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Donor Stem Cell Transplant in Treating Patients With High-Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01027000
First Posted: December 7, 2009
Last Update Posted: June 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
Genentech, Inc.
Biologics, Inc.
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
Results First Submitted: March 23, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Leukemia
Lymphoma
Interventions: Biological: rituximab
Drug: busulfan
Drug: cyclophosphamide
Drug: fludarabine phosphate
Drug: methotrexate
Drug: sirolimus
Drug: tacrolimus
Procedure: allogeneic stem cell transplant

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between February 2010 and January 2014, 68 participants were recruited.

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 (Combination of Chemotherapy and Transplant)

Preparative: Patients receive 1 of 2 preparative regimens (Reg) chosen by the treating institution

  • Reg1: Rituximab (RTX) 500 mg/m^2 IV on days -7, -1, 7, and 14 & fludarabine phosphate (FP) 30 mg/m^2 IV & busulfan 0.8 mg/kg IV on days -5 to -2
  • Reg 2: RTX 500 mg/m^2 IV on days -7, -1, 7, and 14 & FP 30 mg/m^2 IV on days -5 to -2 & cyclophosphamide 1 g/m^2 IV on days -5 to -3

Graft-vs-host disease (GVHD) prophylaxis: Patients treated with preparative regimen 1 received either GVHD prophylaxis regimen 1 or 2; those given preparative regimen 2 received regimen 2

  • Reg 1: Tacrolimus PO or IV & oral sirolimus 12 mg on day -2 through day 60, followed by taper until day 180 & methotrexate (MTX) 5 mg/m^2 IV on days 1, 3, and 6.
  • Reg 2: Tacrolimus PO or IV on day -2 through day 60, followed by taper until day 180 & MTX 5mg/m^2 IV on days 1, 3, 6, & 11 Transplantation: allogeneic peripheral blood transplant on day 0 Maintenance: RTX 500 mg/m^2 IV at 3, 6, 9, & 12 months post-transplant

Participant Flow:   Overall Study
    Treatment (Combination of Chemotherapy and Transplant)
STARTED   68 
COMPLETED   68 
NOT COMPLETED   0 



  Baseline Characteristics
  Hide 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 (Combination of Chemotherapy and Transplant)

Preparative: Patients receive 1 of 2 preparative regimens (Reg) chosen by the treating institution

  • Reg1: Rituximab (RTX) 500 mg/m^2 IV on days -7, -1, 7, and 14 & fludarabine phosphate (FP) 30 mg/m^2 IV & busulfan 0.8 mg/kg IV on days -5 to -2
  • Reg 2: RTX 500 mg/m^2 IV on days -7, -1, 7, and 14 & FP 30 mg/m^2 IV on days -5 to -2 & cyclophosphamide 1 g/m^2 IV on days -5 to -3

Graft-vs-host disease (GVHD) prophylaxis: Patients treated with preparative regimen 1 received either GVHD prophylaxis regimen 1 or 2; those given preparative regimen 2 received regimen 2

  • Reg 1: Tacrolimus PO or IV & oral sirolimus 12 mg on day -2 through day 60, followed by taper until day 180 & methotrexate (MTX) 5 mg/m^2 IV on days 1, 3, and 6.
  • Reg 2: Tacrolimus PO or IV on day -2 through day 60, followed by taper until day 180 & MTX 5mg/m^2 IV on days 1, 3, 6, & 11 Transplantation: allogeneic peripheral blood transplant on day 0 Maintenance: RTX 500 mg/m^2 IV at 3, 6, 9, & 12 months post-transplant

Baseline Measures
   Treatment (Combination of Chemotherapy and Transplant) 
Overall Participants Analyzed 
[Units: Participants]
 68 
Age 
[Units: Years]
Median (Full Range)
 56 
 (26 to 70) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      22  32.4% 
Male      46  67.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      2   2.9% 
Not Hispanic or Latino      62  91.2% 
Unknown or Not Reported      4   5.9% 
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      1   1.5% 
White      66  97.1% 
More than one race      0   0.0% 
Unknown or Not Reported      1   1.5% 
Region of Enrollment 
[Units: Participants]
 
United States   68 
Disease stage [1] 
[Units: Participants]
 
Early Disease   14 
Advanced Disease   50 
Not reported   4 
[1]

Early Disease: Participants must have received ≥2 cycles of induction therapy & have nodes ≤ 5 cm with one or more of the following: FISH deletion 17p, FISH del 11q, failure to achieve a partial response with initial chemotherapy with no progression, or have a 17p deletion by FISH at the time of first progression

Advanced Disease: Participants must have stable disease or better to their most recent chemotherapy & have nodes ≤ 5 cm with one or more of the following:

FISH deletion 17p, first progression < 24 months after completing therapy, or a subsequent progression



  Outcome Measures

1.  Primary:   2-year Progression-free Survival in Early Disease Participants   [ Time Frame: 2 years post-registration ]

2.  Secondary:   Response   [ Time Frame: 5 years post-registration ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Acute Graft-vs-host Disease (GVHD)   [ Time Frame: 5 years post-registration ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Chronic GVHD   [ Time Frame: 5 years post-registration ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Treatment-related Mortality   [ Time Frame: 6 months post-transplant ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Overall Survival   [ Time Frame: 5 years post-registration ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   Chimerism for CD3   [ Time Frame: 5 years post-registration ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Edwin P. Alyea, MD
Organization: Dana Farber Cancer Institute
e-mail: edwin_alyea@dfci.harvard.edu



Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01027000     History of Changes
Other Study ID Numbers: CALGB 100701
CDR0000660555 ( Registry Identifier: Physician Data Query )
U10CA031946 ( U.S. NIH Grant/Contract )
NCI-2011-01995 ( Registry Identifier: NCI Clinical Trials Reporting Office )
First Submitted: December 4, 2009
First Posted: December 7, 2009
Results First Submitted: March 23, 2017
Results First Posted: May 3, 2017
Last Update Posted: June 12, 2017



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