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CompletedLast updated: 5 February 2024

A Phase II trial evaluating whether adding bortezomib (an anti cancer drug) to chemotherapy (ALL R3) improves outcomes for patients with acute lymphoblastic leukaemiaInternational Study for Treatment of High Risk Childhood Relapsed ALL 2010 A Randomized Phase II Study Conducted by the Resistant Disease Committee of the International Berlin, Frankfurt, Münster (BFM) Study Group

Clinical summary

Summary

This is a randomised, open-label trial with two arms. Participants in Arm A will receive Backbone ALL R3. Participants in Arm B will receive Backbone ALL Re + Bortezomib. Bortezomib will be administered at 1.3mg/m2 as intravenous bolus or subcutaneously on days 1 and 4 of weeks 1 and 3.

Conditions

This trial is treating patients with acute lymphoblastic leukaemia.

Cancer

Blood Cancers Haematological

Age

People>17

Phase

II

More information

Trial Identifiers

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Trial sponsor

Charite University, Berlin, Germany, Australian and New Zealand Children's Haematology and Oncology Group (ANZCHOG)

Scientific Title

International Study for Treatment of High Risk Childhood Relapsed ALL 2010 A Randomized Phase II Study Conducted by the Resistant Disease Committee of the International Berlin, Frankfurt, Münster (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 date of inclusion into the study
  • Meeting HR criteria any BM relapse, early/very early isolated BM relapse, very early isolated/combined 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 day prior to study enrolment that interfere with this protocol, except trials for primary ALL

Exclusion

  • Breakpoint cluster region-Abelson (BCR-ABL)/ t(9;22) positive ALL
  • Pregnancy or positive pregnancy test (urine sample positive for β-humane choriongonadotropin (HCG) > 10 U/l)
  • Sexually active adolescents not willing to use highly effective contraceptive method (pearl index <1) until 12 months after end of anti-leukemic therapy
  • Breast feeding
  • Relapse post allogeneic stem-cell transplantation
  • Neuropathy > II°
  • The whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian
  • Objection to the study participation by a minor patient, able to object
  • Any patient being dependent on the investigator
  • 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)
  • 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 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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