Trial Outcomes & Findings for Study of Infusion of Blood Cells (Lymphocytes) to Stimulate the Immune System to Fight Leukemia/Lymphoma (NCT NCT01685606)
NCT ID: NCT01685606
Last Updated: 2022-03-04
Results Overview
Criteria for AML and ALL (adapted from Cheson et al.20) Complete remission (CR) is defined as the presence of all of the following * Peripheral blood o No leukemic blasts present. * No extramedullary findings of leukemia or disappearance of such (i.e. CNS or soft tissue involvement) * Bone marrow * Cellularity \>20% with baseline maturation. * No Auer rods * Less than 5% blast cells. * Complete blood counts and bone marrow normalization criteria must be met within one week of each other. Hematopoeitic recovery is an ANC \> 1.0 x 109/L and platelet count \> 100x109/L. No specific hemoglobin or hematocrit level is specified but the patient must be transfusion free. Complete remission with incomplete recovery (CRi) is defined as the following: * Meets criteria for CR except * ANC \< 1.0 x 109/L or platelet count \< 100x109/L Partial remission (PR). • Must meet all criteria of a CR except that the bone marrow may contain 5-20% blasts.
TERMINATED
PHASE2
6 participants
8 weeks after infusion then 6 months after and every 4 months for approximately 2 years
2022-03-04
Participant Flow
Participant milestones
| Measure |
Cellular Immunotherapy
A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor will be infused, irrespective of the number of CD34+ cells.
cellular immunotherapy: A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor irrespective of the number of CD34+ cells will be infused.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Cellular Immunotherapy
A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor will be infused, irrespective of the number of CD34+ cells.
cellular immunotherapy: A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor irrespective of the number of CD34+ cells will be infused.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Study of Infusion of Blood Cells (Lymphocytes) to Stimulate the Immune System to Fight Leukemia/Lymphoma
Baseline characteristics by cohort
| Measure |
Cellular Immunotherapy
n=5 Participants
A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor will be infused, irrespective of the number of CD34+ cells.
cellular immunotherapy: A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor irrespective of the number of CD34+ cells will be infused.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
66.2 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeks after infusion then 6 months after and every 4 months for approximately 2 yearsCriteria for AML and ALL (adapted from Cheson et al.20) Complete remission (CR) is defined as the presence of all of the following * Peripheral blood o No leukemic blasts present. * No extramedullary findings of leukemia or disappearance of such (i.e. CNS or soft tissue involvement) * Bone marrow * Cellularity \>20% with baseline maturation. * No Auer rods * Less than 5% blast cells. * Complete blood counts and bone marrow normalization criteria must be met within one week of each other. Hematopoeitic recovery is an ANC \> 1.0 x 109/L and platelet count \> 100x109/L. No specific hemoglobin or hematocrit level is specified but the patient must be transfusion free. Complete remission with incomplete recovery (CRi) is defined as the following: * Meets criteria for CR except * ANC \< 1.0 x 109/L or platelet count \< 100x109/L Partial remission (PR). • Must meet all criteria of a CR except that the bone marrow may contain 5-20% blasts.
Outcome measures
| Measure |
Cellular Immunotherapy
n=5 Participants
A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor will be infused, irrespective of the number of CD34+ cells.
cellular immunotherapy: A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor irrespective of the number of CD34+ cells will be infused.
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|---|---|
|
Overall Response Rate of Cellular Immune Therapy With HLA Haploidentical Peripheral Blood Pheresed Cells in Patients With Relapsed/Refractory Hematological Malignancies.
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1 participants
|
SECONDARY outcome
Timeframe: 30 days and 16 weeks after infusionOutcome measures
| Measure |
Cellular Immunotherapy
n=5 Participants
A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor will be infused, irrespective of the number of CD34+ cells.
cellular immunotherapy: A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor irrespective of the number of CD34+ cells will be infused.
|
|---|---|
|
To Evaluate the Rate of Dose Limiting Toxicities of HLA Haploidentical Peripheral Blood Pheresed Cellular Infusions.
|
0 participants
|
Adverse Events
Cellular Immunotherapy
Serious adverse events
| Measure |
Cellular Immunotherapy
n=6 participants at risk
A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor will be infused, irrespective of the number of CD34+ cells.
cellular immunotherapy: A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor irrespective of the number of CD34+ cells will be infused.
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|---|---|
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Investigations
Albumin
|
16.7%
1/6 • Number of events 1
|
|
Investigations
ALT
|
16.7%
1/6 • Number of events 1
|
|
Investigations
anemia
|
33.3%
2/6 • Number of events 2
|
|
Investigations
AST
|
16.7%
1/6 • Number of events 1
|
|
Investigations
bone pain
|
16.7%
1/6 • Number of events 1
|
|
Investigations
ca
|
16.7%
1/6 • Number of events 1
|
|
Investigations
CRS (pt 3 included n, ha, r)
|
16.7%
1/6 • Number of events 1
|
|
Investigations
diarrhea
|
16.7%
1/6 • Number of events 1
|
|
Investigations
dizziness
|
66.7%
4/6 • Number of events 4
|
|
Investigations
Febrile Neutropenia
|
16.7%
1/6 • Number of events 1
|
|
Investigations
fever
|
33.3%
2/6 • Number of events 2
|
|
Investigations
Hypotension
|
50.0%
3/6 • Number of events 3
|
|
Investigations
tachycardia
|
16.7%
1/6 • Number of events 1
|
|
Investigations
infection
|
16.7%
1/6 • Number of events 1
|
|
Investigations
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Nausea
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Neutropenia
|
16.7%
1/6 • Number of events 1
|
|
Investigations
pain-neck
|
16.7%
1/6 • Number of events 1
|
|
Investigations
PLT
|
16.7%
1/6 • Number of events 1
|
|
Investigations
creatinine
|
16.7%
1/6 • Number of events 1
|
|
Investigations
infection: wound
|
16.7%
1/6 • Number of events 2
|
|
Investigations
GI bleed
|
16.7%
1/6 • Number of events 1
|
Other adverse events
| Measure |
Cellular Immunotherapy
n=6 participants at risk
A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor will be infused, irrespective of the number of CD34+ cells.
cellular immunotherapy: A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor irrespective of the number of CD34+ cells will be infused.
|
|---|---|
|
Investigations
alk phos
|
16.7%
1/6 • Number of events 1
|
|
Investigations
anemia
|
66.7%
4/6 • Number of events 4
|
|
Investigations
anxiety
|
16.7%
1/6 • Number of events 1
|
|
Investigations
arthralgia
|
16.7%
1/6 • Number of events 1
|
|
Investigations
bleeding scrotum
|
16.7%
1/6 • Number of events 1
|
|
Investigations
bone pain
|
16.7%
1/6 • Number of events 1
|
|
Investigations
ca
|
33.3%
2/6 • Number of events 2
|
|
Investigations
diarrhea
|
16.7%
1/6 • Number of events 1
|
|
Investigations
cough
|
33.3%
2/6 • Number of events 2
|
|
Investigations
edema
|
33.3%
2/6 • Number of events 2
|
|
Investigations
epistaxis
|
16.7%
1/6 • Number of events 1
|
|
Investigations
erythema
|
16.7%
1/6 • Number of events 1
|
|
Investigations
eye stye Not graded pt 3
|
33.3%
2/6 • Number of events 2
|
|
Investigations
fever
|
33.3%
2/6 • Number of events 2
|
|
Investigations
Hyperglycemia
|
83.3%
5/6 • Number of events 5
|
|
Investigations
K
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Leukocytosis
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Lymph
|
66.7%
4/6 • Number of events 4
|
|
Investigations
minor bleeding superficila leg lesions "minor" NG pt #3
|
16.7%
1/6 • Number of events 1
|
|
Investigations
|
33.3%
2/6 • Number of events 2
|
|
Investigations
Neutropenia
|
50.0%
3/6 • Number of events 3
|
|
Investigations
oral thrush
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Phos
|
33.3%
2/6 • Number of events 2
|
|
Investigations
PLT
|
16.7%
1/6 • Number of events 1
|
|
Investigations
post nasal
|
16.7%
1/6 • Number of events 1
|
|
Investigations
segs/neuts
|
16.7%
1/6 • Number of events 1
|
|
Investigations
sinus pain Not graded pt 3
|
16.7%
1/6 • Number of events 1
|
|
Investigations
sinus tach
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Vomiting
|
16.7%
1/6 • Number of events 1
|
|
Investigations
WBC
|
33.3%
2/6 • Number of events 2
|
|
Investigations
cellulitis
|
16.7%
1/6 • Number of events 1
|
|
Investigations
fatigue
|
16.7%
1/6 • Number of events 1
|
|
Investigations
LE pain
|
16.7%
1/6 • Number of events 1
|
Additional Information
Dr. Peter Quesenberry
Brown University Oncology Research Group (BrUOG)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place