Trial Outcomes & Findings for Donor Lymphocyte Infusion After Alternative Donor Transplantation (NCT NCT01027702)
NCT ID: NCT01027702
Last Updated: 2022-04-22
Results Overview
Immune recovery was measured by CD4+ cells \> 100/μL by Day 120 following transplantation
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
38 participants
Primary outcome timeframe
120 days after transplant
Results posted on
2022-04-22
Participant Flow
Patients who received a CD34+ selected peripheral blood stem cell (PBSC) transplant on the companion study, LCH BMT 09-01, at Levine Children's Hospital between December 2009 and June 2016.
Subjects were enrolled to two cohorts based on donor type, Mismatched Related Donor (MMRD) and Matched Unrelated Donor (MUD).
Participant milestones
| Measure |
MMRD: 3 x 10^4/kg DLI + MTX to Day +24
Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 3 x 10\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Day +1, +3, +10, +17, and +24
|
MMRD: 3 x 10^4/kg DLI + MTX to Day +52
Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 3 x 10\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52
|
MMRD: 4 x 10^4/kg DLI + MTX to Day +52
Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 4 x 10\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52
|
MMRD: 4 x 10^4/kg DLI + MTX to Day +80
Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 4 x 10\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45, +52, +59, +66, +73, and +80
|
MMRD: 5 x 10^4/kg DLI + MTX to Day +80
Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 5 x 10\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45, +52, +59, +66, +73, and +80
|
MUD: 3 x 10^4/kg DLI + MTX to Day +24
Matched Unrelated Donor: Donor Lymphocyte Infusion (DLI) 3 x 10\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Day +1, +3, +10, +17, and +24
|
MUD: 3 x 10^4/kg DLI + MTX to Day +52
Matched Unrelated Donor: Donor Lymphocyte Infusion (DLI) 3 x 10\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
3
|
14
|
10
|
1
|
2
|
|
Overall Study
COMPLETED
|
3
|
2
|
2
|
10
|
9
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
1
|
4
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
MMRD: 3 x 10^4/kg DLI + MTX to Day +24
Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 3 x 10\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Day +1, +3, +10, +17, and +24
|
MMRD: 3 x 10^4/kg DLI + MTX to Day +52
Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 3 x 10\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52
|
MMRD: 4 x 10^4/kg DLI + MTX to Day +52
Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 4 x 10\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52
|
MMRD: 4 x 10^4/kg DLI + MTX to Day +80
Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 4 x 10\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45, +52, +59, +66, +73, and +80
|
MMRD: 5 x 10^4/kg DLI + MTX to Day +80
Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 5 x 10\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45, +52, +59, +66, +73, and +80
|
MUD: 3 x 10^4/kg DLI + MTX to Day +24
Matched Unrelated Donor: Donor Lymphocyte Infusion (DLI) 3 x 10\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Day +1, +3, +10, +17, and +24
|
MUD: 3 x 10^4/kg DLI + MTX to Day +52
Matched Unrelated Donor: Donor Lymphocyte Infusion (DLI) 3 x 10\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Received subsequent therapy
|
1
|
2
|
0
|
4
|
1
|
0
|
1
|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Donor Lymphocyte Infusion After Alternative Donor Transplantation
Baseline characteristics by cohort
| Measure |
Infusion of Donor Lymphocytes
n=38 Participants
Patients will receive an infusion of donor lymphocyte after T-cell depleted transplant.
Infusion of donor lymphocytes: A donor lymphocyte infusion will be given to provide T cells. There will be a dose escalation: 3 x 10\^4, 4 x 10\^4, 5 x 10\^4, 6 X 10\^4, 8 x 10\^4, and 10 X10\^4 cells/kg body weight. At least three patients will be assessed at each dose to determine safety before dose is increased.
|
|---|---|
|
Age, Customized
< 1 year
|
2 participants
n=5 Participants
|
|
Age, Customized
1-2 years
|
3 participants
n=5 Participants
|
|
Age, Customized
2-4 years
|
3 participants
n=5 Participants
|
|
Age, Customized
4-6 years
|
3 participants
n=5 Participants
|
|
Age, Customized
6-8 years
|
3 participants
n=5 Participants
|
|
Age, Customized
8-10 years
|
3 participants
n=5 Participants
|
|
Age, Customized
10-12 years
|
4 participants
n=5 Participants
|
|
Age, Customized
12-14 years
|
4 participants
n=5 Participants
|
|
Age, Customized
14-16 years
|
3 participants
n=5 Participants
|
|
Age, Customized
16-18 years
|
6 participants
n=5 Participants
|
|
Age, Customized
> 18 years
|
4 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 120 days after transplantPopulation: Patients who received subsequent therapy, such as therapeutic DLI (eg. for treatment of viral infection or relapse), chemotherapy, or a PBSC infusion were considered not evaluable as this could interfere with response assessments.
Immune recovery was measured by CD4+ cells \> 100/μL by Day 120 following transplantation
Outcome measures
| Measure |
MMRD: 3 x 10^4/kg DLI + MTX to Day +24
n=3 Participants
Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 3 x 10\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Day +1, +3, +10, +17, and +24
|
MMRD: 3 x 10^4/kg DLI + MTX to Day +52
n=2 Participants
Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 3 x 10\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52
|
MMRD: 4 x 10^4/kg DLI + MTX to Day +52
n=2 Participants
Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 4 x 10\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52
|
MMRD: 4 x 10^4/kg DLI + MTX to Day +80
n=10 Participants
Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 4 x 10\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45, +52, +59, +66, +73, and +80
|
MMRD: 5 x 10^4/kg DLI + MTX to Day +80
n=9 Participants
Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 5 x 10\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45, +52, +59, +66, +73, and +80
|
MUD: 3 x 10^4/kg DLI + MTX to Day +24
n=1 Participants
Matched Unrelated Donor: Donor Lymphocyte Infusion (DLI) 3 x 10\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Day +1, +3, +10, +17, and +24
|
MUD: 3 x 10^4/kg DLI + MTX to Day +52
n=1 Participants
Matched Unrelated Donor: Donor Lymphocyte Infusion (DLI) 3 x 10\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Immune Recovery Following Transplantation
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
6 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 180 days after transplantPopulation: Patients that had not had grade II-IV acute GVHD following prophylactic DLI but received therapeutic DLI (eg. for treatment of viral infection or relapse), chemotherapy, or a PBSC infusion prior to Day +180 were considered not evaluable because these therapies may cause or prevent GVHD and affect the determination of this endpoint.
Patients were evaluated for acute GVHD due to prophylactic DLI between the day of prophylactic DLI infusion and Day +180 after transplant. GVHD was graded using standard criteria.
Outcome measures
| Measure |
MMRD: 3 x 10^4/kg DLI + MTX to Day +24
n=3 Participants
Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 3 x 10\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Day +1, +3, +10, +17, and +24
|
MMRD: 3 x 10^4/kg DLI + MTX to Day +52
n=2 Participants
Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 3 x 10\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52
|
MMRD: 4 x 10^4/kg DLI + MTX to Day +52
n=2 Participants
Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 4 x 10\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52
|
MMRD: 4 x 10^4/kg DLI + MTX to Day +80
n=10 Participants
Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 4 x 10\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45, +52, +59, +66, +73, and +80
|
MMRD: 5 x 10^4/kg DLI + MTX to Day +80
n=9 Participants
Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 5 x 10\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45, +52, +59, +66, +73, and +80
|
MUD: 3 x 10^4/kg DLI + MTX to Day +24
n=1 Participants
Matched Unrelated Donor: Donor Lymphocyte Infusion (DLI) 3 x 10\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Day +1, +3, +10, +17, and +24
|
MUD: 3 x 10^4/kg DLI + MTX to Day +52
n=1 Participants
Matched Unrelated Donor: Donor Lymphocyte Infusion (DLI) 3 x 10\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52
|
|---|---|---|---|---|---|---|---|
|
Incidence and Severity of GVHD
Grade III/IV GVHD
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence and Severity of GVHD
No GVHD/ Grade I GVHD
|
2 Participants
|
1 Participants
|
1 Participants
|
9 Participants
|
8 Participants
|
1 Participants
|
1 Participants
|
|
Incidence and Severity of GVHD
Grade II GVHD
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Patients who relapsed and received subsequent chemotherapy were no longer followed for infections as these therapies increase the risk of infections.
Subjects were actively monitored for adenovirus, cytomegalovirus (CMV), human herpes virus 6 (HHV6), and Epstein-Barr virus (EBV) as part of standard post-transplant care. All infections were collected from date of DLI until 1 year after transplant.
Outcome measures
| Measure |
MMRD: 3 x 10^4/kg DLI + MTX to Day +24
n=38 Participants
Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 3 x 10\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Day +1, +3, +10, +17, and +24
|
MMRD: 3 x 10^4/kg DLI + MTX to Day +52
Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 3 x 10\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52
|
MMRD: 4 x 10^4/kg DLI + MTX to Day +52
Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 4 x 10\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52
|
MMRD: 4 x 10^4/kg DLI + MTX to Day +80
Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 4 x 10\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45, +52, +59, +66, +73, and +80
|
MMRD: 5 x 10^4/kg DLI + MTX to Day +80
Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 5 x 10\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45, +52, +59, +66, +73, and +80
|
MUD: 3 x 10^4/kg DLI + MTX to Day +24
Matched Unrelated Donor: Donor Lymphocyte Infusion (DLI) 3 x 10\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Day +1, +3, +10, +17, and +24
|
MUD: 3 x 10^4/kg DLI + MTX to Day +52
Matched Unrelated Donor: Donor Lymphocyte Infusion (DLI) 3 x 10\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Infection and EBV-related Post-transplant Lymphoproliferative Disease (PTLD)
HHV-6 reactivation, no disease
|
18 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Infection and EBV-related Post-transplant Lymphoproliferative Disease (PTLD)
Viral upper respiratory infections
|
17 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Infection and EBV-related Post-transplant Lymphoproliferative Disease (PTLD)
Adenovirus reactivation, no disease
|
11 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Infection and EBV-related Post-transplant Lymphoproliferative Disease (PTLD)
Clostridium difficile colitis
|
9 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Infection and EBV-related Post-transplant Lymphoproliferative Disease (PTLD)
Sinusitis
|
8 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Infection and EBV-related Post-transplant Lymphoproliferative Disease (PTLD)
CMV reactivation, no disease
|
5 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Infection and EBV-related Post-transplant Lymphoproliferative Disease (PTLD)
Galactomannan positive
|
5 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Infection and EBV-related Post-transplant Lymphoproliferative Disease (PTLD)
BK virus, no disease
|
5 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Infection and EBV-related Post-transplant Lymphoproliferative Disease (PTLD)
BK virus, hemorrhagic cystitis
|
4 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Infection and EBV-related Post-transplant Lymphoproliferative Disease (PTLD)
EBV-related lymphoproliferative disease
|
4 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Infection and EBV-related Post-transplant Lymphoproliferative Disease (PTLD)
Bacteremia, gram negative
|
4 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Infection and EBV-related Post-transplant Lymphoproliferative Disease (PTLD)
Herpes simplex virus
|
4 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Infection and EBV-related Post-transplant Lymphoproliferative Disease (PTLD)
Bacteremia, gram positive
|
4 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Infection and EBV-related Post-transplant Lymphoproliferative Disease (PTLD)
Acute otitis media
|
3 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Infection and EBV-related Post-transplant Lymphoproliferative Disease (PTLD)
Candidiasis (non-invasive)
|
3 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Infection and EBV-related Post-transplant Lymphoproliferative Disease (PTLD)
Pneumonia
|
3 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Infection and EBV-related Post-transplant Lymphoproliferative Disease (PTLD)
Infection with normal ANC - grade 3
|
3 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Infection and EBV-related Post-transplant Lymphoproliferative Disease (PTLD)
Adenovirus disease
|
2 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Infection and EBV-related Post-transplant Lymphoproliferative Disease (PTLD)
EBV reactivation, no disease
|
2 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Infection and EBV-related Post-transplant Lymphoproliferative Disease (PTLD)
Varicella
|
2 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Infection and EBV-related Post-transplant Lymphoproliferative Disease (PTLD)
Nocardia
|
2 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Infection and EBV-related Post-transplant Lymphoproliferative Disease (PTLD)
Pneumonia- fungal
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Infection and EBV-related Post-transplant Lymphoproliferative Disease (PTLD)
Methicillin-resistant staphylococcus aureus (MRSA)
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Infection and EBV-related Post-transplant Lymphoproliferative Disease (PTLD)
Norovirus
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Infection and EBV-related Post-transplant Lymphoproliferative Disease (PTLD)
Parvovirus B19 (low level)
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Infection and EBV-related Post-transplant Lymphoproliferative Disease (PTLD)
Rotavirus
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Infection and EBV-related Post-transplant Lymphoproliferative Disease (PTLD)
Sapovirus
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Infection and EBV-related Post-transplant Lymphoproliferative Disease (PTLD)
Possible respiratory fungal infection (rhizomucor)
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Infusion of Donor Lymphocytes
Serious events: 32 serious events
Other events: 27 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Infusion of Donor Lymphocytes
n=38 participants at risk
Patients will receive an infusion of donor lymphocyte after T-cell depleted transplant.
Infusion of donor lymphocytes: A donor lymphocyte infusion will be given to provide T cells. There will be a dose escalation: 3 x 10\^4, 4 x 10\^4, 5 x 10\^4, 6 X 10\^4, 8 x 10\^4, and 10 X10\^4 cells/kg body weight. At least three patients will be assessed at each dose to determine safety before dose is increased.
|
|---|---|
|
General disorders
Fever
|
63.2%
24/38 • From the time of donor lymphocyte infusion (DLI) up to one year after transplant.
Infections that met the definition of a Serious Adverse Event are reported as the type of infection, when the cause of infection was known.
|
|
Infections and infestations
HHV-6 reactivation
|
15.8%
6/38 • From the time of donor lymphocyte infusion (DLI) up to one year after transplant.
Infections that met the definition of a Serious Adverse Event are reported as the type of infection, when the cause of infection was known.
|
|
Immune system disorders
Graft vs Host disease
|
13.2%
5/38 • From the time of donor lymphocyte infusion (DLI) up to one year after transplant.
Infections that met the definition of a Serious Adverse Event are reported as the type of infection, when the cause of infection was known.
|
|
Infections and infestations
EBV-related lymphoproliferative disease
|
10.5%
4/38 • From the time of donor lymphocyte infusion (DLI) up to one year after transplant.
Infections that met the definition of a Serious Adverse Event are reported as the type of infection, when the cause of infection was known.
|
|
Infections and infestations
Pneumonia
|
7.9%
3/38 • From the time of donor lymphocyte infusion (DLI) up to one year after transplant.
Infections that met the definition of a Serious Adverse Event are reported as the type of infection, when the cause of infection was known.
|
|
Infections and infestations
Gastroenteritis
|
7.9%
3/38 • From the time of donor lymphocyte infusion (DLI) up to one year after transplant.
Infections that met the definition of a Serious Adverse Event are reported as the type of infection, when the cause of infection was known.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Relapse
|
8.0%
2/25 • From the time of donor lymphocyte infusion (DLI) up to one year after transplant.
Infections that met the definition of a Serious Adverse Event are reported as the type of infection, when the cause of infection was known.
|
|
Infections and infestations
CMV reactivation
|
5.3%
2/38 • From the time of donor lymphocyte infusion (DLI) up to one year after transplant.
Infections that met the definition of a Serious Adverse Event are reported as the type of infection, when the cause of infection was known.
|
|
Infections and infestations
Infection w/ unknown absolute neutrophil count (ANC)
|
5.3%
2/38 • From the time of donor lymphocyte infusion (DLI) up to one year after transplant.
Infections that met the definition of a Serious Adverse Event are reported as the type of infection, when the cause of infection was known.
|
|
Blood and lymphatic system disorders
Thrombotic Microangiopathy
|
5.3%
2/38 • From the time of donor lymphocyte infusion (DLI) up to one year after transplant.
Infections that met the definition of a Serious Adverse Event are reported as the type of infection, when the cause of infection was known.
|
|
Investigations
ALT/ AST elevated
|
2.6%
1/38 • From the time of donor lymphocyte infusion (DLI) up to one year after transplant.
Infections that met the definition of a Serious Adverse Event are reported as the type of infection, when the cause of infection was known.
|
|
Infections and infestations
Infection- eye NOS
|
2.6%
1/38 • From the time of donor lymphocyte infusion (DLI) up to one year after transplant.
Infections that met the definition of a Serious Adverse Event are reported as the type of infection, when the cause of infection was known.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/ Upper Respiratory- other
|
2.6%
1/38 • From the time of donor lymphocyte infusion (DLI) up to one year after transplant.
Infections that met the definition of a Serious Adverse Event are reported as the type of infection, when the cause of infection was known.
|
|
Infections and infestations
BK virus/ hemorrhagic cystitis
|
2.6%
1/38 • From the time of donor lymphocyte infusion (DLI) up to one year after transplant.
Infections that met the definition of a Serious Adverse Event are reported as the type of infection, when the cause of infection was known.
|
|
Vascular disorders
Hypertension
|
2.6%
1/38 • From the time of donor lymphocyte infusion (DLI) up to one year after transplant.
Infections that met the definition of a Serious Adverse Event are reported as the type of infection, when the cause of infection was known.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.6%
1/38 • From the time of donor lymphocyte infusion (DLI) up to one year after transplant.
Infections that met the definition of a Serious Adverse Event are reported as the type of infection, when the cause of infection was known.
|
|
Cardiac disorders
Pericardial effusion
|
2.6%
1/38 • From the time of donor lymphocyte infusion (DLI) up to one year after transplant.
Infections that met the definition of a Serious Adverse Event are reported as the type of infection, when the cause of infection was known.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.6%
1/38 • From the time of donor lymphocyte infusion (DLI) up to one year after transplant.
Infections that met the definition of a Serious Adverse Event are reported as the type of infection, when the cause of infection was known.
|
|
Renal and urinary disorders
Renal failure
|
2.6%
1/38 • From the time of donor lymphocyte infusion (DLI) up to one year after transplant.
Infections that met the definition of a Serious Adverse Event are reported as the type of infection, when the cause of infection was known.
|
|
Nervous system disorders
Seizure
|
2.6%
1/38 • From the time of donor lymphocyte infusion (DLI) up to one year after transplant.
Infections that met the definition of a Serious Adverse Event are reported as the type of infection, when the cause of infection was known.
|
|
Infections and infestations
Infection- select
|
2.6%
1/38 • From the time of donor lymphocyte infusion (DLI) up to one year after transplant.
Infections that met the definition of a Serious Adverse Event are reported as the type of infection, when the cause of infection was known.
|
Other adverse events
| Measure |
Infusion of Donor Lymphocytes
n=38 participants at risk
Patients will receive an infusion of donor lymphocyte after T-cell depleted transplant.
Infusion of donor lymphocytes: A donor lymphocyte infusion will be given to provide T cells. There will be a dose escalation: 3 x 10\^4, 4 x 10\^4, 5 x 10\^4, 6 X 10\^4, 8 x 10\^4, and 10 X10\^4 cells/kg body weight. At least three patients will be assessed at each dose to determine safety before dose is increased.
|
|---|---|
|
Investigations
Neutropenia
|
31.6%
12/38 • From the time of donor lymphocyte infusion (DLI) up to one year after transplant.
Infections that met the definition of a Serious Adverse Event are reported as the type of infection, when the cause of infection was known.
|
|
Investigations
Platelet count decreased
|
26.3%
10/38 • From the time of donor lymphocyte infusion (DLI) up to one year after transplant.
Infections that met the definition of a Serious Adverse Event are reported as the type of infection, when the cause of infection was known.
|
|
Investigations
Leukopenia
|
21.1%
8/38 • From the time of donor lymphocyte infusion (DLI) up to one year after transplant.
Infections that met the definition of a Serious Adverse Event are reported as the type of infection, when the cause of infection was known.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Relapse
|
24.0%
6/25 • From the time of donor lymphocyte infusion (DLI) up to one year after transplant.
Infections that met the definition of a Serious Adverse Event are reported as the type of infection, when the cause of infection was known.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.9%
3/38 • From the time of donor lymphocyte infusion (DLI) up to one year after transplant.
Infections that met the definition of a Serious Adverse Event are reported as the type of infection, when the cause of infection was known.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.5%
4/38 • From the time of donor lymphocyte infusion (DLI) up to one year after transplant.
Infections that met the definition of a Serious Adverse Event are reported as the type of infection, when the cause of infection was known.
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
7.9%
3/38 • From the time of donor lymphocyte infusion (DLI) up to one year after transplant.
Infections that met the definition of a Serious Adverse Event are reported as the type of infection, when the cause of infection was known.
|
|
Metabolism and nutrition disorders
ALT elevated
|
5.3%
2/38 • From the time of donor lymphocyte infusion (DLI) up to one year after transplant.
Infections that met the definition of a Serious Adverse Event are reported as the type of infection, when the cause of infection was known.
|
|
Renal and urinary disorders
Hemorrage, GU- urinary NOS
|
5.3%
2/38 • From the time of donor lymphocyte infusion (DLI) up to one year after transplant.
Infections that met the definition of a Serious Adverse Event are reported as the type of infection, when the cause of infection was known.
|
|
Vascular disorders
Hypertension
|
5.3%
2/38 • From the time of donor lymphocyte infusion (DLI) up to one year after transplant.
Infections that met the definition of a Serious Adverse Event are reported as the type of infection, when the cause of infection was known.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.3%
2/38 • From the time of donor lymphocyte infusion (DLI) up to one year after transplant.
Infections that met the definition of a Serious Adverse Event are reported as the type of infection, when the cause of infection was known.
|
|
General disorders
Pain
|
5.3%
2/38 • From the time of donor lymphocyte infusion (DLI) up to one year after transplant.
Infections that met the definition of a Serious Adverse Event are reported as the type of infection, when the cause of infection was known.
|
|
Renal and urinary disorders
Renal/ Genitorurinary NOS
|
5.3%
2/38 • From the time of donor lymphocyte infusion (DLI) up to one year after transplant.
Infections that met the definition of a Serious Adverse Event are reported as the type of infection, when the cause of infection was known.
|
|
Nervous system disorders
Seizures
|
5.3%
2/38 • From the time of donor lymphocyte infusion (DLI) up to one year after transplant.
Infections that met the definition of a Serious Adverse Event are reported as the type of infection, when the cause of infection was known.
|
|
Investigations
Lymphopenia
|
7.9%
3/38 • From the time of donor lymphocyte infusion (DLI) up to one year after transplant.
Infections that met the definition of a Serious Adverse Event are reported as the type of infection, when the cause of infection was known.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place