Trial Outcomes & Findings for Phase II Randomized Trial Comparing GA101 and Rituximab in Untreated Low Tumor Burden Indolent Non-Hodgkin's Lymphoma (NCT NCT01889797)

Last Updated: 2017-05-05

Results Overview

Positron Emission Tomography (PET)-documented CR rates after induction therapy (weekly treatment x 4 weeks with GA101 or rituximab) Definitions for clinical response are modified from the Revised Response Criteria for Malignant Lymphoma (Cheson BD, et al. Revised Response Criteria for Malignant Lymphoma. J Clin Oncol 2007; 25(5): 579-86). Lymph node measurements were taken from CT, CT portion of the PET/CT, or MRI scans where applicable. CR is defined as complete disappearance of all evidence of disease; PR as a \>50% decrease in the sum of the products of the maximal perpendicular diameters of measured lesions (SPD) and no new sites; SD as failure to attain CR/PR or PD; and PD as any new lesion \>1.5cm in any axis or ≥50% increase in previously involved sites.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

32 participants

Primary outcome timeframe

Re-staging (week 12, 13 or 14) and during follow-up if physician feels patient is subsequently in CR for up to 4 years

Results posted on

2017-05-05

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A: Rituximab Rituximab 375 mg/m² IV weekly for 4 weeks. Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses.	Arm B: GA101 GA101 1,000 mg IV weekly for 4 weeks. Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses.
Overall Study STARTED	16	16
Overall Study COMPLETED	16	16
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II Randomized Trial Comparing GA101 and Rituximab in Untreated Low Tumor Burden Indolent Non-Hodgkin's Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: Rituximab n=16 Participants Rituximab 375 mg/m² IV weekly for 4 weeks. Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses.	Arm B: GA101 n=16 Participants GA101 1,000 mg IV weekly for 4 weeks. Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses.	Total n=32 Participants Total of all reporting groups
Age, Continuous	52 years n=5 Participants	59 years n=7 Participants	56 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	16 Participants n=7 Participants	31 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	16 participants n=5 Participants	16 participants n=7 Participants	32 participants n=5 Participants
ECOG Performance Status PS 0	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants
ECOG Performance Status PS 1	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants
Modified Ann Arbor Staging Stage III (1)	1 participants n=5 Participants	5 participants n=7 Participants	6 participants n=5 Participants
Modified Ann Arbor Staging Stage III (2)	5 participants n=5 Participants	4 participants n=7 Participants	9 participants n=5 Participants
Modified Ann Arbor Staging Stage IV	10 participants n=5 Participants	7 participants n=7 Participants	17 participants n=5 Participants
Primary Tumor Type Grade 1 Follicular NHL	10 participants n=5 Participants	13 participants n=7 Participants	23 participants n=5 Participants
Primary Tumor Type Grade 2 Follicular NHL	4 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants
Primary Tumor Type Other	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Re-staging (week 12, 13 or 14) and during follow-up if physician feels patient is subsequently in CR for up to 4 years

Population: All participants were included in the analysis

Outcome measures

Outcome measures
Measure	Arm A: Rituximab n=16 Participants Rituximab 375 mg/m² IV weekly for 4 weeks. Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses.	Arm B: GA101 n=16 Participants GA101 1,000 mg IV weekly for 4 weeks. Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses.
Complete Response (CR) Rate	37.5 percentage of participants Interval 21.0 to 56.5	56.2 percentage of participants Interval 37.5 to 73.7

SECONDARY outcome

Timeframe: Re-staging (week 12, 13 or 14)

PET response rate \[PET-documented CR + Partial Response (PR)\] based on PET scan results. Patients with unevaluable disease were included in the denominator.

Outcome measures

Outcome measures
Measure	Arm A: Rituximab n=16 Participants Rituximab 375 mg/m² IV weekly for 4 weeks. Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses.	Arm B: GA101 n=16 Participants GA101 1,000 mg IV weekly for 4 weeks. Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses.
PET Response Rate Progressive Disease	2 participants	0 participants
PET Response Rate Complete Response	6 participants	9 participants
PET Response Rate Partial Response	5 participants	5 participants
PET Response Rate Stable Disease	3 participants	2 participants

SECONDARY outcome

Timeframe: Baseline and Re-staging (week 12, 13 or 14)

Overall response rate (CR + PR by Cheson criteria) at re-staging (including bone marrow biopsy if CR suspected) by PET and Neck, Chest, Abdomen and Pelvic Computed Tomography (CT) scan. Patients with unevaluable disease were included in the denominator.

Outcome measures

Outcome measures
Measure	Arm A: Rituximab n=16 Participants Rituximab 375 mg/m² IV weekly for 4 weeks. Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses.	Arm B: GA101 n=16 Participants GA101 1,000 mg IV weekly for 4 weeks. Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses.
Overall Response Rate	68.8 percentage of participants Interval 49.6 to 83.9	87.5 percentage of participants Interval 70.0 to 96.6

SECONDARY outcome

Timeframe: Percent of participants alive and progression-free at 1 year

CT scan every 3 months for 2 years, then every 6 months until progression. Compare PFS in each treatment arm. Progressive disease (PD) was defined using Cheson criteria as described in the Primary Outcome section above. Progression-free survival (PFS) was defined as the time from start of treatment to the documentation of PD or death, whichever occurs first. Patients alive and without PD were censored at the date of last disease assessment.

Outcome measures

Outcome measures
Measure	Arm A: Rituximab n=16 Participants Rituximab 375 mg/m² IV weekly for 4 weeks. Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses.	Arm B: GA101 n=16 Participants GA101 1,000 mg IV weekly for 4 weeks. Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses.
Progression Free Survival (PFS)	68.8 percentage of participants Interval 44.2 to 84.2	87.5 percentage of participants Interval 61.8 to 96.4

Adverse Events

Arm A: Rituximab

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Arm B: GA101

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm A: Rituximab n=16 participants at risk Rituximab 375 mg/m² IV weekly for 4 weeks. Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses.	Arm B: GA101 n=16 participants at risk GA101 1,000 mg IV weekly for 4 weeks. Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses.
Vascular disorders Flushing	0.00% 0/16 Adverse events were assessed weekly, prior to and during administration of study drug.	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.
Cardiac disorders Hypotension	0.00% 0/16 Adverse events were assessed weekly, prior to and during administration of study drug.	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.
General disorders Infusion Related Reaction	0.00% 0/16 Adverse events were assessed weekly, prior to and during administration of study drug.	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.

Other adverse events

Additional Information

PrECOG Statistician

ECOG-ACRIN Biostatistics Center

Phone: 617-632-3627

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm A: Rituximab n=16 participants at risk Rituximab 375 mg/m² IV weekly for 4 weeks. Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses.	Arm B: GA101 n=16 participants at risk GA101 1,000 mg IV weekly for 4 weeks. Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses.
Investigations Alanine Aminotransferase Increased	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.	0.00% 0/16 Adverse events were assessed weekly, prior to and during administration of study drug.
Blood and lymphatic system disorders Anemia	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.	0.00% 0/16 Adverse events were assessed weekly, prior to and during administration of study drug.
Nervous system disorders Anxiety	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/16 Adverse events were assessed weekly, prior to and during administration of study drug.	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.
Musculoskeletal and connective tissue disorders Arthritis	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.
Musculoskeletal and connective tissue disorders Asthenia	0.00% 0/16 Adverse events were assessed weekly, prior to and during administration of study drug.	18.8% 3/16 Adverse events were assessed weekly, prior to and during administration of study drug.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/16 Adverse events were assessed weekly, prior to and during administration of study drug.	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.
Investigations Alkaline Phosphatase Increased	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.	0.00% 0/16 Adverse events were assessed weekly, prior to and during administration of study drug.
General disorders Chills	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.
Psychiatric disorders Confusional State	0.00% 0/16 Adverse events were assessed weekly, prior to and during administration of study drug.	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.
Gastrointestinal disorders Constipation	0.00% 0/16 Adverse events were assessed weekly, prior to and during administration of study drug.	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.
Respiratory, thoracic and mediastinal disorders Cough	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.	0.00% 0/16 Adverse events were assessed weekly, prior to and during administration of study drug.
Immune system disorders Cytokine Release Syndrome	0.00% 0/16 Adverse events were assessed weekly, prior to and during administration of study drug.	12.5% 2/16 Adverse events were assessed weekly, prior to and during administration of study drug.
Metabolism and nutrition disorders Decreased Appetite	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.	12.5% 2/16 Adverse events were assessed weekly, prior to and during administration of study drug.
Immune system disorders Dermatitis Allergic	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.	0.00% 0/16 Adverse events were assessed weekly, prior to and during administration of study drug.
Gastrointestinal disorders Diarrhea	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.	12.5% 2/16 Adverse events were assessed weekly, prior to and during administration of study drug.
Nervous system disorders Dizziness	0.00% 0/16 Adverse events were assessed weekly, prior to and during administration of study drug.	12.5% 2/16 Adverse events were assessed weekly, prior to and during administration of study drug.
Gastrointestinal disorders Dysgeusia	0.00% 0/16 Adverse events were assessed weekly, prior to and during administration of study drug.	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.
Gastrointestinal disorders Dyspepsia	0.00% 0/16 Adverse events were assessed weekly, prior to and during administration of study drug.	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnea	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.	0.00% 0/16 Adverse events were assessed weekly, prior to and during administration of study drug.
General disorders Edema	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.	0.00% 0/16 Adverse events were assessed weekly, prior to and during administration of study drug.
General disorders Infusion Site Extravasation	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.
Eye disorders Eye Disorder	0.00% 0/16 Adverse events were assessed weekly, prior to and during administration of study drug.	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.
General disorders Fatigue	18.8% 3/16 Adverse events were assessed weekly, prior to and during administration of study drug.	50.0% 8/16 Adverse events were assessed weekly, prior to and during administration of study drug.
Nervous system disorders Headache	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.	18.8% 3/16 Adverse events were assessed weekly, prior to and during administration of study drug.
Vascular disorders Hot Flashes	0.00% 0/16 Adverse events were assessed weekly, prior to and during administration of study drug.	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.
Metabolism and nutrition disorders Hyperglycemia	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.	0.00% 0/16 Adverse events were assessed weekly, prior to and during administration of study drug.
Skin and subcutaneous tissue disorders Hyperhidrosis	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.
Vascular disorders Hypertension	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.	0.00% 0/16 Adverse events were assessed weekly, prior to and during administration of study drug.
Metabolism and nutrition disorders Hyperuricemia	0.00% 0/16 Adverse events were assessed weekly, prior to and during administration of study drug.	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.
Vascular disorders Hypotension	12.5% 2/16 Adverse events were assessed weekly, prior to and during administration of study drug.	0.00% 0/16 Adverse events were assessed weekly, prior to and during administration of study drug.
General disorders Flu Like Symptoms	0.00% 0/16 Adverse events were assessed weekly, prior to and during administration of study drug.	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.
General disorders Infusion Related Reaction	31.2% 5/16 Adverse events were assessed weekly, prior to and during administration of study drug.	37.5% 6/16 Adverse events were assessed weekly, prior to and during administration of study drug.
Psychiatric disorders Insomnia	0.00% 0/16 Adverse events were assessed weekly, prior to and during administration of study drug.	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.
Investigations Lymphocyte Count Decreased	0.00% 0/16 Adverse events were assessed weekly, prior to and during administration of study drug.	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.
Musculoskeletal and connective tissue disorders Myalgia	12.5% 2/16 Adverse events were assessed weekly, prior to and during administration of study drug.	18.8% 3/16 Adverse events were assessed weekly, prior to and during administration of study drug.
Gastrointestinal disorders Nausea	25.0% 4/16 Adverse events were assessed weekly, prior to and during administration of study drug.	18.8% 3/16 Adverse events were assessed weekly, prior to and during administration of study drug.
Nervous system disorders Peripheral Motor Neuropathy	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.	0.00% 0/16 Adverse events were assessed weekly, prior to and during administration of study drug.
Investigations Neutrophil Count Decreased	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.	0.00% 0/16 Adverse events were assessed weekly, prior to and during administration of study drug.
General disorders Non-cardiac Chest Pain	0.00% 0/16 Adverse events were assessed weekly, prior to and during administration of study drug.	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.
Respiratory, thoracic and mediastinal disorders Sore Throat	0.00% 0/16 Adverse events were assessed weekly, prior to and during administration of study drug.	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/16 Adverse events were assessed weekly, prior to and during administration of study drug.	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.
Investigations Platelet Count Decreased	0.00% 0/16 Adverse events were assessed weekly, prior to and during administration of study drug.	12.5% 2/16 Adverse events were assessed weekly, prior to and during administration of study drug.
General disorders Fever	0.00% 0/16 Adverse events were assessed weekly, prior to and during administration of study drug.	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.
Skin and subcutaneous tissue disorders Rash	0.00% 0/16 Adverse events were assessed weekly, prior to and during administration of study drug.	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.
Nervous system disorders Tremor	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.	0.00% 0/16 Adverse events were assessed weekly, prior to and during administration of study drug.
Eye disorders Blurred Vision	0.00% 0/16 Adverse events were assessed weekly, prior to and during administration of study drug.	6.2% 1/16 Adverse events were assessed weekly, prior to and during administration of study drug.