Phase 2 study for people with Leukaemia

Recruiting Phase 2

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 2
Sponsor Charite University, Berlin, Germany
Registry number NCT03590171
Started 1 September 2017 Today 16 October 2026 Estimated completion 31 December 2027

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Australian & New Zealand Childhood Hematology & Oncology Group Clayton VIC Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age Up to 17 Years
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 250

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Inclusion Criteria:

* 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 Criteria:

* 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

Dates on the record

Started 1 September 2017
Estimated completion 31 December 2027
Registry last updated 17 March 2026
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 17 March 2026.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.