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Lymphoblastic Leukemia, Acute, ChildhoodPhase 2NCT03022747

Optimizing 6-mercaptopurine Therapy in Pediatric Acute Lymphoblastic Leukemia by Using Allopurinol

A Phase 2 study testing Allopurinol and Standard treatment in people with Lymphoblastic Leukemia, Acute, Childhood, run by Vastra Gotaland Region at 3 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 months to 19 years
Conditions the study is for
Lymphoblastic Leukemia, Acute, Childhood
What is being tested?
Allopurinol and Standard treatment
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
3 sitesin 2 countries
Study dates
Jan 2017to Apr 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 19 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 2 countries.

Jonas Abrahamsson, PhD, MD contact

+46 707 695159

vobjab@gmail.com

Torben Ek, PhD, MD contact

+46 706 169284

torben.ek@mac.com

3 sites in 2 countries

Sweden2 sites, 2 recruiting

  • Childrens' Cancer Centre, Queen Silvias Childrens and Adolescents Hospital

    Gothenburg, 416 85

    Lene Karlsson, MD, +46 313435610, lene.karlsson@vgregion.se

    Recruiting

  • Linköping University Hospital, Dept of Pediatrics

    Linköping, 58185

    Hartmut Vogt, MD, PhD, +46 101031343, hartmut.vogt@regionostergotland.se

    Not yet recruiting

Other trials in Sweden

Finland1 site, 1 recruiting

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

    Oulu, 90029 OYS

    Riita Niinimäki, MD, PhD, +358 8 3155832, riita.niinimaki@ppshp.fi

    Not yet recruiting

Other trials in Finland

About this study

Official title: Optimizing 6-mercaptopurine Therapy in Pediatric Acute Lymphoblastic Leukemia by Using Allopurinol Clinical Study in Children 1-19 Years on Maintenance Therapy for Acute Lymphoblastic Leukemia.

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.

Read the detailed description

After one month of conventional maintenance therapy (MT) children and adolescents, treated for acute lymphoblastic leukemia on Nordic protocols and with wild type thiopurine methyltransferase (TPMT) are eligible for the study. They will first receive a 12 week phase with normal MT during which time repeated sampling of 6-mercaptopurine (6MP) metabolite levels and other laboratory parameters will be performed. After 12 weeks, allopurinol at a dose of 50 mg/sqm is added (simultaneously reducing the dose of 6MP by 50%) and during the next 12 weeks patients are monitored closely for toxicity and samples for determination of metabolite levels and hematological and liver toxicity are obtained regularly. If, after 4 weeks of allopurinol treatment, the levels of 6-thioguanine are below 200 nmol/mmol hemoglobin, the dose of allopurinol will be increased to 100 mg/sqm. Allopurinol treatment is continued for 12 weeks after which the patients switch to their original maintenance therapy.

Being tested
Allopurinol, Standard treatment
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AllopurinolDrug

    Allopurinol is added to standard oral 6-mercaptopurine and methotrexate

  • Standard treatmentDrug

    Oral 6-mercaptopurine and methotrexate

Study groups in NCT03022747
Study groupRoleWhat they receive
Standard maintenance therapyActive comparatorStandard maintenance therapy with 6 mercaptopurine and methotrexate
Receives: Drug: Standard treatment
Allopurinol treatmentExperimentalThe second 12 week phase during which allopurinol is added to oral 6-mercaptopurine and methotrexate therapy
Receives: Drug: Allopurinol

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Up to week 25

Secondary outcomes (13)

  1. Mean level of 6-thioguanine

    The mean level of 6TG at week 13 and 25

    Measured: Up to week 25

  2. Mean level of DNA-incorporated thioguanine (DNA-TGN)

    The mean level of DNA-TGN at week 13 and 25

    Measured: Up to week 25

  3. Mean level of 6-methylmercaptopurine (6MMP)

    The mean level of 6MMP at week 13 and 25

    Measured: Up to week 25

  4. Mean levels of platelets

    Comparison of weighted mean of platelets in the treatment phases

    Measured: Up to week 25

  5. Mean levels of hemoglobin

    Comparison of weighted mean of hemoglobin in the treatment phases

    Measured: Up to week 25

  6. Mean levels of absolute neutrophil count (ANC)

    Comparison of weighted mean of ANC in the treatment phases

    Measured: Up to week 25

  7. Mean levels of white blood cells (WBC)

    Comparison of weighted mean of WBC in the treatment phases

    Measured: Up to week 25

  8. Glutamate pyruvate transaminase (GPT)

    Comparison of weighted means of serum GPT in the treatment phases

    Measured: Up to week 25

  9. Bilirubin

    Comparison of weighted means of serum bilirubin in the treatment phases

    Measured: Up to week 25

  10. Hypoglycemia

    Comparison of incidence of hypoglycemia and laboratory measures of metabolic disturbance during the treatment phases

    Measured: Up to week 25

  11. Metabolic disturbance

    Comparison of incidence of laboratory measures of metabolic disturbance during the treatment phases

    Measured: Up to week 25

  12. Incidence of serious adverse events (SAE)

    Comparison of the frequency of SAE in the treatment phases

    Measured: Up to week 29

  13. Cumulative dose of 6-mercaptopurine and methotrexate

    Comparison of the cumulative dose of 6MP and methotrexate and days with treatment interruption in the two treatment arms

    Measured: Up to week 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2017 (estimated)
  2. Study startJan 2017
  3. Primary completionDec 2018 (estimated)
  4. Study completionApr 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03022747
Sponsor's protocol ID
Allopurinol Study V3.0
Status last verified
Jan 2017
First submitted
9 Jan 2017
Last updated
16 Jan 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Allopurinol and Standard treatment in people with Lymphoblastic Leukemia, Acute, Childhood, run by Vastra Gotaland Region at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Sweden, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jonas Abrahamsson, PhD, MD (+46 707 695159, vobjab@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-thioguanine (6TG) levels in erythrocytes (time frame: Up to week 25). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03022747.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2017.

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