Trial Outcomes & Findings for Post Transplant Donor Lymphocyte Infusion (NCT NCT00167180)
NCT ID: NCT00167180
Last Updated: 2019-07-30
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
57 participants
Primary outcome timeframe
1 Year
Results posted on
2019-07-30
Participant Flow
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.
Participant milestones
| Measure |
Chronic Myelogenous Leukemia (CML)
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
|
Non-CML or CML Failing Donor Lymphocyte Infusion
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)
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
57
|
|
Overall Study
COMPLETED
|
0
|
57
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post Transplant Donor Lymphocyte Infusion
Baseline characteristics by cohort
| Measure |
DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg
n=15 Participants
Cyclophosphamide 60mg/kg IV over 2 hours Fludarabine 25 mg/m2 IV over 30 minutes DLI Cell Dose 1.0 x 10\^8 CD3+ T-cells/kg
|
DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg
n=42 Participants
Cyclophosphamide 60mg/kg IV over 2 hours Fludarabine 25 mg/m2 DLI Cell Dose 0.5 x 10\^8 CD3+ T-cells/kg
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 YearThe 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.
Outcome measures
| Measure |
DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg
n=15 Participants
Cyclophosphamide 60mg/kg IV over 2 hours Fludarabine 25 mg/m2 IV over 30 minutes DLI Cell Dose 1.0 x 10\^8 CD3+ T-cells/kg
|
DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg
n=42 Participants
Cyclophosphamide 60mg/kg IV over 2 hours Fludarabine 25 mg/m2 DLI Cell Dose 0.5 x 10\^8 CD3+ T-cells/kg
|
|---|---|---|
|
Number of Patients Alive
|
3 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 1 YearThe 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.
Outcome measures
| Measure |
DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg
n=15 Participants
Cyclophosphamide 60mg/kg IV over 2 hours Fludarabine 25 mg/m2 IV over 30 minutes DLI Cell Dose 1.0 x 10\^8 CD3+ T-cells/kg
|
DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg
n=42 Participants
Cyclophosphamide 60mg/kg IV over 2 hours Fludarabine 25 mg/m2 DLI Cell Dose 0.5 x 10\^8 CD3+ T-cells/kg
|
|---|---|---|
|
Number of Patients Alive Without Disease
|
2 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: one yearIn 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.
Outcome measures
| Measure |
DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg
n=15 Participants
Cyclophosphamide 60mg/kg IV over 2 hours Fludarabine 25 mg/m2 IV over 30 minutes DLI Cell Dose 1.0 x 10\^8 CD3+ T-cells/kg
|
DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg
n=42 Participants
Cyclophosphamide 60mg/kg IV over 2 hours Fludarabine 25 mg/m2 DLI Cell Dose 0.5 x 10\^8 CD3+ T-cells/kg
|
|---|---|---|
|
Number of Participants With Complete Remission
|
7 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Day 100Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host.
Outcome measures
| Measure |
DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg
n=15 Participants
Cyclophosphamide 60mg/kg IV over 2 hours Fludarabine 25 mg/m2 IV over 30 minutes DLI Cell Dose 1.0 x 10\^8 CD3+ T-cells/kg
|
DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg
n=42 Participants
Cyclophosphamide 60mg/kg IV over 2 hours Fludarabine 25 mg/m2 DLI Cell Dose 0.5 x 10\^8 CD3+ T-cells/kg
|
|---|---|---|
|
Number of Patients With Acute Graft-Versus-Host Disease
|
10 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Day 100Aplastic 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.
Outcome measures
| Measure |
DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg
n=15 Participants
Cyclophosphamide 60mg/kg IV over 2 hours Fludarabine 25 mg/m2 IV over 30 minutes DLI Cell Dose 1.0 x 10\^8 CD3+ T-cells/kg
|
DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg
n=42 Participants
Cyclophosphamide 60mg/kg IV over 2 hours Fludarabine 25 mg/m2 DLI Cell Dose 0.5 x 10\^8 CD3+ T-cells/kg
|
|---|---|---|
|
Number of Patients With Bone Marrow Aplasia
|
0 Participants
|
1 Participants
|
Adverse Events
DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg
Serious events: 8 serious events
Other events: 12 other events
Deaths: 12 deaths
DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg
Serious events: 3 serious events
Other events: 11 other events
Deaths: 22 deaths
Serious adverse events
| Measure |
DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg
n=15 participants at risk
Cyclophosphamide 60mg/kg IV over 2 hours Fludarabine 25 mg/m2 IV over 30 minutes DLI Cell Dose 1.0 x 10\^8 CD3+ T-cells/kg
|
DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg
n=42 participants at risk
Cyclophosphamide 60mg/kg IV over 2 hours Fludarabine 25 mg/m2 DLI Cell Dose 0.5 x 10\^8 CD3+ T-cells/kg
|
|---|---|---|
|
General disorders
Death, NOS
|
6.7%
1/15 • 1 Year
|
0.00%
0/42 • 1 Year
|
|
General disorders
Acute Graft vs. Host Disease
|
46.7%
7/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
Infections and infestations
Infection, NOS
|
6.7%
1/15 • 1 Year
|
0.00%
0/42 • 1 Year
|
|
Infections and infestations
Acute Sepsis
|
6.7%
1/15 • 1 Year
|
0.00%
0/42 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Failure
|
0.00%
0/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
General disorders
Graft vs. Host Disease, NOS
|
0.00%
0/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
Other adverse events
| Measure |
DLI Cell Dose of 1.0 x 10^8 CD3+ T-cells/kg
n=15 participants at risk
Cyclophosphamide 60mg/kg IV over 2 hours Fludarabine 25 mg/m2 IV over 30 minutes DLI Cell Dose 1.0 x 10\^8 CD3+ T-cells/kg
|
DLI Cell Dose of 0.5 x 10^8 CD3+ T-cells/kg
n=42 participants at risk
Cyclophosphamide 60mg/kg IV over 2 hours Fludarabine 25 mg/m2 DLI Cell Dose 0.5 x 10\^8 CD3+ T-cells/kg
|
|---|---|---|
|
General disorders
Acute Graft vs. Host Disease
|
40.0%
6/15 • 1 Year
|
0.00%
0/42 • 1 Year
|
|
Renal and urinary disorders
Acute Renal Failure
|
0.00%
0/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
0.00%
0/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
Immune system disorders
Anaphylactic Reaction to Anti-Thymocyte Globulin
|
6.7%
1/15 • 1 Year
|
0.00%
0/42 • 1 Year
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
Infections and infestations
Bacterial Infection, NOS
|
20.0%
3/15 • 1 Year
|
4.8%
2/42 • 1 Year
|
|
Infections and infestations
Blood Infection, Bacterial
|
6.7%
1/15 • 1 Year
|
4.8%
2/42 • 1 Year
|
|
Infections and infestations
Blood Infection, Viral
|
6.7%
1/15 • 1 Year
|
7.1%
3/42 • 1 Year
|
|
Infections and infestations
Bone Marrow Infection, Viral
|
0.00%
0/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
Cardiac disorders
Bradycardic Arrest
|
0.00%
0/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
Vascular disorders
Brain Infarction
|
0.00%
0/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
Cardiac disorders
Cardiac Arrhythmia
|
0.00%
0/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
General disorders
Chronic Graft vs. Host Disease
|
6.7%
1/15 • 1 Year
|
0.00%
0/42 • 1 Year
|
|
Psychiatric disorders
Decreased Consciousness and Delirium
|
6.7%
1/15 • 1 Year
|
0.00%
0/42 • 1 Year
|
|
Vascular disorders
Deep Vein Thrombosis
|
6.7%
1/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
Nervous system disorders
Difficulty with Speech
|
0.00%
0/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
Infections and infestations
Eye Infection, NOS
|
0.00%
0/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Fibrous Pneumonitis
|
0.00%
0/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
Infections and infestations
Fungal Infection, NOS
|
6.7%
1/15 • 1 Year
|
0.00%
0/42 • 1 Year
|
|
Infections and infestations
Gastrointestinal Infection, Bacterial
|
0.00%
0/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
Infections and infestations
Gastrointestinal Infection, Fungal
|
6.7%
1/15 • 1 Year
|
0.00%
0/42 • 1 Year
|
|
Renal and urinary disorders
Genitourinary Hemorrhage
|
0.00%
0/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
Infections and infestations
Genitourinary Infection, Bacterial
|
20.0%
3/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
Infections and infestations
Genitourinary Infection, Fungal
|
0.00%
0/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
Infections and infestations
Genitourinary Infection, Viral
|
0.00%
0/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
General disorders
Graft vs. Host Disease, NOS
|
0.00%
0/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
Gastrointestinal disorders
Gastrointestinal Hemorrhage
|
6.7%
1/15 • 1 Year
|
4.8%
2/42 • 1 Year
|
|
Renal and urinary disorders
Hemorrhagic Cystitis
|
0.00%
0/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
Blood and lymphatic system disorders
Hypovolemia
|
0.00%
0/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
Infections and infestations
Mucosal Infection, Viral
|
6.7%
1/15 • 1 Year
|
0.00%
0/42 • 1 Year
|
|
General disorders
Multi-System Organ Failure
|
0.00%
0/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
Infections and infestations
Nervous System Infection, Viral
|
6.7%
1/15 • 1 Year
|
0.00%
0/42 • 1 Year
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
Cardiac disorders
New Q Wave
|
0.00%
0/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
Nervous system disorders
Pachymeningeal Thickening
|
0.00%
0/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
Gastrointestinal disorders
Pancreatitis, NOS
|
0.00%
0/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
Infections and infestations
Pneumonia
|
20.0%
3/15 • 1 Year
|
9.5%
4/42 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hemorrhage
|
0.00%
0/15 • 1 Year
|
4.8%
2/42 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
0.00%
0/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
Renal and urinary disorders
Requires Dialysis, NOS
|
6.7%
1/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Arrest
|
13.3%
2/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.00%
0/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
Infections and infestations
Respiratory Infection, Bacterial
|
0.00%
0/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
Infections and infestations
Respiratory Infection, NOS
|
6.7%
1/15 • 1 Year
|
4.8%
2/42 • 1 Year
|
|
Eye disorders
Retinal Hemorrhage
|
6.7%
1/15 • 1 Year
|
0.00%
0/42 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
Nervous system disorders
Seizures
|
0.00%
0/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
Infections and infestations
Sepsis
|
0.00%
0/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
Nervous system disorders
Slow Thinking and Movement
|
0.00%
0/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
Gastrointestinal disorders
Small Bowel Obstruction
|
0.00%
0/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
Vascular disorders
Splenic Infarcts
|
0.00%
0/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
Nervous system disorders
Status Epilepticus after Seizures
|
0.00%
0/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
Cardiac disorders
Systolic Ejection Murmur
|
0.00%
0/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/15 • 1 Year
|
2.4%
1/42 • 1 Year
|
|
Gastrointestinal disorders
Tubular Adenoma, Rectum
|
6.7%
1/15 • 1 Year
|
0.00%
0/42 • 1 Year
|
|
Infections and infestations
Viral Infection, NOS
|
0.00%
0/15 • 1 Year
|
7.1%
3/42 • 1 Year
|
|
Infections and infestations
Wound Infection, Bacterial
|
13.3%
2/15 • 1 Year
|
0.00%
0/42 • 1 Year
|
Additional Information
Dr. Jeffrey Miller
Masonic Cancer Center, University of Minnesota
Phone: 612-625-7409
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place