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Fludarabine Phosphate and Total-Body Irradiation Before Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Leukemia

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ClinicalTrials.gov Identifier: NCT00060424
Recruitment Status : Completed
First Posted : May 7, 2003
Results First Posted : December 8, 2017
Last Update Posted : December 8, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
David Maloney, Fred Hutchinson Cancer Research Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: B-Cell Prolymphocytic Leukemia
Chronic Lymphocytic Leukemia
Prolymphocytic Leukemia
Recurrent Chronic Lymphocytic Leukemia
Recurrent Small Lymphocytic Lymphoma
Refractory Chronic Lymphocytic Leukemia
T-Cell Prolymphocytic Leukemia
Interventions: Drug: Cyclosporine
Drug: Fludarabine Phosphate
Procedure: Hematopoietic Cell Transplantation
Other: Laboratory Biomarker Analysis
Drug: Mycophenolate Mofetil
Procedure: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation
Radiation: Total-Body Irradiation

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment (Enzyme Inhibitor, Transplant, GVHD Prophylaxis)

NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and TBI on day 0. TRANSPLANT: Patients undergo allogeneic peripheral blood stem cell transplant on day 0. GVHD PROPHYLAXIS: Patients receive cyclosporine PO every 12 hours on days -3 to 180 with taper on day 56 and mycophenolate mofetil PO every 12 hours on days 0-27.

Cyclosporine: Given PO

Fludarabine Phosphate: Given IV

Hematopoietic Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant

Laboratory Biomarker Analysis: Correlative studies

Mycophenolate Mofetil: Given PO

Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant

Total-Body Irradiation: Undergo TBI


Participant Flow:   Overall Study
    Treatment (Enzyme Inhibitor, Transplant, GVHD Prophylaxis)
STARTED   21 
COMPLETED   21 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment (Enzyme Inhibitor, Transplant, GVHD Prophylaxis)

NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and TBI on day 0. TRANSPLANT: Patients undergo allogeneic peripheral blood stem cell transplant on day 0. GVHD PROPHYLAXIS: Patients receive cyclosporine PO every 12 hours on days -3 to 180 with taper on day 56 and mycophenolate mofetil PO every 12 hours on days 0-27.

Cyclosporine: Given PO

Fludarabine Phosphate: Given IV

Hematopoietic Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant

Laboratory Biomarker Analysis: Correlative studies

Mycophenolate Mofetil: Given PO

Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplant

Total-Body Irradiation: Undergo TBI


Baseline Measures
   Treatment (Enzyme Inhibitor, Transplant, GVHD Prophylaxis) 
Overall Participants Analyzed 
[Units: Participants]
 21 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      20  95.2% 
>=65 years      1   4.8% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      5  23.8% 
Male      16  76.2% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      18  85.7% 
Unknown or Not Reported      3  14.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      20  95.2% 
More than one race      0   0.0% 
Unknown or Not Reported      1   4.8% 
Region of Enrollment 
[Units: Participants]
 
United States   20 
Italy   1 


  Outcome Measures

1.  Primary:   Overall Survival   [ Time Frame: At 18 months ]

2.  Secondary:   Rate of Relapse   [ Time Frame: 18 months ]

3.  Secondary:   Acute Grade II-IV GVHD and Chronic (Extensive) GVHD   [ Time Frame: aGVHD: 100 days after transplant; cGVHD: 1 Year after transplant. ]

4.  Secondary:   Rate and Types of Infections   [ Time Frame: 18 months ]

5.  Secondary:   Transplant-related Mortality   [ Time Frame: At 200 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: David G Maloney, MD PhD
Organization: Fred Hutch
e-mail: dmaloney@fredhutch.org



Responsible Party: David Maloney, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00060424     History of Changes
Other Study ID Numbers: 1711.00
NCI-2010-01276 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NCI-2011-01116
1711.00 ( Other Identifier: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
First Submitted: May 6, 2003
First Posted: May 7, 2003
Results First Submitted: April 14, 2017
Results First Posted: December 8, 2017
Last Update Posted: December 8, 2017