Trial Outcomes & Findings for A Phase 2 Clinical Trial of Rituxan and B-Glucan PGG in Relapsed Indolent Non-Hodgkin Lymphoma (NCT NCT02086175)
NCT ID: NCT02086175
Last Updated: 2024-04-09
Results Overview
Overall response rate is percentage of participants with complete (CR) and partial (PR) responses as best response during treatment. CR: * Nodal Masses: 1. For FDG-avid or PET positive prior to therapy; mass of any size permitted if PET negative 2. For variably FDG-avid or PET negative; regression to normal size on CT. * Liver/Spleen: No palpable nodules -Bone Marrow Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative. PR: * Nodal Masses: * 50% decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes. 1. FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site. 2. Variably FDG-avid or PET negative; regression on CT. * Liver/Spleen: * 50% decrease in SPD of nodules; no increase in size of liver or spleen. * Bone Marrow: Irrelevant if positive prior to therapy; cell type should be specified.
COMPLETED
PHASE2
25 participants
Response assessed at week 14 of study calendar (10 weeks after the 4-week treatment regimen).
2024-04-09
Participant Flow
Participant milestones
| Measure |
Imprime PGG and Rituximab
The study drug, Imprime PGG, will be administered intravenously at a dose of 4mg/kg weekly for 4 weeks. Rituximab will be administered intravenously by institutional standards concurrently at a dose of 375mg/m2 weekly for 4 weeks. Response will be assessed with CT scans 10 weeks +/- 3 days following the completion of treatment
Imprime PGG
Rituximab
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 2 Clinical Trial of Rituxan and B-Glucan PGG in Relapsed Indolent Non-Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Imprime PGG and Rituximab
n=25 Participants
The study drug, Imprime PGG, will be administered intravenously at a dose of 4mg/kg weekly for 4 weeks. Rituximab will be administered intravenously by institutional standards concurrently at a dose of 375mg/m2 weekly for 4 weeks. Response will be assessed with CT scans 10 weeks +/- 3 days following the completion of treatment
Imprime PGG
Rituximab
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
|
Age, Continuous
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
|
ECOG Performance Status
0 - Fully Active
|
18 Participants
n=5 Participants
|
|
ECOG Performance Status
1 - Restricted
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Response assessed at week 14 of study calendar (10 weeks after the 4-week treatment regimen).Population: All evaluated participants including two (2) non evaluable (NE) participants with partial or complete response (PR, CR)
Overall response rate is percentage of participants with complete (CR) and partial (PR) responses as best response during treatment. CR: * Nodal Masses: 1. For FDG-avid or PET positive prior to therapy; mass of any size permitted if PET negative 2. For variably FDG-avid or PET negative; regression to normal size on CT. * Liver/Spleen: No palpable nodules -Bone Marrow Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative. PR: * Nodal Masses: * 50% decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes. 1. FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site. 2. Variably FDG-avid or PET negative; regression on CT. * Liver/Spleen: * 50% decrease in SPD of nodules; no increase in size of liver or spleen. * Bone Marrow: Irrelevant if positive prior to therapy; cell type should be specified.
Outcome measures
| Measure |
Imprime PGG and Rituximab
n=25 Participants
The study drug, Imprime PGG, will be administered intravenously at a dose of 4mg/kg weekly for 4 weeks. Rituximab will be administered intravenously by institutional standards concurrently at a dose of 375mg/m2 weekly for 4 weeks. Response will be assessed with CT scans 10 weeks +/- 3 days following the completion of treatment
Imprime PGG
Rituximab
|
|---|---|
|
Overall Response Rate
|
12 Participants
|
SECONDARY outcome
Timeframe: Patients were followed for a median (range) of 13.6 months (3-25).Progression free survival (PFS) is defined as the time from start of treatment to disease progression or death from any cause as estimated by Kaplan Meier methods. Patients who have not progressed and are alive are censored at the date the patient is known to be progression-free. Response is measure using the International Harmonization Project for Lymphoma criteria Cheson 2007, using CT scans of the chest, abdomen, and pelvis.
Outcome measures
| Measure |
Imprime PGG and Rituximab
n=25 Participants
The study drug, Imprime PGG, will be administered intravenously at a dose of 4mg/kg weekly for 4 weeks. Rituximab will be administered intravenously by institutional standards concurrently at a dose of 375mg/m2 weekly for 4 weeks. Response will be assessed with CT scans 10 weeks +/- 3 days following the completion of treatment
Imprime PGG
Rituximab
|
|---|---|
|
Median Progression-free Survival (PFS)
|
14.4 months
Interval 0.0 to 16.0
|
SECONDARY outcome
Timeframe: Patients were followed for a median (range) of 13.6 months (3-25).Duration of response DR is defined as the time from the date of first response (complete or partial) after treatment to the date of disease progression or death for any cause. Patients who are alive without progression are censored at the date the patient is last know to be progression-free.
Outcome measures
| Measure |
Imprime PGG and Rituximab
n=25 Participants
The study drug, Imprime PGG, will be administered intravenously at a dose of 4mg/kg weekly for 4 weeks. Rituximab will be administered intravenously by institutional standards concurrently at a dose of 375mg/m2 weekly for 4 weeks. Response will be assessed with CT scans 10 weeks +/- 3 days following the completion of treatment
Imprime PGG
Rituximab
|
|---|---|
|
Duration of Response (DOR)
|
11.8 months
Interval 0.0 to 12.0
|
SECONDARY outcome
Timeframe: Up to 14 weeks with a median (range of) 13 weeks (12-14).Population: Imprime PGG-bound neutrophil status only available for this analysis population.
Imprime PGG-bound neutrophils analyzed using established methods (peripheral blood samples and post-treatment tumor samples to quantify the binding of Imprime PGG to neutrophils) by treatment response, best response.
Outcome measures
| Measure |
Imprime PGG and Rituximab
n=22 Participants
The study drug, Imprime PGG, will be administered intravenously at a dose of 4mg/kg weekly for 4 weeks. Rituximab will be administered intravenously by institutional standards concurrently at a dose of 375mg/m2 weekly for 4 weeks. Response will be assessed with CT scans 10 weeks +/- 3 days following the completion of treatment
Imprime PGG
Rituximab
|
|---|---|
|
Imprime PGG-bound Neutrophils Status by Response
Imprime PGG-bound neutrophils · Complete Response
|
0 Participants
|
|
Imprime PGG-bound Neutrophils Status by Response
Imprime PGG-bound neutrophils · Partial Response
|
4 Participants
|
|
Imprime PGG-bound Neutrophils Status by Response
Imprime PGG-bound neutrophils · Stable Disease
|
4 Participants
|
|
Imprime PGG-bound Neutrophils Status by Response
Imprime PGG-bound neutrophils · Progressive Disease
|
0 Participants
|
|
Imprime PGG-bound Neutrophils Status by Response
Non-bound neutrophils · Complete Response
|
1 Participants
|
|
Imprime PGG-bound Neutrophils Status by Response
Non-bound neutrophils · Partial Response
|
5 Participants
|
|
Imprime PGG-bound Neutrophils Status by Response
Non-bound neutrophils · Stable Disease
|
4 Participants
|
|
Imprime PGG-bound Neutrophils Status by Response
Non-bound neutrophils · Progressive Disease
|
4 Participants
|
Adverse Events
Imprime PGG and Rituximab
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Imprime PGG and Rituximab
n=25 participants at risk
The study drug, Imprime PGG, will be administered intravenously at a dose of 4mg/kg weekly for 4 weeks. Rituximab will be administered intravenously by institutional standards concurrently at a dose of 375mg/m2 weekly for 4 weeks. Response will be assessed with CT scans 10 weeks +/- 3 days following the completion of treatment
Imprime PGG
Rituximab
|
|---|---|
|
General disorders
Infusion related reaction
|
20.0%
5/25 • Number of events 8 • Up to 66 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.0%
2/25 • Number of events 3 • Up to 66 weeks
|
|
General disorders
Fatigue
|
8.0%
2/25 • Number of events 2 • Up to 66 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
4.0%
1/25 • Number of events 1 • Up to 66 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
4.0%
1/25 • Number of events 1 • Up to 66 weeks
|
|
General disorders
Chills
|
4.0%
1/25 • Number of events 1 • Up to 66 weeks
|
|
Infections and infestations
Otitis externa
|
4.0%
1/25 • Number of events 1 • Up to 66 weeks
|
|
Investigations
Alanine aminotransferase increased
|
4.0%
1/25 • Number of events 1 • Up to 66 weeks
|
|
Investigations
Alkaline phosphatase increased
|
4.0%
1/25 • Number of events 1 • Up to 66 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
4.0%
1/25 • Number of events 1 • Up to 66 weeks
|
|
Investigations
Neutrophil count decreased
|
4.0%
1/25 • Number of events 2 • Up to 66 weeks
|
|
Investigations
White blood cell decreased
|
4.0%
1/25 • Number of events 2 • Up to 66 weeks
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.0%
1/25 • Number of events 2 • Up to 66 weeks
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.0%
1/25 • Number of events 1 • Up to 66 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.0%
1/25 • Number of events 1 • Up to 66 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.0%
1/25 • Number of events 1 • Up to 66 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
4.0%
1/25 • Number of events 1 • Up to 66 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place