Trial Outcomes & Findings for Study of Immune Response Modifier in the Treatment of Hematologic Malignancies (NCT NCT00276159)

Results Overview

Stable disease in Non-Hogkin's Lymphoma = disease that does not satisfy complete (complete regression), partial (\> or = 50% reduction) or progressive disease (increase of 25%) by at least a 4-week period. Since Acute Myelogenous Leukemia is not a solid tumor, Complete Response (CR) = \<5% blasts with hematopoietic recovery (absolute neutrophil count \>500) at 4 weeks.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

Up to Week 12

Results posted on

2019-09-04

Participant Flow

Participant milestones

Participant milestones
Measure	852A Treatment Patients receiving at least 12 doses of 852A.
Overall Study STARTED	6
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	852A Treatment Patients receiving at least 12 doses of 852A.
Overall Study Did not receive all 24 doses of 852A	6

Baseline Characteristics

Study of Immune Response Modifier in the Treatment of Hematologic Malignancies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	852A Treatment n=6 Participants Patients receiving at least 12 doses of 852A.
Age, Categorical <=18 years	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	39.8 years STANDARD_DEVIATION 23.32 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to Week 12

Population: Includes patients receiving at least 12 doses of 852A study drug.

Stable disease in Non-Hogkin's Lymphoma = disease that does not satisfy complete (complete regression), partial (\> or = 50% reduction) or progressive disease (increase of 25%) by at least a 4-week period. Since Acute Myelogenous Leukemia is not a solid tumor, Complete Response (CR) = \<5% blasts with hematopoietic recovery (absolute neutrophil count \>500) at 4 weeks.

Outcome measures

Outcome measures
Measure	852A Treatment n=6 Participants Patients receiving at least 12 doses of 852A.
Number of Patients With 852A Response Using Modified Response Evaluation Criteria in Solid Tumors Stable Disease	1 Participants
Number of Patients With 852A Response Using Modified Response Evaluation Criteria in Solid Tumors Partial Response	1 Participants
Number of Patients With 852A Response Using Modified Response Evaluation Criteria in Solid Tumors Progressive Disease	4 Participants

SECONDARY outcome

Timeframe: Up to Week 12

Population: Includes patients receiving at least 12 doses of 852A study drug.

Number of patients who received steroids allowing successful continuation of therapy.

Outcome measures

Outcome measures
Measure	852A Treatment n=6 Participants Patients receiving at least 12 doses of 852A.
Number of Patients Who Received Steroids	2 Participants

SECONDARY outcome

Timeframe: Up to Week 12

Population: Analysis not done to sale of agent - unable to perform.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Week 12

Population: Not able to analysis due to sale of agent - unable to perform.

Measurement of peak concentrations of 852A to correlate the side effects of tolerability in patients.

Outcome measures

Outcome data not reported

Adverse Events

852A Treatment

Serious events: 4 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	852A Treatment n=6 participants at risk Patients receiving at least 12 doses of 852A.
Infections and infestations Febrile neutropenia	16.7% 1/6 • Number of events 1 • Day 1 of Treatment through Week 12
General disorders Death	33.3% 2/6 • Number of events 2 • Day 1 of Treatment through Week 12
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	16.7% 1/6 • Number of events 1 • Day 1 of Treatment through Week 12

Other adverse events

Other adverse events
Measure	852A Treatment n=6 participants at risk Patients receiving at least 12 doses of 852A.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 2/6 • Number of events 3 • Day 1 of Treatment through Week 12
Blood and lymphatic system disorders Edema	16.7% 1/6 • Number of events 2 • Day 1 of Treatment through Week 12
General disorders Fatigue	66.7% 4/6 • Number of events 10 • Day 1 of Treatment through Week 12
Respiratory, thoracic and mediastinal disorders Dyspnea	33.3% 2/6 • Number of events 4 • Day 1 of Treatment through Week 12
Gastrointestinal disorders Nausea	66.7% 4/6 • Number of events 5 • Day 1 of Treatment through Week 12
General disorders Fever	33.3% 2/6 • Number of events 4 • Day 1 of Treatment through Week 12
General disorders Chills	66.7% 4/6 • Number of events 5 • Day 1 of Treatment through Week 12
Musculoskeletal and connective tissue disorders Myalgia	50.0% 3/6 • Number of events 10 • Day 1 of Treatment through Week 12
Skin and subcutaneous tissue disorders Diaphoresis	50.0% 3/6 • Number of events 3 • Day 1 of Treatment through Week 12

Additional Information

Sarah Cooley, MD

Masonic Cancer Center, University of Minnesota

Phone: 612-625-8474

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place