Trial Outcomes & Findings for NOPHO ALL-2008 Pilot Study on Consolidation Therapy for Children and Adolescents With Acute Lymphoblastic Leukemia (NCT NCT00548431)

Last Updated: 2017-01-09

Results Overview

Number of participants following the protocol treatment for the full consolidation therapy with toxicity in this pilot study trying to individually titrate 6-mercaptopurine to the highest tolerable level during Consolidation.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

38 participants

Primary outcome timeframe

3 months ( 79 days )

Results posted on

2017-01-09

Participant Flow

38 patients were recruited in 3 different countries. Recruitment period 12/01/2007 - 12/21/2008. All recruitments were done in departments of Pediatric Hematology/oncology

Participant milestones

Participant milestones
Measure	6-mercaptopurine All patients received basic 6-mercaptopurine and in addition high-dose methotrexate(HDM) at 3 week intervals ((3 3-week intervals) in total) and PEG-asparaginase at 2 week intervals(5 dosis in total) . Patients received dose increments of 6-mercaptopurine 14 days after High-dose methotrexate if the myelotoxicity was acceptable
Overall Study STARTED	38
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

NOPHO ALL-2008 Pilot Study on Consolidation Therapy for Children and Adolescents With Acute Lymphoblastic Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	6-mercaptopurine n=38 Participants All patients received basic 6-mercaptopurine and in addition high-dose methotrexate(HDM) at 3 week intervals ((3 3-week intervals) in total) and PEG-asparaginase at 2 week intervals(5 dosis in total) . Patients received dose increments of 6-mercaptopurine 14 days after High-dose methotrexate if the myelotoxicity was acceptable
Age, Categorical <=18 years	38 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	7 years STANDARD_DEVIATION 3 • n=5 Participants
Gender Female	21 Participants n=5 Participants
Gender Male	17 Participants n=5 Participants
Region of Enrollment Denmark	12 participants n=5 Participants
Region of Enrollment Sweden	21 participants n=5 Participants
Region of Enrollment Finland	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months ( 79 days )

Outcome measures

Outcome measures
Measure	6-mercaptopurine n=38 Participants All patients received basic 6-mercaptopurine and in addition high-dose methotrexate(HDM) at 3 week intervals ((3 3-week intervals) in total) and PEG-asparaginase at 2 week intervals(5 dosis in total) . Patients received dose increments of 6-mercaptopurine 14 days after High-dose methotrexate if the myelotoxicity was acceptable
Toxicity of Treatment in Terms of Number of Participants With Serious Adverse Events or Adverse Events, Reported	26 Participants

SECONDARY outcome

Timeframe: During the 3 months consolidation therapy

Biweekly bloodsamples during the 3 months are analyzed for 6TGN incorporation into leucocyte DNA. In addition Methylated Mercaptopurine (MeMP) and Erythrocyte-Methotrexate level is measured

Outcome measures

Outcome data not reported

Adverse Events

6-mercaptopurine

Serious events: 26 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	6-mercaptopurine n=38 participants at risk All patients received basic 6-mercaptopurine and in addition high-dose methotrexate(HDM) at 3 week intervals ((3 3-week intervals) in total) and PEG-asparaginase at 2 week intervals(5 dosis in total) . Patients received dose increments of 6-mercaptopurine 14 days after High-dose methotrexate if the myelotoxicity was acceptable
Hepatobiliary disorders Hypoglycemia	5.3% 2/38 • Number of events 2 • Adverse events were reported for each patient for a period of 3 months Adverse events were recorded in a bi-weekly questionaire to be filled by physician and patient/parents.
Congenital, familial and genetic disorders neutropenic fever	57.9% 22/38 • Number of events 30 • Adverse events were reported for each patient for a period of 3 months Adverse events were recorded in a bi-weekly questionaire to be filled by physician and patient/parents.
Gastrointestinal disorders pancreatitis	2.6% 1/38 • Number of events 1 • Adverse events were reported for each patient for a period of 3 months Adverse events were recorded in a bi-weekly questionaire to be filled by physician and patient/parents.
Nervous system disorders PRES (Posterior Reversible Encephalopathy Syndrome)	2.6% 1/38 • Number of events 1 • Adverse events were reported for each patient for a period of 3 months Adverse events were recorded in a bi-weekly questionaire to be filled by physician and patient/parents.

Other adverse events

Other adverse events
Measure	6-mercaptopurine n=38 participants at risk All patients received basic 6-mercaptopurine and in addition high-dose methotrexate(HDM) at 3 week intervals ((3 3-week intervals) in total) and PEG-asparaginase at 2 week intervals(5 dosis in total) . Patients received dose increments of 6-mercaptopurine 14 days after High-dose methotrexate if the myelotoxicity was acceptable
Gastrointestinal disorders mucositis	57.9% 22/38 • Number of events 30 • Adverse events were reported for each patient for a period of 3 months Adverse events were recorded in a bi-weekly questionaire to be filled by physician and patient/parents.
Gastrointestinal disorders nausea and vomiting	55.3% 21/38 • Number of events 68 • Adverse events were reported for each patient for a period of 3 months Adverse events were recorded in a bi-weekly questionaire to be filled by physician and patient/parents.
Gastrointestinal disorders pain	60.5% 23/38 • Number of events 55 • Adverse events were reported for each patient for a period of 3 months Adverse events were recorded in a bi-weekly questionaire to be filled by physician and patient/parents.

Additional Information

Thomas Frandsen

Rigshospitalet, Juliane Marie Centret

Phone: +45 35458364

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place