Phase 2 Leukaemia Trial, Recruiting NCT03986034 Sponsor: National Heart, Lung, and Blood Institute (NHLBI) Condition: Leukaemia
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Phase 2 Leukaemia Trial, Recruiting

NCT03986034
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 a type of blood cancer called CLL (Chronic Lymphocytic Leukemia) or SLL (Small Lymphocytic Lymphoma).
  • Your disease is considered "active," meaning you have at least one of the following: lost 10% or more of your body weight in the last 6 months; have extreme tiredness; have had unexplained fevers above 100.5°F for 2 or more weeks; have had unexplained night sweats for more than a month; or have worsening blood counts, an enlarged spleen, swollen lymph nodes, or rapidly increasing white blood cell counts.
  • You have a blood cancer specialist (hematologist/oncologist) who will take over your care and continue your treatment after the initial phase of the study.
  • You have had a specific blood test (G6PD) done to check which medications can safely be used to manage a potential side effect called tumor lysis syndrome.
  • You have had genetic (HLA) testing done to check whether you may have a sensitivity to a common medication called allopurinol.
  • You are 18 years of age or older.
  • You are generally able to carry out normal daily activities, or are limited only in physically strenuous activity (confirm with trial site).
  • If you are sexually active and capable of having children, you agree to use an accepted form of birth control for the entire time you are on the study treatment.
  • You are willing and able to attend all required study visits and procedures, and are able to swallow capsules without difficulty.
  • You are able to understand what the study involves and are willing to sign a consent form.

Who may not be able to join:

  • You are currently pregnant or breastfeeding.
  • You have an active infection that is not under control.
  • You have another serious illness or organ problem that the study doctor believes could put your health at risk.
  • You have another cancer that is currently growing or requires active treatment — though some exceptions may apply, such as certain skin cancers, cervical cancer caught early, cancers you have been free of for more than 2 years, or some cancers being managed with hormone therapy (confirm with trial site).
  • Your CLL has transformed into a more aggressive type of lymphoma (called Richter's Transformation).
  • You have previously been treated with a type of drug called a BCL-2 inhibitor (for example, venetoclax).
  • You are currently taking certain medications that strongly affect how the study drug is processed by your body (confirm with trial site which medications apply).
  • You have a condition that seriously affects your digestive system and how your body absorbs medications.
  • You have an uncontrolled autoimmune condition that is causing your body to destroy its own red blood cells or platelets.
  • You are currently receiving other cancer treatments such as chemotherapy, immunotherapy, or radiation therapy.
  • Your blood counts (specifically, infection-fighting white blood cells or platelets) are below certain minimum levels — though an exception may be made if the study doctor believes this is caused by the CLL itself and is expected to improve with treatment (confirm with trial site).
  • Your liver function tests show bilirubin levels more than 3 times the normal upper limit.
  • You have a serious mental health condition or significant difficulty with thinking or memory that would make it hard to safely follow the study requirements.

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 28 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.

Contact this trial

Principal Investigator: Christine E Gruessner, M.D., National Heart, Lung, and Blood Institute (NHLBI)

Phone: (301) 402-0797

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 2
Registry
ClinicalTrials.gov
Start date
26 June 2019
Est. completion
17 November 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Determine the rate of clonal shift during the ramp-up phase of venetoclax

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: 28 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