nited Kingdom Trial for Children and Young Adults with Acute Lymphoblastic Leukaemia and Lymphoblastic Lymphoma 2011

Phase 1

• Conditions: Acute lymphoblastic leukaemia and lymphoblastic lymphoma; MedDRA version: 21.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864; MedDRA version: 21.0Level: LLTClassification code 10065923Term: Lymphoblastic lymphomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-020924-22-IE
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-09
• Last Update Posted: 8 March 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 2640

Inclusion Criteria

The trial is open to all patients from age 1 (first birthday) to age 24 years 364 days (at time of diagnosis) with a first diagnosis of acute lymphoblastic leukaemia or lymphoblastic lymphoma (T-NHL or SmIg negative precursor B-NHL) diagnosed using standard criteria. Written informed consent is required for all patients and a negative pregnancy test for female patients of childbearing potential within 2 weeks prior to starting treatment.
Are the trial subjects under 18? yes
Number of subjects for this age range: 2529
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 111
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Trial entry and R1:

1)Infants less than a year old at diagnosis.
2)Patients with B-ALL (Burkitt-like, t(8;14), L3 morphology, SmIg positive)
3)Patients with Philadelphia-positive ALL (t(9;22) or BCR/ABL positive)
4)Patients in whom informed consent has not been obtained from parents and/or patients prior to randomisation
5) Patients who have received prior therapy for ALL or LBL except the following:
a) Patients who have received a single dose of intrathecal methotrexate at the time of diagnostic LP
b) Patients with ALL who due to clinical urgency have received glucocorticoid (dexamethasone or prednisolone) for no more than 7 days
c) Patients with NHL or lymphomatous presentation of T-ALL who due to concerns over respiratory compromise or thoracic outlet obstruction have received emergency cytoreduction with glucocorticoid (dexamethasone or prednisolone) for no more than 7 days and/or up to 300mg/m2 cyclophosphamide in the previous 7 days.
6) Patients who are sexually active and are unwilling to use adequate contraception during therapy and for one month after last trial treatment.

The following patients are excluded from the methotrexate and pulses randomisation (R2):
1) MRD High Risk ALL patients and LBL patients with a poor response at the end of induction (<35% reduction in tumour volume)
2) Any patients with significant renal impairment, pleural effusions or ascites.
3) Previous history of methotrexate encephalopathy.
4) MRD Intermediate patients with a history of pancreatitis.
5) Candidates for allogeneic SCT in CR1.
6) Down's syndrome patients
7) Patients who have received prior cranial irradiation
8) Patients with M3 marrow at day 29.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified