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	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
Arm/Group Description	BEAM (Carmustine/Etoposide/Cytarabi...	BEAM + Rituxan + ATG(MUD pts only) ...	BEAM + Rituxan + ATG(MUD pts only) ...
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

Baseline Characteristics

Arm/Group Title		Velcade Dose Level 1	Velcade Dose Level 2	Velcade Dose Level 3	Total
Arm/Group Description		BEAM + Rituxan + ATG(MUD pts only) ...	BEAM + Rituxan + ATG(MUD pts only) ...	BEAM + Rituxan + ATG(MUD pts only) ...	Total of all reporting groups
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
Baseline Analysis Population Description		...
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
United States		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.

Outcome Measures

1.Primary Outcome


Title	Number of Participants With Dose Limiting Toxicity (DLT)
Description	To determine the maximum tolerated dose(MTD) of velcade and dose limit...
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

Outcome Measure Data

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
Arm/Group Description:	BEAM + Rituxan + ATG(MUD pts only) ...	BEAM + Rituxan + ATG(MUD pts only) ...	BEAM + Rituxan + ATG(MUD pts only) ...
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
Description	To determine DFS at 1 year post transplant.
Description	To determine DFS at 1 year post transplant.
Time Frame	At 1 year

Outcome Measure Data

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
Arm/Group Description:	BEAM + Rituxan + ATG(MUD pts only) ...	BEAM + Rituxan + ATG(MUD pts only) ...	BEAM + Rituxan + ATG(MUD pts only) ...
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

Adverse Events

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
Arm/Group Description	BEAM + Rituxan + ATG(MUD pts only) ...		BEAM + Rituxan + ATG(MUD pts only) ...		BEAM + Rituxan + ATG(MUD pts only) ...
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
Serious Adverse Events 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
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

Limitations and Caveats

[Not Specified]

More Information

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
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

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