Phase 2 Lymphoma Trial, Recruiting NCT04169737 Sponsor: M.D. Anderson Cancer Center Condition: Lymphoma
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Phase 2 Lymphoma Trial, Recruiting

NCT04169737
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:

  • People who have been diagnosed with a type of blood cancer called CLL or SLL and whose disease meets medical guidelines indicating treatment is needed.
  • People in Group 1 (first-time treatment): Those who have not yet been treated AND have at least one higher-risk feature of their cancer (such as certain genetic changes or no prior treatment), OR are aged 65 or older.
  • People in Group 2 (previously treated): Those whose cancer came back or stopped responding after at least one prior treatment.
  • People aged 18 or older.
  • People who are reasonably active and able to carry out daily activities (as assessed by a standard medical scale called ECOG, with a score of 0, 1, or 2).
  • People whose kidneys and liver are working well enough, based on specific blood test results (confirm specific values with trial site).
  • People with blood cell counts (white cells and platelets) above certain minimum levels, unless low counts are caused by the cancer itself (confirm details with trial site).
  • Women who could become pregnant must have a negative pregnancy test within 7 days before starting the study drugs, and must agree to use effective contraception during the study and for a set period after the last dose of each study drug.
  • Women who cannot become pregnant due to menopause (more than 1 year) or having had their tubes tied or uterus removed are also considered eligible.
  • Men who are sexually active must agree to use highly effective contraception, including a condom, during the study and for a set period after the last dose of certain study drugs.
  • People who have been free of other cancers for the past 2 years, with some exceptions — certain skin cancers or very early-stage cancers of the cervix or breast may still be eligible even if recently diagnosed or treated (confirm with trial site).
  • People who are willing and able to provide written consent to participate.

Who may not be able to join:

  • People who have previously been treated with a combination of the same two types of targeted drugs used in this trial (BTK inhibitor and BCL2 inhibitor together), if their cancer did not respond well or came back within 2 years of finishing that treatment.
  • People who have had major surgery, radiation, chemotherapy, immunotherapy, or certain other treatments, or received a live vaccine, within the 3 weeks before starting the study (a shorter timeframe may apply in some cases — confirm with trial site).
  • People with a history of severe allergic reactions to certain types of antibody-based medicines.
  • People with an active, uncontrolled serious infection (such as a bacterial, viral, or fungal infection).
  • People who have tested positive for HIV, due to possible interactions between HIV medications and the study drugs.
  • People with an active hepatitis B infection, based on certain blood test results (some people with past hepatitis B exposure may still be eligible — confirm with trial site).
  • People with active hepatitis C, confirmed by a specific blood test.
  • People with an active, uncontrolled autoimmune condition affecting blood cells (such as the immune system attacking red blood cells or platelets) that requires higher doses of steroid treatment.
  • People with serious heart conditions, including uncontrolled irregular heartbeat, heart failure, or a heart attack within the past 6 months, or certain other significant heart disease.
  • People who are currently pregnant or breastfeeding.
  • People currently taking the blood-thinning medication warfarin.
  • People who have taken certain medications known to strongly affect how the body processes drugs (called strong CYP3A inhibitors or inducers) within 7 days before starting the study drugs.
  • People who have consumed grapefruit, grapefruit juice, Seville oranges, or star fruit within 7 days before starting one of the study drugs (venetoclax).
  • People with a known bleeding disorder, or who have had a stroke or bleeding in the brain within the past 6 months.
  • People with a condition that prevents them from swallowing or absorbing oral medications properly.
  • People with any other serious medical, psychiatric, or laboratory finding that the trial doctor believes could make participation unsafe or affect the study results.

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 16 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: William G Wierda, M.D. Anderson Cancer Center

Phone: 713-745-0428

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
29 July 2020
Est. completion
9 July 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Disease assessment of bone marrow (BM) undetectable-minimal residual disease,10-4 sensitivity (MRD4) (Treatment-naive [TN] cohort); Disease assessment of BM undetectable-MRD4 (Relapsed/refractory [R/R] cohort)

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: 16 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