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Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD

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ClinicalTrials.gov Identifier: NCT00186628
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : November 28, 2017
Last Update Posted : November 28, 2017
Sponsor:
Collaborators:
The Leukemia and Lymphoma Society
National Cancer Institute (NCI)
Information provided by (Responsible Party):
David Miklos, Stanford University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Leukemia, Mast-Cell
Mantle-cell Lymphoma
Interventions: Procedure: Total lymphoid irradiation
Drug: Rituximab
Drug: Anti-thymoglobulin, rabbit (ATG, rabbit ATG)
Drug: Cyclosporine
Drug: Mycophenylate mofetil
Drug: Filgrastim
Drug: Granisetron
Drug: Solumedrol
Drug: Acetaminophen
Drug: Diphenhydramine
Drug: Hydrocortisone

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Prophylactic Rituximab Participants to receive total lymphoid irradiation + anti-thymoglobulin (TLI + ATG) then nonmyeloablative allogeneic stem cell transplantation, with prophylactic rituximab

Participant Flow:   Overall Study
    Prophylactic Rituximab
STARTED   36 
COMPLETED   33 
NOT COMPLETED   3 
Death                2 
Withdrawal by subject (before treatment)                1 



  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.
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Reporting Groups
  Description
Prophylactic Rituximab Participants to receive total lymphoid irradiation + anti-thymoglobulin (TLI + ATG) then nonmyeloablative allogeneic stem cell transplantation, with prophylactic rituximab

Baseline Measures
   Prophylactic Rituximab 
Overall Participants Analyzed 
[Units: Participants]
 36 
Age 
[Units: Years]
Mean (Full Range)
 57 
 (31 to 66) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      13  36.1% 
Male      23  63.9% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      2   5.6% 
Not Hispanic or Latino      33  91.7% 
Unknown or Not Reported      1   2.8% 
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   2.8% 
White      32  88.9% 
More than one race      0   0.0% 
Unknown or Not Reported      3   8.3% 
Patient Disease characteristics 
[Units: Participants]
 
CLL- Chronic Lymphocytic Leukemia   22 
MCL- Mantle Cell lymphoma   13 
unknown or Not Reported   1 


  Outcome Measures

1.  Primary:   Chronic Graft-vs-Host Disease (cGvHD)   [ Time Frame: 4 years ]

2.  Secondary:   Incidence of Relapse   [ Time Frame: 4 years ]

3.  Secondary:   Mortality   [ Time Frame: Day 100 and 1 year ]

4.  Secondary:   Overall Survival   [ Time Frame: 4 years ]


  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
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: David Miklos, MD, PhD; Associate Professor of Medicine (Blood and Marrow Transplantation)
Organization: Stanford University Medical Center
phone: 650-725-4626
e-mail: dmiklos@stanford.edu


Publications of Results:
Other Publications:

Responsible Party: David Miklos, Stanford University
ClinicalTrials.gov Identifier: NCT00186628     History of Changes
Obsolete Identifiers: NCT00234013
Other Study ID Numbers: IRB-02372
96160 ( Other Identifier: Stanford Secondary IRB Approval Number )
BMT172 ( Other Identifier: OnCore )
SPO ( Other Identifier: Leukemia & Lymphoma Society )
P01CA049605 ( U.S. NIH Grant/Contract )
First Submitted: September 14, 2005
First Posted: September 16, 2005
Results First Submitted: December 12, 2016
Results First Posted: November 28, 2017
Last Update Posted: November 28, 2017