Trial Outcomes & Findings for Azacitidine and Lenalidomide for Acute Myeloid Leukemia (NCT NCT01016600)
NCT ID: NCT01016600
Last Updated: 2015-09-07
Results Overview
* The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle. * Hematologic DLT is as a persistent bone marrow aplasia with ≤ 10 % cellularity, which persists for \> 60 days from the start of a chemotherapy cycle. * Non-hematologic DLT is defined as any Grade 3 or Grade 4 non-hematologic toxicity that occurs during the first cycle with the specific exceptions of nausea, vomiting, anorexia, weight loss, infections or electrolyte abnormalities attributable to any other cause. Grade 3 triglycerides will be considered a DLT only for patients who have Grade 3 in spite of appropriate lipid lowering drug therapy.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
31 participants
Primary outcome timeframe
Completion of the phase I portion of study (approximately 1 year and 4 months)
Results posted on
2015-09-07
Participant Flow
31 participants were enrolled but only 30 participants started treatment and completed treatment.
Participant milestones
| Measure |
Cohort 1
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 25 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 2
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 50 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 3
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Phase II
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
4
|
6
|
12
|
|
Overall Study
COMPLETED
|
8
|
4
|
6
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 25 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 2
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 50 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 3
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Phase II
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
|---|---|---|---|---|
|
Overall Study
Did not start treatment
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Azacitidine and Lenalidomide for Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Cohort 1
n=9 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 25 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 2
n=4 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 50 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 3
n=6 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Phase II
n=12 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
70 years
n=5 Participants
|
67.5 years
n=7 Participants
|
75.5 years
n=5 Participants
|
72 years
n=4 Participants
|
72 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
12 participants
n=4 Participants
|
31 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Completion of the phase I portion of study (approximately 1 year and 4 months)Population: (1) participant in Cohort 1 did not start treatment. The Phase II cohort was not analyzed because this was a Phase I outcome only.
* The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle. * Hematologic DLT is as a persistent bone marrow aplasia with ≤ 10 % cellularity, which persists for \> 60 days from the start of a chemotherapy cycle. * Non-hematologic DLT is defined as any Grade 3 or Grade 4 non-hematologic toxicity that occurs during the first cycle with the specific exceptions of nausea, vomiting, anorexia, weight loss, infections or electrolyte abnormalities attributable to any other cause. Grade 3 triglycerides will be considered a DLT only for patients who have Grade 3 in spite of appropriate lipid lowering drug therapy.
Outcome measures
| Measure |
Cohort 1
n=8 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 25 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 2
n=4 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 50 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 3
n=6 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Phase II
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
|---|---|---|---|---|
|
Phase I Only - Maximum Tolerated Dose (MTD) as Measured by Dose-limiting Toxicities (DLTs)
|
1 dose-limiting toxicities
|
0 dose-limiting toxicities
|
0 dose-limiting toxicities
|
—
|
PRIMARY outcome
Timeframe: Completion of the phase I portion of study (approximately 1 year and 4 months)* The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle. * Hematologic DLT is as a persistent bone marrow aplasia with ≤ 10 % cellularity, which persists for \> 60 days from the start of a chemotherapy cycle. * Non-hematologic DLT is defined as any Grade 3 or Grade 4 non-hematologic toxicity that occurs during the first cycle with the specific exceptions of nausea, vomiting, anorexia, weight loss, infections or electrolyte abnormalities attributable to any other cause. Grade 3 triglycerides will be considered a DLT only for patients who have Grade 3 in spite of appropriate lipid lowering drug therapy.
Outcome measures
| Measure |
Cohort 1
n=18 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 25 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 2
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 50 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 3
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Phase II
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
|---|---|---|---|---|
|
Phase I Only - Maximum Tolerated Dose (MTD)
|
75 mg/m^2
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)Population: Participants in Cohort 1, 2, and 3 were not analyzed for this outcome as it is a Phase II outcome measure only. (3) participants in Phase II cohort were not evaluable for response because they did not complete cycle 1.
* Morphologic complete remission (CRm): Defined as morphologic leukemia-free state, including \<5% blasts in BM aspirate with marrow spicules and a count of \> 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC \> 1000/uL, platelet count \> 100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. * Morphologic complete remission with incomplete blood count recovery (CRi): Defined as CR with the exception of neutropenia \<1000/uL or thrombocytopenia \<100,000/ul.
Outcome measures
| Measure |
Cohort 1
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 25 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 2
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 50 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 3
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Phase II
n=9 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
|---|---|---|---|---|
|
Phase II Only - Complete Remission Rate (CRm + CRi) in Participants With Untreated AML ≥60 Years of Age
|
—
|
—
|
—
|
22 percentage of participants
|
SECONDARY outcome
Timeframe: Median number of cycles completed [3 cycles (12 weeks) full range (1 (4 weeks)-17 (68 weeks))]Population: (3) participants in Cohort 1, (1) participant in Cohort 2, and (3) participants in Phase II did not receive 28 days of lenalidomide and therefore are not evaluable for response. (1) participant in Cohort one had both CRm and CRc.
* Response rate (CRm + CRc + CRi + PR) * CRm = morphologic complete remission * CRc = cytogenetic complete remission * CRi = morphologic complete remission with incomplete blood count recovery * PR = partial remission
Outcome measures
| Measure |
Cohort 1
n=5 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 25 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 2
n=3 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 50 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 3
n=6 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Phase II
n=9 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
|---|---|---|---|---|
|
Response Rate (CRm + CRc + CRi + PR)
CRm
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Response Rate (CRm + CRc + CRi + PR)
CRc
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Response Rate (CRm + CRc + CRi + PR)
CRi
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Response Rate (CRm + CRc + CRi + PR)
PR
|
2 participants
|
0 participants
|
2 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Median number of cycles completed [3 cycles (12 weeks) full range (1 (4 weeks)-17 (68 weeks))]Population: (3) participants in Cohort 1, (1) participant in Cohort 2, and (3) participants in Phase II did not receive 28 days of lenalidomide and therefore are not evaluable for response.
Defined as \< 5% blasts on the BM aspirate with spicules and a count of \>200 nucleated cells and no blasts with Auer rods, and no persistent extramedullary disease.
Outcome measures
| Measure |
Cohort 1
n=5 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 25 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 2
n=3 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 50 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 3
n=6 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Phase II
n=9 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
|---|---|---|---|---|
|
Morphologic Leukemia-free State
|
2 participants
|
1 participants
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)Population: (3) participants in Cohort 1, (1) participant in Cohort 2, and (3) participants in Phase II did not receive 28 days of lenalidomide and therefore are not evaluable for response.
Defined as morphologic leukemia-free state, including \<5% blasts in BM aspirate with marrow spicules and a count of \> 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC \> 1000/uL, platelet count \> 100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. There is no duration requirement for this designation.
Outcome measures
| Measure |
Cohort 1
n=5 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 25 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 2
n=3 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 50 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 3
n=6 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Phase II
n=9 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
|---|---|---|---|---|
|
Morphologic Complete Remission Rate (CRm)
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)Population: (3) participants in Cohort 1, (1) participant in Cohort 2, and (3) participants in Phase II did not receive 28 days of lenalidomide and therefore are not evaluable for response.
Only patients with an identified cytogenetic abnormality may receive this designation. Defines as a morphologic complete remission plus reversion to a normal karyotype (no clonal abnormalities detected in a minimum of 20 mitotic cells).
Outcome measures
| Measure |
Cohort 1
n=5 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 25 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 2
n=3 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 50 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 3
n=6 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Phase II
n=9 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
|---|---|---|---|---|
|
Cytogenetic CR (CRc) Rate
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)Population: (3) participants in Cohort 1, (1) participant in Cohort 2, and (3) participants in Phase II did not receive 28 days of lenalidomide and therefore are not evaluable for response.
Defined as CR with the exception of neutropenia \<1000/uL or thrombocytopenia \<100,000/ul.
Outcome measures
| Measure |
Cohort 1
n=5 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 25 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 2
n=3 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 50 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 3
n=6 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Phase II
n=9 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
|---|---|---|---|---|
|
CR With Incomplete Blood Counts Rate
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)Population: (3) participants in Cohort 1, (1) participant in Cohort 2, and (3) participants in Phase II did not receive 28 days of lenalidomide and therefore are not evaluable for response.
Requires that the criteria for complete remission be met with the following exceptions: decrease of \>50% in the percentage of blasts to 5-25% in the BM aspirate. A value of \< 5% blasts in BM with Auer rods is also considered a partial remission.
Outcome measures
| Measure |
Cohort 1
n=5 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 25 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 2
n=3 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 50 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 3
n=6 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Phase II
n=9 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
|---|---|---|---|---|
|
Partial Remission Rate (PR)
|
2 participants
|
0 participants
|
2 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Until death - median follow-up 4.6 months (full range (0.3-31.4 months))Defined as the date of first dose of study drug to the date of death from any cause.
Outcome measures
| Measure |
Cohort 1
n=8 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 25 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 2
n=4 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 50 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 3
n=6 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Phase II
n=12 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
|---|---|---|---|---|
|
Overall Survival
|
4.2 months
Interval 0.7 to 31.4
|
4.5 months
Interval 0.7 to 10.6
|
8.9 months
Interval 1.8 to 14.8
|
4.3 months
Interval 0.8 to 31.0
|
SECONDARY outcome
Timeframe: Until death - median follow-up 4.6 months (full range (0.3-31.4 months))Defined as the interval from the date of first dose of study drug to date of treatment failure, recurrence, or death due to any cause.
Outcome measures
| Measure |
Cohort 1
n=8 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 25 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 2
n=4 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 50 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 3
n=6 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Phase II
n=12 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
|---|---|---|---|---|
|
Event Free Survival
|
3.8 months
Interval 0.3 to 19.7
|
3.4 months
Interval 0.6 to 6.4
|
7.8 months
Interval 1.8 to 14.8
|
2.9 months
Interval 0.8 to 25.6
|
SECONDARY outcome
Timeframe: Until progressive disease - median follow-up 4.6 months (full range (0.3-31.4 months))Population: (2) cohort 1 participants were not evaluable for this outcome measure because (1) was removed for DLT \& (1) withdrew from study. (2) phase II participants were not evaluable because both were removed from study in the first cycle for adverse events.
Defined as the interval from the date of the first dose of study drug to the date of progressive disease.
Outcome measures
| Measure |
Cohort 1
n=6 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 25 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 2
n=4 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 50 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 3
n=6 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Phase II
n=10 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
|---|---|---|---|---|
|
Time to Progression (TTP)
|
5.7 months
Interval 0.3 to 19.7
|
3.4 months
Interval 0.6 to 6.4
|
7.8 months
Interval 1.8 to 14.8
|
3.7 months
Interval 0.9 to 25.6
|
SECONDARY outcome
Timeframe: Until death - median follow-up 4.6 months (full range (0.3-31.4 months))This is determined only for patients achieving a complete remission. Defined as the interval from the date of first documentation of a leukemia free state to date of recurrence or death due to any cause.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 25 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 2
n=1 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 50 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 3
n=2 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Phase II
n=2 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
|---|---|---|---|---|
|
Relapse Free Survival (RFS)
|
12.0 months
Interval 6.2 to 17.7
|
1.4 months
Interval 1.4 to 1.4
|
4.9 months
Interval 3.2 to 6.7
|
12.2 months
Interval 1.1 to 23.2
|
SECONDARY outcome
Timeframe: Completion of treatment (median follow-up was 8 weeks) (range 4-68 weeks)Population: (6) participants in Cohort 1, (3) participants in Cohort 2, (4) participants in Cohort 3, and (10) participants in Phase II did not have a complete response and are not evaluable for this outcome.
Outcome measures
| Measure |
Cohort 1
n=2 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 25 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 2
n=1 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 50 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 3
n=2 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Phase II
n=2 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
|---|---|---|---|---|
|
Duration of CR for Complete Responders
|
10.9 months
Interval 6.2 to 15.6
|
1.4 months
Interval 1.4 to 1.4
|
4.95 months
Interval 3.2 to 6.7
|
12.15 months
Interval 1.1 to 23.2
|
SECONDARY outcome
Timeframe: 30 days after completion of treatment (median follow-up was 12 weeks (range 8-72 weeks))AML ≥18 years or untreated AML ≥60 years
Outcome measures
| Measure |
Cohort 1
n=8 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 25 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 2
n=4 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 50 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 3
n=6 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Phase II
n=12 Participants
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
|---|---|---|---|---|
|
Toxicity Profile (Grade 3/4 Toxicities)
Hematuria
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Wound infection
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Anemia
|
3 participants
|
0 participants
|
0 participants
|
4 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Febrile neutropenia
|
4 participants
|
1 participants
|
3 participants
|
8 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Otitis mastoditis - worsening
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Diarrhea
|
1 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Nausea
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Vomiting
|
2 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Dental carries
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Fatigue
|
1 participants
|
0 participants
|
4 participants
|
4 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Sepsis
|
1 participants
|
0 participants
|
2 participants
|
1 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Bronchial infection
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Bacteremia
|
2 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Lung infection
|
3 participants
|
0 participants
|
2 participants
|
9 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Skin infection
|
1 participants
|
2 participants
|
2 participants
|
2 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Activated partial thromboplastin time prolonged
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Blood bilirubin increased
|
2 participants
|
0 participants
|
2 participants
|
3 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Creatinine increased
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Neutrophil count decreased
|
7 participants
|
0 participants
|
2 participants
|
2 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Platelet count decreased
|
4 participants
|
2 participants
|
3 participants
|
6 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
White blood cell count decreased
|
7 participants
|
1 participants
|
4 participants
|
10 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Lymphocyte count decreased
|
5 participants
|
1 participants
|
1 participants
|
2 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Dehydration
|
2 participants
|
0 participants
|
0 participants
|
3 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Hypernatremia
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Hypocalcemia
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Hypophosphatemia
|
4 participants
|
0 participants
|
3 participants
|
6 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Back pain
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Generalized muscle weakness
|
2 participants
|
0 participants
|
1 participants
|
2 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Pain in extremity
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Leukemia vasculitis left calf
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Acute kidney injury
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Dyspnea
|
3 participants
|
2 participants
|
1 participants
|
2 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Epistaxis
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Productive cough
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Pulmonary edema
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Rash maculo-papular
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Skin ulceration
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Hypotension
|
3 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Constipation
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Edema limbs
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Catheter related infection
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Alanine aminotransferase increased
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
INR increased
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Hyperglycemia
|
0 participants
|
1 participants
|
0 participants
|
5 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Cough
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Wheezing
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Cardiac arrest
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Perianal hemorrhage
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Cyst infection
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Incarcerated hernia
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Hypoalbuminemia
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Hypokalemia
|
0 participants
|
0 participants
|
2 participants
|
3 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Respiratory failure
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Pruritus
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Hypertension
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Atrial fibrillation
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Chest pain cardiac
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Left ventricular systolic dysfunction
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Supraventricular tachycardia
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Dysphagia
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Esophagitis
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Lower gastrointestinal hemorrhage
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Pain
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Otitis media
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Scrotal infection
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Upper respiratory infection
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Urinary tract infection
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Fall
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Fracture
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Weight loss
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Anorexia
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Hyponatremia
|
0 participants
|
0 participants
|
0 participants
|
3 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Neck pain
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Polyarthropathy
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Syncope
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Toxicity Profile (Grade 3/4 Toxicities)
Pleuritic pain
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
Adverse Events
Cohort 1
Serious events: 8 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 2
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 3
Serious events: 6 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase II
Serious events: 12 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=8 participants at risk
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 25 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 2
n=4 participants at risk
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 50 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 3
n=6 participants at risk
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Phase II
n=12 participants at risk
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/12
|
|
Infections and infestations
Bacteremia blood
|
25.0%
2/8
|
0.00%
0/4
|
16.7%
1/6
|
0.00%
0/12
|
|
General disorders
Bleeding
|
0.00%
0/8
|
0.00%
0/4
|
16.7%
1/6
|
0.00%
0/12
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/8
|
0.00%
0/4
|
16.7%
1/6
|
0.00%
0/12
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/8
|
0.00%
0/4
|
16.7%
1/6
|
8.3%
1/12
|
|
Nervous system disorders
Confusion
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8
|
25.0%
1/4
|
0.00%
0/6
|
0.00%
0/12
|
|
Infections and infestations
Cyst infection
|
0.00%
0/8
|
0.00%
0/4
|
16.7%
1/6
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/8
|
50.0%
2/4
|
0.00%
0/6
|
0.00%
0/12
|
|
General disorders
Edema
|
0.00%
0/8
|
25.0%
1/4
|
0.00%
0/6
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
General disorders
Fatigue
|
0.00%
0/8
|
0.00%
0/4
|
16.7%
1/6
|
0.00%
0/12
|
|
Infections and infestations
Febrile neutropenia
|
37.5%
3/8
|
0.00%
0/4
|
16.7%
1/6
|
25.0%
3/12
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrage
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
General disorders
Hernia
|
0.00%
0/8
|
0.00%
0/4
|
16.7%
1/6
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/8
|
0.00%
0/4
|
16.7%
1/6
|
0.00%
0/12
|
|
Vascular disorders
Hypotension
|
37.5%
3/8
|
0.00%
0/4
|
16.7%
1/6
|
0.00%
0/12
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
General disorders
Itching
|
0.00%
0/8
|
0.00%
0/4
|
16.7%
1/6
|
0.00%
0/12
|
|
Infections and infestations
Lung infection
|
0.00%
0/8
|
0.00%
0/4
|
16.7%
1/6
|
75.0%
9/12
|
|
Ear and labyrinth disorders
Otitis media
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Injury, poisoning and procedural complications
Post operative hemorrhage (bone marrow biopsy site)
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/12
|
|
General disorders
Progressive disease
|
25.0%
2/8
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/8
|
0.00%
0/4
|
16.7%
1/6
|
0.00%
0/12
|
|
Infections and infestations
Scrotal infection
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Infections and infestations
Sepsis
|
0.00%
0/8
|
0.00%
0/4
|
16.7%
1/6
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/12
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Nervous system disorders
Syncope
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Investigations
Thrombocytopenia
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/12
|
|
Vascular disorders
Thromboembolic event DVT
|
0.00%
0/8
|
25.0%
1/4
|
0.00%
0/6
|
0.00%
0/12
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
Other adverse events
| Measure |
Cohort 1
n=8 participants at risk
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 25 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 2
n=4 participants at risk
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 50 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Cohort 3
n=6 participants at risk
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
Phase II
n=12 participants at risk
Induction regimen (total 2 cycles)
Lenalidomide 50 mg PO daily days 1-28
Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5
Maintenance Regimen
Lenalidomide 10 mg PO daily days 1-28
Azacitidine 75 mg/m2 IV days 1-5
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8
|
0.00%
0/4
|
16.7%
1/6
|
41.7%
5/12
|
|
Investigations
Activated partial thromboplastin time prolonged
|
37.5%
3/8
|
0.00%
0/4
|
16.7%
1/6
|
25.0%
3/12
|
|
Musculoskeletal and connective tissue disorders
Acute gout attack
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Renal and urinary disorders
Acute kidney injury
|
12.5%
1/8
|
0.00%
0/4
|
33.3%
2/6
|
16.7%
2/12
|
|
Cardiac disorders
Acute systolic CHF/MV regurgitation
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/12
|
|
Investigations
Alanine aminotransferase increased
|
62.5%
5/8
|
75.0%
3/4
|
50.0%
3/6
|
75.0%
9/12
|
|
Investigations
Alkaline phosphatase increased
|
50.0%
4/8
|
25.0%
1/4
|
50.0%
3/6
|
33.3%
4/12
|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
2/8
|
0.00%
0/4
|
33.3%
2/6
|
33.3%
4/12
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
2/8
|
0.00%
0/4
|
16.7%
1/6
|
41.7%
5/12
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8
|
0.00%
0/4
|
16.7%
1/6
|
8.3%
1/12
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
4/8
|
25.0%
1/4
|
16.7%
1/6
|
50.0%
6/12
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
37.5%
3/8
|
25.0%
1/4
|
0.00%
0/6
|
41.7%
5/12
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/8
|
0.00%
0/4
|
16.7%
1/6
|
33.3%
4/12
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8
|
25.0%
1/4
|
0.00%
0/6
|
25.0%
3/12
|
|
Investigations
Blood bilirubin increased
|
50.0%
4/8
|
0.00%
0/4
|
66.7%
4/6
|
66.7%
8/12
|
|
Eye disorders
Blurred vision
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
25.0%
3/12
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/8
|
0.00%
0/4
|
16.7%
1/6
|
8.3%
1/12
|
|
Infections and infestations
Bronchial infection
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Bruising
|
25.0%
2/8
|
0.00%
0/4
|
0.00%
0/6
|
33.3%
4/12
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/8
|
25.0%
1/4
|
0.00%
0/6
|
0.00%
0/12
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
General disorders
Chills
|
37.5%
3/8
|
25.0%
1/4
|
33.3%
2/6
|
58.3%
7/12
|
|
Infections and infestations
Clostridium difficile
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Psychiatric disorders
Confusion
|
25.0%
2/8
|
0.00%
0/4
|
33.3%
2/6
|
16.7%
2/12
|
|
Gastrointestinal disorders
Constipation
|
37.5%
3/8
|
25.0%
1/4
|
16.7%
1/6
|
58.3%
7/12
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
2/8
|
50.0%
2/4
|
16.7%
1/6
|
50.0%
6/12
|
|
Investigations
Creatinine increased
|
50.0%
4/8
|
25.0%
1/4
|
16.7%
1/6
|
33.3%
4/12
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Metabolism and nutrition disorders
Dehydration
|
50.0%
4/8
|
0.00%
0/4
|
0.00%
0/6
|
33.3%
4/12
|
|
Nervous system disorders
Delerium
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Gastrointestinal disorders
Dental carries
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/12
|
|
Psychiatric disorders
Depression
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/6
|
16.7%
2/12
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
4/8
|
25.0%
1/4
|
66.7%
4/6
|
58.3%
7/12
|
|
Nervous system disorders
Dizziness
|
25.0%
2/8
|
75.0%
3/4
|
0.00%
0/6
|
25.0%
3/12
|
|
Eye disorders
Double vision
|
0.00%
0/8
|
25.0%
1/4
|
0.00%
0/6
|
0.00%
0/12
|
|
Eye disorders
Dry eye
|
0.00%
0/8
|
0.00%
0/4
|
16.7%
1/6
|
0.00%
0/12
|
|
Gastrointestinal disorders
Dry mouth
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Nervous system disorders
Dysgeusia
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Gastrointestinal disorders
Dysphagia
|
25.0%
2/8
|
0.00%
0/4
|
16.7%
1/6
|
25.0%
3/12
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
62.5%
5/8
|
25.0%
1/4
|
66.7%
4/6
|
66.7%
8/12
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
General disorders
Edema face
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
General disorders
Edema limbs
|
75.0%
6/8
|
0.00%
0/4
|
50.0%
3/6
|
66.7%
8/12
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
2/8
|
0.00%
0/4
|
16.7%
1/6
|
25.0%
3/12
|
|
Skin and subcutaneous tissue disorders
Erythemia
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Gastrointestinal disorders
Esophagitis
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Injury, poisoning and procedural complications
Eye abrasion
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Eye disorders
Eye pain
|
0.00%
0/8
|
0.00%
0/4
|
16.7%
1/6
|
0.00%
0/12
|
|
Nervous system disorders
Facial muscle weakness
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/12
|
|
Injury, poisoning and procedural complications
Fall
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/6
|
16.7%
2/12
|
|
General disorders
Fatigue
|
75.0%
6/8
|
100.0%
4/4
|
66.7%
4/6
|
75.0%
9/12
|
|
Infections and infestations
Febrile neutropenia
|
12.5%
1/8
|
25.0%
1/4
|
33.3%
2/6
|
41.7%
5/12
|
|
General disorders
Fever
|
37.5%
3/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Eye disorders
Flashing lights
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
General disorders
Flu Like Symptoms
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
62.5%
5/8
|
25.0%
1/4
|
50.0%
3/6
|
50.0%
6/12
|
|
Infections and infestations
Gram positive cocci
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
16.7%
2/12
|
|
Nervous system disorders
Headache
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/6
|
33.3%
4/12
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
16.7%
2/12
|
|
Vascular disorders
Hematoma
|
0.00%
0/8
|
0.00%
0/4
|
16.7%
1/6
|
8.3%
1/12
|
|
Renal and urinary disorders
Hematuria
|
12.5%
1/8
|
25.0%
1/4
|
16.7%
1/6
|
50.0%
6/12
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Vascular disorders
Hot flashes
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
37.5%
3/8
|
25.0%
1/4
|
16.7%
1/6
|
33.3%
4/12
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/6
|
25.0%
3/12
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
12.5%
1/8
|
0.00%
0/4
|
16.7%
1/6
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hypernatremia
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/6
|
33.3%
4/12
|
|
Vascular disorders
Hypertension
|
12.5%
1/8
|
0.00%
0/4
|
16.7%
1/6
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
75.0%
6/8
|
50.0%
2/4
|
33.3%
2/6
|
91.7%
11/12
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
75.0%
6/8
|
75.0%
3/4
|
83.3%
5/6
|
91.7%
11/12
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.0%
2/8
|
25.0%
1/4
|
16.7%
1/6
|
58.3%
7/12
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Metabolism and nutrition disorders
Hyponatremia
|
37.5%
3/8
|
50.0%
2/4
|
66.7%
4/6
|
58.3%
7/12
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
62.5%
5/8
|
25.0%
1/4
|
50.0%
3/6
|
58.3%
7/12
|
|
Vascular disorders
Hypotension
|
0.00%
0/8
|
0.00%
0/4
|
16.7%
1/6
|
16.7%
2/12
|
|
General disorders
Hypothermia
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Endocrine disorders
Hypothyroidism
|
25.0%
2/8
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/6
|
50.0%
6/12
|
|
Investigations
INR increased
|
25.0%
2/8
|
25.0%
1/4
|
16.7%
1/6
|
66.7%
8/12
|
|
Injury, poisoning and procedural complications
Incarcerated hernia
|
0.00%
0/8
|
0.00%
0/4
|
16.7%
1/6
|
0.00%
0/12
|
|
General disorders
Infusion related reaction
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8
|
0.00%
0/4
|
16.7%
1/6
|
16.7%
2/12
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Nervous system disorders
Lethargy
|
0.00%
0/8
|
0.00%
0/4
|
16.7%
1/6
|
0.00%
0/12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukemia vasculitis left calf
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/12
|
|
Infections and infestations
Lip infection
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/12
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Infections and infestations
Lung infection
|
62.5%
5/8
|
0.00%
0/4
|
16.7%
1/6
|
0.00%
0/12
|
|
Investigations
Lymphocyte count decreased
|
62.5%
5/8
|
25.0%
1/4
|
66.7%
4/6
|
75.0%
9/12
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Musculoskeletal and connective tissue disorders
Lytic lesion in right parietal bone
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/12
|
|
General disorders
Malaise
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
16.7%
2/12
|
|
Gastrointestinal disorders
Mucositis - oral
|
25.0%
2/8
|
25.0%
1/4
|
33.3%
2/6
|
66.7%
8/12
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Gastrointestinal disorders
Nausea
|
62.5%
5/8
|
75.0%
3/4
|
83.3%
5/6
|
66.7%
8/12
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Investigations
Neutrophil count decreased
|
87.5%
7/8
|
0.00%
0/4
|
33.3%
2/6
|
16.7%
2/12
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/8
|
25.0%
1/4
|
0.00%
0/6
|
16.7%
2/12
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Infections and infestations
Oral thrush
|
12.5%
1/8
|
0.00%
0/4
|
16.7%
1/6
|
33.3%
4/12
|
|
Ear and labyrinth disorders
Otitis mastoiditis
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/12
|
|
General disorders
Pain
|
37.5%
3/8
|
25.0%
1/4
|
0.00%
0/6
|
16.7%
2/12
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
2/8
|
50.0%
2/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Cardiac disorders
Palpitations
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
General disorders
Perianal hemorrhage
|
0.00%
0/8
|
0.00%
0/4
|
16.7%
1/6
|
0.00%
0/12
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Injury, poisoning and procedural complications
Perirectal abrasion
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/12
|
|
Investigations
Platelet count decreased
|
37.5%
3/8
|
50.0%
2/4
|
50.0%
3/6
|
58.3%
7/12
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
25.0%
2/8
|
0.00%
0/4
|
0.00%
0/6
|
33.3%
4/12
|
|
Respiratory, thoracic and mediastinal disorders
Pleural hemorrhage
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
16.7%
2/12
|
|
Musculoskeletal and connective tissue disorders
Polyarthropathy
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/8
|
0.00%
0/4
|
16.7%
1/6
|
16.7%
2/12
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/12
|
|
Nervous system disorders
Presyncope
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
25.0%
2/8
|
0.00%
0/4
|
50.0%
3/6
|
33.3%
4/12
|
|
Renal and urinary disorders
Proteinuria
|
12.5%
1/8
|
0.00%
0/4
|
16.7%
1/6
|
41.7%
5/12
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
1/8
|
25.0%
1/4
|
50.0%
3/6
|
33.3%
4/12
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
25.0%
2/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
50.0%
6/12
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
37.5%
3/8
|
25.0%
1/4
|
33.3%
2/6
|
58.3%
7/12
|
|
Skin and subcutaneous tissue disorders
Rash-petechial
|
12.5%
1/8
|
0.00%
0/4
|
16.7%
1/6
|
0.00%
0/12
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Gastrointestinal disorders
Rectal pain
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/12
|
|
Renal and urinary disorders
Renal tubular acidosis
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Infections and infestations
Scrotal infection
|
0.00%
0/8
|
25.0%
1/4
|
0.00%
0/6
|
0.00%
0/12
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Nervous system disorders
Seizure
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
16.7%
2/12
|
|
Infections and infestations
Sepsis
|
12.5%
1/8
|
0.00%
0/4
|
16.7%
1/6
|
8.3%
1/12
|
|
Cardiac disorders
Sinus bradycardia
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Cardiac disorders
Sinus tachycardia
|
12.5%
1/8
|
0.00%
0/4
|
16.7%
1/6
|
33.3%
4/12
|
|
Infections and infestations
Sinusitis
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
16.7%
2/12
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/8
|
0.00%
0/4
|
16.7%
1/6
|
0.00%
0/12
|
|
Infections and infestations
Skin infection
|
37.5%
3/8
|
75.0%
3/4
|
33.3%
2/6
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/8
|
25.0%
1/4
|
0.00%
0/6
|
25.0%
3/12
|
|
Nervous system disorders
Somnolence
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/8
|
25.0%
1/4
|
0.00%
0/6
|
16.7%
2/12
|
|
Hepatobiliary disorders
Splenomegaly
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/12
|
|
Infections and infestations
Staphylococcus epidermis-blood
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Nervous system disorders
Stroke
|
0.00%
0/8
|
0.00%
0/4
|
16.7%
1/6
|
8.3%
1/12
|
|
Cardiac disorders
Supraventricular tachycardia
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/12
|
|
Cardiac disorders
Systolic murmur
|
0.00%
0/8
|
0.00%
0/4
|
16.7%
1/6
|
0.00%
0/12
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/8
|
25.0%
1/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
16.7%
2/12
|
|
Nervous system disorders
Tremor
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
33.3%
4/12
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Infections and infestations
Urinary tract infection
|
12.5%
1/8
|
0.00%
0/4
|
0.00%
0/6
|
16.7%
2/12
|
|
Infections and infestations
VRE stool
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
16.7%
2/12
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Eye disorders
Visual disturbance/double vision
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Gastrointestinal disorders
Vomiting
|
37.5%
3/8
|
50.0%
2/4
|
66.7%
4/6
|
58.3%
7/12
|
|
Infections and infestations
Vulval infection
|
0.00%
0/8
|
0.00%
0/4
|
16.7%
1/6
|
0.00%
0/12
|
|
Investigations
Weight gain
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Investigations
Weight loss
|
0.00%
0/8
|
0.00%
0/4
|
16.7%
1/6
|
41.7%
5/12
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
12.5%
1/8
|
25.0%
1/4
|
0.00%
0/6
|
8.3%
1/12
|
|
Investigations
White blood cell decreased
|
87.5%
7/8
|
25.0%
1/4
|
83.3%
5/6
|
83.3%
10/12
|
|
Infections and infestations
Wound infection
|
0.00%
0/8
|
0.00%
0/4
|
0.00%
0/6
|
8.3%
1/12
|
Additional Information
Ravi Vij, M.D.
Washington University School of Medicine
Phone: 314-454-8304
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place