Trial Outcomes & Findings for Treatment of Older Adults With Acute Lymphoblastic Leukemia (NCT NCT00973752)
NCT ID: NCT00973752
Last Updated: 2017-03-30
Results Overview
The number of participants alive one year after baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
1 years
Results posted on
2017-03-30
Participant Flow
Participant milestones
| Measure |
Experimental
All patients treated on same arm
Prednisone: Orally during Induction, Consolidation 1, CNS (central nervous system), Consolidation 2, and Continuation therapy.
Vincristine: Intravenously during Induction, CNS, Consolidation 2 and Continuation Therapy
Doxorubicin: Intravenously during Induction, CNS, and Consolidation 2 therapy
PEG-asparaginase: Intravenously during Induction, Consolidation 1, CNS, and Consolidation 2 therapy
Cytarabine: Intrathecally during Induction and CNS therapy
Methotrexate: Intrathecally during Induction, CNS, and Continuation Therapy
Imatinib: Orally during Induction, Consolidation 1, CNS, Consolidation 2 and Continuation Therapy
Clofarabine: Intravenously during Consolidation 1 Therapy
6 Mercaptopurine: Orally during CNS, Consolidation 2 and Continuation Therapy
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Older Adults With Acute Lymphoblastic Leukemia
Baseline characteristics by cohort
| Measure |
Experimental
n=30 Participants
All patients treated on same arm
Prednisone: Orally during Induction, Consolidation 1, CNS, Consolidation 2, and Continuation therapy.
Vincristine: Intravenously during Induction, CNS, Consolidation 2 and Continuation Therapy
Doxorubicin: Intravenously during Induction, CNS, and Consolidation 2 therapy
PEG-asparaginase: Intravenously during Induction, Consolidation 1, CNS, and Consolidation 2 therapy
Cytarabine: Intrathecally during Induction and CNS therapy
Methotrexate: Intrathecally during Induction, CNS, and Continuation Therapy
Imatinib: Orally during Induction, Consolidation 1, CNS, Consolidation 2 and Continuation Therapy
Clofarabine: Intravenously during Consolidation 1 Therapy
6 Mercaptopurine: Orally during CNS, Consolidation 2 and Continuation Therapy
|
|---|---|
|
Age, Continuous
|
58 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Available
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=5 Participants
|
|
White blood cell count
|
10.4 10^3 cell per μL
n=5 Participants
|
|
Performance status
ECOG 0
|
14 Participants
n=5 Participants
|
|
Performance status
ECOG 1
|
11 Participants
n=5 Participants
|
|
Performance status
ECOG 2
|
5 Participants
n=5 Participants
|
|
Chromosomal alterations
Philadelphia chromosome positive
|
12 Participants
n=5 Participants
|
|
Chromosomal alterations
Mixed lineage leukemia rearrangement
|
2 Participants
n=5 Participants
|
|
Immunophenotype
B-cell ALL
|
29 Participants
n=5 Participants
|
|
Immunophenotype
T-cell ALL
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearsThe number of participants alive one year after baseline.
Outcome measures
| Measure |
Experimental
n=30 Participants
All patients treated on same arm
Prednisone: Orally during Induction, Consolidation 1, CNS, Consolidation 2, and Continuation therapy.
Vincristine: Intravenously during Induction, CNS, Consolidation 2 and Continuation Therapy
Doxorubicin: Intravenously during Induction, CNS, and Consolidation 2 therapy
PEG-asparaginase: Intravenously during Induction, Consolidation 1, CNS, and Consolidation 2 therapy
Cytarabine: Intrathecally during Induction and CNS therapy
Methotrexate: Intrathecally during Induction, CNS, and Continuation Therapy
Imatinib: Orally during Induction, Consolidation 1, CNS, Consolidation 2 and Continuation Therapy
Clofarabine: Intravenously during Consolidation 1 Therapy
6 Mercaptopurine: Orally during CNS, Consolidation 2 and Continuation Therapy
|
|---|---|
|
Overall Survival at One Year
|
19 Participants
|
Adverse Events
Experimental
Serious events: 10 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental
n=30 participants at risk
All patients treated on same arm
Prednisone: Orally during Induction, Consolidation 1, CNS, Consolidation 2, and Continuation therapy.
Vincristine: Intravenously during Induction, CNS, Consolidation 2 and Continuation Therapy
Doxorubicin: Intravenously during Induction, CNS, and Consolidation 2 therapy
PEG-asparaginase: Intravenously during Induction, Consolidation 1, CNS, and Consolidation 2 therapy
Cytarabine: Intrathecally during Induction and CNS therapy
Methotrexate: Intrathecally during Induction, CNS, and Continuation Therapy
Imatinib: Orally during Induction, Consolidation 1, CNS, Consolidation 2 and Continuation Therapy
Clofarabine: Intravenously during Consolidation 1 Therapy
6 Mercaptopurine: Orally during CNS, Consolidation 2 and Continuation Therapy
|
|---|---|
|
Infections and infestations
Infection w/ gr. 3/4 neutropenia
|
23.3%
7/30
|
|
Infections and infestations
Infection - other
|
10.0%
3/30
|
|
Immune system disorders
Allergic Reaction
|
10.0%
3/30
|
|
Hepatobiliary disorders
Transaminitis
|
23.3%
7/30
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
33.3%
10/30
|
|
Renal and urinary disorders
Azotemia
|
3.3%
1/30
|
|
General disorders
Tumor lysis syndrome
|
6.7%
2/30
|
|
Gastrointestinal disorders
stomatitis
|
3.3%
1/30
|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
6.7%
2/30
|
|
Nervous system disorders
Neuropathy
|
3.3%
1/30
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
23.3%
7/30
|
Other adverse events
| Measure |
Experimental
n=30 participants at risk
All patients treated on same arm
Prednisone: Orally during Induction, Consolidation 1, CNS, Consolidation 2, and Continuation therapy.
Vincristine: Intravenously during Induction, CNS, Consolidation 2 and Continuation Therapy
Doxorubicin: Intravenously during Induction, CNS, and Consolidation 2 therapy
PEG-asparaginase: Intravenously during Induction, Consolidation 1, CNS, and Consolidation 2 therapy
Cytarabine: Intrathecally during Induction and CNS therapy
Methotrexate: Intrathecally during Induction, CNS, and Continuation Therapy
Imatinib: Orally during Induction, Consolidation 1, CNS, Consolidation 2 and Continuation Therapy
Clofarabine: Intravenously during Consolidation 1 Therapy
6 Mercaptopurine: Orally during CNS, Consolidation 2 and Continuation Therapy
|
|---|---|
|
Blood and lymphatic system disorders
Grade 2 Anemia
|
40.0%
12/30
|
|
Immune system disorders
Grade 2 Allergic reaction
|
3.3%
1/30
|
|
Cardiac disorders
Grade 2 Hypertension
|
3.3%
1/30
|
|
Cardiac disorders
Grade 2 hypotension
|
20.0%
6/30
|
|
General disorders
Grade 2 fatigue
|
60.0%
18/30
|
|
General disorders
Grade 2 Insomnia
|
6.7%
2/30
|
|
General disorders
Grade 2 weight loss
|
3.3%
1/30
|
|
Skin and subcutaneous tissue disorders
Grade 2 erythema multiforme
|
3.3%
1/30
|
|
Skin and subcutaneous tissue disorders
Grade 2 pruritis
|
3.3%
1/30
|
|
Skin and subcutaneous tissue disorders
Grade 2 rash
|
3.3%
1/30
|
|
Skin and subcutaneous tissue disorders
Grade 2 decubitus ulcer
|
3.3%
1/30
|
|
Gastrointestinal disorders
Grade 2 anorexia
|
13.3%
4/30
|
|
Gastrointestinal disorders
Grade 2 colitis
|
6.7%
2/30
|
|
Gastrointestinal disorders
Grade 2 constipation
|
10.0%
3/30
|
|
Gastrointestinal disorders
Grade 2 diarrhea
|
13.3%
4/30
|
|
Gastrointestinal disorders
Grade 2 stomatitis
|
13.3%
4/30
|
|
Gastrointestinal disorders
Grade 2 nausea
|
36.7%
11/30
|
|
Gastrointestinal disorders
Grade 2 taste alteration
|
3.3%
1/30
|
|
Gastrointestinal disorders
Grade 2 vomiting
|
13.3%
4/30
|
|
Infections and infestations
Grade 2 febrile neutropenia
|
13.3%
4/30
|
|
Infections and infestations
Grade 2 Infection
|
30.0%
9/30
|
|
General disorders
Grade 2 Edema
|
30.0%
9/30
|
|
Hepatobiliary disorders
Grade 2 transaminitis
|
23.3%
7/30
|
|
Hepatobiliary disorders
Grade 2 Elevated alkaline phosphatase
|
6.7%
2/30
|
|
Hepatobiliary disorders
Grade 2 Hyperbilirubinemia
|
10.0%
3/30
|
|
Renal and urinary disorders
Grade 2 azotemia
|
10.0%
3/30
|
|
Metabolism and nutrition disorders
Grade 2 hyperglycemia
|
10.0%
3/30
|
|
General disorders
Grade 2 hypoalbuminemia
|
13.3%
4/30
|
|
Metabolism and nutrition disorders
Grade 2 hypocalcemia
|
13.3%
4/30
|
|
General disorders
Grade 2 weakness
|
13.3%
4/30
|
|
General disorders
Grade 2 mental status change
|
10.0%
3/30
|
|
Nervous system disorders
Grade 2 neuropathy
|
3.3%
1/30
|
|
Gastrointestinal disorders
Grade 2 Abdominal pain
|
16.7%
5/30
|
|
General disorders
Grade 2 back pain
|
6.7%
2/30
|
|
General disorders
Grade 2 pain, other
|
10.0%
3/30
|
|
Respiratory, thoracic and mediastinal disorders
Grade 2 dyspnea
|
3.3%
1/30
|
|
Respiratory, thoracic and mediastinal disorders
Grade 2 hypoxia
|
3.3%
1/30
|
|
Renal and urinary disorders
Grade 2 ureteral obstruction
|
3.3%
1/30
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place