Trial Outcomes & Findings for CD8+ Memory T-Cells as Consolidative Therapy After Donor Non-myeloablative Hematopoietic Cell Transplant in Treating Patients With Leukemia or Lymphoma (NCT NCT02424968)

Last Updated: 2021-06-24

Results Overview

A measure of success for the therapeutic infusion of allogeneic transplantation of cluster of differentiation 8 (CD8+) memory T-cells is full-dose donor chimerism (FDC). This means to achieve ≥ 95% donor cells in either the CD3+ blood cell lineage or whole blood, within 90 days of the allogeneic CD8+ memory T-cell infusion. The outcome is reported as the number of participants that achieve FDC within 90 days, a number without dispersion.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

3 months

Results posted on

2021-06-24

Participant Flow

Participant milestones

Participant milestones
Measure	Infusion of Allogeneic CD8+ Memory T-cells All participants receive allogeneic CD8+ memory T-cells 30 to 60 days after standard non-myeloablative allogeneic hematopoietic cell transplant (aHCT). Anti-Thymocyte Globulin: Given per standard institutional practice Cyclosporine: Given PO Mycophenolate Mofetil: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplant: Undergo nonmyeloablative allogeneic HSCT Allogeneic Cluster of Differentiation 8 (CD8)+ Memory T-cells: Receive CD8+ memory T-cells via IV Total Nodal Irradiation: Undergo TLI
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CD8+ Memory T-Cells as Consolidative Therapy After Donor Non-myeloablative Hematopoietic Cell Transplant in Treating Patients With Leukemia or Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Infusion of Allogeneic CD8+ Memory T-cells n=18 Participants All participants receive allogeneic CD8+ memory T-cells 30 to 60 days after standard non-myeloablative allogeneic hematopoietic cell transplant (aHCT). Anti-Thymocyte Globulin: Given per standard institutional practice Cyclosporine: Given PO Mycophenolate Mofetil: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplant: Undergo nonmyeloablative allogeneic HSCT Allogeneic Cluster of Differentiation 8 (CD8)+ Memory T-cells: Receive CD8+ memory T-cells via IV Total Nodal Irradiation: Undergo TLI
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age, Continuous	58.2 years STANDARD_DEVIATION 12.8 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Outcome measures

Outcome measures
Measure	Infusion of Allogeneic CD8+ Memory T-cells n=18 Participants All participants receive allogeneic CD8+ memory T-cells 30 to 60 days after standard non-myeloablative allogeneic hematopoietic cell transplant (aHCT). Anti-Thymocyte Globulin: Given per standard institutional practice Cyclosporine: Given PO Mycophenolate Mofetil: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplant: Undergo nonmyeloablative allogeneic HSCT Allogeneic Cluster of Differentiation 8 (CD8)+ Memory T-cells: Receive CD8+ memory T-cells via IV Total Nodal Irradiation: Undergo TLI
Full-dose Donor Chimerism (FDC)	12 Participants

SECONDARY outcome

Timeframe: 1 year

Event-free survival (EFS) is defined as the number of transplant recipients of allogeneic cluster of differentiation 8 (CD8+) memory T-cells that remain alive at 12 months after transplant without disease relapse. Relapse is defined as bone marrow blasts \> 5% . The outcome is expressed as the number of allogeneic CD8+ memory T-cell recipients remaining alive at 1 year after transplant without disease relapse, a number without dispersion.

Outcome measures

Outcome measures
Measure	Infusion of Allogeneic CD8+ Memory T-cells n=18 Participants All participants receive allogeneic CD8+ memory T-cells 30 to 60 days after standard non-myeloablative allogeneic hematopoietic cell transplant (aHCT). Anti-Thymocyte Globulin: Given per standard institutional practice Cyclosporine: Given PO Mycophenolate Mofetil: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplant: Undergo nonmyeloablative allogeneic HSCT Allogeneic Cluster of Differentiation 8 (CD8)+ Memory T-cells: Receive CD8+ memory T-cells via IV Total Nodal Irradiation: Undergo TLI
Event-free Survival (EFS	15 Participants

SECONDARY outcome

Timeframe: Up to 30 days post-infusion

Occurrence of acute graft vs host disease (aGvHD) following the infusion of allogeneic transplantation of cluster of differentiation 8 (CD8+) memory T-cells will be assessed. The outcome is reported as the number of allogeneic CD8+ memory T-cell recipients who experience aGvHD within 30 days of the cellular infusion, a number without dispersion.

Outcome measures

Outcome measures
Measure	Infusion of Allogeneic CD8+ Memory T-cells n=18 Participants All participants receive allogeneic CD8+ memory T-cells 30 to 60 days after standard non-myeloablative allogeneic hematopoietic cell transplant (aHCT). Anti-Thymocyte Globulin: Given per standard institutional practice Cyclosporine: Given PO Mycophenolate Mofetil: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplant: Undergo nonmyeloablative allogeneic HSCT Allogeneic Cluster of Differentiation 8 (CD8)+ Memory T-cells: Receive CD8+ memory T-cells via IV Total Nodal Irradiation: Undergo TLI
Incidence of Acute Graft vs Host Disease (GvHD)	1 Participants

SECONDARY outcome

Timeframe: Up to 60 days post-infusion

Related adverse events, ie, toxicities, ≥ Grade 3 are significant considerations in the treatment of study participants receiving allogeneic transplantation of cluster of differentiation 8 (CD8+) memory T-cells. The outcome is reported as the number of allogeneic CD8+ memory T-cells transplant recipients who experienced ≥ Grade 3 toxicity within 60 days of infusion of the allogeneic transplantation of cluster of differentiation 8 (CD8+) memory T-cells, a number without dispersion.

Outcome measures

Outcome measures
Measure	Infusion of Allogeneic CD8+ Memory T-cells n=18 Participants All participants receive allogeneic CD8+ memory T-cells 30 to 60 days after standard non-myeloablative allogeneic hematopoietic cell transplant (aHCT). Anti-Thymocyte Globulin: Given per standard institutional practice Cyclosporine: Given PO Mycophenolate Mofetil: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplant: Undergo nonmyeloablative allogeneic HSCT Allogeneic Cluster of Differentiation 8 (CD8)+ Memory T-cells: Receive CD8+ memory T-cells via IV Total Nodal Irradiation: Undergo TLI
LOWSKY Grade 3 or Higher Toxicities	0 Participants

SECONDARY outcome

Timeframe: 1 year

The incidence of chronic graft vs host disease (cGvHD) following the infusion of allogeneic transplantation of cluster of differentiation 8 (CD8+) memory T-cells will be assessed. The outcome is reported as the number of allogeneic CD8+ memory T-cell recipients who experience cGvHD more 30 days but within 1 year of the cellular infusion, a number without dispersion.

Outcome measures

Outcome measures
Measure	Infusion of Allogeneic CD8+ Memory T-cells n=18 Participants All participants receive allogeneic CD8+ memory T-cells 30 to 60 days after standard non-myeloablative allogeneic hematopoietic cell transplant (aHCT). Anti-Thymocyte Globulin: Given per standard institutional practice Cyclosporine: Given PO Mycophenolate Mofetil: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplant: Undergo nonmyeloablative allogeneic HSCT Allogeneic Cluster of Differentiation 8 (CD8)+ Memory T-cells: Receive CD8+ memory T-cells via IV Total Nodal Irradiation: Undergo TLI
Chronic Graft vs Host Disease (GvHD)	2 Participants

SECONDARY outcome

Timeframe: 1 year

Non-relapse mortality (NRM) is defined as death without known disease relapse or recurrence. The outcome is expressed as the number of allogeneic CD8+ memory T-cells tr. ansplant recipients whose cause of death was not disease relapse or recurrence, a number without dispersion

Outcome measures

Outcome measures
Measure	Infusion of Allogeneic CD8+ Memory T-cells n=18 Participants All participants receive allogeneic CD8+ memory T-cells 30 to 60 days after standard non-myeloablative allogeneic hematopoietic cell transplant (aHCT). Anti-Thymocyte Globulin: Given per standard institutional practice Cyclosporine: Given PO Mycophenolate Mofetil: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplant: Undergo nonmyeloablative allogeneic HSCT Allogeneic Cluster of Differentiation 8 (CD8)+ Memory T-cells: Receive CD8+ memory T-cells via IV Total Nodal Irradiation: Undergo TLI
Non-relapse Mortality (NRM)	1 Participants

SECONDARY outcome

Timeframe: 1 year

Overall survival (OS) is defined as remaining alive 12 months after the infusion of allogeneic cluster of differentiation 8 (CD8+) memory T-cells. The outcome is reported as the number of allogeneic CD8+ memory T-cell transplant recipients remaining alive at 12 months after the cellular infusion, a number without dispersion

Outcome measures

Outcome measures
Measure	Infusion of Allogeneic CD8+ Memory T-cells n=18 Participants All participants receive allogeneic CD8+ memory T-cells 30 to 60 days after standard non-myeloablative allogeneic hematopoietic cell transplant (aHCT). Anti-Thymocyte Globulin: Given per standard institutional practice Cyclosporine: Given PO Mycophenolate Mofetil: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplant: Undergo nonmyeloablative allogeneic HSCT Allogeneic Cluster of Differentiation 8 (CD8)+ Memory T-cells: Receive CD8+ memory T-cells via IV Total Nodal Irradiation: Undergo TLI
Overall Survival (OS)	15 Participants

SECONDARY outcome

Timeframe: 1 year

Whether or not the treated disease returns, known as disease progression or relapse, is a measure of treatment efficacy. Recipients of allogeneic transplantation of cluster of differentiation 8 (CD8+) memory T-cells were monitored for disease progression through 1 year after the cellular infusion. The outcome is reported as the number of allogeneic CD8+ memory T-cells recipients that experienced disease progression within 12 months (1 year).

Outcome measures

Outcome measures
Measure	Infusion of Allogeneic CD8+ Memory T-cells n=18 Participants All participants receive allogeneic CD8+ memory T-cells 30 to 60 days after standard non-myeloablative allogeneic hematopoietic cell transplant (aHCT). Anti-Thymocyte Globulin: Given per standard institutional practice Cyclosporine: Given PO Mycophenolate Mofetil: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplant: Undergo nonmyeloablative allogeneic HSCT Allogeneic Cluster of Differentiation 8 (CD8)+ Memory T-cells: Receive CD8+ memory T-cells via IV Total Nodal Irradiation: Undergo TLI
Disease Progression (TDP)	4 Participants

Adverse Events

Infusion of Allogeneic CD8+ Memory T-cells

Serious events: 3 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Infusion of Allogeneic CD8+ Memory T-cells n=18 participants at risk All participants receive allogeneic CD8+ memory T-cells 30 to 60 days after standard non-myeloablative allogeneic hematopoietic cell transplant (aHCT). Anti-Thymocyte Globulin: Given per standard institutional practice Cyclosporine: Given PO Mycophenolate Mofetil: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplant: Undergo nonmyeloablative allogeneic HSCT Allogeneic Cluster of Differentiation 8 (CD8)+ Memory T-cells: Receive CD8+ memory T-cells via IV Total Nodal Irradiation: Undergo TLI
Infections and infestations Lung Infection	5.6% 1/18 • Number of events 1 • 90 days Per protocol, Grade 1 to 2 adverse events were not collected. Grade 3 and higher adverse events were collected through 90 days (3 months) after the CD8+ memory T-cell infusion. Per protocol, policy, and practice, mortality (survival) is collected indefinitely.
Gastrointestinal disorders Diarrhea	11.1% 2/18 • Number of events 2 • 90 days Per protocol, Grade 1 to 2 adverse events were not collected. Grade 3 and higher adverse events were collected through 90 days (3 months) after the CD8+ memory T-cell infusion. Per protocol, policy, and practice, mortality (survival) is collected indefinitely.

Other adverse events

Adverse event data not reported

Additional Information

Robert Lowsky, Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Stanford University

Phone: 650-723-0822

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place