Trial Outcomes & Findings for Phase l/II Study of Ruxolitinib for Acute Leukemia (NCT NCT01251965)
NCT ID: NCT01251965
Last Updated: 2025-06-08
Results Overview
MTD defined as highest dose level at which no more than one out of six subject experiences dose limiting toxicity (DLT) during first cycle (28 days) of therapy. A non-hematologic DLT defined as a clinically significant grade 3 or 4 adverse event or abnormal laboratory value (according to Common Toxicity Criteria for Adverse Effects (CTCAE) criteria) assessed as related to study drug (and unrelated to disease progression, intercurrent illness, or concomitant medications) occurring during first 28 days on study. Participants who received at least 80% of the originally assigned doses in the first cycle were evaluable for DLT assessment of each cohort.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
27 participants
Primary outcome timeframe
End of first 28 day cycle for toxicity
Results posted on
2025-06-08
Participant Flow
Recruitment Period: December 9, 2010 to September 26, 2012. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
Participant milestones
| Measure |
Ruxolitinib 50 mg BID
Phase I starting dose of Ruxolitinib 50 mg by mouth twice a day (BID) for 28 day cycle.
|
Ruxolitinib 100 mg BID
Phase I dose of Ruxolitinib 100 mg by mouth twice a day for 28 day cycle.
|
Ruxolitinib 200 mg BID
Phase I dose of Ruxolitinib 200 mg by mouth twice a day for 28 day cycle.
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
18
|
|
Overall Study
COMPLETED
|
3
|
3
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
11
|
Reasons for withdrawal
| Measure |
Ruxolitinib 50 mg BID
Phase I starting dose of Ruxolitinib 50 mg by mouth twice a day (BID) for 28 day cycle.
|
Ruxolitinib 100 mg BID
Phase I dose of Ruxolitinib 100 mg by mouth twice a day for 28 day cycle.
|
Ruxolitinib 200 mg BID
Phase I dose of Ruxolitinib 200 mg by mouth twice a day for 28 day cycle.
|
|---|---|---|---|
|
Overall Study
Participant/physician decision
|
1
|
2
|
0
|
|
Overall Study
Death
|
0
|
0
|
11
|
Baseline Characteristics
Phase l/II Study of Ruxolitinib for Acute Leukemia
Baseline characteristics by cohort
| Measure |
Ruxolitinib 50 mg BID
n=4 Participants
Phase I starting dose of Ruxolitinib 50 mg by mouth twice a day (BID) for 28 day cycle.
|
Ruxolitinib 100 mg BID
n=5 Participants
Phase I dose of Ruxolitinib 100 mg by mouth twice a day for 28 day cycle.
|
Ruxolitinib 200 mg BID
n=18 Participants
Phase I dose of Ruxolitinib 200 mg by mouth twice a day for 28 day cycle.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
70 years
n=7 Participants
|
71 years
n=5 Participants
|
69 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: End of first 28 day cycle for toxicityMTD defined as highest dose level at which no more than one out of six subject experiences dose limiting toxicity (DLT) during first cycle (28 days) of therapy. A non-hematologic DLT defined as a clinically significant grade 3 or 4 adverse event or abnormal laboratory value (according to Common Toxicity Criteria for Adverse Effects (CTCAE) criteria) assessed as related to study drug (and unrelated to disease progression, intercurrent illness, or concomitant medications) occurring during first 28 days on study. Participants who received at least 80% of the originally assigned doses in the first cycle were evaluable for DLT assessment of each cohort.
Outcome measures
| Measure |
Ruxolitinib 50 mg BID
n=3 Participants
Phase I starting dose of Ruxolitinib 50 mg by mouth twice a day (BID) for 28 day cycle.
|
Ruxolitinib 100 mg BID
n=3 Participants
Phase I dose of Ruxolitinib 100 mg by mouth twice a day for 28 day cycle.
|
Ruxolitinib 200 mg BID
n=7 Participants
Phase I dose of Ruxolitinib 200 mg by mouth twice a day for 28 day cycle.
|
|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: End of first 28 day cycleThe MTD is defined as the highest dose level at which no more than one out of six subject experiences DLT during the first cycle (28 days) of therapy.
Outcome measures
| Measure |
Ruxolitinib 50 mg BID
n=13 Participants
Phase I starting dose of Ruxolitinib 50 mg by mouth twice a day (BID) for 28 day cycle.
|
Ruxolitinib 100 mg BID
Phase I dose of Ruxolitinib 100 mg by mouth twice a day for 28 day cycle.
|
Ruxolitinib 200 mg BID
Phase I dose of Ruxolitinib 200 mg by mouth twice a day for 28 day cycle.
|
|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Ruxolitinib
|
NA mg
The Maximum tolerated dose (MTD) was not determined as there were no dose limiting toxicities (DLT's) observed at the doses tested.
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: The study was stopped because of a lack of satisfactory clinical benefit, and did not go on to the Phase II portion. Therefore, data were not collected for this outcome measure.
Response is defined as complete remission (CR) + complete remission with incomplete blood count (CRi) + Hematologic improvement (HI). Response was to be assessed for participants who were evaluated for the Phase II portion of this study. CR is absolute neutrophil count (ANC) \>/= 1x109/L and platelet count \>/= 100x109/L, absence of leukemia blast cells, normal marrow differential, and complete resolution of extramedullary disease. CRi is CR but platelets are \< 100x109/L or ANC is \<1x109/L. HI is described by the number of individual, positively affected cell lines without the use of growth factors and/or transfusions (lasting at least 4 weeks).
Outcome measures
Outcome data not reported
Adverse Events
Ruxolitinib 50 mg BID
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
Ruxolitinib 100 mg BID
Serious events: 5 serious events
Other events: 5 other events
Deaths: 0 deaths
Ruxolitinib 200 mg BID
Serious events: 18 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ruxolitinib 50 mg BID
n=4 participants at risk
Phase I starting dose of Ruxolitinib 50 mg by mouth twice a day (BID) for 28 day cycle.
|
Ruxolitinib 100 mg BID
n=5 participants at risk
Phase I dose of Ruxolitinib 100 mg by mouth twice a day for 28 day cycle.
|
Ruxolitinib 200 mg BID
n=18 participants at risk
Phase I dose of Ruxolitinib 200 mg by mouth twice a day for 28 day cycle.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
5.6%
1/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Alveolar hemorrhage
|
25.0%
1/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Nervous system disorders
Cerebral edema and mass
|
25.0%
1/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
General disorders
Death
|
0.00%
0/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
61.1%
11/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
20.0%
1/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
5.6%
1/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
5.6%
1/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
General disorders
Fever
|
25.0%
1/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
20.0%
1/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
5.6%
1/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
5.6%
1/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
75.0%
3/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
20.0%
1/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
11.1%
2/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Mucositis
|
0.00%
0/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
5.6%
1/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Investigations
Neutropenia
|
25.0%
1/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
General disorders
Pain
|
25.0%
1/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
50.0%
2/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
60.0%
3/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
5.6%
1/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
25.0%
1/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
11.1%
2/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
25.0%
1/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Nervous system disorders
Stroke
|
0.00%
0/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
11.1%
2/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
5.6%
1/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
25.0%
1/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
Other adverse events
| Measure |
Ruxolitinib 50 mg BID
n=4 participants at risk
Phase I starting dose of Ruxolitinib 50 mg by mouth twice a day (BID) for 28 day cycle.
|
Ruxolitinib 100 mg BID
n=5 participants at risk
Phase I dose of Ruxolitinib 100 mg by mouth twice a day for 28 day cycle.
|
Ruxolitinib 200 mg BID
n=18 participants at risk
Phase I dose of Ruxolitinib 200 mg by mouth twice a day for 28 day cycle.
|
|---|---|---|---|
|
Investigations
Hemoglobin Increased
|
25.0%
1/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
20.0%
1/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Investigations
Neutrophils count decreased
|
50.0%
2/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
40.0%
2/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
33.3%
6/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Investigations
Platelets decreased
|
50.0%
2/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
60.0%
3/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
33.3%
6/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
11.1%
2/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
General disorders
Fatigue
|
25.0%
1/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
20.0%
1/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
5.6%
1/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
5.6%
1/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Gastrointestinal disorders
Constiptation
|
0.00%
0/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
5.6%
1/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
5.6%
1/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Gastrointestinal disorders
Mucositis
|
0.00%
0/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
16.7%
3/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage pulmonary
|
25.0%
1/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
20.0%
1/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
General disorders
Edema: head and neck
|
25.0%
1/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
11.1%
2/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
General disorders
Edema: limb
|
0.00%
0/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
5.6%
1/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Investigations
Alkaline phosphatase Increased
|
25.0%
1/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Investigations
Alanine aminotransferase increased (ALT)
|
25.0%
1/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
40.0%
2/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
22.2%
4/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Investigations
Aspartate aminotransferase increased (AST)
|
25.0%
1/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
20.0%
1/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
11.1%
2/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
40.0%
2/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
5.6%
1/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Investigations
Creatinine Increased
|
25.0%
1/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
40.0%
2/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
22.2%
4/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
25.0%
1/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.00%
0/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
40.0%
2/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
5.6%
1/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Nervous system disorders
Central Nervous System Ischemia
|
25.0%
1/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
11.1%
2/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
5.6%
1/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Nervous system disorders
Neurology-Other Issues
|
0.00%
0/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
5.6%
1/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Nervous system disorders
Speech impairment
|
0.00%
0/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
5.6%
1/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Nervous system disorders
Tremor
|
0.00%
0/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
5.6%
1/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
General disorders
Pain
|
25.0%
1/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
11.1%
2/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
20.0%
1/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
5.6%
1/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY INFILTRATES
|
0.00%
0/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
5.6%
1/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Reproductive system and breast disorders
Hot Flash
|
0.00%
0/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
0.00%
0/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
5.6%
1/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
|
Infections and infestations
Infections
|
100.0%
4/4 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
40.0%
2/5 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
100.0%
18/18 • Adverse events collected during 28 day cycle, up to 9 cycles.
|
Additional Information
Srdan Verstovsek, Professor, Leukemia
The University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-7734
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place