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High Dose Chemotherapy and Stem Cell Transplant for Non-Hodgkin's Lymphoma or Central Nervous System (CNS) Lymphoma

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ClinicalTrials.gov Identifier: NCT01182415
Recruitment Status : Completed
First Posted : August 16, 2010
Results First Posted : December 29, 2017
Last Update Posted : December 29, 2017
Sponsor:
Collaborators:
Genentech, Inc.
Otsuka America Pharmaceutical
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Yi-Bin A. Chen, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Non-Hodgkin's Lymphoma
CNS Lymphoma
Interventions Procedure: Autologous stem cell transplant
Drug: High-dose chemotherapy
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title High-dose Chemotherapy With Autologous Stem Cell Transplant
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Autologous stem cell transplant: Autologous stem cell transplant following high-dose chemotherapy

High-dose chemotherapy: High-dose chemotherapy with rituximab, thiotepa, busulfan, and cyclosphosphamide

Period Title: Overall Study
Started 30
Completed 29
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
Arm/Group Title High-dose Chemotherapy With Autologous Stem Cell Transplant
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Autologous stem cell transplant: Autologous stem cell transplant following high-dose chemotherapy

High-dose chemotherapy: High-dose chemotherapy with rituximab, thiotepa, busulfan, and cyclosphosphamide

Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 30 participants
59
(24 to 74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
13
  43.3%
Male
17
  56.7%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
Histology   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Diffuse Large B-cell Lymphoma Number Analyzed 30 participants
27
  90.0%
CLL/ SLL Number Analyzed 30 participants
2
   6.7%
Follicular Non-Hodgkin lymphoma Number Analyzed 30 participants
1
   3.3%
[1]
Measure Description: CLL: Chronic lymphocytic leukemia SLL: Small lymphocytic lymphoma
Prior Treatment History  
Measure Type: Count of Participants
Unit of measure:  Participants
High-Dose Intravenous Methotrexate Number Analyzed 30 participants
29
  96.7%
High-Dose Cytarabine Number Analyzed 30 participants
3
  10.0%
Rituximab (Intravenous) Number Analyzed 30 participants
30
 100.0%
Whole brain radiation therapy (WBRT) Number Analyzed 30 participants
2
   6.7%
Other Radiation Therapy Number Analyzed 30 participants
8
  26.7%
1.Primary Outcome
Title Proportion of Patients With CNS Involvement by B-cell NHL, Relapsed PCNSL, or Relapsed PIOL Who Are Alive and Progression-free at One Year
Hide Description The proportion of patients with central nervous system (CNS) involvement by B-cell Non-Hodgkin's Lymphoma (NHL), relapsed primary central nervous system lymphoma (PCNSL), or relapsed primary intraocular lymphoma (PIOL) who are alive and progression-free at one year
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The participant that was lost to follow-up was not available for analysis.
Arm/Group Title High-dose Chemotherapy With Autologous Stem Cell Transplant
Hide Arm/Group Description:

Autologous stem cell transplant: Autologous stem cell transplant following high-dose chemotherapy

High-dose chemotherapy: High-dose chemotherapy with rituximab, thiotepa, busulfan, and cyclosphosphamide

Overall Number of Participants Analyzed 29
Measure Type: Count of Participants
Unit of Measure: Participants
28
  96.6%
2.Secondary Outcome
Title 2-year Progression Free Survival (PFS)
Hide Description The percentage of participants alive and without disease progression at 2 years.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
The participant that was lost to follow-up was not available for analysis.
Arm/Group Title High-dose Chemotherapy With Autologous Stem Cell Transplant
Hide Arm/Group Description:

Autologous stem cell transplant: Autologous stem cell transplant following high-dose chemotherapy

High-dose chemotherapy: High-dose chemotherapy with rituximab, thiotepa, busulfan, and cyclosphosphamide

Overall Number of Participants Analyzed 29
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
81
(59 to 92)
3.Secondary Outcome
Title 2-year Overall Survival (OS)
Hide Description The percentage of participants alive after two years
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
The participant that was lost to follow-up was not available for analysis.
Arm/Group Title High-dose Chemotherapy With Autologous Stem Cell Transplant
Hide Arm/Group Description:

Autologous stem cell transplant: Autologous stem cell transplant following high-dose chemotherapy

High-dose chemotherapy: High-dose chemotherapy with rituximab, thiotepa, busulfan, and cyclosphosphamide

Overall Number of Participants Analyzed 29
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
93
(76 to 98)
4.Secondary Outcome
Title Response Rate
Hide Description The number of participants that achieved complete remission following high dose chemotherapy and autologous stem cell transplantation (ASCT). Complete remission is defined as the disappearance of all evidence of disease.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The participant that was lost to follow-up was not available for analysis.
Arm/Group Title High-dose Chemotherapy With Autologous Stem Cell Transplant
Hide Arm/Group Description:

Autologous stem cell transplant: Autologous stem cell transplant following high-dose chemotherapy

High-dose chemotherapy: High-dose chemotherapy with rituximab, thiotepa, busulfan, and cyclosphosphamide

Overall Number of Participants Analyzed 29
Measure Type: Count of Participants
Unit of Measure: Participants
29
 100.0%
Time Frame From the start of treatment until disease progression, death, or until taken off study; median duration of 24 months.
Adverse Event Reporting Description All grade 3 or greater adverse events were considered to be serious adverse events regardless of whether or not the adverse event was believed to be treatment related.
 
Arm/Group Title High-dose Chemotherapy With Autologous Stem Cell Transplant
Hide Arm/Group Description

Autologous stem cell transplant: Autologous stem cell transplant following high-dose chemotherapy

High-dose chemotherapy: High-dose chemotherapy with rituximab, thiotepa, busulfan, and cyclosphosphamide

All-Cause Mortality
High-dose Chemotherapy With Autologous Stem Cell Transplant
Affected / at Risk (%)
Total   3/30 (10.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
High-dose Chemotherapy With Autologous Stem Cell Transplant
Affected / at Risk (%) # Events
Total   6/30 (20.00%)    
Blood and lymphatic system disorders   
Anemia  1  2/30 (6.67%)  2
Febrile neutropenia  1  1/30 (3.33%)  1
Gastrointestinal disorders   
Mucositis oral  1  1/30 (3.33%)  1
General disorders   
Gait disturbance  1  1/30 (3.33%)  1
Infections and infestations   
Lung infection  1  1/30 (3.33%)  1
Investigations   
Alanine aminotransferase increased  1  1/30 (3.33%)  1
Aspartate aminotransferase increased  1  1/30 (3.33%)  1
Lymphocyte count decreased  1  1/30 (3.33%)  2
Platelet count decreased  1  2/30 (6.67%)  2
Investigations - Other, specify  1  1/30 (3.33%)  1
Nervous system disorders   
Encephalopathy  1  1/30 (3.33%)  1
Psychiatric disorders   
Depression  1  1/30 (3.33%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumothorax  1  1/30 (3.33%)  1
Respiratory failure  1  1/30 (3.33%)  1
Vascular disorders   
Hypertension  1  1/30 (3.33%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
High-dose Chemotherapy With Autologous Stem Cell Transplant
Affected / at Risk (%) # Events
Total   0/30 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Yi-Bin Chen
Organization: Massachusetts General Hospital
Phone: 617-726-0187
EMail: YCHEN6@PARTNERS.ORG
Layout table for additonal information
Responsible Party: Yi-Bin A. Chen, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01182415     History of Changes
Other Study ID Numbers: 09-444
First Submitted: April 30, 2010
First Posted: August 16, 2010
Results First Submitted: November 27, 2017
Results First Posted: December 29, 2017
Last Update Posted: December 29, 2017