Trial Outcomes & Findings for Lirilumab and Azacitidine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia (NCT NCT02399917)

Last Updated: 2019-09-24

Results Overview

To identify the dose at which \<2/6 participants experience Dose Limiting Toxicities (DLT). The dose level at which 0-1/6 participants experience a DLT in the first 28 days of treatment will be the maximum tolerated dose (MTD) and would be used to treat an additional 34 participants in the phase II potion of the study. (Part A, Lead-In Phase)

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

36 participants

Primary outcome timeframe

Up to 28 days

Results posted on

2019-09-24

Participant Flow

Recruitment Period: May 2015 - June 2017

Participant milestones

Participant milestones
Measure	Phase 1b Lead-in Cohort 1 Patients receive azacitidine SC or IV over 1 hour as determined by the treating physician on days 1-7 and lirilumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 5-Azacitidine 75mg/m\^2 Lirilumab 1.0 mg/kg Azacitidine: Given SC or IV Lirilumab: Given IV	Phase 1b Lead-in Cohort 2 Patients receive azacitidine SC or IV over 1 hour as determined by the treating physician on days 1-7 and lirilumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 5-Azacitidine 75mg/m\^2 Lirilumab 3.0 mg/kg Azacitidine: Given SC or IV Lirilumab: Given IV	Phase 2 Patients receive azacitidine SC or IV over 1 hour as determined by the treating physician on days 1-7 and lirilumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 5-Azacitidine 75mg/m\^2 Lirilumab 3.0 mg/kg Azacitidine: Given SC or IV Lirilumab: Given IV
Overall Study STARTED	6	6	24
Overall Study COMPLETED	6	6	24
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lirilumab and Azacitidine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1b Lead-in Cohort 1 n=6 Participants Patients receive azacitidine SC or IV over 1 hour as determined by the treating physician on days 1-7 and lirilumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 5-Azacitidine 75mg/m\^2 Lirilumab 1.0 mg/kg Azacitidine: Given SC or IV Lirilumab: Given IV	Phase 1b Lead-in Cohort 2 n=6 Participants Patients receive azacitidine SC or IV over 1 hour as determined by the treating physician on days 1-7 and lirilumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 5-Azacitidine 75mg/m\^2 Lirilumab 3.0 mg/kg Azacitidine: Given SC or IV Lirilumab: Given IV	Phase 2 n=24 Participants Patients receive azacitidine SC or IV over 1 hour as determined by the treating physician on days 1-7 and lirilumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 5-Azacitidine 75mg/m\^2 Lirilumab 3.0 mg/kg Azacitidine: Given SC or IV Lirilumab: Given IV	Total n=36 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	3 Participants n=7 Participants	13 Participants n=5 Participants	20 Participants n=4 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants	16 Participants n=4 Participants
Age, Continuous	59.5 years n=5 Participants	68.5 years n=7 Participants	65 years n=5 Participants	64 years n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	14 Participants n=5 Participants	18 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants	18 Participants n=4 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
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 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
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	6 Participants n=7 Participants	19 Participants n=5 Participants	30 Participants n=4 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
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	6 participants n=5 Participants	6 participants n=7 Participants	24 participants n=5 Participants	36 participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 28 days

Outcome measures

Outcome measures
Measure	All Phase 1 Participants n=12 Participants Patients receive azacitidine SC or IV over 1 hour as determined by the treating physician on days 1-7 and lirilumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 5-Azacitidine 75mg/m\^2 Lirilumab 1.0 mg/kg Azacitidine: Given SC or IV Lirilumab: Given IV	Phase 1b Lead-in Cohort 2 Patients receive azacitidine SC or IV over 1 hour as determined by the treating physician on days 1-7 and lirilumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 5-Azacitidine 75mg/m\^2 Lirilumab 3.0 mg/kg Azacitidine: Given SC or IV Lirilumab: Given IV	Phase 2 Patients receive azacitidine SC or IV over 1 hour as determined by the treating physician on days 1-7 and lirilumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 5-Azacitidine 75mg/m\^2 Lirilumab 3.0 mg/kg Azacitidine: Given SC or IV Lirilumab: Given IV
Maximum Tolerated Dose of Iirilumab in Combination With 5-azacitidine	3.0 mg/kg	—	—

PRIMARY outcome

Timeframe: Up to 3 months

Objective Response Rate (ORR) will be monitored using the Bayesian approach of Thall, Simon, Estey and the extension by Thall and Sung. Overall response rate (ORR), defined as complete remission (CR) + CR with incomplete platelet recovery (CRp) + CR with incomplete count recovery (CRi) + partial response (PR) + marrow clearance of blasts + hematological improvement within 3 months of treatment initiation among adult patients with refractory/relapsed Acute Myelogenous Leukemia (AML) (Phase II)

Outcome measures

Outcome measures
Measure	All Phase 1 Participants n=6 Participants Patients receive azacitidine SC or IV over 1 hour as determined by the treating physician on days 1-7 and lirilumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 5-Azacitidine 75mg/m\^2 Lirilumab 1.0 mg/kg Azacitidine: Given SC or IV Lirilumab: Given IV	Phase 1b Lead-in Cohort 2 n=6 Participants Patients receive azacitidine SC or IV over 1 hour as determined by the treating physician on days 1-7 and lirilumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 5-Azacitidine 75mg/m\^2 Lirilumab 3.0 mg/kg Azacitidine: Given SC or IV Lirilumab: Given IV	Phase 2 n=24 Participants Patients receive azacitidine SC or IV over 1 hour as determined by the treating physician on days 1-7 and lirilumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 5-Azacitidine 75mg/m\^2 Lirilumab 3.0 mg/kg Azacitidine: Given SC or IV Lirilumab: Given IV
Participants With an Objective Response	2 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to 2.5 years

Population: The outcome for the secondary response, duration of response was only done on the Phase II portion of this study.

The date of Objective Response to the date of loss of response or last follow-up.

Outcome measures

Outcome measures
Measure	All Phase 1 Participants Patients receive azacitidine SC or IV over 1 hour as determined by the treating physician on days 1-7 and lirilumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 5-Azacitidine 75mg/m\^2 Lirilumab 1.0 mg/kg Azacitidine: Given SC or IV Lirilumab: Given IV	Phase 1b Lead-in Cohort 2 Patients receive azacitidine SC or IV over 1 hour as determined by the treating physician on days 1-7 and lirilumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 5-Azacitidine 75mg/m\^2 Lirilumab 3.0 mg/kg Azacitidine: Given SC or IV Lirilumab: Given IV	Phase 2 n=24 Participants Patients receive azacitidine SC or IV over 1 hour as determined by the treating physician on days 1-7 and lirilumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 5-Azacitidine 75mg/m\^2 Lirilumab 3.0 mg/kg Azacitidine: Given SC or IV Lirilumab: Given IV
Duration of Response	—	—	7.7 Months Interval 2.0 to 17.0

SECONDARY outcome

Timeframe: Up to 2 years

Population: The outcome for the secondary response, overall response was only done on the Phase II portion of this study.

Overall Survival (OS) is defined: Time of presentation to date of death or censored at last follow-up date.

Outcome measures

Outcome measures
Measure	All Phase 1 Participants Patients receive azacitidine SC or IV over 1 hour as determined by the treating physician on days 1-7 and lirilumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 5-Azacitidine 75mg/m\^2 Lirilumab 1.0 mg/kg Azacitidine: Given SC or IV Lirilumab: Given IV	Phase 1b Lead-in Cohort 2 Patients receive azacitidine SC or IV over 1 hour as determined by the treating physician on days 1-7 and lirilumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 5-Azacitidine 75mg/m\^2 Lirilumab 3.0 mg/kg Azacitidine: Given SC or IV Lirilumab: Given IV	Phase 2 n=24 Participants Patients receive azacitidine SC or IV over 1 hour as determined by the treating physician on days 1-7 and lirilumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 5-Azacitidine 75mg/m\^2 Lirilumab 3.0 mg/kg Azacitidine: Given SC or IV Lirilumab: Given IV
Overall Survival	—	—	3.5 Months Interval 0.4 to 22.2

SECONDARY outcome

Timeframe: Up to 2.5 years

Population: The outcome for the secondary response, disease free survival was only done on the Phase II portion of this study.

Disease Free Survival (DFS) is defined: Time from date of treatment start until the date of first objective documentation of disease-relapse

Outcome measures

Outcome measures
Measure	All Phase 1 Participants Patients receive azacitidine SC or IV over 1 hour as determined by the treating physician on days 1-7 and lirilumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 5-Azacitidine 75mg/m\^2 Lirilumab 1.0 mg/kg Azacitidine: Given SC or IV Lirilumab: Given IV	Phase 1b Lead-in Cohort 2 Patients receive azacitidine SC or IV over 1 hour as determined by the treating physician on days 1-7 and lirilumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 5-Azacitidine 75mg/m\^2 Lirilumab 3.0 mg/kg Azacitidine: Given SC or IV Lirilumab: Given IV	Phase 2 n=24 Participants Patients receive azacitidine SC or IV over 1 hour as determined by the treating physician on days 1-7 and lirilumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 5-Azacitidine 75mg/m\^2 Lirilumab 3.0 mg/kg Azacitidine: Given SC or IV Lirilumab: Given IV
Disease Free Survival	—	—	7.7 Months Interval 2.0 to 17.0

Adverse Events

Phase 1b Lead-in Cohort 1

Serious events: 6 serious events

Other events: 6 other events

Deaths: 4 deaths

Phase 1b Lead-in Cohort 2

Serious events: 6 serious events

Other events: 6 other events

Deaths: 2 deaths

Phase 2

Serious events: 20 serious events

Other events: 22 other events

Deaths: 9 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Phase 1b Lead-in Cohort 1 n=6 participants at risk Patients receive azacitidine SC or IV over 1 hour as determined by the treating physician on days 1-7 and lirilumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 5-Azacitidine 75mg/m\^2 Lirilumab 1.0 mg/kg Azacitidine: Given SC or IV Lirilumab: Given IV	Phase 1b Lead-in Cohort 2 n=6 participants at risk Patients receive azacitidine SC or IV over 1 hour as determined by the treating physician on days 1-7 and lirilumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 5-Azacitidine 75mg/m\^2 Lirilumab 3.0 mg/kg Azacitidine: Given SC or IV Lirilumab: Given IV	Phase 2 n=24 participants at risk Patients receive azacitidine SC or IV over 1 hour as determined by the treating physician on days 1-7 and lirilumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 5-Azacitidine 75mg/m\^2 Lirilumab 3.0 mg/kg Azacitidine: Given SC or IV Lirilumab: Given IV
Gastrointestinal disorders Abdominal Distension	33.3% 2/6 • Number of events 2 • Up to two and a half years.	0.00% 0/6 • Up to two and a half years.	4.2% 1/24 • Number of events 1 • Up to two and a half years.
Renal and urinary disorders Acute Kidney Injury	0.00% 0/6 • Up to two and a half years.	50.0% 3/6 • Number of events 3 • Up to two and a half years.	0.00% 0/24 • Up to two and a half years.
Investigations Elevated Alanine Aminotransferase increased	0.00% 0/6 • Up to two and a half years.	16.7% 1/6 • Number of events 1 • Up to two and a half years.	8.3% 2/24 • Number of events 2 • Up to two and a half years.
Metabolism and nutrition disorders Anorexia	0.00% 0/6 • Up to two and a half years.	0.00% 0/6 • Up to two and a half years.	12.5% 3/24 • Number of events 3 • Up to two and a half years.
Investigations Aspartate Aminotransferase Increased	33.3% 2/6 • Number of events 2 • Up to two and a half years.	50.0% 3/6 • Number of events 3 • Up to two and a half years.	16.7% 4/24 • Number of events 4 • Up to two and a half years.
Cardiac disorders Atrial Fibrillation	16.7% 1/6 • Number of events 1 • Up to two and a half years.	0.00% 0/6 • Up to two and a half years.	8.3% 2/24 • Number of events 2 • Up to two and a half years.
Skin and subcutaneous tissue disorders Bruising	0.00% 0/6 • Up to two and a half years.	16.7% 1/6 • Number of events 1 • Up to two and a half years.	8.3% 2/24 • Number of events 3 • Up to two and a half years.
Gastrointestinal disorders Constipation	16.7% 1/6 • Number of events 2 • Up to two and a half years.	16.7% 1/6 • Number of events 1 • Up to two and a half years.	41.7% 10/24 • Number of events 12 • Up to two and a half years.
Gastrointestinal disorders Diarrhea	33.3% 2/6 • Number of events 2 • Up to two and a half years.	0.00% 0/6 • Up to two and a half years.	33.3% 8/24 • Number of events 8 • Up to two and a half years.
General disorders Edema	16.7% 1/6 • Number of events 1 • Up to two and a half years.	16.7% 1/6 • Number of events 1 • Up to two and a half years.	16.7% 4/24 • Number of events 4 • Up to two and a half years.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/6 • Up to two and a half years.	0.00% 0/6 • Up to two and a half years.	12.5% 3/24 • Number of events 3 • Up to two and a half years.
Injury, poisoning and procedural complications Fall	0.00% 0/6 • Up to two and a half years.	0.00% 0/6 • Up to two and a half years.	20.8% 5/24 • Number of events 5 • Up to two and a half years.
General disorders Fever	50.0% 3/6 • Number of events 3 • Up to two and a half years.	0.00% 0/6 • Up to two and a half years.	33.3% 8/24 • Number of events 9 • Up to two and a half years.
General disorders Headache	33.3% 2/6 • Number of events 2 • Up to two and a half years.	0.00% 0/6 • Up to two and a half years.	12.5% 3/24 • Number of events 3 • Up to two and a half years.
Renal and urinary disorders Hematuria	0.00% 0/6 • Up to two and a half years.	0.00% 0/6 • Up to two and a half years.	16.7% 4/24 • Number of events 4 • Up to two and a half years.
Investigations Hyperbilirubinemia	16.7% 1/6 • Number of events 1 • Up to two and a half years.	16.7% 1/6 • Number of events 1 • Up to two and a half years.	20.8% 5/24 • Number of events 5 • Up to two and a half years.
Metabolism and nutrition disorders Hyperglycemia	33.3% 2/6 • Number of events 2 • Up to two and a half years.	0.00% 0/6 • Up to two and a half years.	0.00% 0/24 • Up to two and a half years.
Vascular disorders Hypertension	16.7% 1/6 • Number of events 1 • Up to two and a half years.	0.00% 0/6 • Up to two and a half years.	8.3% 2/24 • Number of events 2 • Up to two and a half years.
Metabolism and nutrition disorders Hypocalcemia	16.7% 1/6 • Number of events 1 • Up to two and a half years.	0.00% 0/6 • Up to two and a half years.	4.2% 1/24 • Number of events 1 • Up to two and a half years.
Metabolism and nutrition disorders Hypokalemia	16.7% 1/6 • Number of events 1 • Up to two and a half years.	50.0% 3/6 • Number of events 3 • Up to two and a half years.	12.5% 3/24 • Number of events 3 • Up to two and a half years.
Metabolism and nutrition disorders Hypomagnesmia	16.7% 1/6 • Number of events 1 • Up to two and a half years.	0.00% 0/6 • Up to two and a half years.	0.00% 0/24 • Up to two and a half years.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/6 • Up to two and a half years.	16.7% 1/6 • Number of events 1 • Up to two and a half years.	12.5% 3/24 • Number of events 3 • Up to two and a half years.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/6 • Up to two and a half years.	0.00% 0/6 • Up to two and a half years.	12.5% 3/24 • Number of events 3 • Up to two and a half years.
Vascular disorders Hypotension	16.7% 1/6 • Number of events 2 • Up to two and a half years.	0.00% 0/6 • Up to two and a half years.	33.3% 8/24 • Number of events 8 • Up to two and a half years.
Infections and infestations Infection	33.3% 2/6 • Number of events 2 • Up to two and a half years.	0.00% 0/6 • Up to two and a half years.	29.2% 7/24 • Number of events 8 • Up to two and a half years.
General disorders Infusion Reaction	16.7% 1/6 • Number of events 1 • Up to two and a half years.	16.7% 1/6 • Number of events 1 • Up to two and a half years.	29.2% 7/24 • Number of events 11 • Up to two and a half years.
Psychiatric disorders Insomnia	16.7% 1/6 • Number of events 1 • Up to two and a half years.	0.00% 0/6 • Up to two and a half years.	16.7% 4/24 • Number of events 4 • Up to two and a half years.
Gastrointestinal disorders Mucositis	0.00% 0/6 • Up to two and a half years.	0.00% 0/6 • Up to two and a half years.	8.3% 2/24 • Number of events 2 • Up to two and a half years.
Musculoskeletal and connective tissue disorders Myalgia	16.7% 1/6 • Number of events 1 • Up to two and a half years.	0.00% 0/6 • Up to two and a half years.	8.3% 2/24 • Number of events 3 • Up to two and a half years.
Gastrointestinal disorders Nausea	0.00% 0/6 • Up to two and a half years.	0.00% 0/6 • Up to two and a half years.	12.5% 3/24 • Number of events 4 • Up to two and a half years.
Infections and infestations Neutropenic Fever	50.0% 3/6 • Number of events 3 • Up to two and a half years.	0.00% 0/6 • Up to two and a half years.	25.0% 6/24 • Number of events 6 • Up to two and a half years.
General disorders Pain	16.7% 1/6 • Number of events 1 • Up to two and a half years.	33.3% 2/6 • Number of events 4 • Up to two and a half years.	41.7% 10/24 • Number of events 16 • Up to two and a half years.
Cardiac disorders Pericardial Effusion	0.00% 0/6 • Up to two and a half years.	0.00% 0/6 • Up to two and a half years.	20.8% 5/24 • Number of events 5 • Up to two and a half years.
Nervous system disorders Peripheral Sensory Neuropathy	0.00% 0/6 • Up to two and a half years.	16.7% 1/6 • Number of events 1 • Up to two and a half years.	0.00% 0/24 • Up to two and a half years.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/6 • Up to two and a half years.	0.00% 0/6 • Up to two and a half years.	29.2% 7/24 • Number of events 7 • Up to two and a half years.
Infections and infestations Pneumonia	50.0% 3/6 • Number of events 5 • Up to two and a half years.	33.3% 2/6 • Number of events 2 • Up to two and a half years.	16.7% 4/24 • Number of events 4 • Up to two and a half years.
Skin and subcutaneous tissue disorders Pruritis	0.00% 0/6 • Up to two and a half years.	0.00% 0/6 • Up to two and a half years.	8.3% 2/24 • Number of events 2 • Up to two and a half years.
Skin and subcutaneous tissue disorders Rash	33.3% 2/6 • Number of events 2 • Up to two and a half years.	0.00% 0/6 • Up to two and a half years.	8.3% 2/24 • Number of events 2 • Up to two and a half years.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/6 • Up to two and a half years.	0.00% 0/6 • Up to two and a half years.	16.7% 4/24 • Number of events 4 • Up to two and a half years.
Cardiac disorders Sinus Bradycardia	16.7% 1/6 • Number of events 1 • Up to two and a half years.	0.00% 0/6 • Up to two and a half years.	25.0% 6/24 • Number of events 7 • Up to two and a half years.
Infections and infestations Sinusitis	0.00% 0/6 • Up to two and a half years.	16.7% 1/6 • Number of events 1 • Up to two and a half years.	12.5% 3/24 • Number of events 3 • Up to two and a half years.
Infections and infestations Urinary Tract Infection	16.7% 1/6 • Number of events 1 • Up to two and a half years.	16.7% 1/6 • Number of events 1 • Up to two and a half years.	29.2% 7/24 • Number of events 9 • Up to two and a half years.
General disorders Weight Loss	16.7% 1/6 • Number of events 1 • Up to two and a half years.	0.00% 0/6 • Up to two and a half years.	4.2% 1/24 • Number of events 1 • Up to two and a half years.
General disorders Fatigue	16.7% 1/6 • Number of events 1 • Up to two and a half years.	0.00% 0/6 • Up to two and a half years.	0.00% 0/24 • Up to two and a half years.

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