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Chemotherapy, Total-Body Irradiation, Rituximab, and Donor Stem Cell Transplant in Treating Patients With B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00425802
First Posted: January 23, 2007
Last Update Posted: October 31, 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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
Results First Submitted: August 11, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Leukemia
Lymphoma
Interventions: Biological: anti-thymocyte globulin
Biological: filgrastim
Biological: graft-versus-tumor induction therapy
Biological: rituximab
Drug: cyclophosphamide
Drug: cyclosporine
Drug: fludarabine phosphate
Drug: mycophenolate mofetil
Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Radiation: total-body irradiation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Protocol Open to Accrual 11/28/2006 Protocol Closed to Accrual 4/22/2014 Primary Completion Date 10/28/2016 Recruitment Location is the medical clinic

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 This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin’s lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL).

Participant Flow:   Overall Study
    Treatment
STARTED   61 
COMPLETED   61 
NOT COMPLETED   0 



  Baseline Characteristics
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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 This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin’s lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL).

Baseline Measures
   Treatment 
Overall Participants Analyzed 
[Units: Participants]
 61 
Age 
[Units: Years]
Median (Full Range)
 54 
 (33 to 69) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female   11 
Male   50 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      2   3.3% 
Not Hispanic or Latino      59  96.7% 
Unknown or Not Reported      0   0.0% 
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   1.6% 
White      59  96.7% 
More than one race      0   0.0% 
Unknown or Not Reported      1   1.6% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   61 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival at 1 Year   [ Time Frame: 1 year ]

2.  Secondary:   Time to Neutrophil Engraftment   [ Time Frame: 2 years ]

3.  Secondary:   Time to Platelet Engraftment   [ Time Frame: 1 year ]

4.  Secondary:   Incidence of Moderate to Severe Grades II to IV Graft Versus Host Disease (GVHD) at 100 Days   [ Time Frame: 100 days ]

5.  Secondary:   Incidence of Chronic GVHD at 1 Year   [ Time Frame: 1 year ]

6.  Secondary:   Immune Reconstruction/CD4+ Count at 3 Months   [ Time Frame: 3 months ]

7.  Secondary:   Response to Treatment   [ Time Frame: 2 years ]

8.  Secondary:   Immune Reconstruction/CD4+ Count at 6 Months   [ Time Frame: 6 months ]

9.  Secondary:   Immune Reconstruction/CD4+ Count at 1 Year   [ Time Frame: 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Hugo Castro-Malaspina, MD
Organization: Memorial Sloan Kettering Cancer Center
phone: 212-639-8197
e-mail: castro-h@mskcc.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00425802     History of Changes
Other Study ID Numbers: 06-150
MSKCC-06150
First Submitted: January 19, 2007
First Posted: January 23, 2007
Results First Submitted: August 11, 2017
Results First Posted: October 31, 2017
Last Update Posted: October 31, 2017