Trial Outcomes & Findings for Ruxolitinib Phosphate or Dasatinib With Chemotherapy in Treating Patients With Relapsed or Refractory Philadelphia Chromosome-Like Acute Lymphoblastic Leukemia (NCT NCT02420717)
NCT ID: NCT02420717
Last Updated: 2025-06-08
Results Overview
The method of Thall, Simon and Estey will be used for toxicity monitoring for this study. The severity of the toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 whenever possible. Safety data will be summarized by category, severity and frequency.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
42 days
Results posted on
2025-06-08
Participant Flow
Recruitment Period: July 2015 to March 2020
There were no participants enrolled in the phase II portion of this study, the study did not move on to phase II due to slow accrual and lack of response.
Participant milestones
| Measure |
Phase I Ruxolitinib 15mg
Patients receive Ruxolitinib phosphate PO BID. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Phase I Ruxolitinib 20mg
Patients receive ruxolitinib phosphate PO BID. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Phase I Ruxolitinib 25mg
Patients receive Ruxolitinib phosphate PO BID. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
Phase I Ruxolitinib 15mg
Patients receive Ruxolitinib phosphate PO BID. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Phase I Ruxolitinib 20mg
Patients receive ruxolitinib phosphate PO BID. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Phase I Ruxolitinib 25mg
Patients receive Ruxolitinib phosphate PO BID. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Overall Study
Did not receive all study medication
|
2
|
0
|
0
|
Baseline Characteristics
Ruxolitinib Phosphate or Dasatinib With Chemotherapy in Treating Patients With Relapsed or Refractory Philadelphia Chromosome-Like Acute Lymphoblastic Leukemia
Baseline characteristics by cohort
| Measure |
Phase I Ruxolitinib 15mg
n=5 Participants
Patients receive Ruxolitinib phosphate PO BID. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Phase I Ruxolitinib 20mg
n=3 Participants
Patients receive ruxolitinib phosphate PO BID. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Phase I Ruxolitinib 25mg
n=3 Participants
Patients receive Ruxolitinib phosphate PO BID. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Total
n=11 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
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
24 years
n=5 Participants
|
21 years
n=7 Participants
|
44 years
n=5 Participants
|
24 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 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
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
11 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 42 daysPopulation: Two out of nine participants were not Analyzed for response because they did not receive all planned study medication.
The method of Thall, Simon and Estey will be used for toxicity monitoring for this study. The severity of the toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 whenever possible. Safety data will be summarized by category, severity and frequency.
Outcome measures
| Measure |
Phase I Ruxolitinib 15mg
n=9 Participants
Patients receive Ruxolitinib phosphate PO BID. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Phase I Ruxolitinib 20mg
Patients receive ruxolitinib phosphate PO BID. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Phase I Ruxolitinib 25mg
Patients receive Ruxolitinib phosphate PO BID. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Maximal Tolerated Dose (MTD) of Ruxolitinib in Combination With Chemotherapy Defined as the Highest Dose Level at Which no More Than 1 Out of 6 Patients Experience a Dose Limiting Toxicity (Phase I)
|
25 Milligrams (mg)
|
—
|
—
|
PRIMARY outcome
Timeframe: 42 daysPopulation: Two out of five participants in the Ruxolitinib 15mg arm were not Analyzed for response because they did not receive all planned study medication.
Complete Response (CR) is disappearance of all clinical and/or radiologic evidence of disease, Neutrophil count ≥ 1.0 x 10\^9/L, Platelet count ≥ 100 x 10\^9/L, Normal bone marrow differential (≤ 5% blasts), No extra-medullary leukemia. Complete Remission with Incomplete Blood Count Recovery (CRi) is CR except for ANC \< 1.0 x 10\^9/L and/or platelets \< 100 x 10\^9/L.
Outcome measures
| Measure |
Phase I Ruxolitinib 15mg
n=3 Participants
Patients receive Ruxolitinib phosphate PO BID. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Phase I Ruxolitinib 20mg
n=3 Participants
Patients receive ruxolitinib phosphate PO BID. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Phase I Ruxolitinib 25mg
n=3 Participants
Patients receive Ruxolitinib phosphate PO BID. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Participants With Complete Response (Complete Response [CR]/CR With Incomplete Marrow Recovery [CRi]) (Phase II)
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 4 years 7 monthsPopulation: Two out of five participants in the Ruxolitinib 15mg arm were not Analyzed for response because they did not receive all planned study medication.
Time from date of treatment start until date of death due to any cause or last Follow-up.
Outcome measures
| Measure |
Phase I Ruxolitinib 15mg
n=3 Participants
Patients receive Ruxolitinib phosphate PO BID. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Phase I Ruxolitinib 20mg
n=3 Participants
Patients receive ruxolitinib phosphate PO BID. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Phase I Ruxolitinib 25mg
n=3 Participants
Patients receive Ruxolitinib phosphate PO BID. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Overall Survival
|
4.8 Months
Interval 2.4 to 11.3
|
5.4 Months
Interval 1.4 to 16.3
|
38.5 Months
Interval 4.9 to 41.9
|
SECONDARY outcome
Timeframe: Up to 4 years 7 monthsPopulation: Two out of five participants in the Ruxolitinib 15mg arm were not Analyzed for response because they did not receive all planned study medication.
Time from date of treatment start until the date of first objective documentation of disease-relapse.
Outcome measures
| Measure |
Phase I Ruxolitinib 15mg
n=3 Participants
Patients receive Ruxolitinib phosphate PO BID. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Phase I Ruxolitinib 20mg
n=3 Participants
Patients receive ruxolitinib phosphate PO BID. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Phase I Ruxolitinib 25mg
n=3 Participants
Patients receive Ruxolitinib phosphate PO BID. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Progression-free Survival
|
2.3 Months
Interval 1.5 to 11.3
|
1.8 Months
Interval 1.3 to 5.4
|
1.9 Months
Interval 1.8 to 3.1
|
Adverse Events
Phase I Ruxolitinib 15mg
Serious events: 5 serious events
Other events: 5 other events
Deaths: 2 deaths
Phase I Ruxolitinib 20mg
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase I Ruxolitinib 25mg
Serious events: 3 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Phase I Ruxolitinib 15mg
n=5 participants at risk
Patients receive Ruxolitinib phosphate PO BID. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Phase I Ruxolitinib 20mg
n=3 participants at risk
Patients receive ruxolitinib phosphate PO BID. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Phase I Ruxolitinib 25mg
n=3 participants at risk
Patients receive Ruxolitinib phosphate PO BID. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Blood and Lymphatic System Disorders
|
40.0%
2/5 • Number of events 2 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
|
Investigations
Blood Antidiuretic Hormone Abnormal
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/5 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/5 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
66.7%
2/3 • Number of events 2 • Up to 5 years
|
|
General disorders
General Disorders and Administration Site Conditions, Other
|
0.00%
0/5 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • Up to 5 years
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
|
Infections and infestations
Infection and Infestations - other
|
0.00%
0/5 • Up to 5 years
|
66.7%
2/3 • Number of events 3 • Up to 5 years
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Lung Infection
|
40.0%
2/5 • Number of events 3 • Up to 5 years
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Mucositis Oral
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
|
General disorders
Non-Cardiac Chest Pain
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
|
Gastrointestinal disorders
Rectal Pain
|
0.00%
0/5 • Up to 5 years
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
|
Infections and infestations
Sepsis
|
60.0%
3/5 • Number of events 3 • Up to 5 years
|
66.7%
2/3 • Number of events 2 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
Other adverse events
| Measure |
Phase I Ruxolitinib 15mg
n=5 participants at risk
Patients receive Ruxolitinib phosphate PO BID. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Phase I Ruxolitinib 20mg
n=3 participants at risk
Patients receive ruxolitinib phosphate PO BID. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Phase I Ruxolitinib 25mg
n=3 participants at risk
Patients receive Ruxolitinib phosphate PO BID. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|
|
Investigations
Alanine Aminotransferase Increased
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
|
Investigations
Alkaline Phosphatase Increased
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
|
Investigations
Aspartate Aminotransferase Increased
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
|
General disorders
Back Pain
|
0.00%
0/5 • Up to 5 years
|
66.7%
2/3 • Number of events 2 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
|
Investigations
Blood Bilirubin Increase
|
40.0%
2/5 • Number of events 2 • Up to 5 years
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
Chest Pain
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
|
Investigations
Creatinine Increased
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
|
Psychiatric disorders
Delirium
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
|
Eye disorders
Eye Disorders - Other
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
|
General disorders
Headache
|
0.00%
0/5 • Up to 5 years
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
60.0%
3/5 • Number of events 3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
20.0%
1/5 • Number of events 2 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
|
Infections and infestations
Infections and Infestations Other
|
0.00%
0/5 • Up to 5 years
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
|
Investigations
Investigations
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
|
Infections and infestations
Lung Infection
|
0.00%
0/5 • Up to 5 years
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
|
Nervous system disorders
Nervous System Disorders
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
|
General disorders
Pain Extremity
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
|
Psychiatric disorders
Psychiatric Disorder
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
|
Renal and urinary disorders
Renal and Urinary Disorders
|
0.00%
0/5 • Up to 5 years
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
|
Infections and infestations
Sepsis
|
20.0%
1/5 • Number of events 1 • Up to 5 years
|
33.3%
1/3 • Number of events 1 • Up to 5 years
|
0.00%
0/3 • Up to 5 years
|
Additional Information
Dr. Nitin Jain MD./Associate Professor
The University of Texas MD Anderson Cancer Center
Phone: 713-745-6080
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place