Trial Outcomes & Findings for Lenalidomide and AT-101 in Treating Patients With Relapsed B-Cell Chronic Lymphocytic Leukemia (NCT NCT01003769)
NCT ID: NCT01003769
Last Updated: 2020-06-16
Results Overview
Maximum tolerated dose of lenalidomide when given in combination with AT-101, defined as the dose level below the lowest dose that induces dose limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients) (Phase I)
TERMINATED
PHASE1/PHASE2
5 participants
Up to day 28 of course 2
2020-06-16
Participant Flow
Participant milestones
| Measure |
Dose Level 1 (Lenalidomide in Combination With AT-101)
Patients receive 5 mg lenalidomide PO QD on days 1-21. Beginning in course 2, patients also receive 40 mg AT-101 PO BID on days 1-3. Treatment repeats every 28 days for up to 11 courses (49-56 days for course 12 or last course of treatment) in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Overall Study
STARTED
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5
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Overall Study
COMPLETED
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5
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lenalidomide and AT-101 in Treating Patients With Relapsed B-Cell Chronic Lymphocytic Leukemia
Baseline characteristics by cohort
| Measure |
Dose Level 1 (Lenalidomide in Combination With AT-101)
n=5 Participants
Patients receive 5 mg lenalidomide PO QD on days 1-21. Beginning in course 2, patients also receive 40 mg AT-101 PO BID on days 1-3. Treatment repeats every 28 days for up to 11 courses (49-56 days for course 12 or last course of treatment) in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Age, Continuous
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61 years
n=5 Participants
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Sex: Female, Male
Female
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1 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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4 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=5 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
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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
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
|
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Region of Enrollment
United States
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5 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Up to day 28 of course 2Population: Trial terminated early with too few patients to analyze this endpoint.
Maximum tolerated dose of lenalidomide when given in combination with AT-101, defined as the dose level below the lowest dose that induces dose limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients) (Phase I)
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: Trial terminated early with too few patients to analyze this endpoint.
The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Trial terminated early with too few patients to analyze this endpoint.
The number and severity of all adverse events (overall and by dose-level) will be tabulated and summarized in this patient population. The grade 3+ adverse events will also be described and summarized in a similar fashion.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: All patients that were registered and treated at dose level 1 are included in this analysis.
Overall toxicity incidence as well as toxicity profiles by dose level, patient and tumor site will be explored and summarized. Frequency distributions, graphical techniques and other descriptive measures will form the basis of these analyses. Here, we report the number of patients that reported a grade 2 or higher as their worst incidence of toxicity.
Outcome measures
| Measure |
Dose Level 1 (Lenalidomide in Combination With AT-101)
n=5 Participants
Patients receive 5 mg lenalidomide PO QD on days 1-21. Beginning in course 2, patients also receive 40 mg AT-101 PO BID on days 1-3. Treatment repeats every 28 days for up to 11 courses (49-56 days for course 12 or last course of treatment) in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Incidence of Toxicity, Defined as Adverse Events Classified as Possibly, Probably, or Definitely Related to Study Treatment, Graded According to the Grading Scale for Hematologic Adverse Events in CLL Studies or Ordinal Common Toxicity Criteria (Phase I)
Grade 2+
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1 Participants
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Incidence of Toxicity, Defined as Adverse Events Classified as Possibly, Probably, or Definitely Related to Study Treatment, Graded According to the Grading Scale for Hematologic Adverse Events in CLL Studies or Ordinal Common Toxicity Criteria (Phase I)
Grade 3+
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4 Participants
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Incidence of Toxicity, Defined as Adverse Events Classified as Possibly, Probably, or Definitely Related to Study Treatment, Graded According to the Grading Scale for Hematologic Adverse Events in CLL Studies or Ordinal Common Toxicity Criteria (Phase I)
Grade 4+
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0 Participants
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SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Trial terminated early with too few patients to analyze this endpoint.
The proportion of responses by 6 months will be estimated by the number of patients who achieve a response by 6 months divided by the total number of evaluable patients. The proportion of responses by 12 months will be estimated in a similar manner. Exact binomial 95% confidence intervals for the true success proportions will be calculated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: The time from registration to the earliest date of documentation of disease progression, assessed up to 2 yearsPopulation: Trial terminated early with too few patients to analyze this endpoint.
The distribution of time to progression will be estimated using the method of Kaplan-Meier.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 days after the last day of study treatmentPopulation: Trial terminated early with too few patients to analyze this endpoint.
The maximum grade for each type of adverse event, regardless of causality, will be recorded and reported for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Outcome measures
Outcome data not reported
Adverse Events
Dose Level 1 (Lenalidomide in Combination With AT-101)
Serious adverse events
| Measure |
Dose Level 1 (Lenalidomide in Combination With AT-101)
n=5 participants at risk
Patients receive 5 mg lenalidomide PO QD on days 1-21. Beginning in course 2, patients also receive 40 mg AT-101 PO BID on days 1-3. Treatment repeats every 28 days for up to 11 courses (49-56 days for course 12 or last course of treatment) in the absence of disease progression or unacceptable toxicity.
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|---|---|
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General disorders
Fatigue
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20.0%
1/5 • Number of events 1 • Adverse Events were collected after each 28 day cycle of treatment for up to 4 cycles.
Adverse Events were collected after each 28 day cycle of treatment for up to 4 cycles.
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Infections and infestations
Lung infection
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20.0%
1/5 • Number of events 1 • Adverse Events were collected after each 28 day cycle of treatment for up to 4 cycles.
Adverse Events were collected after each 28 day cycle of treatment for up to 4 cycles.
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Skin and subcutaneous tissue disorders
Rash maculo-papular
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20.0%
1/5 • Number of events 1 • Adverse Events were collected after each 28 day cycle of treatment for up to 4 cycles.
Adverse Events were collected after each 28 day cycle of treatment for up to 4 cycles.
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Other adverse events
| Measure |
Dose Level 1 (Lenalidomide in Combination With AT-101)
n=5 participants at risk
Patients receive 5 mg lenalidomide PO QD on days 1-21. Beginning in course 2, patients also receive 40 mg AT-101 PO BID on days 1-3. Treatment repeats every 28 days for up to 11 courses (49-56 days for course 12 or last course of treatment) in the absence of disease progression or unacceptable toxicity.
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|---|---|
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Blood and lymphatic system disorders
Anemia
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100.0%
5/5 • Number of events 13 • Adverse Events were collected after each 28 day cycle of treatment for up to 4 cycles.
Adverse Events were collected after each 28 day cycle of treatment for up to 4 cycles.
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Gastrointestinal disorders
Constipation
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60.0%
3/5 • Number of events 4 • Adverse Events were collected after each 28 day cycle of treatment for up to 4 cycles.
Adverse Events were collected after each 28 day cycle of treatment for up to 4 cycles.
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General disorders
Fatigue
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20.0%
1/5 • Number of events 1 • Adverse Events were collected after each 28 day cycle of treatment for up to 4 cycles.
Adverse Events were collected after each 28 day cycle of treatment for up to 4 cycles.
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Infections and infestations
Upper respiratory infection
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20.0%
1/5 • Number of events 1 • Adverse Events were collected after each 28 day cycle of treatment for up to 4 cycles.
Adverse Events were collected after each 28 day cycle of treatment for up to 4 cycles.
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Investigations
Alanine aminotransferase increased
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20.0%
1/5 • Number of events 1 • Adverse Events were collected after each 28 day cycle of treatment for up to 4 cycles.
Adverse Events were collected after each 28 day cycle of treatment for up to 4 cycles.
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Investigations
Aspartate aminotransferase increased
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20.0%
1/5 • Number of events 1 • Adverse Events were collected after each 28 day cycle of treatment for up to 4 cycles.
Adverse Events were collected after each 28 day cycle of treatment for up to 4 cycles.
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Investigations
Blood bilirubin increased
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected after each 28 day cycle of treatment for up to 4 cycles.
Adverse Events were collected after each 28 day cycle of treatment for up to 4 cycles.
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Investigations
Neutrophil count decreased
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100.0%
5/5 • Number of events 9 • Adverse Events were collected after each 28 day cycle of treatment for up to 4 cycles.
Adverse Events were collected after each 28 day cycle of treatment for up to 4 cycles.
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Investigations
Platelet count decreased
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100.0%
5/5 • Number of events 12 • Adverse Events were collected after each 28 day cycle of treatment for up to 4 cycles.
Adverse Events were collected after each 28 day cycle of treatment for up to 4 cycles.
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
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20.0%
1/5 • Number of events 1 • Adverse Events were collected after each 28 day cycle of treatment for up to 4 cycles.
Adverse Events were collected after each 28 day cycle of treatment for up to 4 cycles.
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Respiratory, thoracic and mediastinal disorders
Cough
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20.0%
1/5 • Number of events 1 • Adverse Events were collected after each 28 day cycle of treatment for up to 4 cycles.
Adverse Events were collected after each 28 day cycle of treatment for up to 4 cycles.
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Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
1/5 • Number of events 1 • Adverse Events were collected after each 28 day cycle of treatment for up to 4 cycles.
Adverse Events were collected after each 28 day cycle of treatment for up to 4 cycles.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place