ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Rituxan+BEAM: Autologous Stem Cell Transplant

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


Participant Flow:   Overall Study
    Rituxan+BEAM: Autologous Stem Cell Transplant
STARTED   75 
COMPLETED   28 
NOT COMPLETED   47 
Additional treatment                3 
Progressive disease                5 
Relapse                20 
Death                6 
Lost to Follow-up                2 
Ongoing                11 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Rituxan+BEAM: Autologous Stem Cell Transplant

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


Baseline Measures
   Rituxan+BEAM: Autologous Stem Cell Transplant 
Overall Participants Analyzed 
[Units: Participants]
 75 
Age 
[Units: Years]
Median (Full Range)
 53 
 (14 to 69) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      32  42.7% 
Male      43  57.3% 
Disease at diagnosis 
[Units: Participants]
 
Hodgkin’s Disease   25 
Non-Hodgkin’s Lymphoma   50 


  Outcome Measures

1.  Primary:   Disease-free Survival   [ Time Frame: 12 months post-transplant ]

2.  Secondary:   Median Days to Neutrophil Engraftment   [ Time Frame: 30 days post-transplant ]

3.  Secondary:   Number of Participants With Overall Best Response Achieved After Transplantation   [ Time Frame: 3 months post-transplant ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: GCarrum@houstonmethodist.org



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