Allogeneic Stem Cell Transplantation in Children and Adolescents with Acute Lymphoblastic Leukaemia

Phase 2

• Conditions: Acute lymphoblastic leukaemia; Cancer - Children's - Leukaemia & Lymphoma

• Registration Number: ACTRN12616001394437
• Lead Sponsor: St. Anna Kinderkrebsforschung

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

All patients with ALL (except for patients with mature B-ALL) who fulfil the following criteria:
- Age at diagnosis less than or equal to 18 years. Age at HSCT less than or equal to 21 years.
- indication for allogeneic HSCT
- complete remission (CR) before SCT
- written consent of the parents (legal guardian) and, if necessary, the minor patient via Informed Consent Form”
- no pregnancy
- no secondary malignancy
- no previous HSCT
- HSCT is performed in a study participating centre

Exclusion Criteria

- Non Hodgkin-Lymphoma
- The whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian
- No consent is given for saving and propagation of anonymous medical data for study reasons
- Severe concomitant disease that does not allow treatment according to the protocol at the investigator’s discretion:
e. g. malformation syndromes, cardiac malformations, metabolic disorders;
Renal impairment (< 30% of normal glomerular filtration rate)
Severe pulmonary, hepatic or cardial impairment due to toxicity or infection
- Karnofsky / Lansky score < 50%
- Subjects unwilling or unable to comply with the study procedures

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS) Stratum 1 (randomisation TBI+ chemo-conditioning vs. chemo-conditioning only)<br>[ First: 18 months after inclusion of first patient, afterwards annually up to 10 years <br>];Event free survival (EFS) Stratum 2 (mismatched donor transplantation)<br>The following will be considered as events:<br>1. disease progression or relapse (defined by >= 5% blasts in bone marrow or CSF or any histological evidence in other tissues).<br>2. death from any cause<br>3. secondary neoplasm.<br>[ First: 18 months after inclusion of first patient, afterwards annually up to 10 years.<br>This will be assessed by routine bone marrow aspirates and lumber punctures and by the review of medical records. ]