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Bortezomib and Chemotherapy in Treating Participants With Lymphoid Malignancies Undergoing Stem Cell Transplant

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ClinicalTrials.gov Identifier: NCT00439556
Recruitment Status : Completed
First Posted : February 23, 2007
Results First Posted : August 13, 2019
Last Update Posted : September 10, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions CD20 Positive
Hematopoietic and Lymphoid Cell Neoplasm
Lymphocytic Neoplasm
Lymphoma
Interventions Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Biological: Anti-Thymocyte Globulin
Drug: Bortezomib
Drug: Carmustine
Drug: Cytarabine
Drug: Etoposide
Biological: Filgrastim
Drug: Melphalan
Drug: Methotrexate
Biological: Rituximab
Drug: Tacrolimus
Enrollment 40
Recruitment Details Patients enrolled at MD Anderson clinic from February 2007 through May 2011.
Pre-assignment Details  
Arm/Group Title Velcade Dose Level 1 Velcade Dose Level 2 Velcade Dose Level 3
Hide Arm/Group Description BEAM (Carmustine/Etoposide/Cytarabine/Melphalan) + Rituxan + ATG (Thymoglobulin) (MUD pts only) + Velcade 1.0mg/m2 + ALLO SCT BEAM + Rituxan + ATG(MUD pts only) + Velcade 1.3mg/m2 + ALLO SCT BEAM + Rituxan + ATG(MUD pts only) + Velcade 1.6mg/m2 + ALLO SCT
Period Title: Overall Study
Started 36 4 0
Completed 36 3 0
Not Completed 0 1 0
Reason Not Completed
Patient was taken off study for non-comp             0             1             0
Arm/Group Title Velcade Dose Level 1 Velcade Dose Level 2 Velcade Dose Level 3 Total
Hide Arm/Group Description BEAM + Rituxan + ATG(MUD pts only) + Velcade (1-1.3mg/m2) + ALLO SCT BEAM + Rituxan + ATG(MUD pts only) + Velcade 1.3mg/m2 + ALLO SCT BEAM + Rituxan + ATG(MUD pts only) + Velcade 1.6mg/m2 + ALLO SCT Total of all reporting groups
Overall Number of Baseline Participants 36 3 0 39
Hide Baseline Analysis Population Description
Patients up to 70 years of age with any histological subtype of CD20+ lymphoid malignancy or T-Cell lymphoid malignancy who were not eligible for a non-myeloablative transplant.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 3 participants 0 participants 39 participants
<=18 years
0
   0.0%
0
   0.0%
0
0
   0.0%
Between 18 and 65 years
36
 100.0%
3
 100.0%
0
39
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 36 participants 3 participants 0 participants 39 participants
54
(22 to 65)
58
(47 to 65)
54
(22 to 65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 3 participants 0 participants 39 participants
Female
8
  22.2%
1
  33.3%
9
  23.1%
Male
28
  77.8%
2
  66.7%
30
  76.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 3 participants 0 participants 39 participants
Hispanic or Latino
5
  13.9%
0
   0.0%
5
  12.8%
Not Hispanic or Latino
4
  11.1%
0
   0.0%
4
  10.3%
Unknown or Not Reported
27
  75.0%
3
 100.0%
30
  76.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 3 participants 0 participants 39 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   5.6%
0
   0.0%
2
   5.1%
White
32
  88.9%
3
 100.0%
35
  89.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   5.6%
0
   0.0%
2
   5.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 36 participants 3 participants 0 participants 39 participants
36 3 39
Breakdown of Disease by Number of Participants in each Dose Level   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 3 participants 0 participants 39 participants
Large Cell Lymphoma
9
  25.0%
2
  66.7%
11
  28.2%
CLL
12
  33.3%
1
  33.3%
13
  33.3%
Folicular Lymphoma
8
  22.2%
0
   0.0%
8
  20.5%
Mantle Cell Lymphoma
2
   5.6%
0
   0.0%
2
   5.1%
Marginal Zone Lymphoma
1
   2.8%
0
   0.0%
1
   2.6%
T-Cell Lymphoma
4
  11.1%
0
   0.0%
4
  10.3%
[1]
Measure Description: Patients up to 70 years of age with any histological subtype of CD20+ lymphoid malignancy or T-Cell lymphoid malignancy who were not eligible for a non-myeloablative transplant.
1.Primary Outcome
Title Number of Participants With Dose Limiting Toxicity (DLT)
Hide Description To determine the maximum tolerated dose(MTD) of velcade and dose limiting toxicity(DLT). A dose limiting toxicity (DLT) was defined as a grade 3-4 neurological toxicity, graft failure, or death due to GvHD. The Commom Terminlogy Criteria for Adverse Events v3.0 was used.
Time Frame From start of treatment to 90 days after the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Patients up to 70 years of age with any histological subtype of CD20+ lymphoid malignancy or T-Cell lymphoid malignancy who were not eligible for a non-myeloablative transplant.
Arm/Group Title Treatment (Chemotherapy, Transplant, Filgrastim, Tacrolimus) Velcade Dose Level 2 Velcade Dose Level 3
Hide Arm/Group Description:
BEAM + Rituxan + ATG(MUD pts only) + Velcade (1-1.3mg/m2) + ALLO SCT
BEAM + Rituxan + ATG(MUD pts only) + Velcade 1.3mg/m2 + ALLO SCT
BEAM + Rituxan + ATG(MUD pts only) + Velcade 1.6mg/m2 + ALLO SCT
Overall Number of Participants Analyzed 36 3 0
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
2.Primary Outcome
Title Disease-free Survival
Hide Description To determine DFS at 1 year post transplant.
Time Frame At 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Patients up to 70 years of age with any histological subtype of CD20+ lymphoid malignancy or T-Cell lymphoid malignancy who were not eligible for a non-myeloablative transplant.
Arm/Group Title Velcade Dose Level 1 Velcade Dose Level 2 Velcade Dose Level 3
Hide Arm/Group Description:
BEAM + Rituxan + ATG(MUD pts only) + Velcade 1.0mg/m2 + ALLO SCT
BEAM + Rituxan + ATG(MUD pts only) + Velcade 1.3mg/m2 + ALLO SCT
BEAM + Rituxan + ATG(MUD pts only) + Velcade 1.6mg/m2 + ALLO SCT
Overall Number of Participants Analyzed 36 3 0
Measure Type: Count of Participants
Unit of Measure: Participants
16
  44.4%
0
   0.0%
0
Time Frame Up to 100 Days post transplant
Adverse Event Reporting Description There were no participants enrolled on Velcade dose level 3
 
Arm/Group Title Velcade Dose Level 1 Velcade Dose Level 2 Gemcitabine Dose Level 3
Hide Arm/Group Description BEAM + Rituxan + ATG(MUD pts only) + Velcade 1.0mg/m2 + ALLO SCT BEAM + Rituxan + ATG(MUD pts only) + Velcade 1.3mg/m2 + ALLO SCT BEAM + Rituxan + ATG(MUD pts only) + Velcade 1.6mg/m2 + ALLO SCT
All-Cause Mortality
Velcade Dose Level 1 Velcade Dose Level 2 Gemcitabine Dose Level 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/36 (16.67%)      2/3 (66.67%)      0/0    
Show Serious Adverse Events Hide Serious Adverse Events
Velcade Dose Level 1 Velcade Dose Level 2 Gemcitabine Dose Level 3
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/36 (16.67%)      2/3 (66.67%)      0/0    
General disorders       
Acute GvHD(graft vs Host Disease)  1  2/36 (5.56%)  2 0/3 (0.00%)  0 0/0  0
Infections and infestations       
Infection  1  4/36 (11.11%)  4 2/3 (66.67%)  2 0/0  0
1
Term from vocabulary, CTCAE v3.0
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%
Velcade Dose Level 1 Velcade Dose Level 2 Gemcitabine Dose Level 3
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   36/36 (100.00%)      3/3 (100.00%)      0/0    
Cardiac disorders       
Dysrhythmia  1  4/36 (11.11%)  4 0/3 (0.00%)  0 /0 
Decreased Cardiac Function  1  3/36 (8.33%)  3 0/3 (0.00%)  0 /0 
Hypertension  1  5/36 (13.89%)  5 0/3 (0.00%)  0 /0 
Gastrointestinal disorders       
Diarrhea  1  23/36 (63.89%)  23 3/3 (100.00%)  3 /0 
Mucositis  1  12/36 (33.33%)  12 2/3 (66.67%)  2 /0 
Nausea  1  31/36 (86.11%)  31 3/3 (100.00%)  3 /0 
General disorders       
Fluid Overload  1  13/36 (36.11%)  13 3/3 (100.00%)  3 /0 
Fever  1  13/36 (36.11%)  14 0/3 (0.00%)  0 /0 
Acute GvHD  1  24/36 (66.67%)  41 1/3 (33.33%)  1 /0 
Chronic GvHD  1  7/36 (19.44%)  9 2/3 (66.67%)  2 /0 
Hepatobiliary disorders       
Transaminitis  1  5/36 (13.89%)  5 0/3 (0.00%)  0 /0 
Infections and infestations       
Infection  1  27/36 (75.00%)  56 3/3 (100.00%)  5 /0 
Neutropenic Fever  1  19/36 (52.78%)  19 0/3 (0.00%)  0 /0 
Renal and urinary disorders       
Elevated Creatinine  1  3/36 (8.33%)  3 2/3 (66.67%)  2 /0 
Hemorrhagic Cystitis  1  1/36 (2.78%)  1 1/3 (33.33%)  1 /0 
Respiratory, thoracic and mediastinal disorders       
SOB (Shortness of breath)  1  5/36 (13.89%)  5 0/3 (0.00%)  0 /0 
1
Term from vocabulary, CTCAE v3.0
Indicates events were collected by systematic assessment
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. Khouri,Issa,M.D. / Stem Cell Transplantation
Organization: UT MD Anderson Cancer Center
Phone: 713-792-8750
EMail: ikhouri@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00439556     History of Changes
Other Study ID Numbers: 2006-0066
NCI-2018-01830 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2006-0066 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Submitted: February 22, 2007
First Posted: February 23, 2007
Results First Submitted: July 26, 2019
Results First Posted: August 13, 2019
Last Update Posted: September 10, 2019