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New treatment option for Diffuse Large B-Cell Lymphoma
Official title Study of Acalabrutinib and Rituximab in Untreated Elderly and/or Frail Patients With DLBCL
ClinicalTrials.gov ID: NCT05952024
What this study is testing
What is Acalabrutinib?
Acalabrutinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for diffuse large b-cell lymphoma.
Also referred to as CALQUENCE®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 to 99
You may be able to join if
- ≥ 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
- Stage II, III, or IV disease by the Ann Arbor Classification .
You likely can't join if
- Any evidence of diseases (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, renal transplant, and active...
- 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.
- Active central nervous system involvement by lymphoma, leptomeningeal disease, or spinal cord compression.
- Any comorbidity or organ system impairment rated with a single Cumulative Illness Rating Scale-Geriatric score (CIRS-G) of 4 or a total CIRS-G score...
See the full eligibility criteria
- ≥ 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
- Stage II, III, or IV disease by the Ann Arbor Classification .
- Eastern Cooperative Oncology Group performance status of 0, 1, or 2 with no deterioration over the previous 2 weeks prior to baseline or day of the first dosing except when due to underlying lymphoma.
- At least 1 lesion that can be accurately measured at baseline as ≥ 10 mm in the longest diameter with computed tomography or magnetic resonance imaging and is suitable for accurate repeated measurements.
- Adequate organ and marrow function independent of growth factor or transfusion support within 1 week of Screening.
- 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...
- 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.
- Active central nervous system involvement by lymphoma, leptomeningeal disease, or spinal cord compression.
- Any comorbidity or organ system impairment rated with a single Cumulative Illness Rating Scale-Geriatric score (CIRS-G) of 4 or a total CIRS-G score of \> 17.
- History of or ongoing confirmed Progressive Multifocal Leukoencephalopathy.
- Known active significant infection.
- History of stroke or intracranial haemorrhage within 6 months before the first dose of study drug.
- History of bleeding diathesis (eg, haemophilia, von Willebrand disease).
- Major surgical procedure within 30 days of first dose of study intervention or anticipated major surgery during the study timeframe.
- Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists.
- Received a live virus vaccination within 28 days of the first dose of study drug.
The study team makes the final eligibility decision.
Where it's taking place
- Berkeley, California, United States
- La Jolla, California, United States
- Orange, California, United States
- Stamford, Connecticut, United States
- Jacksonville, Florida, United States
- Des Moines, Iowa, United States
- Lexington, Kentucky, United States
- Beltsville, Maryland, United States
- Towson, Maryland, United States
- Detroit, Michigan, United States
- Sioux Falls, South Dakota, United States
- Lubbock, Texas, United States
- Olympia, Washington, United States
- Tacoma, Washington, United States
- Barretos, Brazil
- Belo Horizonte, Brazil
- Brasília, Brazil
- Campinas, Brazil
- Curitiba, Brazil
- Florianópolis, Brazil
+ 23 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Berkeley, California, United States; La Jolla, California, United States; Orange, California, United States; Stamford, Connecticut, United States; Jacksonville, Florida, United States; Des Moines, Iowa, United States and 37 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.