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Study on Two Different Formulations of 6-mercaptopurine. Tablet Versus Oral Liquid

K

Kjeld Schmiegelow

Status and phase

Unknown
Phase 4

Conditions

Acute Lymphoblastic Leukemia
6-mercaptopurine Therapy

Treatments

Drug: Puri-Nethol
Drug: Xaluprine

Study type

Interventional

Funder types

Other

Identifiers

NCT01906671
2013-001236-21 (EudraCT Number)
6-MP formulation

Details and patient eligibility

About

Acute lymphoblastic leukemia (ALL) accounts for 30 % of all childhood malignancies. The patients undergo four phases of treatment, finishing with a late maintenance phase in which 6-mercaptopurine and Methotrexate are essential components. Insufficient treatment intensity in this phase is associated with increased risk of relapse. Excessive variation in the bioavailability of 6-mercaptopurine has been observed which can cause both risks of undertreatment/relapse as well as overtreatment with severe side effects.

In the attempt to achieve individualized 6-mercaptopurine dosing different approaches have been pursued. Nonetheless variation in bioavailability remains a problem.

Earlier, oral tablets of 50 mg (Purinethol) were the only administration form of 6-mercaptopurine and it was primarily designed for adult patients. Challenges with accurate dosing and getting the children to swallow the tablets have been a widespread problem, forcing the caregivers to divide or crush the tablets as well as having to administer different dosages over 2-3 days. Due to these problems, an oral liquid formulation of 6-mercaptopurine (Xaluprine) has been developed. However this oral liquid has only been tested on healthy adult volunteers, and not on the target group, childhood patients. This project will assess the bioavailability and plasma kinetics of oral liquid and tablet formulation of 6-mercaptopurine in children with acute lymphoblastic leukemia.

The investigators hypothesize to observe comparable plasma kinetics, in children with acute lymphoblastic leukemia when treated with 6-mercaptopurine in the form of a tablet and oral liquid formulation, as previously observed in healthy adults.

Enrollment

16 estimated patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Childhood acute lymphoblastic leukemia patients, age 0-18 years at diagnosis, treated at the department of pediatrics and adolescent medicine, Rigshospitalet.
  • Informed consent

Exclusion criteria

  • None

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

16 participants in 2 patient groups

Puri-Nethol
Experimental group
Description:
Tablet formulation of 6-mercaptopurine
Treatment:
Drug: Xaluprine
Drug: Puri-Nethol
Xaluprine
Experimental group
Description:
Oral liquid formulation of 6-mercaptopurine
Treatment:
Drug: Xaluprine
Drug: Puri-Nethol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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