Trial Outcomes & Findings for OX40, Venetoclax, Avelumab, Glasdegib, Gemtuzumab Ozogamicin, and Azacitidine in Relapsed or Refractory Acute Myeloid Leukemia (NCT NCT03390296)
NCT ID: NCT03390296
Last Updated: 2023-09-05
Results Overview
Response is: CR + complete response with incomplete recovery of platelets (CRp) + complete response with incomplete recovery of counts (CRi) within 3 months. CR: Bone Marrow blasts \</= 5%, Absolute neutrophil count \>/= 1,000, Platelets \>/= 100 and no extra medullary disease.CRp: Bone Marrow blasts \</= 5%, Absolute neutrophil count \>/= 1,000 and no extra medullary disease. CRi: Bone Marrow blasts \</= 5%
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
50 participants
Primary outcome timeframe
within 3 months of initiation of therapy
Results posted on
2023-09-05
Participant Flow
Zero participants were registered on Arm E.
Participant milestones
| Measure |
Arm A (Anti-OX40 Antibody PF-04518600)
Patients receive anti-OX40 antibody PF-04518600 IV over 60 minutes on days 1 and 14. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Anti-OX40 Agonist Monoclonal Antibody PF-04518600: Given IV
|
Arm B (Azacitidine, Venetoclax, GO)
Patients receive azacitidine IV over 10-40 minutes or via injection SC on days 1-7 or 1-5 and 8-9. Patients also receive venetoclax PO on days 1-28 and GO IV over 2 hours on day 8. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given IV or SC
Gemtuzumab Ozogamicin: Given IV
Venetoclax: Given PO
|
Arm C (Azacitidine, GO, Avelumab)
Patients receive azacitidine and GO as in Arm B. Patients also receive avelumab IV over 60 minutes on days 1 and 14. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Avelumab: Given IV
Gemtuzumab Ozogamicin: Given IV
Azacitidine: Given IV or SC
|
Arm D (Azacitidine, Venetoclax, Avelumab)
Patients receive azacitidine and venetoclax as in Arm A and avelumab as in Arm C. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Avelumab: Given IV
Azacitidine: Given IV or SC
Venetoclax: Given PO
|
Arm E (Azacitidine, Avelumab, Anti-OX40 Antibody PF-04518600)
Patients receive azacitidine and avelumab as in Arm C and anti-OX40 antibody PF-04518600 as in Arm A. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Anti-OX40 Agonist Monoclonal Antibody PF-04518600: Given IV
Avelumab: Given IV
Azacitidine: Given IV or SC
|
Arm F (GO, Glasdegib)
Patients receive GO IV over 2 hours on days 1, 4, and 7, and glasdegib PO on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Gemtuzumab Ozogamicin: Given IV
Glasdegib: Given PO
Glasdegib Maleate: Given PO
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
21
|
7
|
13
|
0
|
5
|
|
Overall Study
COMPLETED
|
4
|
21
|
7
|
13
|
0
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
OX40, Venetoclax, Avelumab, Glasdegib, Gemtuzumab Ozogamicin, and Azacitidine in Relapsed or Refractory Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Arm A (Anti-OX40 Antibody PF-04518600)
n=4 Participants
Patients receive anti-OX40 antibody PF-04518600 IV over 60 minutes on days 1 and 14. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Anti-OX40 Agonist Monoclonal Antibody PF-04518600: Given IV
|
Arm B (Azacitidine, Venetoclax, GO)
n=21 Participants
Patients receive azacitidine IV over 10-40 minutes or via injection SC on days 1-7 or 1-5 and 8-9. Patients also receive venetoclax PO on days 1-28 and GO IV over 2 hours on day 8. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given IV or SC
Gemtuzumab Ozogamicin: Given IV
Venetoclax: Given PO
|
Arm C (Azacitidine, GO, Avelumab)
n=7 Participants
Patients receive azacitidine and GO as in Arm B. Patients also receive avelumab IV over 60 minutes on days 1 and 14. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Avelumab: Given IV
Gemtuzumab Ozogamicin: Given IV
Azacitidine: Given IV or SC
|
Arm D (Azacitidine, Venetoclax, Avelumab)
n=13 Participants
Patients receive azacitidine and venetoclax as in Arm A and avelumab as in Arm C. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Avelumab: Given IV
Azacitidine: Given IV or SC
Venetoclax: Given PO
|
Arm E (Azacitidine, Avelumab, Anti-OX40 Antibody PF-04518600)
Patients receive azacitidine and avelumab as in Arm C and anti-OX40 antibody PF-04518600 as in Arm A. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Anti-OX40 Agonist Monoclonal Antibody PF-04518600: Given IV
Avelumab: Given IV
Azacitidine: Given IV or SC
|
Arm F (GO, Glasdegib)
n=5 Participants
Patients receive GO IV over 2 hours on days 1, 4, and 7, and glasdegib PO on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Gemtuzumab Ozogamicin: Given IV
Glasdegib: Given PO
Glasdegib Maleate: Given PO
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
24 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
24 Participants
n=8 Participants
|
|
Age, Continuous
|
55 years
n=5 Participants
|
66 years
n=7 Participants
|
63 years
n=5 Participants
|
67 years
n=4 Participants
|
—
|
64 years
n=8 Participants
|
64 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
—
|
3 Participants
n=8 Participants
|
23 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
—
|
2 Participants
n=8 Participants
|
27 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
—
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
—
|
4 Participants
n=8 Participants
|
41 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
—
|
0 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
21 participants
n=7 Participants
|
7 participants
n=5 Participants
|
13 participants
n=4 Participants
|
—
|
5 participants
n=8 Participants
|
50 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: within 3 months of initiation of therapyPopulation: Zero participants were registered on Arm E. Four participants in Arm B, One participant in arm C, two participants in arm D and two participants in arm F were not evaluable for response.
Response is: CR + complete response with incomplete recovery of platelets (CRp) + complete response with incomplete recovery of counts (CRi) within 3 months. CR: Bone Marrow blasts \</= 5%, Absolute neutrophil count \>/= 1,000, Platelets \>/= 100 and no extra medullary disease.CRp: Bone Marrow blasts \</= 5%, Absolute neutrophil count \>/= 1,000 and no extra medullary disease. CRi: Bone Marrow blasts \</= 5%
Outcome measures
| Measure |
Arm A (Anti-OX40 Antibody PF-04518600)
n=4 Participants
Patients receive anti-OX40 antibody PF-04518600 IV over 60 minutes on days 1 and 14. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Anti-OX40 Agonist Monoclonal Antibody PF-04518600: Given IV
|
Arm B (Azacitidine, Venetoclax, GO)
n=17 Participants
Patients receive azacitidine IV over 10-40 minutes or via injection SC on days 1-7 or 1-5 and 8-9. Patients also receive venetoclax PO on days 1-28 and GO IV over 2 hours on day 8. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given IV or SC
Gemtuzumab Ozogamicin: Given IV
Venetoclax: Given PO
|
Arm C (Azacitidine, GO, Avelumab)
n=6 Participants
Patients receive azacitidine and GO as in Arm B. Patients also receive avelumab IV over 60 minutes on days 1 and 14. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Avelumab: Given IV
Gemtuzumab Ozogamicin: Given IV
Azacitidine: Given IV or SC
|
Arm D (Azacitidine, Venetoclax, Avelumab)
n=11 Participants
Patients receive azacitidine and venetoclax as in Arm A and avelumab as in Arm C. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Avelumab: Given IV
Azacitidine: Given IV or SC
Venetoclax: Given PO
|
Arm E (Azacitidine, Avelumab, Anti-OX40 Antibody PF-04518600)
Patients receive azacitidine and avelumab as in Arm C and anti-OX40 antibody PF-04518600 as in Arm A. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Anti-OX40 Agonist Monoclonal Antibody PF-04518600: Given IV
Avelumab: Given IV
Azacitidine: Given IV or SC
|
Arm F (GO, Glasdegib)
n=3 Participants
Patients receive GO IV over 2 hours on days 1, 4, and 7, and glasdegib PO on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Gemtuzumab Ozogamicin: Given IV
Glasdegib: Given PO
Glasdegib Maleate: Given PO
|
|---|---|---|---|---|---|---|
|
Number of Participants With a Response
|
0 Participants
|
8 Participants
|
1 Participants
|
2 Participants
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: Zero Participants were registered on Arm E. Four participants in Arm B, One participant in arm C, two participants in arm D and two participants in arm F were not evaluable for response.
Time from date of treatment start until date of death due to any cause or last Follow-up.
Outcome measures
| Measure |
Arm A (Anti-OX40 Antibody PF-04518600)
n=4 Participants
Patients receive anti-OX40 antibody PF-04518600 IV over 60 minutes on days 1 and 14. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Anti-OX40 Agonist Monoclonal Antibody PF-04518600: Given IV
|
Arm B (Azacitidine, Venetoclax, GO)
n=17 Participants
Patients receive azacitidine IV over 10-40 minutes or via injection SC on days 1-7 or 1-5 and 8-9. Patients also receive venetoclax PO on days 1-28 and GO IV over 2 hours on day 8. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given IV or SC
Gemtuzumab Ozogamicin: Given IV
Venetoclax: Given PO
|
Arm C (Azacitidine, GO, Avelumab)
n=6 Participants
Patients receive azacitidine and GO as in Arm B. Patients also receive avelumab IV over 60 minutes on days 1 and 14. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Avelumab: Given IV
Gemtuzumab Ozogamicin: Given IV
Azacitidine: Given IV or SC
|
Arm D (Azacitidine, Venetoclax, Avelumab)
n=11 Participants
Patients receive azacitidine and venetoclax as in Arm A and avelumab as in Arm C. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Avelumab: Given IV
Azacitidine: Given IV or SC
Venetoclax: Given PO
|
Arm E (Azacitidine, Avelumab, Anti-OX40 Antibody PF-04518600)
Patients receive azacitidine and avelumab as in Arm C and anti-OX40 antibody PF-04518600 as in Arm A. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Anti-OX40 Agonist Monoclonal Antibody PF-04518600: Given IV
Avelumab: Given IV
Azacitidine: Given IV or SC
|
Arm F (GO, Glasdegib)
n=3 Participants
Patients receive GO IV over 2 hours on days 1, 4, and 7, and glasdegib PO on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Gemtuzumab Ozogamicin: Given IV
Glasdegib: Given PO
Glasdegib Maleate: Given PO
|
|---|---|---|---|---|---|---|
|
Overall Survival
|
3.0 Months
Interval 2.5 to 17.9
|
7.6 Months
Interval 0.7 to 30.3
|
5.9 Months
Interval 2.9 to 37.7
|
4.8 Months
Interval 1.0 to 34.0
|
—
|
1.1 Months
Interval 0.3 to 1.8
|
Adverse Events
Arm A (Anti-OX40 Antibody PF-04518600)
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Arm B (Azacitidine, Venetoclax, GO)
Serious events: 17 serious events
Other events: 5 other events
Deaths: 3 deaths
Arm C (Azacitidine, GO, Avelumab)
Serious events: 6 serious events
Other events: 1 other events
Deaths: 1 deaths
Arm D (Azacitidine, Venetoclax, Avelumab)
Serious events: 9 serious events
Other events: 3 other events
Deaths: 2 deaths
Arm E (Azacitidine, Avelumab, Anti-OX40 Antibody PF-04518600)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm F (GO, Glasdegib)
Serious events: 5 serious events
Other events: 1 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Arm A (Anti-OX40 Antibody PF-04518600)
n=4 participants at risk
Patients receive anti-OX40 antibody PF-04518600 IV over 60 minutes on days 1 and 14. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Anti-OX40 Agonist Monoclonal Antibody PF-04518600: Given IV
|
Arm B (Azacitidine, Venetoclax, GO)
n=21 participants at risk
Patients receive azacitidine IV over 10-40 minutes or via injection SC on days 1-7 or 1-5 and 8-9. Patients also receive venetoclax PO on days 1-28 and GO IV over 2 hours on day 8. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given IV or SC
Gemtuzumab Ozogamicin: Given IV
Venetoclax: Given PO
|
Arm C (Azacitidine, GO, Avelumab)
n=7 participants at risk
Patients receive azacitidine and GO as in Arm B. Patients also receive avelumab IV over 60 minutes on days 1 and 14. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Avelumab: Given IV
Gemtuzumab Ozogamicin: Given IV
Azacitidine: Given IV or SC
|
Arm D (Azacitidine, Venetoclax, Avelumab)
n=13 participants at risk
Patients receive azacitidine and venetoclax as in Arm A and avelumab as in Arm C. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Avelumab: Given IV
Azacitidine: Given IV or SC
Venetoclax: Given PO
|
Arm E (Azacitidine, Avelumab, Anti-OX40 Antibody PF-04518600)
Patients receive azacitidine and avelumab as in Arm C and anti-OX40 antibody PF-04518600 as in Arm A. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Anti-OX40 Agonist Monoclonal Antibody PF-04518600: Given IV
Avelumab: Given IV
Azacitidine: Given IV or SC
|
Arm F (GO, Glasdegib)
n=5 participants at risk
Patients receive GO IV over 2 hours on days 1, 4, and 7, and glasdegib PO on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Gemtuzumab Ozogamicin: Given IV
Glasdegib: Given PO
Glasdegib Maleate: Given PO
|
|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
4.8%
1/21 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
7.7%
1/13 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
20.0%
1/5 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/21 • Up to 4 years
Zero participants were registered on Arm E.
|
14.3%
1/7 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/13 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
4.8%
1/21 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/13 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
4.8%
1/21 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
7.7%
1/13 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Investigations
Cardiac troponin T increased
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
4.8%
1/21 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/13 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
4.8%
1/21 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/13 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
14.3%
3/21 • Number of events 3 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/13 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Investigations
Creatinine Increased
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
4.8%
1/21 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/13 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
4.8%
1/21 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
14.3%
1/7 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/13 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
4.8%
1/21 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
14.3%
1/7 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/13 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/21 • Up to 4 years
Zero participants were registered on Arm E.
|
14.3%
1/7 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/13 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
General disorders
Fatigue
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/21 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
7.7%
1/13 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
25.0%
1/4 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
33.3%
7/21 • Number of events 10 • Up to 4 years
Zero participants were registered on Arm E.
|
28.6%
2/7 • Number of events 4 • Up to 4 years
Zero participants were registered on Arm E.
|
23.1%
3/13 • Number of events 3 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
20.0%
1/5 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
|
General disorders
Fever
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/21 • Up to 4 years
Zero participants were registered on Arm E.
|
14.3%
1/7 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/13 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/21 • Up to 4 years
Zero participants were registered on Arm E.
|
14.3%
1/7 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/13 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/21 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
7.7%
1/13 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Infections and infestations
Hepatic Infection
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/21 • Up to 4 years
Zero participants were registered on Arm E.
|
14.3%
1/7 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/13 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Vascular disorders
Hypotension
|
25.0%
1/4 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/21 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/13 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnes
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/21 • Up to 4 years
Zero participants were registered on Arm E.
|
14.3%
1/7 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/13 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Immune system disorders
Immune System Disorders
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/21 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
7.7%
1/13 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Infections and infestations
Infection
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
14.3%
3/21 • Number of events 3 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/13 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
20.0%
1/5 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
4.8%
1/21 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/13 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
4.8%
1/21 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/13 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/21 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
7.7%
1/13 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
4.8%
1/21 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
7.7%
1/13 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
20.0%
1/5 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Infections and infestations
Lung infection
|
25.0%
1/4 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
28.6%
6/21 • Number of events 10 • Up to 4 years
Zero participants were registered on Arm E.
|
42.9%
3/7 • Number of events 3 • Up to 4 years
Zero participants were registered on Arm E.
|
23.1%
3/13 • Number of events 7 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
General disorders
Multi-organ failure
|
25.0%
1/4 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/21 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/13 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
4.8%
1/21 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/13 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/21 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
7.7%
1/13 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/21 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
7.7%
1/13 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/21 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/13 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
40.0%
2/5 • Number of events 2 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Infections and infestations
Sepsis
|
25.0%
1/4 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
9.5%
2/21 • Number of events 2 • Up to 4 years
Zero participants were registered on Arm E.
|
14.3%
1/7 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/13 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
20.0%
1/5 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/21 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
7.7%
1/13 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/21 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
7.7%
1/13 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/21 • Up to 4 years
Zero participants were registered on Arm E.
|
14.3%
1/7 • Number of events 10 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/13 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/21 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
7.7%
1/13 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/21 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
7.7%
1/13 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
4.8%
1/21 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/13 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Infections and infestations
Alpha Hemolytic Strep Bacteremia
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
4.8%
1/21 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/13 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Infections and infestations
septicemia
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
4.8%
1/21 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/13 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
Other adverse events
| Measure |
Arm A (Anti-OX40 Antibody PF-04518600)
n=4 participants at risk
Patients receive anti-OX40 antibody PF-04518600 IV over 60 minutes on days 1 and 14. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Anti-OX40 Agonist Monoclonal Antibody PF-04518600: Given IV
|
Arm B (Azacitidine, Venetoclax, GO)
n=21 participants at risk
Patients receive azacitidine IV over 10-40 minutes or via injection SC on days 1-7 or 1-5 and 8-9. Patients also receive venetoclax PO on days 1-28 and GO IV over 2 hours on day 8. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given IV or SC
Gemtuzumab Ozogamicin: Given IV
Venetoclax: Given PO
|
Arm C (Azacitidine, GO, Avelumab)
n=7 participants at risk
Patients receive azacitidine and GO as in Arm B. Patients also receive avelumab IV over 60 minutes on days 1 and 14. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Avelumab: Given IV
Gemtuzumab Ozogamicin: Given IV
Azacitidine: Given IV or SC
|
Arm D (Azacitidine, Venetoclax, Avelumab)
n=13 participants at risk
Patients receive azacitidine and venetoclax as in Arm A and avelumab as in Arm C. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Avelumab: Given IV
Azacitidine: Given IV or SC
Venetoclax: Given PO
|
Arm E (Azacitidine, Avelumab, Anti-OX40 Antibody PF-04518600)
Patients receive azacitidine and avelumab as in Arm C and anti-OX40 antibody PF-04518600 as in Arm A. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Anti-OX40 Agonist Monoclonal Antibody PF-04518600: Given IV
Avelumab: Given IV
Azacitidine: Given IV or SC
|
Arm F (GO, Glasdegib)
n=5 participants at risk
Patients receive GO IV over 2 hours on days 1, 4, and 7, and glasdegib PO on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Gemtuzumab Ozogamicin: Given IV
Glasdegib: Given PO
Glasdegib Maleate: Given PO
|
|---|---|---|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
25.0%
1/4 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/21 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
15.4%
2/13 • Number of events 2 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/21 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
7.7%
1/13 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
4.8%
1/21 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/13 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Investigations
Aspartate aminotransferase
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/21 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
7.7%
1/13 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Investigations
Blood bilirubin increased
|
25.0%
1/4 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/21 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
7.7%
1/13 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
20.0%
1/5 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
9.5%
2/21 • Number of events 2 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
7.7%
1/13 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/21 • Up to 4 years
Zero participants were registered on Arm E.
|
14.3%
1/7 • Number of events 3 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/13 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
General disorders
Fatigue
|
50.0%
2/4 • Number of events 2 • Up to 4 years
Zero participants were registered on Arm E.
|
4.8%
1/21 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/13 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/21 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
7.7%
1/13 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
4.8%
1/21 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/13 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
19.0%
4/21 • Number of events 5 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
7.7%
1/13 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/21 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
7.7%
1/13 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Up to 4 years
Zero participants were registered on Arm E.
|
4.8%
1/21 • Number of events 1 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/7 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/13 • Up to 4 years
Zero participants were registered on Arm E.
|
—
0/0 • Up to 4 years
Zero participants were registered on Arm E.
|
0.00%
0/5 • Up to 4 years
Zero participants were registered on Arm E.
|
Additional Information
Naval Daver MD./Associate Professor
The University of Texas MD Anderson Cancer Center
Phone: 713-794-4392
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place