Actively Recruiting

Phase 2
Age: 0 - 17Years
All Genders
NCT03590171

International Study for Treatment of High Risk Childhood Relapsed ALL 2010

Led by Charite University, Berlin, Germany · Updated on 2026-03-17

250

Participants Needed

15

Research Sites

539 weeks

Total Duration

On this page

Sponsors

C

Charite University, Berlin, Germany

Lead Sponsor

A

Australian & New Zealand Children's Haematology/Oncology Group

Collaborating Sponsor

AI-Summary

What this Trial Is About

The main goal of this study is to improve the outcome of children and adolescents with acute lymphoblastic leukemia with high risk first relapse by optimization of treatment strategies within a large international trial and the integration of new agents.

CONDITIONS

Official Title

International Study for Treatment of High Risk Childhood Relapsed ALL 2010

Who Can Participate

Age: 0 - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Morphologically confirmed diagnosis of 1st relapsed precursor B-cell or T-cell ALL
  • Children less than 18 years of age at date of inclusion into the study
  • Meeting high-risk criteria including any bone marrow relapse, early or very early isolated bone marrow relapse, or very early isolated or combined extramedullary relapse
  • Patient enrolled in a participating center
  • Written informed consent obtained
  • Start of treatment falls within the study period
  • No participation in other clinical trials 30 days prior to enrollment that interfere with this protocol, except trials for primary ALL
Not Eligible

You will not qualify if you...

  • Breakpoint cluster region-Abelson (BCR-ABL)/ t(9;22) positive ALL
  • Pregnancy or positive pregnancy test (urine b2-human choriongonadotropin > 10 U/l)
  • Sexually active adolescents not willing to use highly effective contraceptive methods until 12 months after anti-leukemic therapy
  • Breastfeeding
  • Relapse after allogeneic stem cell transplantation
  • Neuropathy greater than grade II
  • Decline of protocol participation by patient or legal guardian
  • Objection to participation by a minor able to object
  • Dependency on the investigator
  • No consent given for saving and use of pseudonymized medical data
  • Severe concomitant diseases preventing treatment according to protocol (e.g., malformation syndromes, cardiac malformations, metabolic disorders)
  • Unwillingness or inability to comply with study procedures
  • Legal detention in an official institute

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 15 locations

1

Australian & New Zealand Childhood Hematology & Oncology Group

Clayton, Victoria, Australia, 3168

Actively Recruiting

2

St. Anna Kinderkrebsforschung, CCRI

Vienna, Austria, 1090

Actively Recruiting

3

Hòpital Universitaire des Enfants Reine Fabiola

Brussels, Belgium, 1020

Actively Recruiting

4

University Hospital Motol

Prague, Czechia

Actively Recruiting

5

Copenhagen University Hospital (Rigshospitalet)

Copenhagen, Denmark, 2100

Not Yet Recruiting

6

Turku University Central Hospital

Turku, Finland, SF-20520

Actively Recruiting

7

CHU Nice

Nice, France

Actively Recruiting

8

Tel Aviv Sourasky Medical Centre

Tel Aviv, Israel, 64239

Actively Recruiting

9

Ospedale Pediatrico Bambino Gesù

Roma, Italy, 00165

Actively Recruiting

10

Prinses Máxima Centrum, Lundlaan

Utrecht, Netherlands

Actively Recruiting

11

Oslo University Hospital

Oslo, Norway, 0027

Not Yet Recruiting

12

Dpt. SCT and Hematology/Oncology University Wroclaw

Wroclaw, Poland, 50354

Actively Recruiting

13

Instituto Português de Oncologia de Lisboa

Lisbon, Portugal

Not Yet Recruiting

14

University Hospital Stockholm

Stockholm, Sweden, 17176

Not Yet Recruiting

15

Royal Manchester Children's Hospital

Manchester, United Kingdom, M13 9WL

Not Yet Recruiting

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Research Team

A

Arend von Stackelberg, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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