CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 1,800 target
Drug / intervention
VP16 +8 moredrug
Likely dose
VP16 60 mg/kgfrom record
Key inclusion· 9
  • ✓Age at diagnosis ≤18 years; age at HSCT ≤21 years
  • ✓Acute lymphoblastic leukemia (excluding B-ALL)
  • ✓Indication for allogeneic HSCT
  • ✓Complete remission before HSCT
Key exclusion· 5
  • ✕Non-Hodgkin Lymphoma
  • ✕Patient or legal guardian declines protocol or essential parts
  • ✕No consent for saving and propagation of anonymous medical data
  • ✕Severe concomitant disease precluding protocol treatment (e.g., malformation syndromes, cardiac malformations, metabolic disorders)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01949129
NCT01949129Phase 3RecruitingUpdate OverdueUpdated 29mo ago · Completion was 13mo ago
Enrollment Stalled
Long Recruiting
Update Overdue
CompareCT.gov

Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia

St. Anna Kinderkrebsforschung·interventional·Posted Sep 24, 2013·Updated Jan 16, 2024

In Brief

A Phase 3 clinical trial evaluating VP16, TBI, and 7 other interventions for Acute Lymphoblastic Leukaemia. Currently recruiting, targeting 1,800 participants across 119 sites in 31 countries.

Signals

Enrollment appears stalled

Detailed Summary

The ALL SCTped 2012 FORUM is a multinational, multi-centre, controlled, prospective phase III study for the therapy and therapy optimisation for children and adolescents with ALL in complete morphological remission (CR, less than 5% bone marrow blasts, no blasts in cerebrospinal fluid, no other extramedullary leukemia), who have an indication for HSCT with a myeloablative conditioning regimen. The stratification of patients in first and following remissions according to the individual transplantation modalities rests upon an indication for allogeneic HSCT and the availability of a suitable donor within the individual transplantation groups.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Lymphoblastic Leukaemia
CountriesArgentina, Australia, Austria, Belarus, Belgium, Canada, Chile, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Romania, Saudi Arabia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey (Türkiye)
CollaboratorsALL SCTped Forum, European Society for Blood and Marrow Transplantation, ALL-BFM Study Group, Assistance Publique - Hôpitaux de Paris, Dutch Childhood Oncology Group, Swiss Pediatric Oncology Group, Australian & New Zealand Children's Haematology/Oncology Group

Timeline

Phase 3Recruiting
201320142015201620172018201920202021202220232024202520262027202820292030
First PostedSep 24, 2013
Enrollment StartApr 1, 2013
Primary CompletionJun 1, 2025
Study CompletionApr 1, 2030
TodayJul 2, 2026
Enrollment to primary: 12.2 yearsPosted 12.8 years ago

Interventions

VP16drug

60 mg/kg BW,1 day in TBI/VP16 conditioning; 40 mg/kg BW in Bu/VP16/Cy conditioning

TBIradiation

2 x 2Gy/day , 3 days (total 12Gy)

Thiotepadrug

2x5 mg/kg BW, 1 day

Treosulfandrug

14g/m² BS, 3 days

Fludarabinedrug

30 mg/m² BS, 5 days

Busulfandrug

iV, dosage according therapeutic drug monitoring, 4 days

ATG Thymoglobulindrug

MD: ATG Thymo: 2,5mg/kg BW/d 3 days.

Cyclophosphamidedrug

as part of conditioning 60 mg/kg BW 2 days or as GvHD Prophylaxis 50mg/kg BW/d 2 days with Mesna

Grafalondrug

MD: 15mg/kg BW/d 3 days MMD: 10mg/kg BW/d 3 days