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Monoclonal Antibody Therapy Before Stem Cell Transplant in Treating Patients With Relapsed or Refractory Lymphoid Malignancies

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: NCT01678443
Recruitment Status : Active, not recruiting
First Posted : September 5, 2012
Results First Posted : November 9, 2017
Last Update Posted : November 9, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Adult Nasal Type Extranodal NK/T-cell Lymphoma
Anaplastic Large Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
Cutaneous B-cell Non-Hodgkin Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Hepatosplenic T-cell Lymphoma
Intraocular Lymphoma
Nodal Marginal Zone B-cell Lymphoma
Noncutaneous Extranodal Lymphoma
Peripheral T-cell Lymphoma
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Adult Grade III Lymphomatoid Granulomatosis
Recurrent Adult Hodgkin Lymphoma
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Adult T-cell Leukemia/Lymphoma
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Mycosis Fungoides/Sezary Syndrome
Recurrent Small Lymphocytic Lymphoma
Refractory Hairy Cell Leukemia
Small Intestine Lymphoma
Splenic Marginal Zone Lymphoma
T-cell Large Granular Lymphocyte Leukemia
Testicular Lymphoma
Waldenström Macroglobulinemia
Interventions: Biological: indium In 111 anti-CD45 monoclonal antibody BC8
Radiation: yttrium Y 90 anti-CD45 monoclonal antibody BC8
Procedure: peripheral blood stem cell transplantation

  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 (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8)

Patients receive indium-111 anti-CD45 monoclonal antibody BC8 IV on day -28 and (if necessary) day -21. Patients receive yttrium-90 anti-CD45 monoclonal antibody BC8 IV on day -28, -14, and -13. Patients then undergo autologous peripheral blood stem cell transplantation on day 0.

indium In 111 anti-CD45 monoclonal antibody BC8: Given IV

yttrium Y 90 anti-CD45 monoclonal antibody BC8: Given IV

peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell transplant


Participant Flow:   Overall Study
    Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8)
STARTED   2 
COMPLETED   2 
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 (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8)

Patients receive indium-111 anti-CD45 monoclonal antibody BC8 IV on day -28 and (if necessary) day -21. Patients receive yttrium-90 anti-CD45 monoclonal antibody BC8 IV on day -28, -14, and -13. Patients then undergo autologous peripheral blood stem cell transplantation on day 0.

indium In 111 anti-CD45 monoclonal antibody BC8: Given IV

yttrium Y 90 anti-CD45 monoclonal antibody BC8: Given IV

peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell transplant


Baseline Measures
   Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8) 
Overall Participants Analyzed 
[Units: Participants]
 2 
Age 
[Units: Years]
Mean (Standard Deviation)
 52  (0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      1  50.0% 
Male      1  50.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      2 100.0% 
Unknown or Not Reported      0   0.0% 
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      1  50.0% 
White      1  50.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   2 


  Outcome Measures

1.  Primary:   Percentage of Participants With Dose Limiting Toxicities (DLT) of Yttrium-90 Anti-CD45   [ Time Frame: Up to 30 days after receiving study drug ]

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

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

4.  Secondary:   Progression-free Survival   [ Time Frame: Up to 6 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Tumor to Normal Organ Ratios   [ 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 study was closed when replaced by a new study adding chemotherapy to this regimen


  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: Ajay Gopal, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01678443     History of Changes
Other Study ID Numbers: 2361.00
NCI-2012-01505 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2361.00 ( Other Identifier: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium )
P01CA044991 ( U.S. NIH Grant/Contract )
P30CA015704 ( U.S. NIH Grant/Contract )
First Submitted: August 31, 2012
First Posted: September 5, 2012
Results First Submitted: October 7, 2016
Results First Posted: November 9, 2017
Last Update Posted: November 9, 2017