Trial Outcomes & Findings for CPX-351 in Treating Patients With Newly Diagnosed, High-Risk Acute Myeloid Leukemia (NCT NCT02286726)
NCT ID: NCT02286726
Last Updated: 2026-03-04
Results Overview
Response is defined as Complete response (CR) or CR with incomplete blood count recovery (CRi) rate: Complete Remission (CR) is Bone marrow blasts \<5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \>1.0 x 10\^9/L (1000/μL); platelet count \>100 x 10\^9/L (100,000/μL). Complete Response with incomplete blood count recovery (CRi) is All CR criteria except for residual neutropenia (\<1.0 x 10\^9/L \[1000/μL\]) and/or thrombocytopenia (\<100 x 10\^9/L \[100,000/μL\]).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
56 participants
Primary outcome timeframe
Up to 8 weeks (after induction therapy)
Results posted on
2026-03-04
Participant Flow
Recruitment Period: May 2015 to January 2020
Participant milestones
| Measure |
Arm I (Lower-dose (50 Units/m^2) CPX-351)
Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5 of a 28-day course. Patients with persistent disease may receive a second course with treatment on days 1 and 3.
Laboratory Biomarker Analysis: Correlative studies
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
|
Arm II (Intermediate-dose (75 Units/m^2) CPX-351)
Patients receive intermediate-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Patients with persistent disease may receive a second course with treatment on days 1 and 3.
Laboratory Biomarker Analysis: Correlative studies
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
|
Arm III (Standard-dose (100 Units/m^2) CPX-351)
Patients receive standard-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Patients with persistent disease may receive a second course with treatment on days 1 and 3.
Laboratory Biomarker Analysis: Correlative studies
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
24
|
16
|
|
Overall Study
COMPLETED
|
16
|
24
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CPX-351 in Treating Patients With Newly Diagnosed, High-Risk Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Arm I (Lower-dose (50 Units/m^2) CPX-351)
n=16 Participants
Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5 of a 28-day course. Patients with persistent disease may receive a second course with treatment on days 1 and 3.
Laboratory Biomarker Analysis: Correlative studies
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
|
Arm II (Intermediate-dose (75 Units/m^2) CPX-351)
n=24 Participants
Patients receive intermediate-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Patients with persistent disease may receive a second course with treatment on days 1 and 3.
Laboratory Biomarker Analysis: Correlative studies
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
|
Arm III (Standard-dose (100 Units/m^2) CPX-351)
n=16 Participants
Patients receive standard-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Patients with persistent disease may receive a second course with treatment on days 1 and 3.
Laboratory Biomarker Analysis: Correlative studies
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=565 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
5 Participants
n=76 Participants
|
22 Participants
n=565 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=41 Participants
|
15 Participants
n=35 Participants
|
11 Participants
n=76 Participants
|
34 Participants
n=565 Participants
|
|
Age, Continuous
|
63 years
n=41 Participants
|
66 years
n=35 Participants
|
69 years
n=76 Participants
|
67 years
n=565 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
4 Participants
n=76 Participants
|
19 Participants
n=565 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=41 Participants
|
16 Participants
n=35 Participants
|
12 Participants
n=76 Participants
|
37 Participants
n=565 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=565 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=565 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=565 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
1 Participants
n=565 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=41 Participants
|
24 Participants
n=35 Participants
|
16 Participants
n=76 Participants
|
54 Participants
n=565 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=565 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
1 Participants
n=565 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=41 Participants
|
24 participants
n=35 Participants
|
16 participants
n=76 Participants
|
56 participants
n=565 Participants
|
PRIMARY outcome
Timeframe: Up to 8 weeks (after induction therapy)Response is defined as Complete response (CR) or CR with incomplete blood count recovery (CRi) rate: Complete Remission (CR) is Bone marrow blasts \<5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \>1.0 x 10\^9/L (1000/μL); platelet count \>100 x 10\^9/L (100,000/μL). Complete Response with incomplete blood count recovery (CRi) is All CR criteria except for residual neutropenia (\<1.0 x 10\^9/L \[1000/μL\]) and/or thrombocytopenia (\<100 x 10\^9/L \[100,000/μL\]).
Outcome measures
| Measure |
Arm I (Lower-dose (50 Units/m^2) CPX-351)
n=16 Participants
Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5 of a 28-day course. Patients with persistent disease may receive a second course with treatment on days 1 and 3.
Laboratory Biomarker Analysis: Correlative studies
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
|
Arm II (Intermediate-dose (75 Units/m^2) CPX-351)
n=24 Participants
Patients receive intermediate-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Patients with persistent disease may receive a second course with treatment on days 1 and 3.
Laboratory Biomarker Analysis: Correlative studies
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
|
Arm III (Standard-dose (100 Units/m^2) CPX-351)
n=16 Participants
Patients receive standard-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Patients with persistent disease may receive a second course with treatment on days 1 and 3.
Laboratory Biomarker Analysis: Correlative studies
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
|
|---|---|---|---|
|
Number of Participants With a Response
Complete Response (CR)
|
3 Participants
|
6 Participants
|
7 Participants
|
|
Number of Participants With a Response
Complete Response with incomplete blood count recovery (CRi)
|
0 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to day 60Defined as induction mortality (death occurring on or before day 60), grade 3 or 4 non-hematologic toxicity, or dose limiting hematologic toxicity at least possibly related to the study drug occurring during the first 28 days from the start of therapy. Estimated for each arm with 95% confidence intervals. Fisher's exact test will be used to compare the toxicity rate between the two dose levels.
Outcome measures
| Measure |
Arm I (Lower-dose (50 Units/m^2) CPX-351)
n=16 Participants
Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5 of a 28-day course. Patients with persistent disease may receive a second course with treatment on days 1 and 3.
Laboratory Biomarker Analysis: Correlative studies
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
|
Arm II (Intermediate-dose (75 Units/m^2) CPX-351)
n=24 Participants
Patients receive intermediate-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Patients with persistent disease may receive a second course with treatment on days 1 and 3.
Laboratory Biomarker Analysis: Correlative studies
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
|
Arm III (Standard-dose (100 Units/m^2) CPX-351)
n=16 Participants
Patients receive standard-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Patients with persistent disease may receive a second course with treatment on days 1 and 3.
Laboratory Biomarker Analysis: Correlative studies
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
|
|---|---|---|---|
|
Number of Participants Who Experienced Dose-limiting Toxicity (DLT)
|
5 Participants
|
3 Participants
|
3 Participants
|
Adverse Events
Arm I (Lower-dose (50 Units/m^2) CPX-351)
Serious events: 11 serious events
Other events: 0 other events
Deaths: 6 deaths
Arm II (Intermediate-dose (75 Units/m^2) CPX-351)
Serious events: 15 serious events
Other events: 11 other events
Deaths: 3 deaths
Arm III (Standard-dose (100 Units/m^2) CPX-351)
Serious events: 11 serious events
Other events: 10 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Arm I (Lower-dose (50 Units/m^2) CPX-351)
n=16 participants at risk
Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5 of a 28-day course. Patients with persistent disease may receive a second course with treatment on days 1 and 3.
Laboratory Biomarker Analysis: Correlative studies
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
|
Arm II (Intermediate-dose (75 Units/m^2) CPX-351)
n=24 participants at risk
Patients receive intermediate-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Patients with persistent disease may receive a second course with treatment on days 1 and 3.
Laboratory Biomarker Analysis: Correlative studies
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
|
Arm III (Standard-dose (100 Units/m^2) CPX-351)
n=16 participants at risk
Patients receive standard-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Patients with persistent disease may receive a second course with treatment on days 1 and 3.
Laboratory Biomarker Analysis: Correlative studies
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
|
|---|---|---|---|
|
General disorders
Abdominal Pain
|
0.00%
0/16 • up to 4 years
|
0.00%
0/24 • up to 4 years
|
6.2%
1/16 • Number of events 1 • up to 4 years
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.00%
0/16 • up to 4 years
|
4.2%
1/24 • Number of events 1 • up to 4 years
|
0.00%
0/16 • up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
0.00%
0/16 • up to 4 years
|
0.00%
0/24 • up to 4 years
|
6.2%
1/16 • Number of events 1 • up to 4 years
|
|
General disorders
Back Pain
|
6.2%
1/16 • Number of events 1 • up to 4 years
|
0.00%
0/24 • up to 4 years
|
0.00%
0/16 • up to 4 years
|
|
Cardiac disorders
Cardiac Arrest
|
6.2%
1/16 • Number of events 1 • up to 4 years
|
0.00%
0/24 • up to 4 years
|
0.00%
0/16 • up to 4 years
|
|
General disorders
Death
|
12.5%
2/16 • Number of events 2 • up to 4 years
|
0.00%
0/24 • up to 4 years
|
0.00%
0/16 • up to 4 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/16 • up to 4 years
|
0.00%
0/24 • up to 4 years
|
6.2%
1/16 • Number of events 2 • up to 4 years
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
6.2%
1/16 • Number of events 2 • up to 4 years
|
25.0%
6/24 • Number of events 7 • up to 4 years
|
12.5%
2/16 • Number of events 2 • up to 4 years
|
|
General disorders
Fever
|
18.8%
3/16 • Number of events 6 • up to 4 years
|
4.2%
1/24 • Number of events 1 • up to 4 years
|
6.2%
1/16 • Number of events 2 • up to 4 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/16 • up to 4 years
|
0.00%
0/24 • up to 4 years
|
6.2%
1/16 • Number of events 1 • up to 4 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/16 • up to 4 years
|
0.00%
0/24 • up to 4 years
|
6.2%
1/16 • Number of events 1 • up to 4 years
|
|
Infections and infestations
Infection Right Arm Abcess
|
0.00%
0/16 • up to 4 years
|
0.00%
0/24 • up to 4 years
|
6.2%
1/16 • Number of events 1 • up to 4 years
|
|
Infections and infestations
Infection
|
6.2%
1/16 • Number of events 1 • up to 4 years
|
8.3%
2/24 • Number of events 3 • up to 4 years
|
25.0%
4/16 • Number of events 4 • up to 4 years
|
|
Nervous system disorders
Intracranial Hemorrhage
|
6.2%
1/16 • Number of events 1 • up to 4 years
|
4.2%
1/24 • Number of events 1 • up to 4 years
|
6.2%
1/16 • Number of events 1 • up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Joint Effusion
|
0.00%
0/16 • up to 4 years
|
4.2%
1/24 • Number of events 1 • up to 4 years
|
0.00%
0/16 • up to 4 years
|
|
Infections and infestations
Lung Infection
|
12.5%
2/16 • Number of events 2 • up to 4 years
|
16.7%
4/24 • Number of events 6 • up to 4 years
|
25.0%
4/16 • Number of events 5 • up to 4 years
|
|
General disorders
Multi-Organ Failure
|
0.00%
0/16 • up to 4 years
|
4.2%
1/24 • Number of events 1 • up to 4 years
|
6.2%
1/16 • Number of events 1 • up to 4 years
|
|
Infections and infestations
Orbital Cellulitis
|
6.2%
1/16 • Number of events 1 • up to 4 years
|
0.00%
0/24 • up to 4 years
|
0.00%
0/16 • up to 4 years
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/16 • up to 4 years
|
4.2%
1/24 • Number of events 1 • up to 4 years
|
0.00%
0/16 • up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/16 • up to 4 years
|
4.2%
1/24 • Number of events 1 • up to 4 years
|
0.00%
0/16 • up to 4 years
|
|
Reproductive system and breast disorders
Reproductive System and Breast Disorders
|
6.2%
1/16 • Number of events 1 • up to 4 years
|
0.00%
0/24 • up to 4 years
|
0.00%
0/16 • up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/16 • up to 4 years
|
4.2%
1/24 • Number of events 1 • up to 4 years
|
12.5%
2/16 • Number of events 2 • up to 4 years
|
|
Infections and infestations
Sepsis
|
6.2%
1/16 • Number of events 1 • up to 4 years
|
16.7%
4/24 • Number of events 4 • up to 4 years
|
6.2%
1/16 • Number of events 1 • up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
0.00%
0/16 • up to 4 years
|
0.00%
0/24 • up to 4 years
|
6.2%
1/16 • Number of events 1 • up to 4 years
|
|
Gastrointestinal disorders
Gastrointestinal Disorders
|
6.2%
1/16 • Number of events 1 • up to 4 years
|
0.00%
0/24 • up to 4 years
|
6.2%
1/16 • Number of events 1 • up to 4 years
|
Other adverse events
| Measure |
Arm I (Lower-dose (50 Units/m^2) CPX-351)
n=16 participants at risk
Patients receive lower-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5 of a 28-day course. Patients with persistent disease may receive a second course with treatment on days 1 and 3.
Laboratory Biomarker Analysis: Correlative studies
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
|
Arm II (Intermediate-dose (75 Units/m^2) CPX-351)
n=24 participants at risk
Patients receive intermediate-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Patients with persistent disease may receive a second course with treatment on days 1 and 3.
Laboratory Biomarker Analysis: Correlative studies
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
|
Arm III (Standard-dose (100 Units/m^2) CPX-351)
n=16 participants at risk
Patients receive standard-dose liposomal cytarabine-daunorubicin CPX-351 IV over 90 minutes on days 1, 3, and 5. Patients with persistent disease may receive a second course with treatment on days 1 and 3.
Laboratory Biomarker Analysis: Correlative studies
Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
|
|---|---|---|---|
|
Vascular disorders
Hypertension
|
0.00%
0/16 • up to 4 years
|
8.3%
2/24 • Number of events 2 • up to 4 years
|
6.2%
1/16 • Number of events 1 • up to 4 years
|
|
Infections and infestations
Infection
|
0.00%
0/16 • up to 4 years
|
0.00%
0/24 • up to 4 years
|
6.2%
1/16 • Number of events 1 • up to 4 years
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/16 • up to 4 years
|
0.00%
0/24 • up to 4 years
|
6.2%
1/16 • Number of events 1 • up to 4 years
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/16 • up to 4 years
|
12.5%
3/24 • Number of events 3 • up to 4 years
|
0.00%
0/16 • up to 4 years
|
|
Investigations
Investigation
|
0.00%
0/16 • up to 4 years
|
0.00%
0/24 • up to 4 years
|
6.2%
1/16 • Number of events 1 • up to 4 years
|
|
Infections and infestations
Lung Infection
|
0.00%
0/16 • up to 4 years
|
16.7%
4/24 • Number of events 4 • up to 4 years
|
25.0%
4/16 • Number of events 4 • up to 4 years
|
|
Gastrointestinal disorders
Mucositis
|
0.00%
0/16 • up to 4 years
|
0.00%
0/24 • up to 4 years
|
18.8%
3/16 • Number of events 3 • up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Disorder
|
0.00%
0/16 • up to 4 years
|
0.00%
0/24 • up to 4 years
|
6.2%
1/16 • Number of events 1 • up to 4 years
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/16 • up to 4 years
|
8.3%
2/24 • Number of events 2 • up to 4 years
|
0.00%
0/16 • up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/16 • up to 4 years
|
0.00%
0/24 • up to 4 years
|
6.2%
1/16 • Number of events 1 • up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
0.00%
0/16 • up to 4 years
|
0.00%
0/24 • up to 4 years
|
6.2%
1/16 • Number of events 1 • up to 4 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/16 • up to 4 years
|
0.00%
0/24 • up to 4 years
|
6.2%
1/16 • Number of events 1 • up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/16 • up to 4 years
|
0.00%
0/24 • up to 4 years
|
6.2%
1/16 • Number of events 1 • up to 4 years
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/16 • up to 4 years
|
0.00%
0/24 • up to 4 years
|
6.2%
1/16 • Number of events 1 • up to 4 years
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/16 • up to 4 years
|
0.00%
0/24 • up to 4 years
|
6.2%
1/16 • Number of events 2 • up to 4 years
|
|
Vascular disorders
Vascular Disorders
|
0.00%
0/16 • up to 4 years
|
0.00%
0/24 • up to 4 years
|
6.2%
1/16 • Number of events 1 • up to 4 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/16 • up to 4 years
|
0.00%
0/24 • up to 4 years
|
6.2%
1/16 • Number of events 1 • up to 4 years
|
|
Blood and lymphatic system disorders
Neutropenic Fever
|
0.00%
0/16 • up to 4 years
|
20.8%
5/24 • Number of events 5 • up to 4 years
|
12.5%
2/16 • Number of events 2 • up to 4 years
|
|
General disorders
Fever
|
0.00%
0/16 • up to 4 years
|
4.2%
1/24 • Number of events 1 • up to 4 years
|
6.2%
1/16 • Number of events 1 • up to 4 years
|
|
Gastrointestinal disorders
Gastric Hemorrhage
|
0.00%
0/16 • up to 4 years
|
0.00%
0/24 • up to 4 years
|
12.5%
2/16 • Number of events 2 • up to 4 years
|
|
Gastrointestinal disorders
Gastrointestinal Disorders
|
0.00%
0/16 • up to 4 years
|
0.00%
0/24 • up to 4 years
|
6.2%
1/16 • Number of events 1 • up to 4 years
|
|
General disorders
Headache
|
0.00%
0/16 • up to 4 years
|
0.00%
0/24 • up to 4 years
|
6.2%
1/16 • Number of events 1 • up to 4 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/16 • up to 4 years
|
0.00%
0/24 • up to 4 years
|
6.2%
1/16 • Number of events 1 • up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome
|
0.00%
0/16 • up to 4 years
|
0.00%
0/24 • up to 4 years
|
6.2%
1/16 • Number of events 1 • up to 4 years
|
|
Investigations
Alanine aminotransferase Increase
|
0.00%
0/16 • up to 4 years
|
4.2%
1/24 • Number of events 1 • up to 4 years
|
6.2%
1/16 • Number of events 1 • up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
0.00%
0/16 • up to 4 years
|
0.00%
0/24 • up to 4 years
|
6.2%
1/16 • Number of events 1 • up to 4 years
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/16 • up to 4 years
|
4.2%
1/24 • Number of events 1 • up to 4 years
|
12.5%
2/16 • Number of events 2 • up to 4 years
|
|
Investigations
Blood Bilirubin Increase
|
0.00%
0/16 • up to 4 years
|
4.2%
1/24 • Number of events 1 • up to 4 years
|
12.5%
2/16 • Number of events 2 • up to 4 years
|
|
Cardiac disorders
Cardiac Disorders
|
0.00%
0/16 • up to 4 years
|
4.2%
1/24 • Number of events 1 • up to 4 years
|
18.8%
3/16 • Number of events 3 • up to 4 years
|
|
Investigations
Ejection Fraction Decreased
|
0.00%
0/16 • up to 4 years
|
0.00%
0/24 • up to 4 years
|
6.2%
1/16 • Number of events 1 • up to 4 years
|
Additional Information
Ghayas Issa C. MD./Assistant Professor
The University of Texas MD Anderson Cancer Center
Phone: 713-745-6798
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place