Phase 3 Leukaemia Trial, Recruiting NCT03643276 Sponsor: Martin Schrappe Condition: Leukaemia
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Phase 3 Leukaemia Trial, Recruiting

NCT03643276
Recruiting Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People newly diagnosed with acute lymphoblastic leukemia (a type of blood cancer affecting white blood cells)
  • People newly diagnosed with a mixed type of blood cancer (called MPAL) where one blood cell type is more dominant, or where the treating doctor has a clear medical reason to use a leukemia treatment plan like the one in this trial
  • People newly diagnosed with a type of blood cancer where the cancer cells have not developed clear features (called acute undifferentiated leukemia)
  • People who are under 18 years old (up to 17 years and 365 days) at the time of diagnosis
  • People enrolled at a participating treatment centre
  • People (or their guardians) who have given written consent to take part and to have their data collected and processed

Who may not be able to join:

  • People whose leukemia has a specific genetic change known as Ph+ (BCR-ABL1 or t(9;22)-positive)
  • People with a mixed blood cancer where a separate group of non-lymphoblastic (a different cancer cell type) makes up 10% or more of the total cancer cells
  • People who have already received chemotherapy-type (cytostatic) drugs before entering the trial
  • People who have taken high-dose steroid medications (1 mg/kg/day or more) for more than two weeks in the month before diagnosis
  • People who have already started treatment under a different medical protocol
  • People with an existing condition that would prevent them from safely following this treatment plan — for example, a serious heart condition present from birth, or certain nerve or movement disorders (confirm with trial site)
  • People whose leukemia has been diagnosed as a second cancer, where chemotherapy or radiation therapy was already given for a previous cancer
  • People who are pregnant or currently breastfeeding
  • Sexually active young people who are not willing to use highly effective contraception (with a Pearl Index below 1) until 12 months after completing anti-leukemia treatment
  • People already taking part in another clinical trial, unless it is an add-on supportive care trial that has been approved by the trial sponsor
  • People who have received a live vaccine within two weeks before starting the trial treatment

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 8 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Martin Schrappe, MD, Department of Pediatrics, University Hospital of Schleswig-Holstein, Campus Kiel

Phone: +4943150020150

Australian sites

Sydney Children's Hospital, Sydney,
The Children's Hospital at Westmead, Westmead,

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Martin Schrappe
Registry
ClinicalTrials.gov
Start date
15 July 2018
Est. completion
14 July 2028

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇨🇿 Czechia 🇩🇪 Germany 🇮🇱 Israel 🇮🇹 Italy 🇸🇰 Slovakia 🇨🇭 Switzerland

2 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Event-free survival; Disease-free survival

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 8 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov