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AVD Therapy for Richter Transformation
This trial tests acalabrutinib, venetoclax, and durvalumab in treating Richter transformation, a rare condition in which chronic lymphocytic leukemia or small lymphocytic lymphoma changes into a fast-growing type of lymphoma.
- Chronic Lymphocytic Leukemia
- Richter Syndrome
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Side effects dataFrom 2020 Phase 2 trial • 177 Patients • NCT04346199
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Who is running the clinical trial?
- You have been diagnosed with a type of lymphoma called SLL, or you have a high level of small to moderate lymphocytes in your blood. If you have already been diagnosed with CLL, you don't need to have a high level of lymphocytes in your blood.You are 18 years old or older and willing to agree to participate in the study and come back for check-ups.You have had surgery to prevent pregnancy by blocking or cutting your fallopian tubes.You have been diagnosed with a type of cancer called Richter's transformation of the CLL, which has been confirmed by a biopsy.You have heart failure.If you are taking a type of birth control pill called "minipill" that contains desogestrel (brand name Cerazette), you cannot participate.You are currently breastfeeding.You have either vitiligo or alopecia.You have had a previous cancer diagnosis, except for:You have a type of cancer that grows slowly and you are expected to live for more than 2 years.You cannot use nasal sprays, inhalers, skin creams, or steroid injections.Your doctor believes you have less than 3 months to live.Swollen spleen, liver, or lymph nodes are not needed to confirm you have chronic lymphocytic leukemia (CLL).You do not need to have an enlarged spleen, liver, or lymph nodes to be diagnosed with CLL.You are pregnant.You currently have chronic GVHD that needs to be treated.The following methods are considered effective:You are using a Copper T intrauterine device (IUD) for birth control.You are using a specific type of intrauterine device (IUD) that releases levonorgestrel (e.g., Mirena).You have an etonogestrel-releasing implant such as Implanon or Norplant.You have received a birth control injection called Depo-Provera or medroxyprogesterone.You have a sickness that is not under control.You have a heart condition that could be dangerous to your health.You have severe heart disease categorized as class 3 or 4 by the New York Heart Association.Your high blood pressure is not under control.You have inconsistent or unpredictable chest pain caused by heart disease.You can join the study even if you have atrial fibrillation, as long as it is under control and you aren't experiencing any symptoms.You have had a stroke or bleeding in your brain in the last 6 months before starting the study.You cannot participate if you are pregnant or planning to become pregnant because the safety of the study drug on developing fetuses and newborns is unknown.You have recently received an experimental medication (excluding venetoclax, acalabrutinib, or ibrutinib) and it has not yet cleared your system. You should talk to the study chair to find out if this exclusion applies to the specific medication you took.You have already received durvalumab treatment before. However, if you have received other similar treatments called PD1 or PDL1 blockade, you may still be eligible.You have a long-term skin condition that does not need medication taken throughout your whole body.You have a mental health or drug abuse condition that could make it difficult for you to follow the trial requirements.You have received steroids as a premedication for hypersensitivity reactions, such as before a CT scan.Your lymphocytes have specific markers called CD19, CD20, CD23, and CD5, but do not have other markers like CD3 or CD2.You have a type of cancer called Richter's Syndrome and your doctor has determined that you do not have any other options for standard treatment. You also have a diagnosis of Chronic Lymphocytic Leukemia (CLL).Your cells show specific markers indicating that they come from the same clone or family of cells.Before being diagnosed with CLL or SLL, the doctors have to make sure that you don't have mantle cell lymphoma. They will do this by checking your blood or tissue samples to see if there is a specific genetic marker (t(11;14)(IgH/CCND1)) or protein (cyclin D1) present.If you were diagnosed with chronic lymphocytic leukemia (CLL) and had a bone marrow or tissue biopsy, you can still participate if your B cell count is above 5 x 10^9/L.You can participate in the trial even if you have received treatment for your CLL in the past. However, if your CLL transformed into Richter's syndrome and you have not received any treatment for it, you cannot participate.
- Group 1: Treatment (acalabrutinib, durvalumab, venetoclax)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this trial still recruiting participants?
"Yes, the data on clinicaltrials.gov suggests that this research endeavour is actively recruiting candidates. The study was first posted in 15th June 2022 and its most recent edit occurred on the same day. 33 individuals are required to be recruited from a single medical site."
Could you please elucidate the risks associated with taking Acalabrutinib?
"While there has been some evidence of safety, Acalabrutinib's efficacy is still undemonstrated. As such, our team at Power graded its risk level as a 2 on the 1-3 scale."
How many participants are partaking in this experiment at the most?
"Yes, indeed. The clinical trial is actively recruiting and the data hosted on clinicialtrials.gov suggests that recruitment began on June 15th 2022. 33 participants are needed at a single medical site for this study to be successful."
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