M15-550: Venetoclax in Relapsed/Refractory subjects with CLL
Research type
Research Study
Full title
Clinical Study Protocol M15-550- Open-Label, Single Arm, Phase 3b, Multi-Center Study Evaluating the Efficacy of Venetoclax(ABT-199) in Relapsed/Refractory Subjects with Chronic Lymphocytic Leukemia (CLL) Including Those with the 17p Deletion or TP53 Mutation OR Those Who Are Refractory or Intolerant to B-Cell Receptor Inhibitors
IRAS ID
204922
Contact name
Francesco Forconi
Contact email
Sponsor organisation
AbbVie Ltd
Eudract number
2015-003667-11
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 11 months, 29 days
Research summary
Research Summary
Chronic Lymphocytic Leukaemia (CLL) is the most common type of leukaemia (cancer of blood cells) in adults affecting men more so than women. The average age of diagnosis is 72. Many patients initially do not show any ill effects so no treatment is required until symptoms develop. Chemotherapy, the standard treatment, is often poorly tolerated by the elderly due to side effects. No cure currently exists.
Venetoclax is approved for use in the USA but not yet in the UK. It kills cancer cells by blocking a protein (part of a cell) that allows cancer cells to stay alive. This study will look at how well venetoclax works in relapsed (the cancer has come back) refractory (the patients have not had a response from previous cancer treatments) CLL patients.
In this study, all patients will receive venetoclax to look at the efficacy (how well the drug works) and safety of venetoclax. The study will include patients who may have certain gene mutations or patients who's CLL has not got better after previous BCRi treatment (B Cell Receptor signal Inhibitor- a type of drug used to treat CLL). All patients will receive a starting dose of 20 mg daily. The dose will be gradually increased over 5 weeks up to the daily dose of 400 mg. The patients will take Venetoclax for 108 weeks. After this they will be followed up for 2 years. The patient may be on the study for 4 years with approximately 28 visits to the study site. Abbvie is funding this study which will take place at roughly 63 hospitals and will enrol approximately 250 patients.
The effect of the treatment on CLL will be checked by taking blood, performing physical exams, CT scan at screening and week 48, measuring side effects and by completing health questionnaires.
Summary of Results
Overall Summary
• Chronic lymphocytic leukemia (CLL) is a long-lasting cancer of the blood and bone marrow (the spongy tissue inside bones) that affects the body’s immune system.
• CLL may not cause any symptoms for years.
When symptoms start, they may include swollen lymph nodes (small bean-shaped organs that filter substances in the body), tiredness, and easy bruising.
• In this study doctors tested venetoclax alone in patients with CLL that came back or did not get better with previous treatment.
• This study took place from June 2016 to March 2022 in
19 countries.
• All patients received venetoclax once a day for up to 5 years.
• The main goal of this study was to see how patients with CLL, who were not previously treated with a type of medicine called a B-cell receptor inhibitor (BCRi), responded to treatment with venetoclax alone.
• In this study, response to treatment (complete
remission) was determined by the study doctor and was based on the disappearance of all signs of cancer.
This was determined through physical exams, blood tests, and CT scans (series of x-rays).
• The study showed that 34.6% of patients (66 patients) who were not previously treated with a BCRi achieved complete remission when treated with venetoclax alone.
• 86.4% of patients in the study had side effects. Side effects are unwanted medical events considered by the study doctors to be at least possibly related to the study treatment.
• The most common side effects were neutropenia (large decrease in a type of white blood cell, which may affect the body’s ability to fight infection), diarrhea, and thrombocytopenia (decrease in the number of platelets in the blood, which help stop bleeding).
• The results of this study will be used by researchers to further develop venetoclax.
• If you participated in this study and have questions about your individual care, contact the doctor or staff at your study site.Available at: https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbQHvPHxRsI5n4yUVVAkKgTsl8Kf8-2FjIIk4dojZz9Q-2FRdIXjjIZtxPBEgJHIWJcVSwmDwBW98bV9IFH-2FVb1njr9Dv6x2hZttXjy1AdKB5aMzc4TN34uJ2u7A7jusCe7Y8pmA96mjirQbOGlxbXbac-2B9o8iRptBcAgNrpLNZFsf-2B0OpMdFHqkdFTf4DT2bDn46n-2Bt9ZUZf7pDzG0muOR16jXNKQY6EbTswKWwv1OoiB-2B92Y5UXmhpP-2B-2B9rlILfSeljlTKyJUpM6H-2BVVXj8cXX3AZiMiSuSdiS9NBupZ-2FjGIOndOqcKOj9ZcKxFwWgRkCHFVYdHRgDFB-2B38XyIn84l-2Fu5xAL6e5bX5ZLBt2fa-2BDU0Max7JAJV7ORip3SC-2BVARBpL-2BEYLrYsOsrx-2FImodd5P5-2FWYrwFoWSGHq2VrPs5kqagO2DQBu1QIFB9EqiT6jimEgsVvP5PD3sg4MsLrxDk-2FKRq0-2FA-2FDN-2BwObXNx611c-2BsZPR6TzvSD12b5IUGhv4-2BqRBqQO53dsgnPJX9Bxn6kdJA7FrYnUCXPOrbB8y4PCL3Y0AVH-2FZxKAMw02eTJ45FhtmjppEB32wxSABFUbEA7oOdIpLSrkYCUeeDsRpvQ3a3sCDuYr2uk0B1mRo6f-2FwM0qB0BvHdunNoIE806MD1vkXH2qts3r7g-2BQ6E8XhqNkel7nrHsuMG8090goDeJAbQLQfUS8ysY4phDbw3FYthDlV1U-3DqCOO_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YKydlHf-2Fo4eYiKqYu3V7dXNBQRPf9KKwdh5CsIY0Muh1aqYxUjQh-2BtrdkPm-2FwZ9y6eeLR2LHyHauLaWWjC5-2F2pKBzCnPjxUgJaaYsJ4Ev1giVTuVCPY5GrEdayJ0jUET3YBSAMkaahi-2BacSuiHXDxMcGqVfe2kU0oomgx3SDNZ3wA-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7Cac72602b73674cd452b508db255b5083%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638144846338207112%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=Vwqqz%2B0WDuIlj8uxB7qmdg9ew8pRfqLqX%2FK4Rk9foyo%3D&reserved=0
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
16/EE/0325
Date of REC Opinion
22 Sep 2016
REC opinion
Further Information Favourable Opinion