Trial Outcomes & Findings for Chemotherapy and a Donor Natural Killer Cell Infusion in Treating Patients With Relapsed or Persistent Leukemia or Myelodysplastic Syndrome After a Donor Stem Cell Transplant (NCT NCT00526292)
NCT ID: NCT00526292
Last Updated: 2016-02-12
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
3 Months following treatment
Results posted on
2016-02-12
Participant Flow
Participant milestones
| Measure |
HLA Haploidentical Natural Killer Cell Infusion
HLA Haploidentical Natural Killer Cell Infusion for Treatment of Relapsed or Persistent Leukemia
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chemotherapy and a Donor Natural Killer Cell Infusion in Treating Patients With Relapsed or Persistent Leukemia or Myelodysplastic Syndrome After a Donor Stem Cell Transplant
Baseline characteristics by cohort
| Measure |
HLA Haploidentical Natural Killer Cell Infusion
n=6 Participants
HLA Haploidentical Natural Killer Cell Infusion for Treatment of Relapsed or Persistent Leukemia
|
|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 Months following treatmentOutcome measures
| Measure |
HLA Haploidentical Natural Killer Cell Infusion
n=6 Participants
HLA Haploidentical Natural Killer Cell Infusion for Treatment of Relapsed or Persistent Leukemia
|
|---|---|
|
Treatment Efficacy as Defined by Complete or Partial Remission
Progression of Disease (POD)
|
5 participants
|
|
Treatment Efficacy as Defined by Complete or Partial Remission
Complete Remission
|
1 participants
|
Adverse Events
HLA Haploidentical Natural Killer Cell Infusion
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HLA Haploidentical Natural Killer Cell Infusion
n=6 participants at risk
HLA Haploidentical Natural Killer Cell Infusion for Treatment of Relapsed or Persistent Leukemia
|
|---|---|
|
General disorders
Death not associated with CTCAE term-Disease progression NOS
|
50.0%
3/6
|
|
General disorders
Febrile neutropenia
|
16.7%
1/6
|
Other adverse events
| Measure |
HLA Haploidentical Natural Killer Cell Infusion
n=6 participants at risk
HLA Haploidentical Natural Killer Cell Infusion for Treatment of Relapsed or Persistent Leukemia
|
|---|---|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
16.7%
1/6
|
|
Blood and lymphatic system disorders
Hemoglobin
|
83.3%
5/6
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
100.0%
6/6
|
|
Blood and lymphatic system disorders
Lymphopenia
|
100.0%
6/6
|
|
Metabolism and nutrition disorders
Magnesium, high (hypermagnesemia)
|
33.3%
2/6
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
100.0%
6/6
|
|
Metabolism and nutrition disorders
Phosphate, low (hypophosphatemia)
|
33.3%
2/6
|
|
Blood and lymphatic system disorders
Platelets
|
100.0%
6/6
|
|
Metabolism and nutrition disorders
Potassium, high (hyperkalemia)
|
16.7%
1/6
|
|
Metabolism and nutrition disorders
Potassium, low (hypokalemia)
|
16.7%
1/6
|
Additional Information
Dr. Katherine Hsu
Memorial Sloan Kettering Cancer Center
Phone: 646-888-2667
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place