A feasibility Study of 6-Thioguanine in Combination with Methotrexate and 6-Mercaptopurine During Maintenance Therapy of Childhood, Adolescent, and Adult Lymphoblastic Non-Hodgkin’s Lymphoma and Acute Lymphoblastic Leukemia.
- Conditions
- Acute Lymphoblastic LeukemiaLymphoblastic Non-Hodgkin’s LymphomaTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-002248-42-DK
- Lead Sponsor
- Bonkolab, Rigshospitalet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
Male and female patients of all ethnicities meeting all of the following criteria will be considered eligible for study participation:
1.Meet just one of the following:
a.Confirmed diagnosis with non-HR-ALL and in first remission at inclusion into this investigation. Patients aged 1-45 years at diagnosis are eligible or
b.Confirmed diagnosis with T-LBL or pB-LBL, and in first remission at inclusion into this investigation. Patients aged 0.6-45 years at the time of inclusion are eligible and
c. Scheduled to receive 6MP/MTX maintenance therapy without any other concomitant myelosuppressive agents.
2. Patients must have reached the maintenance II therapy phase upon inclusion.
3.Patients must have a minimum of 3 months of 6MP/MTX maintenance therapy remaining at the time of inclusion.
4.Bilirubin < UNL according to age, factor 2-7-10 > 0.5 or INR < 1.5 within 1 week prior to inclusion.
5.WBC > 1.5 x109/L, ANC > 0.5 x109/L and TBC > 50 x109/L within 1 week prior to inclusion.
6.Subject, if female of child-bearing potential (defined as postmenarche), must present with a negative pregnancy test and must be nonlactating.
7.Sexually active females and males must use accepted safe contraception (OCPs, IUD, transdermal hormonal patch, vaginal hormonal ring or subdermal hormonal implants for women and condom for men) during therapy and until three months after study exit/early termination.
8.No live vaccines given within 2 months prior to inclusion.
9.Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
10.Whenever appropriate, the child should participate in the oral and written informed consent process together with the parents. Involving the child in discussions and the decision-making process respects their emerging maturity. This process will be conducted with enough time and at the same time as obtaining the consent from the parents or the legal representative, so that the informed consent reflects the presumed will of the minor, in accordance with Article 4(a) of the Clinical Trial Directive.
11.If the study participant is unable to provide legally binding consent subject's legally authorized representative (e.g., both parent, legal guardian) must voluntarily sign and date a parental permission/ Informed Consent that is approved by the Danish Ethical Committee(EC), and the subject must sign an EC approved assent, before undergoing any protocol specific procedures or assessments according to Ethical considerations for clinical trials on medicinal products conducted with the paediatric population Directive 2001/20/EC1, ICH/GCP guidelines, and the Helsinki II Declaration.
Are the trial subjects under 18? yes
Number of subjects for this age range: 25
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Patients with ALL with negative bone-marrow minimal residual disease at treatment day 29 (counted from diagnosis), since these patients have an excellent prognosis on current therapy.
2.Any clinical suspicion of relapse or disease progression on routine imaging or in laboratory results.
3.DNA-TGN > 1500 fmol/µg DNA, since the correlation between reduced risk of relapse and DNA-TGN levels of this magnitude has not been sufficiently clarified.
4.Previous sinusoidal obstruction syndrome (SOS) / veno-occlusive disease (VOD)
5.Allergic hypersensitivity towards any ingredients in the three medicinal products used in the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method