NCT03022747

Brief Summary

The study will investigate, in children with acute lymphoblastic leukemia during maintenance treatment, if addition of allopurinol to conventional oral 6-mercaptopurine and methotrexate therapy, affects erythrocyte concentrations of 6-thioguanine and 6 methylmercaptopurine. The effect on hematological and liver toxicity parameters in blood will also be investigated as well as clinical toxicity.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2017

Geographic Reach
2 countries

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 16, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

January 16, 2017

Status Verified

January 1, 2017

Enrollment Period

1.9 years

First QC Date

January 9, 2017

Last Update Submit

January 11, 2017

Conditions

Lymphoblastic Leukemia, Acute, Childhood

Outcome Measures

Primary Outcomes (1)

  • 6-thioguanine (6TG) levels in erythrocytes

    The fraction of patients with 6TG levels over 200 nmol/mmol Hb at week 13 and 25 (ie after 12 weeks standard and allopurinol treatment respectively)

    Up to week 25

Secondary Outcomes (13)

  • Mean level of 6-thioguanine

    Up to week 25

  • Mean level of DNA-incorporated thioguanine (DNA-TGN)

    Up to week 25

  • Mean level of 6-methylmercaptopurine (6MMP)

    Up to week 25

  • Mean levels of platelets

    Up to week 25

  • Mean levels of hemoglobin

    Up to week 25

  • +8 more secondary outcomes

Study Arms (2)

Standard maintenance therapy

ACTIVE COMPARATOR

Standard maintenance therapy with 6 mercaptopurine and methotrexate

Drug: Standard treatment

Allopurinol treatment

EXPERIMENTAL

The second 12 week phase during which allopurinol is added to oral 6-mercaptopurine and methotrexate therapy

Drug: Allopurinol

Interventions

AllopurinolDRUG

Allopurinol is added to standard oral 6-mercaptopurine and methotrexate

Allopurinol treatment
Standard treatmentDRUG

Oral 6-mercaptopurine and methotrexate

Standard maintenance therapy

Eligibility Criteria

Age6 Months - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Confirmed diagnosis of acute lymphoblastic leukemia
  • Treatment according to Nordic Society for pediatric hematology/oncology (NOPHO) ALL2008 based protocols
  • Age 0-18y at time of initial diagnosis
  • TPMT wild type
  • Written informed consent

You may not qualify if:

  • Mature B cell lymphoblastic leukemia
  • t(9;22) positive acute lymphoblastic leukemia
  • Unknown TPMT status or presence of TPMT mutation (both heterozygous and homozygous)
  • Known intolerance to any of the chemotherapeutic drugs in the protocol
  • Major organ failure precluding administration of planned chemotherapy
  • Severe liver toxicity defined as persistent (≥ two weeks) elevation of either S-bilirubin \> 50 μmol/l or S-GPT \> 20 x Upper normal limit (UNL) or P-Prothrombin complex \> 1.5.
  • Reduced kidney function defined as S-creatinine ≥ 1.5 x UNL.
  • Lactating female or female of childbearing potential not using adequate contraception.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Dept of Pediatrics and Adolescents, Oulu University Hospital, Box 23, 90029 OYS, Finland

Oulu, 90029 OYS, Finland

NOT YET RECRUITING

Childrens' Cancer Centre, Queen Silvias Childrens and Adolescents Hospital

Gothenburg, 416 85, Sweden

RECRUITING

Linköping University Hospital, Dept of Pediatrics

Linköping, 58185, Sweden

NOT YET RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Allopurinol

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

PurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Jonas Abrahamsson, PhD, MD

    Childrens Cancer Center, Queen Silvia Children Hospital, Sahlgrenska Academy, Gothenburg, Sweden

    STUDY CHAIR

  • Riita Niinimäki, PhD, MD

    Dept of Pediatrics and Adolescents, Oulu University Hospital, Box 23, 90029 OYS, Finland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonas Abrahamsson, PhD, MD

CONTACT

+46 707 695159vobjab@gmail.com

Torben Ek, PhD, MD

CONTACT

+46 706 169284torben.ek@mac.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2017

First Posted

January 16, 2017

Study Start

January 1, 2017

Primary Completion

December 1, 2018

Study Completion

April 1, 2019

Last Updated

January 16, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)SE(2)