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Phase 2 Poor Risk DLBCL of TLI and ATG Followed by Matched Allogeneic HT as Consolidation to Autologous HCT

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ClinicalTrials.gov Identifier: NCT00482053
Recruitment Status : Terminated (Low accrual)
First Posted : June 4, 2007
Results First Posted : May 14, 2018
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Wen-Kai Weng, Stanford University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Lymphoma, B-cell
Lymphoma, Non-Hodgkin
Diffuse Large B-cell Lymphoma (DLBCL)
Malignant Lymphoma, Non-Hodgkin
Interventions Procedure: Autologous hematopoietic stem cell transplantation (auto-HSCT)
Procedure: Allogeneic hematopoietic stem cell transplantation (allo-HSCT)
Procedure: Total lymphoid irradiation (TLI)
Drug: Rituximab
Drug: Carmustine
Drug: Etoposide
Drug: Filgrastim
Drug: Anti-thymocyte globulin (ATG)
Drug: Cyclosporine
Drug: Mycophenolate mofetil (MMF)
Drug: Cyclophosphamide
Drug: Acetaminophen
Drug: Diphenhydramine
Drug: Hydrocortisone
Drug: Methylprednisolone
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL
Hide Arm/Group Description

Participants will have peripheral blood stem cells (PBSC, aka progenitor / stem cells) mobilized to peripheral blood with rituximab, chemotherapy (cyclophosphamide or etoposide), and filgrastim; undergo apheresis to collect (self/autologous PBSC), and receive carmustine, etoposide, and cyclophosphamide as conditioning for PBSC infusion as a hematopoietic cell transplant (auto-HCT).

Then participants will receive allogeneic HCT (allo-HCT) transplant conditioning [total lymphoid irradiation (TLI) + anti-thymocyte globulin (ATG)] followed by allogenic PBSC (allo-HCT) obtained from a human leukocyte antigen (HLA)-matched or single mismatch filgrastim-mobilized donor. Participant allo-HCT transplant is to occur within 150 days of auto-HCT. Post-allo-HCT treatment includes cyclosporine + mycophenolate mofetil (MMF).

Subject's participation ends if donor is not identified within 150 days. Pre-medication includes acetaminophen; diphenhydramine; hydrocortisone; & methylprednisolone.

Period Title: Autologous Peripheral Stem Cells
Started 3
Completed 3
Not Completed 0
Period Title: Inter-treatment Period
Started 3
Completed 2
Not Completed 1
Reason Not Completed
Disease progression             1
Period Title: Allogeneic Peripheral Stem Cells
Started 2
Completed 2
Not Completed 0
Arm/Group Title Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL
Hide Arm/Group Description

Participants will have peripheral blood stem cells (PBSC, aka progenitor / stem cells) mobilized to peripheral blood with rituximab, chemotherapy (cyclophosphamide or etoposide), and filgrastim; undergo apheresis to collect (self/autologous PBSC), and receive carmustine, etoposide, and cyclophosphamide as conditioning for PBSC infusion as a hematopoietic cell transplant (auto-HCT).

Then participants will receive allogeneic HCT (allo-HCT) transplant conditioning [total lymphoid irradiation (TLI) + anti-thymocyte globulin (ATG)] followed by allogenic PBSC (allo-HCT) obtained from a human leukocyte antigen (HLA)-matched or single mismatch filgrastim-mobilized donor. Participant allo-HCT transplant is to occur within 150 days of auto-HCT. Post-allo-HCT treatment includes cyclosporine + mycophenolate mofetil (MMF).

Subject's participation ends if donor is not identified within 150 days. Pre-medication includes acetaminophen; diphenhydramine; hydrocortisone; & methylprednisolone.

Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
1
  33.3%
Male
2
  66.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
3
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 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
2
  66.7%
More than one race
0
   0.0%
Unknown or Not Reported
1
  33.3%
1.Primary Outcome
Title Event-free Survival (EFS) Per Protocol
Hide Description Event-free survival (EFS) through 4 years, as assessed in participants with poor-risk recurrent or primary refractory DLBCL treated with TLI and ATG followed by matched allogeneic hematopoietic cell transplantation as a consolidation to HCT. Event is defined as tumor progression or death.
Time Frame 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
Reported data values are limited by protocol-specified upper boundary for the timeframe of this assessment.
Arm/Group Title Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL
Hide Arm/Group Description:

Participants will have peripheral blood stem cells (PBSC, aka progenitor / stem cells) mobilized to peripheral blood with rituximab, chemotherapy (cyclophosphamide or etoposide), and filgrastim; undergo apheresis to collect (self/autologous PBSC), and receive carmustine, etoposide, and cyclophosphamide as conditioning for PBSC infusion as a hematopoietic cell transplant (auto-HCT).

Then participants will receive allogeneic HCT (allo-HCT) transplant conditioning [total lymphoid irradiation (TLI) + anti-thymocyte globulin (ATG)] followed by allogenic PBSC (allo-HCT) obtained from a human leukocyte antigen (HLA)-matched or single mismatch filgrastim-mobilized donor. Participant allo-HCT transplant is to occur within 150 days of auto-HCT. Post-allo-HCT treatment includes cyclosporine + mycophenolate mofetil (MMF).

Subject's participation ends if donor is not identified within 150 days. Pre-medication includes acetaminophen; diphenhydramine; hydrocortisone; & methylprednisolone.

Overall Number of Participants Analyzed 2
Median (95% Confidence Interval)
Unit of Measure: months
48
(48 to 48)
2.Secondary Outcome
Title Median Time to Neutrophil Engraftment After Autologous Transplant
Hide Description Reported as neutrophil engraftment after autologous transplant, defined as absolute neutrophil count (ANC) > 500/µL, counting from the day of transplant.
Time Frame within 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL
Hide Arm/Group Description:

Participants will have peripheral blood stem cells (PBSC, aka progenitor / stem cells) mobilized to peripheral blood with rituximab, chemotherapy (cyclophosphamide or etoposide), and filgrastim; undergo apheresis to collect (self/autologous PBSC), and receive carmustine, etoposide, and cyclophosphamide as conditioning for PBSC infusion as a hematopoietic cell transplant (auto-HCT).

Then participants will receive allogeneic HCT (allo-HCT) transplant conditioning [total lymphoid irradiation (TLI) + anti-thymocyte globulin (ATG)] followed by allogenic PBSC (allo-HCT) obtained from a human leukocyte antigen (HLA)-matched or single mismatch filgrastim-mobilized donor. Participant allo-HCT transplant is to occur within 150 days of auto-HCT. Post-allo-HCT treatment includes cyclosporine + mycophenolate mofetil (MMF).

Subject's participation ends if donor is not identified within 150 days. Pre-medication includes acetaminophen; diphenhydramine; hydrocortisone; & methylprednisolone.

Overall Number of Participants Analyzed 3
Median (Full Range)
Unit of Measure: Days
11
(9 to 12)
3.Secondary Outcome
Title Median Time to Platelet Engraftment After Autologous Transplant
Hide Description Reported as platelet engraftment after autologous transplant, defined as platelet count > 20,000/µL, counting from the day of transplant.
Time Frame within 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL
Hide Arm/Group Description:

Participants will have peripheral blood stem cells (PBSC, aka progenitor / stem cells) mobilized to peripheral blood with rituximab, chemotherapy (cyclophosphamide or etoposide), and filgrastim; undergo apheresis to collect (self/autologous PBSC), and receive carmustine, etoposide, and cyclophosphamide as conditioning for PBSC infusion as a hematopoietic cell transplant (auto-HCT).

Then participants will receive allogeneic HCT (allo-HCT) transplant conditioning [total lymphoid irradiation (TLI) + anti-thymocyte globulin (ATG)] followed by allogenic PBSC (allo-HCT) obtained from a human leukocyte antigen (HLA)-matched or single mismatch filgrastim-mobilized donor. Participant allo-HCT transplant is to occur within 150 days of auto-HCT. Post-allo-HCT treatment includes cyclosporine + mycophenolate mofetil (MMF).

Subject's participation ends if donor is not identified within 150 days. Pre-medication includes acetaminophen; diphenhydramine; hydrocortisone; & methylprednisolone.

Overall Number of Participants Analyzed 3
Median (95% Confidence Interval)
Unit of Measure: Days
19
(15 to 19)
4.Secondary Outcome
Title Median Time to Neutrophil Engraftment After Allogeneic Transplant
Hide Description Reported as neutrophil engraftment after allogeneic transplant, defined as absolute neutrophil count (ANC) > 500/µL, counting from the day of transplant.
Time Frame within 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL
Hide Arm/Group Description:

Participants will have peripheral blood stem cells (PBSC, aka progenitor / stem cells) mobilized to peripheral blood with rituximab, chemotherapy (cyclophosphamide or etoposide), and filgrastim; undergo apheresis to collect (self/autologous PBSC), and receive carmustine, etoposide, and cyclophosphamide as conditioning for PBSC infusion as a hematopoietic cell transplant (auto-HCT).

Then participants will receive allogeneic HCT (allo-HCT) transplant conditioning [total lymphoid irradiation (TLI) + anti-thymocyte globulin (ATG)] followed by allogenic PBSC (allo-HCT) obtained from a human leukocyte antigen (HLA)-matched or single mismatch filgrastim-mobilized donor. Participant allo-HCT transplant is to occur within 150 days of auto-HCT. Post-allo-HCT treatment includes cyclosporine + mycophenolate mofetil (MMF).

Subject's participation ends if donor is not identified within 150 days. Pre-medication includes acetaminophen; diphenhydramine; hydrocortisone; & methylprednisolone.

Overall Number of Participants Analyzed 2
Median (Full Range)
Unit of Measure: Days
10.5
(9 to 12)
5.Secondary Outcome
Title Median Time to Platelet Engraftment After Allogeneic Transplant
Hide Description Reported as platelet engraftment after allogeneic transplant, defined as platelet count > 20,000/µL, counting from the day of transplant.
Time Frame within 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
Note: all participants engrafted platelets on the same day (see below for data values).
Arm/Group Title Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL
Hide Arm/Group Description:

Participants will have peripheral blood stem cells (PBSC, aka progenitor / stem cells) mobilized to peripheral blood with rituximab, chemotherapy (cyclophosphamide or etoposide), and filgrastim; undergo apheresis to collect (self/autologous PBSC), and receive carmustine, etoposide, and cyclophosphamide as conditioning for PBSC infusion as a hematopoietic cell transplant (auto-HCT).

Then participants will receive allogeneic HCT (allo-HCT) transplant conditioning [total lymphoid irradiation (TLI) + anti-thymocyte globulin (ATG)] followed by allogenic PBSC (allo-HCT) obtained from a human leukocyte antigen (HLA)-matched or single mismatch filgrastim-mobilized donor. Participant allo-HCT transplant is to occur within 150 days of auto-HCT. Post-allo-HCT treatment includes cyclosporine + mycophenolate mofetil (MMF).

Subject's participation ends if donor is not identified within 150 days. Pre-medication includes acetaminophen; diphenhydramine; hydrocortisone; & methylprednisolone.

Overall Number of Participants Analyzed 2
Median (Full Range)
Unit of Measure: Days
10
(10 to 10)
6.Secondary Outcome
Title Incidence of Chronic Graft vs Host Disease (GvHD)
Hide Description The incidence of chronic graft vs host disease (GvHD) is reported as any events within 3 years. Note that GvHD was assessed per investigator judgement. There was no protocol-specified criteria of GvHD.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL
Hide Arm/Group Description:

Participants will have peripheral blood stem cells (PBSC, aka progenitor / stem cells) mobilized to peripheral blood with rituximab, chemotherapy (cyclophosphamide or etoposide), and filgrastim; undergo apheresis to collect (self/autologous PBSC), and receive carmustine, etoposide, and cyclophosphamide as conditioning for PBSC infusion as a hematopoietic cell transplant (auto-HCT).

Then participants will receive allogeneic HCT (allo-HCT) transplant conditioning [total lymphoid irradiation (TLI) + anti-thymocyte globulin (ATG)] followed by allogenic PBSC (allo-HCT) obtained from a human leukocyte antigen (HLA)-matched or single mismatch filgrastim-mobilized donor. Participant allo-HCT transplant is to occur within 150 days of auto-HCT. Post-allo-HCT treatment includes cyclosporine + mycophenolate mofetil (MMF).

Subject's participation ends if donor is not identified within 150 days. Pre-medication includes acetaminophen; diphenhydramine; hydrocortisone; & methylprednisolone.

Overall Number of Participants Analyzed 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
7.Secondary Outcome
Title Overall Survival (OS)
Hide Description To evaluate the overall and transplant related mortality rate, reported as the number of subjects remaining alive 3 years after transplant.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL
Hide Arm/Group Description:

Participants will have peripheral blood stem cells (PBSC, aka progenitor / stem cells) mobilized to peripheral blood with rituximab, chemotherapy (cyclophosphamide or etoposide), and filgrastim; undergo apheresis to collect (self/autologous PBSC), and receive carmustine, etoposide, and cyclophosphamide as conditioning for PBSC infusion as a hematopoietic cell transplant (auto-HCT).

Then participants will receive allogeneic HCT (allo-HCT) transplant conditioning [total lymphoid irradiation (TLI) + anti-thymocyte globulin (ATG)] followed by allogenic PBSC (allo-HCT) obtained from a human leukocyte antigen (HLA)-matched or single mismatch filgrastim-mobilized donor. Participant allo-HCT transplant is to occur within 150 days of auto-HCT. Post-allo-HCT treatment includes cyclosporine + mycophenolate mofetil (MMF).

Subject's participation ends if donor is not identified within 150 days. Pre-medication includes acetaminophen; diphenhydramine; hydrocortisone; & methylprednisolone.

Overall Number of Participants Analyzed 3
Measure Type: Count of Participants
Unit of Measure: Participants
2
  66.7%
Time Frame 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL
Hide Arm/Group Description

Participants will have peripheral blood stem cells (PBSC, aka progenitor / stem cells) mobilized to peripheral blood with rituximab, chemotherapy (cyclophosphamide or etoposide), and filgrastim; undergo apheresis to collect (self/autologous PBSC), and receive carmustine, etoposide, and cyclophosphamide as conditioning for PBSC infusion as a hematopoietic cell transplant (auto-HCT).

Then participants will receive allogeneic HCT (allo-HCT) transplant conditioning [total lymphoid irradiation (TLI) + anti-thymocyte globulin (ATG)] followed by allogenic PBSC (allo-HCT) obtained from a human leukocyte antigen (HLA)-matched or single mismatch filgrastim-mobilized donor. Participant allo-HCT transplant is to occur within 150 days of auto-HCT. Post-allo-HCT treatment includes cyclosporine + mycophenolate mofetil (MMF).

Subject's participation ends if donor is not identified within 150 days. Pre-medication includes acetaminophen; diphenhydramine; hydrocortisone; & methylprednisolone.

All-Cause Mortality
Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL
Affected / at Risk (%) # Events
Total   3/3 (100.00%)    
Blood and lymphatic system disorders   
Platelet count decrease * 1  1/3 (33.33%)  1
Recurrent lymphoma * 1 [1]  1/3 (33.33%)  2
lymph nodes * 1 [2]  1/3 (33.33%)  2
Gastrointestinal disorders   
Nausea * 1  1/3 (33.33%)  1
Mucositis * 1  2/3 (66.67%)  2
Constipation * 1  1/3 (33.33%)  1
Infections and infestations   
Febrile neutropenia * 1  2/3 (66.67%)  2
Respiratory, thoracic and mediastinal disorders   
Dyspnea * 1  1/3 (33.33%)  1
Skin and subcutaneous tissue disorders   
Thrush * 1  1/3 (33.33%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
[1]
Includes progressive lymphoma
[2]
left groin
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL
Affected / at Risk (%) # Events
Total   3/3 (100.00%)    
Blood and lymphatic system disorders   
Hypermetabolic lymphadenopathy * 1 [1]  1/3 (33.33%)  1
Leukopenic * 1  1/3 (33.33%)  1
Gastrointestinal disorders   
Mucositis * 1  1/3 (33.33%)  1
Nausea * 1  1/3 (33.33%)  1
General disorders   
Headache * 1  1/3 (33.33%)  1
Infections and infestations   
Bacteremia * 1  1/3 (33.33%)  1
facial cellulitis * 1  1/3 (33.33%)  1
Fever * 1 [2]  3/3 (100.00%)  3
Residual disease * 1 [3]  1/3 (33.33%)  1
Musculoskeletal and connective tissue disorders   
Myalgia * 1  1/3 (33.33%)  1
Nervous system disorders   
Peripheral sensory neuropathy * 1  1/3 (33.33%)  1
Respiratory, thoracic and mediastinal disorders   
Pleural effusion * 1  1/3 (33.33%)  1
Pneumonitis * 1  1/3 (33.33%)  1
Sinusitis * 1  1/3 (33.33%)  1
Skin and subcutaneous tissue disorders   
Maculo-papular rash * 1  1/3 (33.33%)  1
Thrush * 1  1/3 (33.33%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
[1]
In the necksupraclavicular area, axilla, chest wall, and groin.
[2]
Includes: Febrile Neutropenia
[3]
in the left groin
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
Layout table for Results Point of Contact information
Name/Title: Wen-Kai Weng, Assistant Professor of Medicine
Organization: Stanford University Medical Center
Phone: 650-723-7689
EMail: wkweng@stanford.edu
Layout table for additonal information
Responsible Party: Wen-Kai Weng, Stanford University
ClinicalTrials.gov Identifier: NCT00482053    
Other Study ID Numbers: IRB-06703
97355 ( Other Identifier: Stanford University alternate IRB Number )
BMT186 ( Other Identifier: OnCore number )
First Submitted: May 31, 2007
First Posted: June 4, 2007
Results First Submitted: October 25, 2017
Results First Posted: May 14, 2018
Last Update Posted: May 14, 2018