Trial Outcomes & Findings for Combination Chemotherapy and Dasatinib in Treating Participants With Philadelphia Positive or BCR-ABL Positive Acute Lymphoblastic Leukemia. (NCT NCT00390793)
NCT ID: NCT00390793
Last Updated: 2025-02-17
Results Overview
Time from date of treatment start until the date of failure or death from any cause.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
107 participants
Primary outcome timeframe
Up to 17 years, 4 months, 2 days
Results posted on
2025-02-17
Participant Flow
Participant milestones
| Measure |
Treatment (Chemotherapy, Dasatinib)
See detailed description in outline.
Cyclophosphamide: Given IV
Cytarabine: Given IV or IT
Dasatinib: Given PO
Dexamethasone: Given IV or PO
Doxorubicin: Given IV
Methotrexate: Given IV or IT
Prednisone: Given PO
Vincristine: Given IV
|
|---|---|
|
Overall Study
STARTED
|
107
|
|
Overall Study
COMPLETED
|
107
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combination Chemotherapy and Dasatinib in Treating Participants With Philadelphia Positive or BCR-ABL Positive Acute Lymphoblastic Leukemia.
Baseline characteristics by cohort
| Measure |
Treatment (Chemotherapy, Dasatinib)
n=107 Participants
See detailed description in outline.
Cyclophosphamide: Given IV
Cytarabine: Given IV or IT
Dasatinib: Given PO
Dexamethasone: Given IV or PO
Doxorubicin: Given IV
Methotrexate: Given IV or IT
Prednisone: Given PO
Vincristine: Given IV
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
87 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=5 Participants
|
|
Age, Continuous
|
53 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
30 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
107 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 17 years, 4 months, 2 daysPopulation: Of the 107 participants registered on study, 106 were evaluable for Event Free Survival.
Time from date of treatment start until the date of failure or death from any cause.
Outcome measures
| Measure |
Treatment (Chemotherapy, Dasatinib)
n=106 Participants
See detailed description in outline.
Cyclophosphamide: Given IV
Cytarabine: Given IV or IT
Dasatinib: Given PO
Dexamethasone: Given IV or PO
Doxorubicin: Given IV
Methotrexate: Given IV or IT
Prednisone: Given PO
Vincristine: Given IV
|
|---|---|
|
Event-free Survival Rate (EFS)
|
21.3 Months
Interval 0.2 to 208.0
|
PRIMARY outcome
Timeframe: Up to 17 years, 4 months, 2 daysPopulation: Of the 107 participants registered on study, 95 were evaluable for Disease Free Survival.
Time from date of treatment start until the date of first objective documentation of disease-relapse.
Outcome measures
| Measure |
Treatment (Chemotherapy, Dasatinib)
n=95 Participants
See detailed description in outline.
Cyclophosphamide: Given IV
Cytarabine: Given IV or IT
Dasatinib: Given PO
Dexamethasone: Given IV or PO
Doxorubicin: Given IV
Methotrexate: Given IV or IT
Prednisone: Given PO
Vincristine: Given IV
|
|---|---|
|
Disease-free Survival
|
25.3 Months
Interval 0.3 to 208.0
|
SECONDARY outcome
Timeframe: Up to 17 years, 4 months, 2 daysParticipants achieving complete remission (CR) + partial remission (PR) - Complete Remission (CR): Normalization of the peripheral blood and bone marrow with 5% or less blasts in normocellular or hypercellular marrow with a granulocyte count of 1 x 10\^9/L or above, and platelet count of 100 x 10\^9/L. Complete resolution of all sites of extramedullary disease is required for CR.
Outcome measures
| Measure |
Treatment (Chemotherapy, Dasatinib)
n=106 Participants
See detailed description in outline.
Cyclophosphamide: Given IV
Cytarabine: Given IV or IT
Dasatinib: Given PO
Dexamethasone: Given IV or PO
Doxorubicin: Given IV
Methotrexate: Given IV or IT
Prednisone: Given PO
Vincristine: Given IV
|
|---|---|
|
Participants With a Response
|
95 Participants
|
SECONDARY outcome
Timeframe: Up to 17 years, 4 months, 2 daysPopulation: Of the 107 participants registered on study, 106 were evaluable for Overall Survival.
Time from date of treatment start until date of death due to any cause or last Follow-up.
Outcome measures
| Measure |
Treatment (Chemotherapy, Dasatinib)
n=106 Participants
See detailed description in outline.
Cyclophosphamide: Given IV
Cytarabine: Given IV or IT
Dasatinib: Given PO
Dexamethasone: Given IV or PO
Doxorubicin: Given IV
Methotrexate: Given IV or IT
Prednisone: Given PO
Vincristine: Given IV
|
|---|---|
|
Overall Survival
|
42.9 Months
Interval 0.2 to 208.0
|
Adverse Events
Treatment (Chemotherapy, Dasatinib)
Serious events: 38 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Treatment (Chemotherapy, Dasatinib)
n=107 participants at risk
See detailed description in outline.
Cyclophosphamide: Given IV
Cytarabine: Given IV or IT
Dasatinib: Given PO
Dexamethasone: Given IV or PO
Doxorubicin: Given IV
Methotrexate: Given IV or IT
Prednisone: Given PO
Vincristine: Given IV
|
|---|---|
|
Gastrointestinal disorders
abdominal Pain
|
1.9%
2/107 • Number of events 2 • Up to 17 years, 4 months, 2 days
|
|
Respiratory, thoracic and mediastinal disorders
Bilateral Pleural Effusion
|
1.9%
2/107 • Number of events 2 • Up to 17 years, 4 months, 2 days
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.93%
1/107 • Number of events 1 • Up to 17 years, 4 months, 2 days
|
|
Infections and infestations
Cellulitis
|
0.93%
1/107 • Number of events 1 • Up to 17 years, 4 months, 2 days
|
|
Infections and infestations
Cellulitis buttocks
|
0.93%
1/107 • Number of events 1 • Up to 17 years, 4 months, 2 days
|
|
Gastrointestinal disorders
Colitis
|
0.93%
1/107 • Number of events 2 • Up to 17 years, 4 months, 2 days
|
|
General disorders
Death
|
1.9%
2/107 • Number of events 2 • Up to 17 years, 4 months, 2 days
|
|
Metabolism and nutrition disorders
Dehydration
|
0.93%
1/107 • Number of events 1 • Up to 17 years, 4 months, 2 days
|
|
Gastrointestinal disorders
Diarrhea
|
3.7%
4/107 • Number of events 4 • Up to 17 years, 4 months, 2 days
|
|
Gastrointestinal disorders
Diverticulitis
|
0.93%
1/107 • Number of events 1 • Up to 17 years, 4 months, 2 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.93%
1/107 • Number of events 1 • Up to 17 years, 4 months, 2 days
|
|
Infections and infestations
Entercoccal Bacteremia
|
0.93%
1/107 • Number of events 1 • Up to 17 years, 4 months, 2 days
|
|
General disorders
Facial Pain
|
0.93%
1/107 • Number of events 1 • Up to 17 years, 4 months, 2 days
|
|
Injury, poisoning and procedural complications
Fall
|
0.93%
1/107 • Number of events 1 • Up to 17 years, 4 months, 2 days
|
|
General disorders
Fatigue
|
0.93%
1/107 • Number of events 1 • Up to 17 years, 4 months, 2 days
|
|
General disorders
Fever
|
7.5%
8/107 • Number of events 10 • Up to 17 years, 4 months, 2 days
|
|
Injury, poisoning and procedural complications
Fracture Ribs
|
0.93%
1/107 • Number of events 1 • Up to 17 years, 4 months, 2 days
|
|
Gastrointestinal disorders
Gastrointestinal Bleed
|
2.8%
3/107 • Number of events 3 • Up to 17 years, 4 months, 2 days
|
|
Gastrointestinal disorders
Hematemesis
|
0.93%
1/107 • Number of events 1 • Up to 17 years, 4 months, 2 days
|
|
Respiratory, thoracic and mediastinal disorders
Hematothorax
|
0.93%
1/107 • Number of events 1 • Up to 17 years, 4 months, 2 days
|
|
Vascular disorders
Hypertension
|
0.93%
1/107 • Number of events 1 • Up to 17 years, 4 months, 2 days
|
|
Vascular disorders
Hypotension
|
0.93%
1/107 • Number of events 3 • Up to 17 years, 4 months, 2 days
|
|
Infections and infestations
Infection
|
1.9%
2/107 • Number of events 3 • Up to 17 years, 4 months, 2 days
|
|
General disorders
Jaw Pain
|
0.93%
1/107 • Number of events 1 • Up to 17 years, 4 months, 2 days
|
|
Cardiac disorders
Miocardial Infarction
|
0.93%
1/107 • Number of events 1 • Up to 17 years, 4 months, 2 days
|
|
Gastrointestinal disorders
Mucositis
|
0.93%
1/107 • Number of events 1 • Up to 17 years, 4 months, 2 days
|
|
Gastrointestinal disorders
Nausea
|
0.93%
1/107 • Number of events 1 • Up to 17 years, 4 months, 2 days
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
3.7%
4/107 • Number of events 4 • Up to 17 years, 4 months, 2 days
|
|
Blood and lymphatic system disorders
Neutropenic Fever
|
12.1%
13/107 • Number of events 18 • Up to 17 years, 4 months, 2 days
|
|
General disorders
Pain
|
0.93%
1/107 • Number of events 1 • Up to 17 years, 4 months, 2 days
|
|
Gastrointestinal disorders
Perianal Pain
|
0.93%
1/107 • Number of events 1 • Up to 17 years, 4 months, 2 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
10.3%
11/107 • Number of events 11 • Up to 17 years, 4 months, 2 days
|
|
Infections and infestations
Pneumonia
|
4.7%
5/107 • Number of events 6 • Up to 17 years, 4 months, 2 days
|
|
General disorders
Positive West Niles Virus
|
0.93%
1/107 • Number of events 1 • Up to 17 years, 4 months, 2 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.93%
1/107 • Number of events 1 • Up to 17 years, 4 months, 2 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.93%
1/107 • Number of events 1 • Up to 17 years, 4 months, 2 days
|
|
Infections and infestations
Sepsis
|
0.93%
1/107 • Number of events 1 • Up to 17 years, 4 months, 2 days
|
|
Infections and infestations
Septic Shock
|
1.9%
2/107 • Number of events 3 • Up to 17 years, 4 months, 2 days
|
|
Musculoskeletal and connective tissue disorders
Shoulder/Neck Pain
|
0.93%
1/107 • Number of events 1 • Up to 17 years, 4 months, 2 days
|
|
Vascular disorders
Subdural Hematoma
|
0.93%
1/107 • Number of events 1 • Up to 17 years, 4 months, 2 days
|
|
Infections and infestations
Upper Respiratory Infection
|
0.93%
1/107 • Number of events 1 • Up to 17 years, 4 months, 2 days
|
|
Infections and infestations
Urinary Tract Infection
|
2.8%
3/107 • Number of events 3 • Up to 17 years, 4 months, 2 days
|
|
General disorders
Weakness
|
1.9%
2/107 • Number of events 2 • Up to 17 years, 4 months, 2 days
|
Other adverse events
Adverse event data not reported
Additional Information
Farhad Ravandi-Kashani, MD./ Professor
The University of Texas MD Anderson Cancer Center
Phone: 713-745-0394
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place