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Donor Lymphocyte Infusion in Treating Patients With Persistent, Relapsed, or Progressing Cancer After Donor Hematopoietic Cell Transplant

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Brenda Sandmaier, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00068718
First received: September 10, 2003
Last updated: March 10, 2017
Last verified: March 2017
Results First Received: January 20, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Conditions: Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Recurrent Adult Acute Lymphoblastic Leukemia
Recurrent Adult Acute Myeloid Leukemia
Recurrent Hodgkin Lymphoma
Recurrent Non-Hodgkin Lymphoma
Recurrent Plasma Cell Myeloma
Intervention: Biological: Therapeutic Allogeneic Lymphocytes

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Treatment (DLI)

Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.

Therapeutic Allogeneic Lymphocytes: Given IV


Participant Flow:   Overall Study
    Treatment (DLI)
STARTED   35 
COMPLETED   35 
NOT COMPLETED   0 



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Treatment (DLI)

Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.

Therapeutic Allogeneic Lymphocytes: Given IV


Baseline Measures
   Treatment (DLI) 
Overall Participants Analyzed 
[Units: Participants]
 35 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      28  80.0% 
>=65 years      7  20.0% 
Age 
[Units: Years]
Median (Full Range)
 59.2 
 (21 to 74) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      15  42.9% 
Male      20  57.1% 
Region of Enrollment 
[Units: Participants]
 
United States   26 
Italy   9 


  Outcome Measures
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1.  Primary:   Safety of DLI Following a Non-myeloablative Transplant, Defined as Incidence of Grade IV Acute GVHD   [ Time Frame: 100 days after DLI ]

2.  Secondary:   Incidence of Graft Rejection   [ Time Frame: 100 days after DLI ]

3.  Secondary:   Incidence of Relapse/Progression   [ Time Frame: 1 year after DLI ]

4.  Secondary:   Incidence of Grade II-IV GVHD in Patients Undergoing DLI Following a Non-myeloablative Transplant   [ Time Frame: 100 days after DLI ]

5.  Secondary:   Incidence of Infections in Patients Undergoing DLI Following a Non-myeloablative Transplant   [ Time Frame: 100 days after DLI ]

6.  Secondary:   Overall Survival   [ Time Frame: 1 year after DLI ]

7.  Secondary:   Progression-free Survival   [ Time Frame: 1 year after DLI ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Brenda M. Sandmaier
Organization: Fred Hutchinson Cancer Research Center
phone: (206) 667-4961
e-mail: bsandmai@fhcrc.org



Responsible Party: Brenda Sandmaier, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00068718     History of Changes
Other Study ID Numbers: 1803.00
NCI-2010-00163 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
1803.00 ( Other Identifier: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium )
P01CA078902 ( US NIH Grant/Contract Award Number )
P30CA015704 ( US NIH Grant/Contract Award Number )
Study First Received: September 10, 2003
Results First Received: January 20, 2017
Last Updated: March 10, 2017