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Post Transplant Donor Lymphocyte Infusion

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ClinicalTrials.gov Identifier: NCT00167180
Recruitment Status : Completed
First Posted : September 14, 2005
Results First Posted : July 11, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Leukemia, Myeloid, Chronic
Lymphomas
Multiple Myeloma
Myelodysplastic Syndrome
Leukemia, Lymphocytic, Acute
Leukemia, Lymphocytic, Chronic
AML
Interventions Procedure: Donor Lymphocyte Infusion
Drug: Induction Chemotherapy
Enrollment 57
Recruitment Details  
Pre-assignment Details During the recruitment period of the study, the donor lymphocyte infusion (DLI) was reduced from 1.0 x 10^8 CD3+ T-cells/kg to 0.5 x 10^8 CD3+ T-cells/kg due to an excess rate and intensity of graft vs. host disease.
Arm/Group Title Chronic Myelogenous Leukemia (CML) Non-CML or CML Failing Donor Lymphocyte Infusion
Hide Arm/Group Description

Patients who have failed or refused Gleevec (TM) therapy and will receive Donor Lymphocyte Infusion.

Donor Lymphocyte Infusion: donor cells infused over 2 hrs at cell dose of 0.5 dx 10^8 CD3+T-cells/kg

Patients with non-CML or CML who have failed DLI and will receive Induction Chemotherapy + DLI.

Induction Chemotherapy + DLI: Fludarabine 25 mg/m2 IV Cyclosphosphamide 60 mg/kg IV Donor Lymphocyte Infusion (DLI)

Period Title: Overall Study
Started 0 57
Completed 0 57
Not Completed 0 0
Arm/Group Title DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 15 42 57
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 42 participants 57 participants
<=18 years
1
   6.7%
2
   4.8%
3
   5.3%
Between 18 and 65 years
14
  93.3%
36
  85.7%
50
  87.7%
>=65 years
0
   0.0%
4
   9.5%
4
   7.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 42 participants 57 participants
Female
7
  46.7%
18
  42.9%
25
  43.9%
Male
8
  53.3%
24
  57.1%
32
  56.1%
1.Primary Outcome
Title Number of Patients Alive
Hide Description

The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate.

Overall survival will be defined as time from date of enrollment to date of death or censored at the date of last documented contact for patients still alive.

Time Frame 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 15 42
Measure Type: Count of Participants
Unit of Measure: Participants
3
  20.0%
20
  47.6%
2.Secondary Outcome
Title Number of Patients Alive Without Disease
Hide Description The number of patients alive one year after treatment without any signs or symptoms of the cancer being treated or any other type of cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works.
Time Frame 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 15 42
Measure Type: Count of Participants
Unit of Measure: Participants
2
  13.3%
10
  23.8%
3.Secondary Outcome
Title Number of Participants With Complete Remission
Hide Description In complete remission, all signs and symptoms of cancer that can be detected with modern technology have disappeared, although cancer still may be in the body.
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 15 42
Measure Type: Count of Participants
Unit of Measure: Participants
7
  46.7%
22
  52.4%
4.Secondary Outcome
Title Number of Patients With Acute Graft-Versus-Host Disease
Hide Description Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host.
Time Frame Day 100
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 15 42
Measure Type: Count of Participants
Unit of Measure: Participants
10
  66.7%
10
  23.8%
5.Secondary Outcome
Title Number of Patients With Bone Marrow Aplasia
Hide Description

Aplastic anemia is a disorder in which the bone marrow greatly decreases or stops production of blood cells.

In aplastic anemia, the basic structure of the marrow becomes abnormal, and those cells responsible for generating blood cells (hematopoietic cells) are greatly decreased in number or absent. These hematopoietic cells are replaced by large quantities of fat.

Time Frame Day 100
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 15 42
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   2.4%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   8/15 (53.33%)   3/42 (7.14%) 
General disorders     
Death, NOS  1/15 (6.67%)  0/42 (0.00%) 
Acute Graft vs. Host Disease  7/15 (46.67%)  1/42 (2.38%) 
Graft vs. Host Disease, NOS  0/15 (0.00%)  1/42 (2.38%) 
Infections and infestations     
Infection, NOS  1/15 (6.67%)  0/42 (0.00%) 
Acute Sepsis  1/15 (6.67%)  0/42 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary Failure  0/15 (0.00%)  1/42 (2.38%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   12/15 (80.00%)   11/42 (26.19%) 
Blood and lymphatic system disorders     
Hypovolemia  0/15 (0.00%)  1/42 (2.38%) 
Cardiac disorders     
Atrial Flutter  0/15 (0.00%)  1/42 (2.38%) 
Bradycardic Arrest  0/15 (0.00%)  1/42 (2.38%) 
Cardiac Arrhythmia  0/15 (0.00%)  1/42 (2.38%) 
New Q Wave  0/15 (0.00%)  1/42 (2.38%) 
Pericardial Effusion  0/15 (0.00%)  1/42 (2.38%) 
Systolic Ejection Murmur  0/15 (0.00%)  1/42 (2.38%) 
Tachycardia  0/15 (0.00%)  1/42 (2.38%) 
Eye disorders     
Retinal Hemorrhage  1/15 (6.67%)  0/42 (0.00%) 
Gastrointestinal disorders     
Gastrointestinal Hemorrhage  1/15 (6.67%)  2/42 (4.76%) 
Pancreatitis, NOS  0/15 (0.00%)  1/42 (2.38%) 
Small Bowel Obstruction  0/15 (0.00%)  1/42 (2.38%) 
Tubular Adenoma, Rectum  1/15 (6.67%)  0/42 (0.00%) 
General disorders     
Acute Graft vs. Host Disease  6/15 (40.00%)  0/42 (0.00%) 
Chronic Graft vs. Host Disease  1/15 (6.67%)  0/42 (0.00%) 
Graft vs. Host Disease, NOS  0/15 (0.00%)  1/42 (2.38%) 
Multi-System Organ Failure  0/15 (0.00%)  1/42 (2.38%) 
Immune system disorders     
Anaphylactic Reaction to Anti-Thymocyte Globulin  1/15 (6.67%)  0/42 (0.00%) 
Infections and infestations     
Bacterial Infection, NOS  3/15 (20.00%)  2/42 (4.76%) 
Blood Infection, Bacterial  1/15 (6.67%)  2/42 (4.76%) 
Blood Infection, Viral  1/15 (6.67%)  3/42 (7.14%) 
Bone Marrow Infection, Viral  0/15 (0.00%)  1/42 (2.38%) 
Eye Infection, NOS  0/15 (0.00%)  1/42 (2.38%) 
Fungal Infection, NOS  1/15 (6.67%)  0/42 (0.00%) 
Gastrointestinal Infection, Bacterial  0/15 (0.00%)  1/42 (2.38%) 
Gastrointestinal Infection, Fungal  1/15 (6.67%)  0/42 (0.00%) 
Genitourinary Infection, Bacterial  3/15 (20.00%)  1/42 (2.38%) 
Genitourinary Infection, Fungal  0/15 (0.00%)  1/42 (2.38%) 
Genitourinary Infection, Viral  0/15 (0.00%)  1/42 (2.38%) 
Mucosal Infection, Viral  1/15 (6.67%)  0/42 (0.00%) 
Nervous System Infection, Viral  1/15 (6.67%)  0/42 (0.00%) 
Pneumonia  3/15 (20.00%)  4/42 (9.52%) 
Respiratory Infection, Bacterial  0/15 (0.00%)  1/42 (2.38%) 
Respiratory Infection, NOS  1/15 (6.67%)  2/42 (4.76%) 
Sepsis  0/15 (0.00%)  1/42 (2.38%) 
Viral Infection, NOS  0/15 (0.00%)  3/42 (7.14%) 
Wound Infection, Bacterial  2/15 (13.33%)  0/42 (0.00%) 
Musculoskeletal and connective tissue disorders     
Scoliosis  0/15 (0.00%)  1/42 (2.38%) 
Nervous system disorders     
Difficulty with Speech  0/15 (0.00%)  1/42 (2.38%) 
Neuropathy  0/15 (0.00%)  1/42 (2.38%) 
Pachymeningeal Thickening  0/15 (0.00%)  1/42 (2.38%) 
Seizures  0/15 (0.00%)  1/42 (2.38%) 
Slow Thinking and Movement  0/15 (0.00%)  1/42 (2.38%) 
Status Epilepticus after Seizures  0/15 (0.00%)  1/42 (2.38%) 
Psychiatric disorders     
Decreased Consciousness and Delirium  1/15 (6.67%)  0/42 (0.00%) 
Renal and urinary disorders     
Acute Renal Failure  0/15 (0.00%)  1/42 (2.38%) 
Genitourinary Hemorrhage  0/15 (0.00%)  1/42 (2.38%) 
Hemorrhagic Cystitis  0/15 (0.00%)  1/42 (2.38%) 
Requires Dialysis, NOS  1/15 (6.67%)  1/42 (2.38%) 
Respiratory, thoracic and mediastinal disorders     
Acute Respiratory Distress Syndrome  0/15 (0.00%)  1/42 (2.38%) 
Fibrous Pneumonitis  0/15 (0.00%)  1/42 (2.38%) 
Pneumothorax  0/15 (0.00%)  1/42 (2.38%) 
Pulmonary Hemorrhage  0/15 (0.00%)  2/42 (4.76%) 
Pulmonary Hypertension  0/15 (0.00%)  1/42 (2.38%) 
Respiratory Arrest  2/15 (13.33%)  1/42 (2.38%) 
Respiratory Distress  0/15 (0.00%)  1/42 (2.38%) 
Vascular disorders     
Brain Infarction  0/15 (0.00%)  1/42 (2.38%) 
Deep Vein Thrombosis  1/15 (6.67%)  1/42 (2.38%) 
Splenic Infarcts  0/15 (0.00%)  1/42 (2.38%) 
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
Name/Title: Dr. Jeffrey Miller
Organization: Masonic Cancer Center, University of Minnesota
Phone: 612-625-7409
Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00167180     History of Changes
Obsolete Identifiers: NCT00303693
Other Study ID Numbers: 2004LS006
MT2003-15 ( Other Identifier: Blood and Marrow Transplantation Program )
0401M55207 ( Other Identifier: IRB, University of Minnesota )
First Submitted: September 9, 2005
First Posted: September 14, 2005
Results First Submitted: April 28, 2017
Results First Posted: July 11, 2017
Last Update Posted: December 5, 2017