'To assess the role of an early intensification of 2 AML induction blocks versus protocol Ib directly after induction in randomized MR & HR patients'

Phase 1

• Conditions: acute lymphoblastic leukemia (including acute biphenotypic leukemia) in infants <1 year of age; MedDRA version: 14.1Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2005-004599-19-BE
• Lead Sponsor: Dutch Childhood Oncology Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-10-17
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 445

Inclusion Criteria

1. Children aged 365 days or less with newly diagnosed acute lymphoblastic leukemia (ALL) or biphenotypic leukemia according to EGIL criteria. Children with CNS or testicular leukemia at diagnosis are eligible.
2. Morphological verification of the diagnosis, confirmed with cytochemistry and immunophenotyping. In case a bone marrow aspiration results in a dry tap”, a trephine biopsy is advised unless it is possible to confirm the diagnosis by peripheral blood examination.
3. Informed consent of the parents or other legally authorized guardian of the patient.
4. Mandatory guidelines as per Amendment 23 May 2012.
5. An amendment to the Stem Cell Transplantation (SCT) regimen was made on the 23 May 2012 because of the high SCT related mortality.
5.a The SCT conditioning regimen Busulfan Cyclofosfamide-Melphalan will be replaced by the less toxic conditioning regimen iv Busulfan (or Treosulfan), Fludarabine and Thiotepa.
5.b. It is advised to refer infant Acute Lymphoblastic Leukemia (ALL) cases to SCT to large experienced transplant centers.
Are the trial subjects under 18? yes
Number of subjects for this age range: 445
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Mature B-ALL, defined by the immunophenotypical presence of surface immunoglobulines or t(8;14) and breakpoint as in B-ALL.
2. the presence of the t(9;22) (q34;q11) or bcr-abl fusion in the leukemic cells (if these data are not known, the patient is eligible).
3. Age > 365 days
4. Relapsed ALL
5. Systemic use of corticosteroids less than 4 weeks before diagnosis. Patients who received corticosteroids by aerosol are eligible for the study.
6. HR patients who have MRD level of <10e-4 by PCR at the start of OCTADA(D) will not be eligible for mismatched donor transplant.

Study & Design

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