A study to look at the safety and efficacy of Acalabrutinib and Rituximab followed by chemo with or without Autologous stem cell transplant (ASCT) and maintenance Acalabrutinib and Rituximab in fit patients with previously untreated mantle cell lymphoma.
- Conditions
- Mantle cell LymphomaCancer - Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
- Registration Number
- ACTRN12619000990123
- Lead Sponsor
- Australasian Leukaemia and Lymphoma Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 44
1. Age 18 – 70 years
2. Histologically confirmed diagnosis of CD20 positive mantle cell lymphoma (MCL)
3. No prior lymphoma treatment including chemotherapy, radiotherapy or other investigational drug
4. Stage II-IV disease by Ann Arbor Criteria. Patients with stage I disease with bulk (greater than 7cms) that require systemic treatment will also be eligible. (must be able to undergo PET/CT imaging for staging purposes).
5. PET/CT avid disease at baseline.
6. Eastern Collaborative Oncology Group (ECOG) performance status 0, or 1, unless attributable to lymphoma in which case patients of performance status 2 are also eligible.
7. Adequate bone marrow function with haemoglobin greater than 80g/L, neutrophils greater than 1.0x109/L and platelets greater than 80x109/L at the time of study entry unless attributed to bone marrow infiltration by lymphoma.
8. Adequate renal function defined by an estimated creatinine clearance greater than or equal to 40 mL/min according to the Cockcroft-Gault formula (or local institutional standard method).
9. Adequate hepatic function defined by a total bilirubin level less than or equal to 2 × the upper limit of normal (ULN) range and AST and alanine aminotransferase (ALT) levels less than or equal to 3 × upper limit of institutional normal range unless attributed to lymphoma or Gilbert’s syndrome.
10. Patients must have an acceptable left ventricular ejection fraction (LVEF) i.e. within the local normal range for gated heart pool scan or echocardiogram
11. Life expectancy greater than 3 months.
12. Negative blood pregnancy test at screening for women of childbearing potential.
13. Signed written informed consent before any trial-related procedure is undertaken that is not part of the standard patient management.
1. Any lymphoma not fulfilling the WHO diagnostic criteria1 for mantle cell lymphoma
2. Central nervous system involvement including meningeal involvement or cord compression from lymphoma
3. Subjects aged less than 18 or more than 70 years at screening
4. Subjects that are deemed not suitable for autologous stem cell transplant, in the opinion of the treating physician, at time of screening.
5. Subjects with a contraindication to study treatments
6. Prior organ transplantation, including allogeneic stem-cell transplantation
7. Prior malignancy, active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast
8. Major surgery for any reason, except diagnostic biopsy, within 4 weeks of enrolment and/or if the subject has not fully recovered from the surgery within 4 weeks of enrolment
9. Past history of interstitial lung disease.
10. Any other serious active disease
11. Presence of human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS), Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening. Only patients who are HBV surface antigen (HBVsAg) and/or HBV core antibody (HBVcAb) positive are required to undergo HBV DNA PCR testing. Subjects that are HBV DNA negative who are HBVcAb positive are permitted in the study but must be on HBV prophylaxis.
12. Live vaccines within 30 days prior to the first dose of study drug and while participating in the study.
13. Uncontrolled AIHA (autoimmune hemolytic anaemia) or ITP (idiopathic thrombocytopenia pupura).
14. Suspicion of or confirmed progressive multifocal leukoencephalopathy
15. Has difficulty with or is unable to swallow oral medication, or significant gastrointestinal disease that would limit absorption of oral medication
16. Pregnant or lactating
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete metabolic response rate <br>Response will be assessed in accordance with the 2014 Lugano Response assessment for Non-Hodgkin’s Lymphoma by review of PET/CT Scan.[ To be measured after Acalabrutinib + Rituximab induction followed by R-DHAOx chemotherapy. Approximately 6 months post commencement of treatment.]
- Secondary Outcome Measures
Name Time Method