Trial Outcomes & Findings for Nilotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia (NCT NCT00844298)

Results Overview

approximate time: at the recovery of cytopenia

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

91 participants

Primary outcome timeframe

1 month

Results posted on

2015-09-07

Participant Flow

Participant milestones

Participant milestones
Measure	Nilotinib+mVPD Patients who were Philadelphia-positive, newly-diagnosed adult ALL and treated with nilotinib + mVPD treatment plan Nilotinib+mVPD: 1.Induction: * Daunorubicin 90 mg/m2/day by continuous iv infusion (d1-3) * Vincristine 2 mg iv push (d1, 8, 15, 22) * Prednisolone 60 mg/m2/day po (d1-28) * Nilotinib 400mg bid/d (d8-) 2.Consolidation A (cycle1) * Daunorubicin 45 mg/m2/day by continuous iv (d1, 2) * Vincristine 2 mg iv (d1, 8) * Prednisolone 60 mg/m2/day po (d1-14) * Nilotinib 400mg bid/d 3\. Consolidation B (cycles 2\&4) * Cytarabine 2,000 mg/m2/day iv over 2 hours (d1-4) * Etoposide 150 mg/m2/day iv over 3 hours (d1-4) * Nilotinib 400mg bid/d 4.Consolidation C (cycles 3\&5) * Methotrexate 220 mg/m2 iv bolus, then 60mg/m2/h for 36 hours (d1-2, 15-16) * Leucovorin followed immediately by 50 mg/m2 iv every 6hrs for three doses, * Nilotinib 400mg bid/d 5.Maintenance * Nilotinib 400mg bid/d (during 2 years, for patients without alloHCT) 6.Consider alloHCT
Overall Study STARTED	91
Overall Study COMPLETED	91
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nilotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nilotinib+mVPD n=90 Participants Patients who were Philadelphia-positive, newly-diagnosed adult ALL and treated with nilotinib + mVPD treatment plan Nilotinib+mVPD: 1.Induction: * Daunorubicin 90 mg/m2/day by continuous iv infusion (d1-3) * Vincristine 2 mg iv push (d1, 8, 15, 22) * Prednisolone 60 mg/m2/day po (d1-28) * Nilotinib 400mg bid/d (d8-) 2.Consolidation A (cycle1) * Daunorubicin 45 mg/m2/day by continuous iv (d1, 2) * Vincristine 2 mg iv (d1, 8) * Prednisolone 60 mg/m2/day po (d1-14) * Nilotinib 400mg bid/d 3\. Consolidation B (cycles 2\&4) * Cytarabine 2,000 mg/m2/day iv over 2 hours (d1-4) * Etoposide 150 mg/m2/day iv over 3 hours (d1-4) * Nilotinib 400mg bid/d 4.Consolidation C (cycles 3\&5) * Methotrexate 220 mg/m2 iv bolus, then 60mg/m2/h for 36 hours (d1-2, 15-16) * Leucovorin followed immediately by 50 mg/m2 iv every 6hrs for three doses, * Nilotinib 400mg bid/d 5.Maintenance * Nilotinib 400mg bid/d (during 2 years, for patients without alloHCT) 6.Consider alloHCT
Age, Continuous	47.0 years n=93 Participants
Sex: Female, Male Female	45 Participants n=93 Participants
Sex: Female, Male Male	45 Participants n=93 Participants

PRIMARY outcome

Timeframe: 1 month

approximate time: at the recovery of cytopenia

Outcome measures

Outcome measures
Measure	Nilotinib+mVPD n=90 Participants Patients who were Philadelphia-positive, newly-diagnosed adult ALL and treated with nilotinib + mVPD treatment plan Nilotinib+mVPD: 1.Induction: * Daunorubicin 90 mg/m2/day by continuous iv infusion (d1-3) * Vincristine 2 mg iv push (d1, 8, 15, 22) * Prednisolone 60 mg/m2/day po (d1-28) * Nilotinib 400mg bid/d (d8-) 2.Consolidation A (cycle1) * Daunorubicin 45 mg/m2/day by continuous iv (d1, 2) * Vincristine 2 mg iv (d1, 8) * Prednisolone 60 mg/m2/day po (d1-14) * Nilotinib 400mg bid/d 3\. Consolidation B (cycles 2\&4) * Cytarabine 2,000 mg/m2/day iv over 2 hours (d1-4) * Etoposide 150 mg/m2/day iv over 3 hours (d1-4) * Nilotinib 400mg bid/d 4.Consolidation C (cycles 3\&5) * Methotrexate 220 mg/m2 iv bolus, then 60mg/m2/h for 36 hours (d1-2, 15-16) * Leucovorin followed immediately by 50 mg/m2 iv every 6hrs for three doses, * Nilotinib 400mg bid/d 5.Maintenance * Nilotinib 400mg bid/d (during 2 years, for patients without alloHCT) 6.Consider alloHCT
Proportion of Patients Achieving Hematologic and Molecular Complete Remission (CR) After Induction Therapy	91 percentage of analyzable subjects

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome data not reported

Adverse Events

Nilotinib+mVPD

Serious events: 18 serious events

Other events: 79 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Nilotinib+mVPD n=91 participants at risk Patients who were Philadelphia-positive, newly-diagnosed adult ALL and treated with nilotinib + mVPD treatment plan Nilotinib+mVPD: 1.Induction: * Daunorubicin 90 mg/m2/day by continuous iv infusion (d1-3) * Vincristine 2 mg iv push (d1, 8, 15, 22) * Prednisolone 60 mg/m2/day po (d1-28) * Nilotinib 400mg bid/d (d8-) 2.Consolidation A (cycle1) * Daunorubicin 45 mg/m2/day by continuous iv (d1, 2) * Vincristine 2 mg iv (d1, 8) * Prednisolone 60 mg/m2/day po (d1-14) * Nilotinib 400mg bid/d 3\. Consolidation B (cycles 2\&4) * Cytarabine 2,000 mg/m2/day iv over 2 hours (d1-4) * Etoposide 150 mg/m2/day iv over 3 hours (d1-4) * Nilotinib 400mg bid/d 4.Consolidation C (cycles 3\&5) * Methotrexate 220 mg/m2 iv bolus, then 60mg/m2/h for 36 hours (d1-2, 15-16) * Leucovorin followed immediately by 50 mg/m2 iv every 6hrs for three doses, * Nilotinib 400mg bid/d 5.Maintenance * Nilotinib 400mg bid/d (during 2 years, for patients without alloHCT) 6.Consider alloHCT
Infections and infestations Febrile neutropenia	19.8% 18/91

Other adverse events

Other adverse events
Measure	Nilotinib+mVPD n=91 participants at risk Patients who were Philadelphia-positive, newly-diagnosed adult ALL and treated with nilotinib + mVPD treatment plan Nilotinib+mVPD: 1.Induction: * Daunorubicin 90 mg/m2/day by continuous iv infusion (d1-3) * Vincristine 2 mg iv push (d1, 8, 15, 22) * Prednisolone 60 mg/m2/day po (d1-28) * Nilotinib 400mg bid/d (d8-) 2.Consolidation A (cycle1) * Daunorubicin 45 mg/m2/day by continuous iv (d1, 2) * Vincristine 2 mg iv (d1, 8) * Prednisolone 60 mg/m2/day po (d1-14) * Nilotinib 400mg bid/d 3\. Consolidation B (cycles 2\&4) * Cytarabine 2,000 mg/m2/day iv over 2 hours (d1-4) * Etoposide 150 mg/m2/day iv over 3 hours (d1-4) * Nilotinib 400mg bid/d 4.Consolidation C (cycles 3\&5) * Methotrexate 220 mg/m2 iv bolus, then 60mg/m2/h for 36 hours (d1-2, 15-16) * Leucovorin followed immediately by 50 mg/m2 iv every 6hrs for three doses, * Nilotinib 400mg bid/d 5.Maintenance * Nilotinib 400mg bid/d (during 2 years, for patients without alloHCT) 6.Consider alloHCT
Hepatobiliary disorders Jaundice	86.8% 79/91 • Number of events 214

Additional Information

Dr. Dae-Young Kim

Asan Medical Center, University of Ulsan College of Medicine

Phone: 82230105930

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place