Large B-cell Lymphoma study: AZD0486 vs R-mini-CHOP
Official title AZD0486 1L Therapy for Elderly or Unfit Participants With LBCL
ClinicalTrials.gov ID: NCT07215585
What this study is testing
What is AZD0486?
AZD0486 is an investigational medicine, being studied as a potential treatment for large b-cell lymphoma.
Also referred to as TNB-486.
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
- This study aims to see if a shorter treatment plan using two rounds of chemo and a new drug is just as effective and safe as the standard six rounds of chemo.
- Who it's for
- The study is looking for older adults or people who are not healthy enough for standard treatment who have just been diagnosed with large B-cell lymphoma.
- What's involved
- Participants will receive either two cycles of a reduced-dose chemo mix (R-mini-CHOP) followed by the new drug AZD0486, or six cycles of the same chemo mix.
- Time commitment
- The study involves regular visits to receive treatment and monitor health, but the specific total duration is not listed in the provided text.
- Phase 3: a large, late-stage study
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 130
You may be able to join if
- Participants are either 80 years of age or older, OR 65 to 79 years of age or older and classified as unfit per sGA, and otherwise not considered...
- Histologically confirmed diagnosis of previously untreated LBCL as per WHO-HEM5 (excluding plasmablastic lymphoma) and follicular large cell lymphoma;
- FDG-avid and measurable disease as per Lugano and Ann Arbor staging;
- Stage I bulky (7.5 cm and greater) to Stage IV;
- ECOG performance status 0 to 2;
You likely can't join if
- details may apply.
See the full eligibility criteria
- Participants are either 80 years of age or older, OR 65 to 79 years of age or older and classified as unfit per sGA, and otherwise not considered candidates for full-dose R-CHOP per investigator assessment;
- Histologically confirmed diagnosis of previously untreated LBCL as per WHO-HEM5 (excluding plasmablastic lymphoma) and follicular large cell lymphoma;
- FDG-avid and measurable disease as per Lugano and Ann Arbor staging;
- Stage I bulky (7.5 cm and greater) to Stage IV;
- ECOG performance status 0 to 2;
- Adequate bone marrow, liver, renal and cardiac function. The above is a summary, other details may apply.
- As judged by the investigator, any evidence of diseases which make it undesirable for the participant to participate in the study, or that would jeopardise compliance with the protocol
- Diagnosis of post-transplant lymphoproliferative disease, plasmablastic lymphoma, Richter's transformation, prior history of or concurrent indolent lymphoma (including de novo transformed or composite lymphoma).
- History of CNS involvement by their B-NHL or history of clinically relevant CNS medical condition
- Known history of hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS).
- Active or uncontrolled infection
- Major cardiac abnormalities
- Prior anti-lymphoma therapy except for corticosteroids for symptom control
- Requires chronic immunosuppressive therapy for active autoimmune/inflammatory condition, with some exceptions The above is a summary, other
- details may apply.
The study team makes the final eligibility decision.
Where it is enrolling
- Melbourne, Australia
- Ghent, Belgium
- Leuven, Belgium
- Yvoir, Belgium
- Porto Alegre, Brazil
- São Paulo, Brazil
- Calgary, Alberta, Canada
- Ottawa, Ontario, Canada
- Beijing, China
- Changchun, China
- Chengdu, China
- Guangzhou, China
- Jinan, China
- Shanghai, China
- Hong Kong, Hong Kong
- Bunkyō City, Japan
- Kōtoku, Japan
- Meguro-ku, Japan
- Osaka, Japan
- Yamagata, Japan
+ 7 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, but 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 130 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Melbourne, Australia; Ghent, Belgium; Leuven, Belgium; Yvoir, Belgium; Porto Alegre, Brazil; São Paulo, Brazil and 21 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.