Adding Pirtobrutinib to the Usual Treatment for People with Newly Diagnosed Richter Transformation (PIRAMID Trial)
What is the purpose of this clinical trial?
This study asks if the drug pirtobrutinib can help the usual treatment for Richter transformation work better. Richter transformation (also called Richter syndrome) is when chronic lymphocytic leukemia or small lymphocytic lymphoma turns into a fast-growing form of lymphoma.
One of the usual treatments for Richter transformation is a combination of drugs called R-CHOP. R-CHOP includes:
- The antibody drug rituximab
- The chemotherapy drugs cyclophosphamide, doxorubicin hydrochloride (hydroxydaunomycin), and vincristine sulfate (Oncovin)
- The steroid prednisone
This study compares 2 different treatment approaches:
|
Study Treatment R-CHOP |
vs. |
Usual Treatment R-CHOP |
This trial is set up to find out:
- If it’s safe to add pirtobrutinib to R-CHOP
- If adding pirtobrutinib to R-CHOP helps keep Richter transformation under control for a longer time
- If adding pirtobrutinib to R-CHOP helps people with Richter transformation live longer
In this study, people younger than 75 will get R-CHOP and people age 75 or older will get R-mini-CHOP. R-mini-CHOP includes the same drugs as R-CHOP, but some of the drugs are given in smaller doses to help prevent serious side effects. Throughout this summary, the term “R-CHOP” refers to both R-CHOP and R-mini-CHOP.
Why is this trial important?
R-CHOP often doesn’t work well for people with Richter transformation. But researchers think pirtobrutinib could help R-CHOP work better. This study will help researchers learn if that’s true, which could give people better, safer treatment options in the future.
Who can be in this trial?
This trial is for adults age 18 or older with Richter transformation.
This trial may be for people who:
- Had chronic lymphocytic leukemia or small lymphocytic lymphoma that turned into large B-cell lymphoma – not into Hodgkin or T-cell lymphoma
This trial is not for people who:
- Previously received pirtobrutinib
- Were already treated for Richter transformation (it’s okay if you received a corticosteroid, like prednisone, for less than a week)
- Are pregnant or breastfeeding
What treatments will I get?
There are 2 parts in this study. Your doctor will tell you which part you’re in.
Part 1
The first 12 or so people in the study will receive R-CHOP plus pirtobrutinib. See details about how and when people will get the drugs in the Part 2 section below.
If this treatment combination is found to be safe, the study will move on to Part 2.
Part 2
Most people in the study will be in Part 2. If you’re in Part 2, a computer will randomly assign you to one of these groups:
|
Group 1 R-CHOP (rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone) |
Group 2 R-CHOP (rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone) |
Your doctor will not have control over which group you’re assigned to. This helps make sure the study results are fair and reliable.
No matter which group you’re in, you’ll get R-CHOP in cycles. There will be up to 6 treatment cycles, and each cycle will last 21 days:
- You’ll get rituximab, cyclophosphamide, doxorubicin hydrochloride, and vincristine sulfate through an IV (intravenous) infusion – a needle placed into a vein in your arm. You’ll get these drugs on Day 1 of every cycle. (After the first cycle, you might get rituximab as an injection instead of through an IV.)
- You’ll take prednisone (a pill) on Days 1 to 5 of every cycle.
If you’re in Group 1, you’ll also take pirtobrutinib (a pill) every day. If the treatment is working, you can keep taking pirtobrutinib for up to 5 years after you start the study.
How long will I be in the trial?
You’ll be in the study for 7 years. After you finish study treatment, you’ll have office visits or phone calls with the study team so they can see how you’re feeling and if the cancer has gotten worse. You’ll have these visits or calls once or twice a year.
Are there costs? Will I get paid?
Pirtobrutinib is provided free in the study. To learn more about what costs will and won’t be covered, talk to your health care provider and insurance provider.
You will not be paid for joining the study.
Where can I find more information about this trial?
- Talk with your health care provider
- Call the National Cancer Institute at 1-800-4-CANCER
- Go to www.ClinicalTrials.gov and search the national clinical trial number: NCT07220187
- For a list of trial locations, visit swog.org/NCI-S2504