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Closed (no longer recruiting)Last updated: 23 January 2024

IntReALL SR 2010: This phase III trial is evaluating treatment options for children and adolescents with standard risk of first relapsed Acute Lymphoblastic Leukemia (ALL)International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010 A Randomized Phase III Study Conducted by the Resistant Disease Committee of the International BFM Study Group

Clinical summary

Summary

The main goal of this study is to improve the outcome of children and adolescents with standard risk first relapsed acute lymphoblastic leukemia. Furthermore, goal is to set up a large international study group platform allowing for optimization of standard treatment strategies and integration of new agents.

Conditions

This trial is treating patients with Acute Lymphoblastic Leukaemia.

Cancer

Blood Cancers Haematological

Age

People0 - 17

Phase

III

Trial Acronym

IntReALL SR 2010

More information

Trial Identifiers

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Trial sponsor

University Hospital of Berlin

Scientific Title

International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010 A Randomized Phase III Study Conducted by the Resistant Disease Committee of the International BFM Study Group

Eligibility

Inclusion

  • Morphologically confirmed diagnosis of 1st relapsed precursor B-cell or T-cell ALL
  • Children less than 18 years of age at inclusion
  • Meeting SR criteria: late isolated or late/early combined B-cell precursor (BCP) bone marrow (BM) relapse, any late/early isolated extramedullary relapse
  • Patient enrolled in a participating centre
  • Written informed consent
  • Start of treatment falling into the study period
  • No participation in other clinical trials 30 days prior to study enrolment that interfere with this protocol, except trials for primary ALL Inclusion criteria specific for the epratuzumab randomization
  • Precursor B-cell immunophenotype. A specific CD22 expression level is not required
  • M1 or M2 status of the bone marrow after induction

Exclusion

  • BCR-ABL / t(9;22) positive ALL
  • Pregnancy or positive pregnancy test (urine sample positive for β-HCG > 10 U/l)
  • Sexually active adolescents not willing to use highly effective contraceptive method (pearl index <1) until 2 years after end of antileukemic therapy
  • Breast feeding
  • Relapse post allogeneic stem-cell transplantation
  • 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 pseudonymized 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)
  • Karnovsky / Lansky score < 50%
  • Subjects unwilling or unable to comply with the study procedures
  • Subjects who are legally detained in an official institute

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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