Phase 2 Leukaemia Trial, Recruiting NCT06311227 Sponsor: National Cancer Institute (NCI) Condition: Leukaemia
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Phase 2 Leukaemia Trial, Recruiting

NCT06311227
Recruiting Phase 2

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:

  • You have been diagnosed with Hairy Cell Leukemia (HCL or HCLv), confirmed by a lab test, and have already received a type of chemotherapy called purine analog therapy
  • You either tried a BRAF-targeted treatment and it stopped working, or you are not able to receive BRAF therapy — and you have never taken a drug called venetoclax
  • You are 18 years of age or older
  • You are generally able to carry out daily activities with no more than moderate limitations (confirm with trial site)
  • Your liver is functioning well enough, based on standard blood test results (confirm with trial site)
  • Your kidneys are functioning well enough, based on standard blood test results (confirm with trial site)
  • If you have HIV, you are on effective treatment and your virus levels have been undetectable within the last 6 months
  • If you have a history of Hepatitis B, your virus levels must be undetectable while on appropriate treatment
  • If you have a history of Hepatitis C, you must have been successfully treated and cured, or currently be on treatment with undetectable virus levels
  • If you have or have had another type of cancer, it must not interfere with this trial's treatment or results (confirm with trial site)
  • If you have a history of heart problems, your heart function must meet a minimum standard based on a doctor's assessment (confirm with trial site)
  • You have not received any HCL/HCLv treatment for at least 4 weeks before joining, and your disease is not currently responding to or improving from your last treatment
  • Your disease is active enough to require treatment, based on specific blood counts, spleen size, or other disease-related measurements (confirm with trial site)
  • You are willing and able to use reliable birth control during the treatment period and for 30 days after your last dose — this applies to both women who could become pregnant and men
  • You are able to understand the study and are willing to sign a consent form (or have a legal representative do so on your behalf)
  • You are able to swallow pills

Who may not be able to join:

  • You have previously taken venetoclax
  • You are currently taking part in another clinical trial involving an experimental treatment
  • You have had a serious allergic reaction to a drug that is chemically similar to venetoclax
  • You have an uncontrolled illness or serious health condition that would make joining the trial unsafe
  • You are currently pregnant, as venetoclax may harm an unborn baby
  • You are breastfeeding, as venetoclax may harm a nursing infant
  • You have a condition that affects how your body absorbs food or medication through the digestive system
  • You have received a live vaccine (such as certain flu, shingles, or other vaccines) within 4 weeks before starting, or plan to receive one during or within 30 days after completing the study 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 5 July 2026
Phase 2: approximately ~30% 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.

GP referral letter

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

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
16 December 2024
Est. completion
20 May 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Objective response rate

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: 5 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