Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Acalabrutinib

    Drug

    Patients will receive acalabrutinib orally with dosing schedule of X.

  • Rituximab

    Biological/Vaccine

    Patients will receive rituximab via IV infusion on Cycle 1 Day 15 and via SC injection on Day 1 of Cycle 2 through Cycle 8.

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Acalabrutinib and RituximabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Percentage of patients with Grade 3 to 4 treatment emergent adverse events (TEAEs)

Time frame
Cycle 1 Day 1 (Cycles 1 to 8 is 21 days and Cycles 9 to 28 is 28 days) through End of treatment EoT [30 days of discontinuation] (Up to 3.5 Years)

Secondary outcomes

1

Objective response rate (ORR)

Time frame
Cycle 1 Day 1 (Cycles 1 to 8 is 21 days and Cycles 9 to 28 is 28 days) Until disease progression or last evaluable assessment in the absence of progression (Up to 3.5 Years)
2

Progression free survival (PFS)

Time frame
Cycle 1 Day 1 (Cycles 1 to 8 is 21 days and Cycles 9 to 28 is 28 days) Until disease progression or last evaluable assessment in the absence of progression (Up to 3.5 Years)
3

Event-Free Survival (EFS)

Time frame
Cycle 1 Day 1 (Cycles 1 to 8 is 21 days and Cycles 9 to 28 is 28 days) Until disease progression or last evaluable assessment in the absence of progression (Up to 3.5 Years)
4

Overall survival (OS)

Time frame
Cycle 1 Day 1 (Cycles 1 to 8 is 21 days and Cycles 9 to 28 is 28 days) Until Post-treatment follow-up (Up to 3.5 Years)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov
Apply now