Trial Outcomes & Findings for Imprime PGG, Alemtuzumab, and Rituximab in Treating Patients With High Risk Chronic Lymphocytic Leukemia (NCT NCT01269385)
NCT ID: NCT01269385
Last Updated: 2020-06-23
Results Overview
MTD is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients (at least 2 of a maximum of 6 new patients). A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD. Three patients will be treated at a given dose level combination for at least 5 weeks to assess toxicity. If dose-limiting toxicity (DLT) is not seen in any of the 3 patients, 3 new patients will be accrued and treated at the next higher dose level. If DLT is seen in 2 or 3 of 3 patients treated at a given dose level, then the next 3 patients will be treated at the next lower dose level, if only 3 patients were enrolled and treated at this lower dose level. We tabulate the number of patients reporting a DLT.
COMPLETED
PHASE1/PHASE2
22 participants
First cycle of treatment (35 days)
2020-06-23
Participant Flow
Participant milestones
| Measure |
Phase I: Dose Level 0
During one 35-day period of treatment:
Patients receive 1 mg/kg/dose PGG (poly-(1-6)-beta-glucotriosyl-(1-3)-beta-glucopyranose) IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31
Alemtuzumab subcutaneously 3 mg day 3 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31.
Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Phase I: Dose Level 1
During one 35-day period of treatment:
Patients receive 2 mg/kg/dose PGG (poly-(1-6)-beta-glucotriosyl-(1-3)-beta-glucopyranose) IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31
Alemtuzumab subcutaneously 3 mg day 3 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31.
Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Phase I: Dose Level 2
During one 35-day period of treatment:
Patients receive 4 mg/kg/dose PGG (poly-(1-6)-beta-glucotriosyl-(1-3)-beta-glucopyranose) IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31
Alemtuzumab subcutaneously 3 mg day 3 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31.
Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Phase II: Dose Level 2
During one 35-day period of treatment:
Patients receive 4 mg/kg/dose PGG (poly-(1-6)-beta-glucotriosyl-(1-3)-beta-glucopyranose) IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31
Alemtuzumab subcutaneously 3 mg day 3 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31.
Treatment continues in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
6
|
8
|
|
Overall Study
COMPLETED
|
3
|
3
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Phase I: Dose Level 0
During one 35-day period of treatment:
Patients receive 1 mg/kg/dose PGG (poly-(1-6)-beta-glucotriosyl-(1-3)-beta-glucopyranose) IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31
Alemtuzumab subcutaneously 3 mg day 3 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31.
Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Phase I: Dose Level 1
During one 35-day period of treatment:
Patients receive 2 mg/kg/dose PGG (poly-(1-6)-beta-glucotriosyl-(1-3)-beta-glucopyranose) IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31
Alemtuzumab subcutaneously 3 mg day 3 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31.
Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Phase I: Dose Level 2
During one 35-day period of treatment:
Patients receive 4 mg/kg/dose PGG (poly-(1-6)-beta-glucotriosyl-(1-3)-beta-glucopyranose) IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31
Alemtuzumab subcutaneously 3 mg day 3 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31.
Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Phase II: Dose Level 2
During one 35-day period of treatment:
Patients receive 4 mg/kg/dose PGG (poly-(1-6)-beta-glucotriosyl-(1-3)-beta-glucopyranose) IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31
Alemtuzumab subcutaneously 3 mg day 3 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31.
Treatment continues in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Imprime PGG, Alemtuzumab, and Rituximab in Treating Patients With High Risk Chronic Lymphocytic Leukemia
Baseline characteristics by cohort
| Measure |
All Patients
n=20 Participants
During one 35-day period of treatment:
Patients receive 1, 2, or 4 mg/kg/dose PGG beta-glucan IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31
Alemtuzumab subcutaneously
3 mg day 3
10 mg day 4
30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31.
Treatment continues in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First cycle of treatment (35 days)Population: All Phase I patients that were eligible and completed cycle 1 treatment were used in the MTD assessment.
MTD is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients (at least 2 of a maximum of 6 new patients). A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD. Three patients will be treated at a given dose level combination for at least 5 weeks to assess toxicity. If dose-limiting toxicity (DLT) is not seen in any of the 3 patients, 3 new patients will be accrued and treated at the next higher dose level. If DLT is seen in 2 or 3 of 3 patients treated at a given dose level, then the next 3 patients will be treated at the next lower dose level, if only 3 patients were enrolled and treated at this lower dose level. We tabulate the number of patients reporting a DLT.
Outcome measures
| Measure |
Phase I: Dose Level 0
n=3 Participants
During one 35-day period of treatment:
Patients receive 1 mg/kg/dose PGG beta-glucan IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31
Alemtuzumab subcutaneously 3 mg day 3 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33; Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31.
Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Phase I: Dose Level 1
n=3 Participants
During one 35-day period of treatment:
Patients receive 2 mg/kg/dose PGG beta-glucan IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31
Alemtuzumab subcutaneously 3 mg day 3 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31.
Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Phase I: Dose Level 2
n=6 Participants
During one 35-day period of treatment:
Patients receive 4 mg/kg/dose PGG beta-glucan IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31
Alemtuzumab subcutaneously 3 mg day 3 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31.
Treatment continues in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of PGG Beta Glucan in Combination With Alemtuzumab and Rituximab Assessed by Analyzing the Number of Dose-limiting Toxicity Events (Phase I)
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 3 months after the completion of treatment, up to 5 yearsPopulation: All patients treated at dose level 2 were included in this analysis. This includes 6 patients registered to the Phase I: Dose level 2 and 8 patients registered to Phase II.
The number of patients that demonstrate a Complete Response (CR) during treatment on Dose Level 2 divided by the number of eligible patients starting Dose Level 2 treatment. A CR requires all of the following for a period of at least 2 months: Absence of lymphadenopathy by physical examination, no hepatomegaly or splenomegaly, absence of constitutional symptoms, neutrophils \>1500/ul, Platelets \>100,000/ul, Hemoglobin \>11.0 gm/dl, Peripheral blood lymphocytes \<4000/uL.
Outcome measures
| Measure |
Phase I: Dose Level 0
n=14 Participants
During one 35-day period of treatment:
Patients receive 1 mg/kg/dose PGG beta-glucan IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31
Alemtuzumab subcutaneously 3 mg day 3 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33; Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31.
Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Phase I: Dose Level 1
During one 35-day period of treatment:
Patients receive 2 mg/kg/dose PGG beta-glucan IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31
Alemtuzumab subcutaneously 3 mg day 3 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31.
Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Phase I: Dose Level 2
During one 35-day period of treatment:
Patients receive 4 mg/kg/dose PGG beta-glucan IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31
Alemtuzumab subcutaneously 3 mg day 3 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31.
Treatment continues in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Proportion of Complete Responses (Dose Level 2)
|
.65 proportion of participants
Interval 0.41 to 0.85
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 months after the completion of treatment, up to 5 yearsPopulation: All patients treated at dose level 2 were included in this analysis. This includes 6 patients registered to the Phase I: Dose level 2 and 8 patients registered to Phase II.
Overall response rate was estimated by the total number of patients receiving Dose Level 2 reporting complete responses or partial responses (CR or PR) divided by the total number of evaluable patients that started Dose Level 2 treatment. A COMPLETE RESPONSE (CR) requires all of the following for a period of at least 2 months: Absence of lymphadenopathy by physical examination, no hepatomegaly or splenomegaly, absence of constitutional symptoms, neutrophils \>1500/ul, Platelets \>100,000/ul, Hemoglobin \>11.0 gm/dl, Peripheral blood lymphocytes \<4000/uL. A PARTIAL RESPONSE (PR) requires the patient exhibits at least two of the features: ≥ 50% decrease in peripheral blood lymphocyte count from baseline, ≥ 50% reduction in the sum of the products of the maximal perpendicular diameters of the largest measured node or nodal masses in the right and left cervical, axillary, and inguinal lymph node regions on physical examination.
Outcome measures
| Measure |
Phase I: Dose Level 0
n=14 Participants
During one 35-day period of treatment:
Patients receive 1 mg/kg/dose PGG beta-glucan IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31
Alemtuzumab subcutaneously 3 mg day 3 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33; Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31.
Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Phase I: Dose Level 1
During one 35-day period of treatment:
Patients receive 2 mg/kg/dose PGG beta-glucan IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31
Alemtuzumab subcutaneously 3 mg day 3 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31.
Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Phase I: Dose Level 2
During one 35-day period of treatment:
Patients receive 4 mg/kg/dose PGG beta-glucan IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31
Alemtuzumab subcutaneously 3 mg day 3 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31.
Treatment continues in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Overall Response Rate (Dose Level 2)
|
.93 proportion of patients
Interval 0.75 to 1.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: All 20 eligible patients that started and completed protocol treatment were combined in this analysis to assess overall benefit of protocol treatment.
Time to disease progression is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. The distribution of time to disease progression will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Phase I: Dose Level 0
n=20 Participants
During one 35-day period of treatment:
Patients receive 1 mg/kg/dose PGG beta-glucan IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31
Alemtuzumab subcutaneously 3 mg day 3 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33; Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31.
Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Phase I: Dose Level 1
During one 35-day period of treatment:
Patients receive 2 mg/kg/dose PGG beta-glucan IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31
Alemtuzumab subcutaneously 3 mg day 3 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31.
Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Phase I: Dose Level 2
During one 35-day period of treatment:
Patients receive 4 mg/kg/dose PGG beta-glucan IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31
Alemtuzumab subcutaneously 3 mg day 3 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31.
Treatment continues in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Time to Disease Progression
|
17.6 months
Interval 9.7 to 32.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Data was not collected to run this analysis.
Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a CR or PR to the earliest date progression is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: All 20 eligible patients that started and completed protocol treatment were combined in this analysis to assess overall benefit of protocol treatment.
Time to subsequent therapy is defined to be the time from the end of active treatment date to the date subsequent therapy is initiated. The distribution of time to subsequent therapy will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Phase I: Dose Level 0
n=20 Participants
During one 35-day period of treatment:
Patients receive 1 mg/kg/dose PGG beta-glucan IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31
Alemtuzumab subcutaneously 3 mg day 3 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33; Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31.
Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Phase I: Dose Level 1
During one 35-day period of treatment:
Patients receive 2 mg/kg/dose PGG beta-glucan IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31
Alemtuzumab subcutaneously 3 mg day 3 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31.
Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Phase I: Dose Level 2
During one 35-day period of treatment:
Patients receive 4 mg/kg/dose PGG beta-glucan IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31
Alemtuzumab subcutaneously 3 mg day 3 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31.
Treatment continues in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Time to Subsequent Therapy
|
NA months
Interval 14.9 to
Too few patients had an event (subsequent treatment) to estimate a median nor a upper 95% confidence interval.
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 5 years of treatmentPopulation: All 20 eligible patients that started and completed protocol treatment were combined in this analysis to assess overall effect of protocol treatment.
Adverse events were collected at the end of each cycle according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The number of grade 3+ events at least possibly related to treatment are recorded. For a complete set of all recorded adverse events, please see the Adverse Events section of this report.
Outcome measures
| Measure |
Phase I: Dose Level 0
n=20 Participants
During one 35-day period of treatment:
Patients receive 1 mg/kg/dose PGG beta-glucan IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31
Alemtuzumab subcutaneously 3 mg day 3 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33; Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31.
Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Phase I: Dose Level 1
During one 35-day period of treatment:
Patients receive 2 mg/kg/dose PGG beta-glucan IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31
Alemtuzumab subcutaneously 3 mg day 3 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31.
Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Phase I: Dose Level 2
During one 35-day period of treatment:
Patients receive 4 mg/kg/dose PGG beta-glucan IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31
Alemtuzumab subcutaneously 3 mg day 3 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33;
Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31.
Treatment continues in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Number of Participants With Grade 3+ Adverse Events
Grade 3 Adverse Event
|
1 Participants
|
—
|
—
|
|
Number of Participants With Grade 3+ Adverse Events
Grade 4 Adverse Event
|
2 Participants
|
—
|
—
|
Adverse Events
Dose Level 0
Dose Level 1
Dose Level 2
Serious adverse events
| Measure |
Dose Level 0
n=4 participants at risk
During one 35-day period of treatment:
Patients receive 1 mg/kg/dose PGG beta-glucan IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31
Alemtuzumab subcutaneously 3 mg day 3, 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33.
Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Dose Level 1
n=4 participants at risk
During one 35-day period of treatment:
Patients receive 2 mg/kg/dose PGG beta-glucan IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31
Alemtuzumab subcutaneously 3 mg day 3, 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33.
Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Dose Level 2
n=14 participants at risk
During one 35-day period of treatment:
Patients receive 4 mg/kg/dose PGG beta-glucan IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31
Alemtuzumab subcutaneously 3 mg day 3, 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33.
Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4
|
0.00%
0/4
|
14.3%
2/14 • Number of events 2
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/4
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Fever
|
0.00%
0/4
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/14
|
|
Vascular disorders
Hypertension
|
0.00%
0/4
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.00%
0/4
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
Other adverse events
| Measure |
Dose Level 0
n=4 participants at risk
During one 35-day period of treatment:
Patients receive 1 mg/kg/dose PGG beta-glucan IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31
Alemtuzumab subcutaneously 3 mg day 3, 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33.
Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Dose Level 1
n=4 participants at risk
During one 35-day period of treatment:
Patients receive 2 mg/kg/dose PGG beta-glucan IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31
Alemtuzumab subcutaneously 3 mg day 3, 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33.
Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Dose Level 2
n=14 participants at risk
During one 35-day period of treatment:
Patients receive 4 mg/kg/dose PGG beta-glucan IV over 2-4 hours on days 1, 5, 10, 17, 24, and 31
Alemtuzumab subcutaneously 3 mg day 3, 10 mg day 4 30 mg days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33.
Rituximab 375 mg/m2 IV on days 10, 17, 24, and 31. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
4/4 • Number of events 5
|
75.0%
3/4 • Number of events 6
|
78.6%
11/14 • Number of events 40
|
|
Cardiac disorders
Mitral valve disease
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/14
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4
|
0.00%
0/4
|
14.3%
2/14 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Chills
|
0.00%
0/4
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Fatigue
|
0.00%
0/4
|
0.00%
0/4
|
28.6%
4/14 • Number of events 6
|
|
General disorders
Fever
|
75.0%
3/4 • Number of events 5
|
50.0%
2/4 • Number of events 2
|
28.6%
4/14 • Number of events 5
|
|
Immune system disorders
Cytokine release syndrome
|
50.0%
2/4 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
0.00%
0/14
|
|
Infections and infestations
Bladder infection
|
0.00%
0/4
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/4
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/4
|
0.00%
0/4
|
28.6%
4/14 • Number of events 5
|
|
Infections and infestations
Lung infection
|
25.0%
1/4 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
7.1%
1/14 • Number of events 2
|
|
Infections and infestations
Peripheral nerve infection
|
0.00%
0/4
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Pharyngitis
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/14
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/14
|
|
Infections and infestations
Upper respiratory infection
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
21.4%
3/14 • Number of events 4
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
100.0%
4/4 • Number of events 7
|
100.0%
4/4 • Number of events 13
|
100.0%
14/14 • Number of events 43
|
|
Investigations
Lymphocyte count increased
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/14
|
|
Investigations
Neutrophil count decreased
|
25.0%
1/4 • Number of events 1
|
25.0%
1/4 • Number of events 3
|
42.9%
6/14 • Number of events 7
|
|
Investigations
Platelet count decreased
|
75.0%
3/4 • Number of events 5
|
75.0%
3/4 • Number of events 9
|
50.0%
7/14 • Number of events 23
|
|
Investigations
White blood cell decreased
|
75.0%
3/4 • Number of events 3
|
50.0%
2/4 • Number of events 4
|
57.1%
8/14 • Number of events 15
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/4
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/4
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/4
|
0.00%
0/4
|
7.1%
1/14 • Number of events 2
|
|
Nervous system disorders
Headache
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/14
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/4
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/4
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/4
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
50.0%
2/4 • Number of events 2
|
50.0%
2/4 • Number of events 3
|
64.3%
9/14 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/4
|
0.00%
0/4
|
7.1%
1/14 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place