Study of Acalabrutinib and Rituximab in Untreated Elderly and/or Frail Patients With DLBCL
ConditionDiffuse Large B-Cell Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65-99
SponsorAstraZeneca
About this trial
The study will measure the safety, tolerability, and efficacy with acalabrutinib in combination with rituximab in treatment-naïve elderly and/or frail patients with diffuse large B-cell lymphoma (DLBCL), who are otherwise unsuitable for standard front line chemoimmunotherapy treatments.
Eligibility criteria
Qualifiers
≥ 80 years of age at the time of screening, or
≥ 65 to 79 years of age at the time of screening and considered ineligible for chemoimmunotherapy
Histologically documented DLBCL
No prior treatment for DLBCL
Disqualifiers
Any evidence of diseases (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, renal transplant, and active bleeding diseases), that would make the study undesirable for the patient or that would impact compliance with the protocol.
History of prior or current malignancy, that would affect compliance with the protocol or interpretation of the results.
Serologic status reflecting active hepatitis B or C infection.
Serological positivity or known infection with HIV.
Trial design
Treatments tested in this trial
- Acalabrutinib
- Rituximab
Treatment groups
80 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov