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Iodine I 131 Monoclonal Antibody BC8 Before Autologous Stem Cell Transplant in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma or Non-Hodgkin Lymphoma

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: NCT00860171
Recruitment Status : Active, not recruiting
First Posted : March 12, 2009
Results First Posted : October 12, 2017
Last Update Posted : December 13, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Recurrent B-Cell Non-Hodgkin Lymphoma
Recurrent Hodgkin Lymphoma
Recurrent T-Cell Non-Hodgkin Lymphoma
Refractory B-Cell Non-Hodgkin Lymphoma
Refractory Hodgkin Lymphoma
Refractory T-Cell Non-Hodgkin Lymphoma
Interventions: Procedure: Autologous Hematopoietic Stem Cell Transplantation
Radiation: Iodine I 131 Monoclonal Antibody BC8
Other: Laboratory Biomarker Analysis

  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
Treatment (Iodine I 131 Monoclonal Antibody B, Autologous HCT)

Patients receive a dosimetric dose of iodine I 131 monoclonal antibody BC8 IV on day -20 and a therapeutic dose on day -11. Before day -20, patients may also receive up to 2 additional dosimetric doses of iodine I 131 monoclonal antibody BC8 IV approximately 1-2 weeks apart. Patients then undergo autologous stem cell transplantation on day 0.

Autologous Hematopoietic Stem Cell Transplantation: Autologous stem cells given via central catheter

Iodine I 131 Monoclonal Antibody BC8: Given IV

Laboratory Biomarker Analysis: Correlative studies


Participant Flow:   Overall Study
    Treatment (Iodine I 131 Monoclonal Antibody B, Autologous HCT)
STARTED   16 
COMPLETED   16 
NOT COMPLETED   0 



  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
Treatment (Iodine I 131 Monoclonal Antibody B, Autologous HCT)

Patients receive a dosimetric dose of iodine I 131 monoclonal antibody BC8 IV on day -20 and a therapeutic dose on day -11. Before day -20, patients may also receive up to 2 additional dosimetric doses of iodine I 131 monoclonal antibody BC8 IV approximately 1-2 weeks apart. Patients then undergo autologous stem cell transplantation on day 0.

Autologous Hematopoietic Stem Cell Transplantation: Autologous stem cells given via central catheter

Iodine I 131 Monoclonal Antibody BC8: Given IV

Laboratory Biomarker Analysis: Correlative studies


Baseline Measures
   Treatment (Iodine I 131 Monoclonal Antibody B, Autologous HCT) 
Overall Participants Analyzed 
[Units: Participants]
 16 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.81  (15.63) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      6  37.5% 
Male      10  62.5% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      16 100.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   16 


  Outcome Measures

1.  Primary:   Maximum Tolerated Dose (MTD) of I-131-BC8 That Can be Delivered Prior to Transplant   [ Time Frame: Within 30 days post-transplant ]

2.  Primary:   I-131 Activity Administered   [ Time Frame: At time of I-131 therapy ]

3.  Secondary:   Adverse Events   [ Time Frame: Up to 6 years ]

4.  Secondary:   Overall Survival   [ Time Frame: Up to 6 years ]

5.  Secondary:   Progression-free Survival   [ Time Frame: Up to 6 years ]
Results not yet reported.   Anticipated Reporting Date:   12/2018  

6.  Secondary:   Relapse Rate   [ Time Frame: Up to 6 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
This protocol was closed to enrollment when replaced by a newer approach.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Ajay K. Gopal, MD
Organization: Fred Hutchinson Cancer Research Center
phone: 206-288-2037
e-mail: agopal@u.washington.edu



Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00860171     History of Changes
Other Study ID Numbers: 2238.00
NCI-2010-00128 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2238.00 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P01CA044991 ( U.S. NIH Grant/Contract )
P30CA015704 ( U.S. NIH Grant/Contract )
First Submitted: March 11, 2009
First Posted: March 12, 2009
Results First Submitted: October 7, 2016
Results First Posted: October 12, 2017
Last Update Posted: December 13, 2017