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
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Sponsor:
M.D. Anderson Cancer Center
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
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Study Type | Interventional |
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Study Design | Allocation: N/A; 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 |
Participant Flow
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 |
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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 |
Baseline Characteristics
Arm/Group Title | Velcade Dose Level 1 | Velcade Dose Level 2 | Velcade Dose Level 3 | Total | |
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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 | |
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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.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 36 participants | 3 participants | 0 participants | 39 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 |
0 0.0%
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Between 18 and 65 years |
36 100.0%
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3 100.0%
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0 |
39 100.0%
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>=65 years |
0 0.0%
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0 0.0%
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0 |
0 0.0%
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 36 participants | 3 participants | 0 participants | 39 participants | |
54
(22 to 65)
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58
(47 to 65)
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54
(22 to 65)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 36 participants | 3 participants | 0 participants | 39 participants | |
Female |
8 22.2%
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1 33.3%
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9 23.1%
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Male |
28 77.8%
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2 66.7%
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30 76.9%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 36 participants | 3 participants | 0 participants | 39 participants | |
Hispanic or Latino |
5 13.9%
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0 0.0%
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5 12.8%
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Not Hispanic or Latino |
4 11.1%
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0 0.0%
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4 10.3%
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Unknown or Not Reported |
27 75.0%
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3 100.0%
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30 76.9%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 36 participants | 3 participants | 0 participants | 39 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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Asian |
0 0.0%
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0 0.0%
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0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
2 5.6%
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0 0.0%
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2 5.1%
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White |
32 88.9%
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3 100.0%
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35 89.7%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
2 5.6%
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0 0.0%
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2 5.1%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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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%
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2 66.7%
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11 28.2%
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CLL |
12 33.3%
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1 33.3%
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13 33.3%
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Folicular Lymphoma |
8 22.2%
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0 0.0%
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8 20.5%
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Mantle Cell Lymphoma |
2 5.6%
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0 0.0%
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2 5.1%
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Marginal Zone Lymphoma |
1 2.8%
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0 0.0%
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1 2.6%
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T-Cell Lymphoma |
4 11.1%
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0 0.0%
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4 10.3%
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[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.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Dr. Khouri,Issa,M.D. / Stem Cell Transplantation |
Organization: | UT MD Anderson Cancer Center |
Phone: | 713-792-8750 |
EMail: | ikhouri@mdanderson.org |
Responsible Party: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00439556 |
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 |