A Clinical Trial of MK-1045 in People With B-cell Cancer (MK-1045-006)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC
About this trial
Researchers are looking for new ways to treat people with B-cell cancers. In this trial, researchers will look at chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). These are blood cancers that affect B-cells in the blood, bone marrow, or lymph nodes.
The goals of this trial are to learn about:
* The safety of MK-1045 and if participants tolerate it. Tolerate means participants will receive trial treatment unless they need to stop treatment due to health problems. * The number of participants who respond. Respond means the number of cancer cells goes down or signs of cancer go away.
Eligibility criteria
Qualifiers
Has histologically confirmed chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) active disease that is relapsed/refractory (r/r) to prior therapy.
Has confirmed CD19-positive disease.
If human immunodeficiency virus (HIV)-positive, has well-controlled HIV on antiretroviral therapy.
If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load.
Disqualifiers
Has a history of serious cardiovascular and cerebrovascular diseases.
Has a history or presence of central nervous system disease.
Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
Has a diagnosis of immunodeficiency.
Trial design
Treatments tested in this trial
- MK-1045
- Acetaminophen (or similar antipyretic)
- Diphenhydramine (or similar antihistamine)
- Dexamethasone
- Tocilizumab
- Tocilizumab biosimilar
- Siltuximab
Treatment groups
60 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov