Study on Limiting Treatment Time with Acalabrutinib and Obinutuzumab for People with CLL or SLL

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60

ClinicalTrials ID:NCT04722172

This clinical trial is exploring whether stopping treatment with acalabrutinib and obinutuzumab when the cancer responds, followed by a period of observation, is as effective as continuous treatment for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Patient Parameters

Program Overview

The study aims to test if limiting the time patients receive acalabrutinib and obinutuzumab can be safe and effective for those with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Researchers want to see if stopping the medication when the cancer shows a positive response, and then observing without treatment, is better, the same, or worse than the usual approach of continuous treatment. Continuous treatment can lead to serious side effects and resistance to the drugs.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have not received previous treatment for CLL or SLL.
  • Have a confirmed diagnosis of CLL or SLL and need treatment according to specific guidelines.
  • Be in good general health with a performance status score of 0, 1, or 2.
  • Have adequate organ and bone marrow function, as shown by specific blood test results.
  • Women of childbearing potential must agree to use effective birth control during the study and for 18 months after the last dose.
  • Men must agree to use effective birth control during the study and for 6 months after the last dose.

Exclusion Criteria

  • Have received any prior treatment specifically for CLL.
  • Have taken any investigational drug within 30 days before starting the study.
  • Have a history of other cancers that could interfere with the study, except for certain skin cancers or other cancers treated successfully over 3 years ago.
  • Have CLL that has transformed into a more aggressive form of lymphoma.
  • Have certain genetic mutations or deletions in the cancer cells.
  • Have a history of central nervous system lymphoma.
  • Have known allergies to the study drugs.
  • Have active bleeding or a bleeding disorder.
  • Have severe or uncontrolled medical conditions that could affect participation.
  • Have active infections or have had a major infection requiring hospitalization recently.
  • Require the use of certain medications that could interfere with the study.
  • Have uncontrolled autoimmune conditions.
  • Have a gastrointestinal ulcer diagnosed recently.
  • Have an active HIV infection.
  • Have received live vaccines recently.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study.
  • Have had major surgery recently and not fully recovered.
  • Have conditions that prevent taking oral medication.
  • Are participating in another clinical trial.
  • Are unable or unwilling to follow study procedures and evaluations.

Locations

FACILITYZIPCITYSTATE
Memorial Sloan Kettering Basking Ridge (All protocol activities)07920Basking RidgeNew Jersey
Hackensack Meridian Health (Data collection only)07601HackensackNew Jersey
Memorial Sloan Kettering Monmouth (All protocol activities)07748MiddletownNew Jersey
Memorial Sloan Kettering Bergen (All protocol activities)07645MontvaleNew Jersey
Memorial Sloan Kettering Commack (All protocol activities)11725CommackNew York
Memorial Sloan Kettering Westchester (All protocol activities)10604HarrisonNew York
Memorial Sloan Kettering Cancer Center (All Protocol Activities)10065New YorkNew York
Memorial Sloan Kettering Nassau (All protocol activities)11553UniondaleNew York

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