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Rituxan + BEAM and Auto Stem Cell Transplant for High Risk Lymphoma or Hodgkin's Disease (Rituxan+BEAM)

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ClinicalTrials.gov Identifier: NCT01702961
Recruitment Status : Active, not recruiting
First Posted : October 10, 2012
Results First Posted : September 28, 2015
Last Update Posted : June 29, 2018
Sponsor:
Collaborators:
The Methodist Hospital System
Center for Cell and Gene Therapy, Baylor College of Medicine
Information provided by (Responsible Party):
George Carrum, Baylor College of Medicine

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Lymphoma
Hodgkin's Disease
Interventions Drug: Melphalan
Drug: Ara-C
Drug: VP-16
Drug: BCNU
Drug: Rituxan
Drug: Stem Cells
Enrollment 75
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rituxan+BEAM: Autologous Stem Cell Transplant
Hide Arm/Group Description

Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning.

Melphalan: Given on Day -1

Melphalan is administered according to the current SOP.

Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2

VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2

BCNU: BCNU 300 mg/m2 IV given on Day -6

Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28

Stem Cells: Stem cells given on Day 0

Period Title: Overall Study
Started 75
Completed 28
Not Completed 47
Reason Not Completed
Additional treatment             3
Progressive disease             5
Relapse             20
Death             6
Lost to Follow-up             2
Ongoing             11
Arm/Group Title Rituxan+BEAM: Autologous Stem Cell Transplant
Hide Arm/Group Description

Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells

BEAM Conditioning.

Melphalan: Given on Day -1

Melphalan is administered according to the current SOP.

Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2

VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2

BCNU: BCNU 300 mg/m2 IV given on Day -6

Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28

Stem Cells: Stem cells given on Day 0

Overall Number of Baseline Participants 75
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 75 participants
53
(14 to 69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants
Female
32
  42.7%
Male
43
  57.3%
Disease at diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 75 participants
Hodgkin’s Disease 25
Non-Hodgkin’s Lymphoma 50
1.Primary Outcome
Title Disease-free Survival
Hide Description Disease-free survival at 12 months post-transplant in patients with Hodgkin's disease or non-Hodgkin’s lymphomas
Time Frame 12 months post-transplant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BEAM + R: Autologous Stem Cell Transplant
Hide Arm/Group Description:

Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning.

Melphalan: Given on Day -1

Melphalan is administered according to the current SOP.

Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2

VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2

BCNU: BCNU 300 mg/m2 IV given on Day -6

Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28

Stem Cells: Stem cells given on Day 0

Overall Number of Participants Analyzed 75
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participant
All patients
76
(65 to 84)
Hodgkin's Disease
88
(67 to 96)
Non-Hodgkin’s Lymphomas
70
(55 to 81)
2.Secondary Outcome
Title Median Days to Neutrophil Engraftment
Hide Description Neutrophil engraftment was recorded as the first day that absolute neutrophil counts (ANC) exceeds 0.5 X 10^9/L for three consecutive readings.
Time Frame 30 days post-transplant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All of the participants enrolled in the study engrafted.
Arm/Group Title BEAM + R: Autologous Stem Cell Transplant
Hide Arm/Group Description:

Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning.

Melphalan: Given on Day -1

Melphalan is administered according to the current SOP.

Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2

VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2

BCNU: BCNU 300 mg/m2 IV given on Day -6

Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28

Stem Cells: Stem cells given on Day 0

Overall Number of Participants Analyzed 75
Median (Full Range)
Unit of Measure: days
11
(9 to 23)
3.Secondary Outcome
Title Number of Participants With Overall Best Response Achieved After Transplantation
Hide Description Response was summarized as complete remission (CR): disappearance of all evidence of disease; partial remission (PR): regression of measurable disease (>=50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses) and no new sites; stable disease (SD): failure to attain CR/PR/PD; relapsed disease or progressive disease (PD): any new lesion or increase by >= 50% of previously involved sites from nadir.
Time Frame 3 months post-transplant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis comprised of all participants who received standard BEAM chemotherapy and adjuvant rituximab while undergoing autologous blood stem cell transplantation for high-risk lymphoma or Hodgkin’s disease.
Arm/Group Title BEAM + R: Autologous Stem Cell Transplant
Hide Arm/Group Description:

Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning.

Melphalan: Given on Day -1

Melphalan is administered according to the current SOP.

Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2

VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2

BCNU: BCNU 300 mg/m2 IV given on Day -6

Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28

Stem Cells: Stem cells given on Day 0

Overall Number of Participants Analyzed 75
Measure Type: Number
Unit of Measure: participants
Complete Remission (CR) 63
Partial Remission (PR) 8
Stable Disease (SD) 0
Relapsed Disease or Progressive Disease (PD) 4
Time Frame Adverse events related to the study drug, rituximab, are reported during the period of 30 days after transplant.
Adverse Event Reporting Description Only related adverse events were collected for this study.
 
Arm/Group Title Rituxan+BEAM: Autologous Stem Cell Transplant
Hide Arm/Group Description

Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning.

BEAM Conditioning.

Melphalan: Given on Day -1

Melphalan is administered according to the current SOP.

Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2

VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2

BCNU: BCNU 300 mg/m2 IV given on Day -6

Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28

Stem Cells: Stem cells given on Day 0

All-Cause Mortality
Rituxan+BEAM: Autologous Stem Cell Transplant
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Rituxan+BEAM: Autologous Stem Cell Transplant
Affected / at Risk (%) # Events
Total   1/75 (1.33%)    
Infections and infestations   
Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia  1 [1]  1/75 (1.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
[1]
Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia (ANC <1.0 x 10e9/L)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Rituxan+BEAM: Autologous Stem Cell Transplant
Affected / at Risk (%) # Events
Total   2/75 (2.67%)    
Cardiac disorders   
Cardiovascular/ General - Other  1  1/75 (1.33%)  1
Gastrointestinal disorders   
Stomatitis/pharyngitis (oral/pharyngeal mucositis)  1  1/75 (1.33%)  1
General disorders   
Pain - Other  1  1/75 (1.33%)  1
Infections and infestations   
Infection without neutropenia  1  1/75 (1.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: George Carrum, MD
Organization: Baylor College of Medicine
Responsible Party: George Carrum, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01702961     History of Changes
Other Study ID Numbers: H-11892
Rituxan+BEAM ( Other Identifier: BCM Center for Cell and Gene Therapy )
First Submitted: October 5, 2012
First Posted: October 10, 2012
Results First Submitted: August 27, 2015
Results First Posted: September 28, 2015
Last Update Posted: June 29, 2018