Allogenic stem cell transplantation in children and adolescents with acute lymphoblastic leukaemia - ALL SCT BFM international

Phase 1

• Conditions: very high risk acute lymphoblastic leukaemia in children and adolescents with indicaton for allogenic hematopoetic stem cell transplantation; MedDRA version: 8.1Level: LLTClassification code 10000844Term: Acute lymphoblastic leukaemia

• Registration Number: EUCTR2005-005106-23-AT
• Lead Sponsor: St. Anna Kinderkrebsforschung

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-01-11
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 405

Inclusion Criteria

*Age at ALL diagnosis (for HSCT indication in CR1) or at ALL relapse diagnosis: =18 years
*ALL in first, second or any following complete remission
*Indication for allogeneic HSCT (see chapter Indications for allogeneic HSCT, page 11)
*Signed informed consent of parents or legal guardian of the minor patient (and in certain cases the patient himself/herself) for participation in the study ALL SCT BFM international.
*The patient is treated in a hospital participating in the study during the study period.
*No evidence of pregnancy
*No secondary malignancy
*No history of allogeneic or autologous HSCT

All patients who are entered into the study according to these criteria are study patients. Once registered into the study, a patient is only excluded from the study, if the diagnosis ALL turns out to be clearly wrong.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

none - see above

Study & Design

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