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New treatment option for Richter Syndrome
Official title A Trial of CHOP-R Therapy, With or Without Acalabrutinib, in Patients With Newly Diagnosed Richter's Syndrome
ClinicalTrials.gov ID: NCT03899337
What this study is testing
What is Acalabrutinib?
Acalabrutinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for richter syndrome.
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
- The STELLAR trial will assess the effect of acalabrutinib taken in combination with CHOP-R compared to taking CHOP-R alone in patients with newly diagnosed Richter's Syndrome (RS). It will also be a platform to test other new drugs that show potential for treating RS.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Entry criteria for assigned by chance trial component (standard of care and experimental arms): for the assigned by chance trial component:
- Suitable for anthracycline-containing chemo-immunotherapy.
- Patients with CLL and newly diagnosed biopsy proven DLBCL-type RS.
- ECOG performance status of 0, 1, 2 or 3.
- Age 16 years and over.
You likely can't join if
- for the assigned by chance trial component:
- Prior therapy with CHOP or any anthracycline containing treatment at any time prior to randomisation. (Please note that pre-treatment with...
- Ibrutinib-exposed CLL patients who have been newly diagnosed with RS within four weeks of their last dose of ibrutinib. (Ibrutinib-exposed CLL...
- Previous acalabrutinib exposure. (Prior exposure to other Bruton tyrosine kinase (BTK), phosphoinositide-3-kinase (PI3K), or BCL-2 inhibitors is...
- Known central nervous system (CNS) involvement of CLL or DLBCL.
- Any other active malignancy that requires active treatment, with the exception of basal cell carcinoma, in-situ cervical cancer, and non-invasive...
See the full eligibility criteria
Who can join
- Entry criteria for assigned by chance trial component (standard of care and experimental arms): for the assigned by chance trial component:
- Suitable for anthracycline-containing chemo-immunotherapy.
- Patients with CLL and newly diagnosed biopsy proven DLBCL-type RS.
- ECOG performance status of 0, 1, 2 or 3.
- Age 16 years and over.
- Signed written informed consent prior to performing any study-specific procedures.
What rules you out
- for the assigned by chance trial component:
- Prior therapy with CHOP or any anthracycline containing treatment at any time prior to randomisation. (Please note that pre-treatment with prednisolone up to 2mg/kg is allowed for up to 14 days prior to the start of...
- Ibrutinib-exposed CLL patients who have been newly diagnosed with RS within four weeks of their last dose of ibrutinib. (Ibrutinib-exposed CLL patients who discontinue ibrutinib due to toxicity or progressive CLL and...
- Previous acalabrutinib exposure. (Prior exposure to other Bruton tyrosine kinase (BTK), phosphoinositide-3-kinase (PI3K), or BCL-2 inhibitors is permitted, with the exception of patients who have progressed on ibrutinib...
- Known central nervous system (CNS) involvement of CLL or DLBCL.
- Any other active malignancy that requires active treatment, with the exception of basal cell carcinoma, in-situ cervical cancer, and non-invasive squamous cell carcinoma of the skin.
- Chronic or ongoing active infectious disease requiring systemic treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis, and active hepatitis
- Positive serology for Hepatitis B (HB) defined as a positive test for HB surface antigen (HBsAg). In addition, if negative for HBsAg but HB core antibody (HBcAb) positive (regardless of HBsAb status), a HBV...
- Known human immunodeficiency virus (HIV) positive.
- Patients with active bleeding or history of bleeding diathesis (e.g. haemophilia, von Willebrand disease).
- Patients receiving therapeutic anticoagulation with warfarin or equivalent (e.g. phenprocoumon).
- Uncorrected prolonged prothrombin time (PT) or an activated partial thromboplastin time (APTT) \> 2 x the upper limit of normal (ULN).
- Major surgery within 30 days prior to randomisation and/or inadequate recovery (at Investigators discretion) from any prior major surgery, toxicity or complications.
- Patients with malabsorption syndrome or medical conditions significantly affecting gastrointestinal function.
- Clinically significant cardiac disease including unstable angina, uncontrolled congestive heart failure, and unstable arrhythmias requiring therapy, with the exception of extra systoles or minor conduction...
- Significant concurrent, uncontrolled severe medical condition including, but not limited to, renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease.
- History of significant cerebrovascular disease in the 6 months prior to randomisation, including intracranial haemorrhage.
- Known or suspected hypersensitivity to components of the investigational products
- Patients who have received treatment with any non-marketed drug substance or experimental therapy within 4 weeks prior to proposed start of treatment unless discussed and approved by the Chief Investigator or Clinical...
- Current participation in any other treatment clinical study.
- Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder).
- Breast feeding women or women with a positive pregnancy test at screening.
- Women of childbearing potential and men not willing to use highly effective contraception during study and for 12 months after last dose of study therapy. Highly effective contraception is defined as abstinence...
- Patients with relapsed/refractory RS who received anthracycline based chemotherapy with anti-CD20 monoclonal antibody If fewer than the expected number of patients from the assigned by chance component enter into Cohort...
- ECOG performance status of 0, 1, 2 or 3.
- Age 16 years and over.
- Signed written informed consent prior to performing any study-specific procedures. Exclusion criteria for Cohort 1 (progressive RS following chemo-immunotherapy):
- Previous acalabrutinib exposure. (Prior exposure to other Bruton tyrosine kinase (BTK), phosphoinositide-3-kinase (PI3K), or BCL-2 inhibitors is permitted).
- Known central nervous system (CNS) involvement of CLL or DLBCL.
- Any other active malignancy that requires active treatment, with the exception of basal cell carcinoma, in-situ cervical cancer, and non-invasive squamous cell carcinoma of the skin.
- Chronic or ongoing active infectious disease requiring systemic treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis, and active hepatitis
- Positive serology for Hepatitis B (HB) defined as a positive test for HB surface antigen (HBsAg). In addition, if negative for HBsAg but HB core antibody (HBcAb) positive (regardless of HBsAb status), a HBV...
- Known human immunodeficiency virus (HIV) positive.
- Patients with active bleeding or history of bleeding diathesis (e.g. haemophilia, von Willebrand disease).
- Patients receiving therapeutic anticoagulation with warfarin or equivalent (e.g. phenprocoumon).
- Uncorrected prolonged prothrombin time (PT) or an activated partial thromboplastin time (APTT) \> 2 x the upper limit of normal (ULN).
- Major surgery within 30 days prior to registration and/or inadequate recovery (at Investigators discretion) from any prior major surgery, toxicity or complications.
- Patients with malabsorption syndrome or medical conditions significantly affecting gastrointestinal function.
- Clinically significant cardiac disease including unstable angina, uncontrolled congestive heart failure, and unstable arrhythmias requiring therapy, with the exception of extra systoles or minor conduction...
- Significant concurrent, uncontrolled severe medical condition including, but not limited to, renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease.
- History of significant cerebrovascular disease in the 6 months prior to registration, including intracranial haemorrhage.
- Known or suspected hypersensitivity to components of the investigational products
- Patients who have received treatment with any non-marketed drug substance or experimental therapy within 4 weeks prior to proposed start of treatment unless discussed and approved by the Chief Investigator or Clinical...
- Current participation in any other treatment clinical study.
- Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder).
- Breast feeding women or women with a positive pregnancy test at screening.
- Women of childbearing potential and men not willing to use highly effective contraception during study and for 12 months after last dose of study therapy. Highly effective contraception is defined as abstinence...
- Ibrutinib-exposed CLL patients who have developed biopsy-proven DLBCL-type RS within four weeks of last dose of ibrutinib.
- No previous anthracycline treatment and suitable for anthracycline-containing chemo-immunotherapy.
- Patients with CLL and newly diagnosed biopsy proven DLBCL-type RS.
- ECOG performance status of 0, 1, 2 or 3.
- Age 16 years and over.
- Signed written informed consent prior to performing any study-specific procedures. Exclusion criteria for Cohort 2 (anthracycline-naïve RS patients, diagnosed while on ibrutinib):
- Prior therapy with CHOP or any anthracycline containing treatment at any time prior to registration. (Please note that pre-treatment with prednisolone up to 2mg/kg is allowed for up to 14 days prior to the start of...
- Previous acalabrutinib exposure. (Prior exposure to other Bruton tyrosine kinase (BTK), phosphoinositide-3-kinase (PI3K), or BCL-2 inhibitors is permitted)
- Known central nervous system (CNS) involvement of CLL or DLBCL.
- Any other active malignancy that requires active treatment, with the exception of basal cell carcinoma, in-situ cervical cancer, and non-invasive squamous cell carcinoma of the skin.
- Chronic or ongoing active infectious disease requiring systemic treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis, and active hepatitis
- Positive serology for Hepatitis B (HB) defined as a positive test for HB surface antigen (HBsAg). In addition, if negative for HBsAg but HB core antibody (HBcAb) positive (regardless of HBsAb status), a HBV...
- Known human immunodeficiency virus (HIV) positive.
- Patients with active bleeding or history of bleeding diathesis (e.g. haemophilia, von Willebrand disease).
- Patients receiving therapeutic anticoagulation with warfarin or equivalent (e.g. phenprocoumon).
- Uncorrected prolonged prothrombin time (PT) or an activated partial thromboplastin time (APTT) \> 2 x the upper limit of normal (ULN).
- Major surgery within 30 days prior to registration and/or inadequate recovery (at Investigators discretion) from any prior major surgery, toxicity or complications.
- Patients with malabsorption syndrome or medical conditions significantly affecting gastrointestinal function.
- Clinically significant cardiac disease including unstable angina, uncontrolled congestive heart failure, and unstable arrhythmias requiring therapy, with the exception of extra systoles or minor conduction...
- Significant concurrent, uncontrolled severe medical condition including, but not limited to, renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease.
- History of significant cerebrovascular disease in the 6 months prior to registration, including intracranial haemorrhage.
- Known or suspected hypersensitivity to components of the investigational products
- Patients who have received treatment with any non-marketed drug substance or experimental therapy within 4 weeks prior to proposed start of treatment unless discussed and approved by the Chief Investigator or Clinical...
- Current participation in any other treatment clinical study.
- Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder).
- Breast feeding women or women with a positive pregnancy test at screening.
- Women of childbearing potential and men not willing to use highly effective contraception during study and for 12 months after last dose of study therapy. Highly effective contraception is defined as abstinence...
The study team makes the final eligibility decision.
Where it's taking place
- Belfast, United Kingdom
- Bournemouth, United Kingdom
- Cardiff, United Kingdom
- Glasgow, United Kingdom
- Leeds, United Kingdom
- Leicester, United Kingdom
- London, United Kingdom
- Manchester, United Kingdom
- Norwich, United Kingdom
- Nottingham, United Kingdom
- Oxford, United Kingdom
- Plymouth, United Kingdom
- Sheffield, United Kingdom
- Southampton, United Kingdom
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 - 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Belfast, United Kingdom; Bournemouth, United Kingdom; Cardiff, United Kingdom; Glasgow, United Kingdom; Leeds, United Kingdom; Leicester, United Kingdom and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.