Trial purpose
Cancer treatment
Tumor type
Haematological
Age
65 - 130
Trial acronym
SOUNDTRACK-D2
Clinical summary
Summary
You may be eligible for this study if you are either 80 years of age or older, or 65 to 79 years of age or older and classifed as unfit per sGA, and otherwise not considered candidates for full-dose R-CHOP chemotherapy. You must have a diagnosis of large B-cell lymphoma or follicular large cell lymphoma and not have received any prior treatment.
The study has two parts, a safety run-in followed by the phase III part of the study.
In the safety run-in part, participants will receive a R-mini-CHOP chemotherapy followed by AZD0486 immunotherapy. R-CHOP consists of rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone.
Once that is complete, participants will be randomly allocated to one of two arms.
- Experimental Arm: 2 cycles of R-mini-CHOP followed by multiple cycles of AZD0486
- Active Comparator Arm: 6 cycles of R-mini-CHOP as per standard of care regimen.
Conditions
This trial is treating people with previously untreated large B-cell lymphoma
Eligibility
Inclusion
- 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 inclusion criteria details may apply.
Exclusion
- 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 exclusion criteria details may apply.
Inclusion
- You have been diagnosed with cancer, but have not received any treatment.
- You have the type of cancer, symptoms, or health risks that this clinical trial is focused on.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
AstraZeneca
Scientific Title
A Phase III, Multicentre, Open-Label, Randomised Study Evaluating the Efficacy and Safety of R-mini-CHOP x2 Followed by AZD0486 Versus R-mini-CHOP x6 in Elderly or Unfit Participants With Newly Diagnosed Large B-cell Lymphoma (SOUNDTRACK-D2)
Get Support
You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.
Know more about Peer Connect
If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.
Get support
Learn more about clinical trials through this collection of resources in languages other than English.
View information