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Donor T Cells After Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies

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ClinicalTrials.gov Identifier: NCT01839916
Recruitment Status : Completed
First Posted : April 25, 2013
Results First Posted : August 7, 2019
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Chicago

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Accelerated Phase Chronic Myelogenous Leukemia
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Adult Nasal Type Extranodal NK/T-cell Lymphoma
Anaplastic Large Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
Blastic Phase Chronic Myelogenous Leukemia
Childhood Burkitt Lymphoma
Childhood Chronic Myelogenous Leukemia
Childhood Diffuse Large Cell Lymphoma
Childhood Immunoblastic Large Cell Lymphoma
Childhood Myelodysplastic Syndromes
Childhood Nasal Type Extranodal NK/T-cell Lymphoma
Chronic Phase Chronic Myelogenous Leukemia
Cutaneous B-cell Non-Hodgkin Lymphoma
de Novo Myelodysplastic Syndromes
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
Post-transplant Lymphoproliferative Disorder
Previously Treated Myelodysplastic Syndromes
Recurrent Adult Acute Lymphoblastic Leukemia
Recurrent Adult Acute Myeloid Leukemia
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 Childhood Acute Lymphoblastic Leukemia
Recurrent Childhood Acute Myeloid Leukemia
Recurrent Childhood Anaplastic Large Cell Lymphoma
Recurrent Childhood Grade III Lymphomatoid Granulomatosis
Recurrent Childhood Large Cell Lymphoma
Recurrent Childhood Lymphoblastic Lymphoma
Recurrent Childhood Small Noncleaved Cell 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
Recurrent/Refractory Childhood Hodgkin Lymphoma
Refractory Chronic Lymphocytic Leukemia
Refractory Hairy Cell Leukemia
Relapsing Chronic Myelogenous Leukemia
Secondary Myelodysplastic Syndromes
Small Intestine Lymphoma
Splenic Marginal Zone Lymphoma
T-cell Large Granular Lymphocyte Leukemia
Testicular Lymphoma
Waldenström Macroglobulinemia
Interventions Biological: therapeutic allogeneic lymphocytes
Other: laboratory biomarker analysis
Enrollment 77
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (DLI)
Hide Arm/Group Description

Patients receive DLI IV. Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity.

therapeutic allogeneic lymphocytes: Given IV

laboratory biomarker analysis: Correlative studies

Period Title: Overall Study
Started 77
Completed 36
Not Completed 41
Reason Not Completed
Death             9
Physician Decision             17
Relapse             12
GVHD             2
Graft Failure             1
Arm/Group Title Treatment (DLI)
Hide Arm/Group Description

Patients receive DLI IV. Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity.

therapeutic allogeneic lymphocytes: Given IV

laboratory biomarker analysis: Correlative studies

Overall Number of Baseline Participants 77
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 77 participants
53
(20 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants
Female
26
  33.8%
Male
51
  66.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants
American Indian or Alaska Native
0
   0.0%
Asian
3
   3.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
   3.9%
White
70
  90.9%
More than one race
0
   0.0%
Unknown or Not Reported
1
   1.3%
1.Primary Outcome
Title Percentage of Patients Who Are Able to Receive at Least One DLI Treatment
Hide Description [Not Specified]
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (DLI)
Hide Arm/Group Description:

Patients receive DLI IV. Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity.

therapeutic allogeneic lymphocytes: Given IV

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 77
Measure Type: Count of Participants
Unit of Measure: Participants
36
  46.8%
2.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description Time to relapse or death as a result of any cause was evaluated at 2 years and the progression free survival rate was reported.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients received at least one DLI Treatment.
Arm/Group Title Treatment (DLI)
Hide Arm/Group Description:

Patients receive DLI IV. Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity.

therapeutic allogeneic lymphocytes: Given IV

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 36
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
43
(29 to 63.9)
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description Computed using the Kaplan-Meier product-limit estimate and expressed as probabilities with a 95% CI.
Time Frame At 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients received at least one DLI Treatment.
Arm/Group Title Treatment (DLI)
Hide Arm/Group Description:

Patients receive DLI IV. Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity.

therapeutic allogeneic lymphocytes: Given IV

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 36
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
59.7
(44.8 to 79.4)
4.Secondary Outcome
Title Rate of Acute GVHD (aGVHD) With Any Grade
Hide Description Estimated by cumulative incidence method.
Time Frame At 1 year and 2 year
Hide Outcome Measure Data
Hide Analysis Population Description
Patients received at least one DLI Treatment.
Arm/Group Title Treatment (DLI)
Hide Arm/Group Description:

Patients receive DLI IV. Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity.

therapeutic allogeneic lymphocytes: Given IV

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 36
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
At 1 year
41.8
(24.6 to 58.1)
At 2 year
41.8
(24.6 to 58.1)
5.Secondary Outcome
Title Rate of Chronic GVHD (cGVHD)
Hide Description Estimated by cumulative incidence method.
Time Frame At 1 year and 2 year
Hide Outcome Measure Data
Hide Analysis Population Description
Patients received at least one DLI treatment.
Arm/Group Title Treatment (DLI)
Hide Arm/Group Description:

Patients receive DLI IV. Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity.

therapeutic allogeneic lymphocytes: Given IV

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 36
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
At 1 year
26.6
(12.2 to 43.4)
At 2 year
26.6
(12.2 to 43.4)
6.Secondary Outcome
Title Treatment-related Mortality
Hide Description Estimated by cumulative incidence method. Cumulative incidence of treatment-related mortality with relapse of the original disease as the competing risk will be calculated.
Time Frame At 2 year
Hide Outcome Measure Data
Hide Analysis Population Description
Patients received at least one DLI treatment.
Arm/Group Title Treatment (DLI)
Hide Arm/Group Description:

Patients receive DLI IV. Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity.

therapeutic allogeneic lymphocytes: Given IV

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 36
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
12.1
(3.7 to 25.9)
Time Frame 2 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (DLI)
Hide Arm/Group Description

Patients receive DLI IV. Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity.

therapeutic allogeneic lymphocytes: Given IV

laboratory biomarker analysis: Correlative studies

All-Cause Mortality
Treatment (DLI)
Affected / at Risk (%)
Total   17/36 (47.22%) 
Hide Serious Adverse Events
Treatment (DLI)
Affected / at Risk (%)
Total   12/36 (33.33%) 
Gastrointestinal disorders   
Diarrhea from drug   1/36 (2.78%) 
Viral diarrhea   1/36 (2.78%) 
General disorders   
Death   2/36 (5.56%) 
Fever   2/36 (5.56%) 
Immune system disorders   
Disseminated zoster   1/36 (2.78%) 
Infections and infestations   
Infection   1/36 (2.78%) 
Injury, poisoning and procedural complications   
Burn   1/36 (2.78%) 
leg fracture due to fall   1/36 (2.78%) 
Investigations   
Liver GVHD   2/36 (5.56%) 
Nervous system disorders   
Dizziness   1/36 (2.78%) 
nervous system disorder   1/36 (2.78%) 
Renal and urinary disorders   
Acute Kindey Injury   1/36 (2.78%) 
Small Bowel obstruction   1/36 (2.78%) 
Reproductive system and breast disorders   
Pneumonia   1/36 (2.78%) 
Respiratory, thoracic and mediastinal disorders   
Bronchopulmonary hemorrhage   1/36 (2.78%) 
Skin and subcutaneous tissue disorders   
Rash   1/36 (2.78%) 
Vascular disorders   
Hypotension   1/36 (2.78%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (DLI)
Affected / at Risk (%)
Total   1/36 (2.78%) 
Infections and infestations   
Sepsis   1/36 (2.78%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Hongtao Liu
Organization: University of Chicago
Phone: 773-834-1736
EMail: hliu2@medicine.bsd.uchicago.edu
Layout table for additonal information
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01839916    
Other Study ID Numbers: 12-1191
NCI-2013-00782 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: April 22, 2013
First Posted: April 25, 2013
Results First Submitted: June 12, 2019
Results First Posted: August 7, 2019
Last Update Posted: August 7, 2019