Trial Outcomes & Findings for Irradiated Donor Cells Following Stem Cell Transplant in Controlling Cancer in Patients With Hematologic Malignancies (NCT NCT03272633)

Last Updated: 2023-06-26

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Recruitment status

TERMINATED

Study phase

EARLY_PHASE1

Target enrollment

2 participants

Primary outcome timeframe

Up to 8 weeks after last protocol treatment

Results posted on

2023-06-26

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort I (Initial IHC Within 42 Days) Within 42 days after hematopoietic engraftment (both neutrophils and platelets) after autologous HSCT, patients receive initial treatment with IHC. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses. Allogeneic Hematopoietic Stem Cell Transplantation: Receive IHC Irradiated Allogeneic Cells: Correlative studies	Cohort II (Initial IHC Within 70 Days or After Relapse) Patients with high-risk disease receive initial treatment with IHC within 70 days after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT. Patients being treated for relapsed disease may receive initial treatment with IHC any time after relapse is documented. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses. Allogeneic Hematopoietic Stem Cell Transplantation: Receive IHC Irradiated Allogeneic Cells: Correlative studies
Overall Study STARTED	0	2
Overall Study COMPLETED	0	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Irradiated Donor Cells Following Stem Cell Transplant in Controlling Cancer in Patients With Hematologic Malignancies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort I (Initial IHC Within 42 Days) Within 42 days after hematopoietic engraftment (both neutrophils and platelets) after autologous HSCT, patients receive initial treatment with IHC. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses. Allogeneic Hematopoietic Stem Cell Transplantation: Receive IHC Irradiated Allogeneic Cells: Correlative studies	Cohort II (Initial IHC Within 70 Days or After Relapse) n=2 Participants Patients with high-risk disease receive initial treatment with IHC within 70 days after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT. Patients being treated for relapsed disease may receive initial treatment with IHC any time after relapse is documented. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses. Allogeneic Hematopoietic Stem Cell Transplantation: Receive IHC Irradiated Allogeneic Cells: Correlative studies	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	2 Participants n=7 Participants	2 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
Region of Enrollment United States	—	2 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 8 weeks after last protocol treatment

Population: no data was collected. Refers to the Cohort 1 Arm

Outcome measures

Outcome measures
Measure	Cohort I (Initial IHC Within 42 Days) Within 42 days after hematopoietic engraftment (both neutrophils and platelets) after autologous HSCT, patients receive initial treatment with IHC. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses. Allogeneic Hematopoietic Stem Cell Transplantation: Receive IHC Irradiated Allogeneic Cells: Correlative studies	Cohort II (Initial IHC Within 70 Days or After Relapse) n=2 Participants Patients with high-risk disease receive initial treatment with IHC within 70 days after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT. Patients being treated for relapsed disease may receive initial treatment with IHC any time after relapse is documented. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses. Allogeneic Hematopoietic Stem Cell Transplantation: Receive IHC Irradiated Allogeneic Cells: Correlative studies
Number of Participants Who Received Irradiated Haploidentical Cells (IHC) With Disease Response	—	2 Participants

PRIMARY outcome

Timeframe: Up to 12 weeks of completion of therapy

Population: no data was collected. Refers to the Cohort 1 Arm

The anticipated/projected IHC-associated toxicities of greatest concern include: short-term toxicities- constitutional/systemic adverse events including fevers, hypotension, pulmonary infiltrates; long-term toxicities: autoimmune effects, graft-versus-host disease (GVHD), graft rejection. Toxicity will be measured by occurrence of any experimental treatment-related adverse events (AE) up to 12 weeks of completion of therapy. The CTCAE version 4.0 will be utilized for the description and grading of the AE. All symptoms, signs, or diseases assessed as experimental treatment-related will be captu

Outcome measures

Outcome measures
Measure	Cohort I (Initial IHC Within 42 Days) Within 42 days after hematopoietic engraftment (both neutrophils and platelets) after autologous HSCT, patients receive initial treatment with IHC. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses. Allogeneic Hematopoietic Stem Cell Transplantation: Receive IHC Irradiated Allogeneic Cells: Correlative studies	Cohort II (Initial IHC Within 70 Days or After Relapse) n=2 Participants Patients with high-risk disease receive initial treatment with IHC within 70 days after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT. Patients being treated for relapsed disease may receive initial treatment with IHC any time after relapse is documented. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses. Allogeneic Hematopoietic Stem Cell Transplantation: Receive IHC Irradiated Allogeneic Cells: Correlative studies
the Number of Participants With Toxicities Associated With Administration of Irradiated Haploidentical Cells (IHC) Evaluated According to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0	—	2 Participants

SECONDARY outcome

Timeframe: Up to 8 weeks after last protocol treatment

Population: no data was collected

It will be determined if treatment with the irradiated cells induces an immune response targeting tumor associated epitopes.

Outcome measures

Outcome data not reported

Adverse Events

Cohort I (Initial IHC Within 42 Days)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort II (Initial IHC Within 70 Days or After Relapse)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort I (Initial IHC Within 42 Days) Within 42 days after hematopoietic engraftment (both neutrophils and platelets) after autologous HSCT, patients receive initial treatment with IHC. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses. Allogeneic Hematopoietic Stem Cell Transplantation: Receive IHC Irradiated Allogeneic Cells: Correlative studies	Cohort II (Initial IHC Within 70 Days or After Relapse) n=2 participants at risk Patients with high-risk disease receive initial treatment with IHC within 70 days after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT. Patients being treated for relapsed disease may receive initial treatment with IHC any time after relapse is documented. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses. Allogeneic Hematopoietic Stem Cell Transplantation: Receive IHC Irradiated Allogeneic Cells: Correlative studies
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	— 0/0 • Up to 8 weeks after last protocol treatment no data was collected. Adverse Events Description text only refers to the Cohort II No participants were enrolled in Cohort I, so no adverse events were monitored/assessed for Cohort I	0.00% 0/2 • Up to 8 weeks after last protocol treatment no data was collected. Adverse Events Description text only refers to the Cohort II No participants were enrolled in Cohort I, so no adverse events were monitored/assessed for Cohort I

Other adverse events

Other adverse events
Measure	Cohort I (Initial IHC Within 42 Days) Within 42 days after hematopoietic engraftment (both neutrophils and platelets) after autologous HSCT, patients receive initial treatment with IHC. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses. Allogeneic Hematopoietic Stem Cell Transplantation: Receive IHC Irradiated Allogeneic Cells: Correlative studies	Cohort II (Initial IHC Within 70 Days or After Relapse) n=2 participants at risk Patients with high-risk disease receive initial treatment with IHC within 70 days after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT. Patients being treated for relapsed disease may receive initial treatment with IHC any time after relapse is documented. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses. Allogeneic Hematopoietic Stem Cell Transplantation: Receive IHC Irradiated Allogeneic Cells: Correlative studies
General disorders General disorders and administration site conditions	— 0/0 • Up to 8 weeks after last protocol treatment no data was collected. Adverse Events Description text only refers to the Cohort II No participants were enrolled in Cohort I, so no adverse events were monitored/assessed for Cohort I	100.0% 2/2 • Up to 8 weeks after last protocol treatment no data was collected. Adverse Events Description text only refers to the Cohort II No participants were enrolled in Cohort I, so no adverse events were monitored/assessed for Cohort I
Investigations Investigations	— 0/0 • Up to 8 weeks after last protocol treatment no data was collected. Adverse Events Description text only refers to the Cohort II No participants were enrolled in Cohort I, so no adverse events were monitored/assessed for Cohort I	100.0% 2/2 • Number of events 5 • Up to 8 weeks after last protocol treatment no data was collected. Adverse Events Description text only refers to the Cohort II No participants were enrolled in Cohort I, so no adverse events were monitored/assessed for Cohort I
Eye disorders Eye disorders	— 0/0 • Up to 8 weeks after last protocol treatment no data was collected. Adverse Events Description text only refers to the Cohort II No participants were enrolled in Cohort I, so no adverse events were monitored/assessed for Cohort I	50.0% 1/2 • Number of events 1 • Up to 8 weeks after last protocol treatment no data was collected. Adverse Events Description text only refers to the Cohort II No participants were enrolled in Cohort I, so no adverse events were monitored/assessed for Cohort I
Metabolism and nutrition disorders Metabolism and nutrition disorders	— 0/0 • Up to 8 weeks after last protocol treatment no data was collected. Adverse Events Description text only refers to the Cohort II No participants were enrolled in Cohort I, so no adverse events were monitored/assessed for Cohort I	50.0% 1/2 • Number of events 1 • Up to 8 weeks after last protocol treatment no data was collected. Adverse Events Description text only refers to the Cohort II No participants were enrolled in Cohort I, so no adverse events were monitored/assessed for Cohort I
Nervous system disorders Nervous system disorders	— 0/0 • Up to 8 weeks after last protocol treatment no data was collected. Adverse Events Description text only refers to the Cohort II No participants were enrolled in Cohort I, so no adverse events were monitored/assessed for Cohort I	50.0% 1/2 • Number of events 1 • Up to 8 weeks after last protocol treatment no data was collected. Adverse Events Description text only refers to the Cohort II No participants were enrolled in Cohort I, so no adverse events were monitored/assessed for Cohort I

Additional Information

Roger K. Strair, MD

Cancer Institute of New Jersey Rutgers

Phone: 732-235-4523

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place