Phase 1 Leukaemia Trial, Recruiting NCT03571321 Sponsor: University of Chicago Condition: Leukaemia
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Phase 1 Leukaemia Trial, Recruiting

NCT03571321
Recruiting Phase 1

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 who have been newly diagnosed (with no prior treatment) with a specific type of blood cancer called B-precursor acute lymphoblastic leukemia (ALL), confirmed by standard testing.
  • People whose leukemia has a specific genetic pattern called "Ph-like," identified through a special laboratory test called an LDA card.
  • People whose leukemia has specific genetic changes affecting a pathway in the body called the JAK pathway — this includes certain gene rearrangements, fusions, deletions, or mutations (confirm specific details with trial site).
  • People who have already completed a standard four-drug chemotherapy starting treatment (induction), which includes chemotherapy given into the spinal fluid, before beginning the trial drug ruxolitinib.
  • People whose only prior treatment for this leukemia was emergency treatment such as steroids or hydroxyurea for serious complications, or a blood-filtering procedure to reduce white blood cell counts — no other prior leukemia treatment is permitted.
  • People aged 18 years old up to (but not including) 40 years old.
  • People who are reasonably physically functional, as measured by a standard medical scoring system (ECOG score of 2 or lower, or Karnofsky score of 60% or higher).
  • People with a platelet count above 25,000 per microliter of blood.
  • People whose liver and kidney function fall within acceptable ranges as measured by standard blood tests (confirm specific values with trial site).
  • People who are willing and able to use reliable contraception (hormonal or barrier methods, or abstinence) throughout the study, because the drugs used may harm an unborn baby — this applies to both women who could become pregnant and men.
  • People who are able to understand the study and are willing to sign a written consent form.

Who may not be able to join:

  • People who are currently taking part in another clinical trial involving an experimental treatment.
  • People who currently have a second cancer, unless they have finished treatment for it and have been cancer-free for 3 or more years (non-melanoma skin cancers are an exception).
  • People who have had a serious allergic reaction to ruxolitinib or to medicines with a similar chemical makeup to drugs used in this study.
  • People who have taken certain strong medications that affect how the body processes drugs (known as potent CYP3A4 inhibitors or inducers — examples include ketoconazole, voriconazole, clarithromycin, and itraconazole) within a certain timeframe before the trial drug begins (confirm timing with trial site). Note: fluconazole at the dose used in this study is allowed.
  • People with serious uncontrolled health conditions, such as active infection, unstable heart problems, irregular heart rhythm, or mental health or personal circumstances that would make it difficult to follow the study requirements.
  • People who are pregnant, as the trial drug ruxolitinib may harm an unborn baby.
  • People who are breastfeeding, as the trial drug may pose risks to a nursing infant.
  • People with Down Syndrome, due to a higher risk of serious side effects from the treatment.
  • People whose leukemia is classified as Burkitt type leukemia.
  • People who have a specific genetic abnormality in their leukemia called Philadelphia chromosome positive (Ph+) ALL at the time of diagnosis.

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 9 July 2026
Phase 1: approximately ~10% 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: Wendy Stock, MD, University of Chicago

Phone: 1-855-702-8222

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 1
Registry
ClinicalTrials.gov
Start date
28 May 2019
Est. completion
1 September 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Feasibility of adding ruxolitinib to a standard-of-care pediatric-based chemotherapy regimen in adolescents and young adult patients as determined by rate of side effects seen when combination is given

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: 9 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