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Tandem Auto-Allo Transplant for Lymphoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01181271
First Posted: August 13, 2010
Last Update Posted: March 9, 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:
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Yi-Bin A. Chen, MD, Massachusetts General Hospital
Results First Submitted: January 19, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Diffuse, Large B-Cell, Lymphoma
Lymphoma, Low-Grade
T-Cell Lymphoma
Mantle-Cell Lymphoma
Hodgkin's Lymphoma
Chronic Lymphocytic Leukemia
Lymphoma, Small Lymphocytic
Interventions: Drug: Busulfan (conditioning for AUTO transplant)
Drug: Etoposide (conditioning for AUTO transplant)
Drug: Cyclophosphamide (conditioning for AUTO transplant)
Drug: Mesna (prior to AUTO transplant)
Other: autologous (auto) peripheral blood stem cell transplantation
Drug: Neupogen
Drug: Fludarabine (conditioning for ALLO Transplant)
Drug: Busulfan (conditioning for ALLO Transplant)
Other: non-myeloablative allogeneic (allo) transplant
Drug: Tacrolimus
Drug: Sirolimus
Drug: Methotrexate

  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
Participants were enrolled between October 2010 and June 2013.

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
Autologous Then Allogeneic Transplant Autologous, then Allogeneic Stem Cell Transplantation

Participant Flow for 3 periods

Period 1:   Autologous Transplant
    Autologous Then Allogeneic Transplant
STARTED   42 
COMPLETED   42 
NOT COMPLETED   0 

Period 2:   Evaluation for Allogeneic Transplant
    Autologous Then Allogeneic Transplant
STARTED   42 
COMPLETED   29 
NOT COMPLETED   13 
Lack of Efficacy                6 
Withdrawal by Subject                4 
No suitable donor                2 
therapy-related AML diagnosed                1 

Period 3:   Allogeneic Transplant
    Autologous Then Allogeneic Transplant
STARTED   29 
COMPLETED   29 
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
Autologous Then Allogeneic Transplant Autologous then allogeneic stem cell transplantation

Baseline Measures
   Autologous Then Allogeneic Transplant 
Overall Participants Analyzed 
[Units: Participants]
 42 
Age 
[Units: Years]
Median (Full Range)
 56.5 
 (22 to 69) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      16  38.1% 
Male      26  61.9% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   42 
Prior lines of chemotherapy 
[Units: Lines]
Median (Full Range)
 2 
 (1 to 6) 
Diagnosis 
[Units: Participants]
Count of Participants
 
Relapsed/refractory Diffuse Large B-cell Lymphoma      10  23.8% 
Relapsed/refractory Non-Hodgkin Lymphoma      6  14.3% 
Double-Expressing Non-Hodgkin Lymphoma      9  21.4% 
Transformed B-cell Non-Hodgkin Lymphoma      8  19.0% 
T-cell Non-Hodgkin Lymphoma      4   9.5% 
Mantle cell Non-Hodgkin Lymphoma      3   7.1% 
Relapsed/Refractory Hodgkin Lymphoma      1   2.4% 
Heavy chain disease      1   2.4% 
Disease status at study entry 
[Units: Participants]
Count of Participants
 
Partial Response      21  50.0% 
Complete Response      21  50.0% 


  Outcome Measures
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1.  Primary:   Peripheral Blood All-cell Donor Chimerism   [ Time Frame: 100 days post allogeneic transplant ]

2.  Secondary:   Number of Days After Allogeneic Transplant Until Absolute Neutrophil Count Was Equal to or Greater Than 500/uL   [ Time Frame: within 28 days after allogeneic transplant ]

3.  Secondary:   Cumulative Incidence of Grades II to IV Acute Graft Versus Host Disease (GVHD)   [ Time Frame: within 200 days after allogeneic transplant ]

4.  Secondary:   Cumulative Incidence of Extensive Chronic Graft-versus-host-disease   [ Time Frame: 1-year after allogeneic transplant ]

5.  Secondary:   Cumulative Incidence of Non-relapse Mortality   [ Time Frame: 2-years after allogeneic transplant ]

6.  Secondary:   Cumulative Incidence of Disease Relapse   [ Time Frame: 2-years after allogeneic transplant ]

7.  Secondary:   Estimated Two Year Progression Free Survival Rate for Participants Undergoing Both Autologous and Allogeneic Transplants   [ Time Frame: 2 years after allogeneic transplant ]

8.  Secondary:   Estimated Two Year Overall Survival Rate for Participants Undergoing Both Autologous and Allogeneic Transplants   [ Time Frame: Two-years after Allogeneic Transplant ]

9.  Secondary:   Estimated Two Year Progression Free Survival Rate for All Participants   [ Time Frame: 2 years ]

10.  Secondary:   Estimated Two Year Overall Survival Rate for All Participants   [ Time Frame: 2 years ]

11.  Secondary:   Estimated Two Year Progression Free Survival Rate for Participants Undergoing Only Autologous Transplant   [ Time Frame: Two Years ]

12.  Secondary:   Estimated Two Year Overall Survival Rate for Participants Undergoing Only Autologous Transplant   [ Time Frame: two years ]


  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: Yi-Bin Chen, MD
Organization: Mass General Hospital
phone: 617-726-5765
e-mail: ychen6@partners.org


Publications of Results:

Responsible Party: Yi-Bin A. Chen, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01181271     History of Changes
Other Study ID Numbers: 10-057
First Submitted: August 12, 2010
First Posted: August 13, 2010
Results First Submitted: January 19, 2017
Results First Posted: March 9, 2017
Last Update Posted: March 9, 2017