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RecruitingLast updated: 6 June 2024

BELLWAVE-010: This study is assessing the appropriate dose level, safety and tolerability of a targeted therapy called Nemtabrutinib when given in combination with Venetoclax targeted therapy in people with relapsed or refractory, chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) who have had prior treatmentA Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Nemtabrutinib (MK-1026) Plus Venetoclax Versus Venetoclax Plus Rituximab in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Following at Least 1 Prior Therapy

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Trial acronym

BELLWAVE-010

Clinical summary

Summary

This study has two parts. Part 1 will confirm the appropriate dose of Nemtabrutinib when given in combiantion with Venetoclax.

In this part, participants will be randomly assigned to one of two treatment groups. Both groups will receive Nemtabrutinib + Venetoclax, and both drugs will be given orally.

Part 2 will further assess the safety and efficacy of Nemtabrutinib at the dose confirmed in Part 1, in combination with Venetoclax. 

In this part, participants will be randomly assigned to one of two treatment arms. Arm 1 will receive Nemtabrutinib plus Venetoclax, and Arm 2 will receive Venetoclax plus Rituximab targeted therapy (or Rituximab biosimilar). Rituximab will be given via intravenous (IV) infusion.

Conditions

This trial is treating people with relapsed or refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) who have had prior treatment

Eligibility

Inclusion

  • Confirmed diagnosis of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and active disease clearly documented to initiate therapy.
  • Deletion (Del) (17p) status, tumor protein 53 (TP53) mutation status, immunoglobulin heavy chain gene (IGHV) mutation status and Bruton's tyrosine kinase (BTK)-C481 mutation status results required before randomization for Part 2 participants only.
  • Relapsed or refractory to at least 1 prior available therapy.
  • Have at least 1 marker of disease burden.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days before randomization.
  • Has a life expectancy of at least 3 months.
  • Has the ability to swallow and retain oral medication.
  • Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV deoxyribonucleic acid (DNA) viral load before randomization.
  • Participants with history of hepatitis C virus (HCV) infection are eligible if HCV ribonucleic acid (RNA) viral load is undetectable at screening.
  • Participants with human immunodeficiency virus (HIV) who meet ALL eligibility criteria.
  • Participants with adequate organ function with specimens collected within 7 days before the start of study intervention.
  • If capable of producing sperm, participant agrees to eliminate Nemtabrutinib: 12 days, Venetoclax: 1 month (30 days), Rituximab (rituximab biosimilar): not applicable; abstains from penile-vaginal intercourse as their preferred and usual lifestyle; OR uses prescribed contraception.
  • Participant assigned female sex at birth are eligible to participate if not pregnant or breastfeeding and are not a person of childbearing potential (POCBP) OR is a POCBP and uses a contraceptive method that is highly effective, has a negative highly sensitive pregnancy test, and abstains from breastfeeding.

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You are able to swallow medication by mouth.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You are currently being treated on a clinical trial.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

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Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Merck Sharp & Dohme LLC

Scientific Title

A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Nemtabrutinib (MK-1026) Plus Venetoclax Versus Venetoclax Plus Rituximab in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Following at Least 1 Prior Therapy

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