular:

  • LVEF at least 30% by MUGA

Pulmonary:

  • DLCO greater than 40%
  • No symptomatic pulmonary disease

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior autologous transplantation

Chemotherapy:

  • At least 4 weeks since prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 4 weeks since prior radiotherapy

Surgery:

  • At least 4 weeks since prior surgery
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006252

Locations
United States, California
Rebecca and John Moores UCSD Cancer Center    
      La Jolla, California, United States, 92093-0658
UCSF Comprehensive Cancer Center    
      San Francisco, California, United States, 94115
Veterans Affairs Medical Center - San Diego    
      San Diego, California, United States, 92161
United States, Delaware
Beebe Medical Center    
      Lewes, Delaware, United States, 19958
CCOP - Christiana Care Health Services    
      Newark, Delaware, United States, 19713
St. Francis Hospital    
      Wilmington, Delaware, United States, 19805
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa    
      Iowa City, Iowa, United States, 52242
United States, Maryland
Union Hospital Cancer Center at Union Hospital    
      Elkton MD, Maryland, United States, 21921
United States, Massachusetts
UMASS Memorial Cancer Center - University Campus    
      Worcester, Massachusetts, United States, 01655
United States, New Jersey
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees    
      Voorhees, New Jersey, United States, 08043
United States, New York
Elmhurst Hospital Center    
      Elmhurst, New York, United States, 11373
Mount Sinai Medical Center    
      New York, New York, United States, 10029
Queens Cancer Center of Queens Hospital    
      Jamaica, New York, United States, 11432
Roswell Park Cancer Institute    
      Buffalo, New York, United States, 14263-0001
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill    
      Chapel Hill, North Carolina, United States, 27599-7295
Wake Forest University Comprehensive Cancer Center    
      Winston-Salem, North Carolina, United States, 27157-1096
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University    
      Columbus, Ohio, United States, 43210-1240
United States, Pennsylvania
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital    
      Pittsburgh, Pennsylvania, United States, 15224-1791
United States, Virginia
Massey Cancer Center at Virginia Commonwealth University    
      Richmond, Virginia, United States, 23298-0037

Sponsors and Collaborators
Cancer and Leukemia Group B
National Cancer Institute (NCI)

Investigators
Study Chair:     Thomas C. Shea, MD     UNC Lineberger Comprehensive Cancer Center    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:
Shea TC, Johnston J, Walsh W, et al.: Reduced intensity allogeneic transplantation provides high disease-free and overall survival in patients (pts) with advanced indolent NHL and CLL: CALGB 109901. [Abstract] Blood 110 (11): A-486, 2007.

Study ID Numbers:   CDR0000068185, CALGB-109901
First Received:   September 11, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00006252
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
refractory chronic lymphocytic leukemia  
stage I grade 1 follicular lymphoma  
stage I grade 2 follicular lymphoma  
stage I adult diffuse small cleaved cell lymphoma  
stage III grade 1 follicular lymphoma  
stage III grade 2 follicular lymphoma  
stage III adult diffuse small cleaved cell lymphoma  
stage IV grade 1 follicular lymphoma  
stage IV grade 2 follicular lymphoma  
stage IV adult diffuse small cleaved cell lymphoma  
recurrent grade 1 follicular lymphoma  
recurrent grade 2 follicular lymphoma  
recurrent adult diffuse small cleaved cell lymphoma  
prolymphocytic leukemia  
stage I mantle cell lymphoma  
contiguous stage II grade 1 follicular lymphoma
contiguous stage II grade 2 follicular lymphoma
contiguous stage II adult diffuse small cleaved cell lymphoma
contiguous stage II mantle cell lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II adult diffuse small cleaved cell lymphoma
noncontiguous stage II mantle cell lymphoma
stage III mantle cell lymphoma
stage IV mantle cell lymphoma
recurrent mantle cell lymphoma
contiguous stage II small lymphocytic lymphoma
contiguous stage II marginal zone lymphoma
noncontiguous stage II small lymphocytic lymphoma
noncontiguous stage II marginal zone lymphoma

Study placed in the following topic categories:
Leukemia, Lymphoid
Lymphoma, Mantle-Cell
Lymphoma, Follicular
Lymphoma, small cleaved-cell, diffuse
Lymphoma, B-Cell, Marginal Zone
Cyclophosphamide
Lymphoma, B-Cell
Leukemia
Leukemia, Prolymphocytic
Leukemia, Lymphocytic, Chronic, B-Cell
Prolymphocytic leukemia
Lymphoma
Chronic lymphocytic leukemia
Immunoproliferative Disorders
Leukemia, B-cell, chronic
Fludarabine monophosphate
Mantle cell lymphoma
Recurrence
Lymphatic Diseases
B-cell lymphomas
Fludarabine
Lymphoproliferative Disorders
Leukemia, B-Cell
Lymphoma, Non-Hodgkin
Follicular lymphoma

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Immune System Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on August 21, 2008




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