Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/EUCTR2018-001850-80-DK
EUCTR2018-001850-80-DKActive, not recruitingPhase 1

Acalabrutinib and rituximab in elderly patients with untreated mantle cell lymphoma - ALTAMIRA

ordic Lymphoma Group0 sites80 target enrollmentStarted: January 3, 2022Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
80
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1. Age =60 years
  • •2. Pathologically confirmed MCL (according to the 2016 WHO classification),with documentation of monoclonal B cells that have a chromosome translocation t(11;14)(q13;q32) and/or overexpress cyclin D1
  • •3. Stage II-IV, measurable by imaging and requiring treatment in the opinion of the treating clinician
  • •4. No previous treatment for MCL (other than localised radiotherapy or 7 day pulse of steroids for symptom control)
  • •5. ECOG performance status 0 – 2
  • •6. Absolute neutrophil count (ANC) >1.0x 109 and platelet count >100 x 109, unless related to lymphoma - in this situation, the threshold for inclusion is ANC >0.5x 109 and platelet count >50 x 109
  • •7. Creatinine clearance >30 ml/min (Cockcroft-Gault)
  • •8. AST and/or ALT <3xULN and/or total bilirubin <3xULN
  • •9. Able to give voluntary written informed consent
  • •10. Woman of childbearing potential (WOCBP) who are sexually active must use highly effective methods of contraception during treatment and for 2 days after the last dose of acalabrutinib or for 12 months after last dose of rituximab, whichever is longer.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 40
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

  • •1. Patients considered fit enough to undergo autologous or allogeneic stem cell transplant for MCL
  • •2. Major surgery within two weeks prior to day 1 of cycle 1
  • •3. Patients who are unable to swallow capsules, or who have disease significantly affecting gastrointestinal function that would limit oral absorption of medication.
  • •4. Known serological positivity for HBV, HCV, HIV. Patients who are hepatitis B core antibody (anti-HBc) positive and who are surface antigen negative will need to have a negative polymerase chain reaction (PCR) result. Those who are hepatitis B surface antigen (HbsAg) positive or hepatitis B PCR positive will be excluded. Patients who are hepatitis C antibody positive will need to have a negative PCR result. Those who are hepatitis C PCR positive will be excluded.
  • •5. Diagnosed with or treated for any other malignancy than MCL within 2 years prior to day 1 of cycle 1 (except basal cell carcinoma, cutaneous squamous cell carcinoma or any other in situ malignancy)
  • •6. Active infection requiring treatment
  • •7. Serious medical or psychiatric illness likely to interfere with participation in this clinical study
  • •8. Concurrent treatment with another investigational agent outside of this protocol
  • •9. Known history of drug-specific hypersensitivity or anaphylaxis to study drug (including active product or excipient components).
  • •10. Active bleeding, history of bleeding diathesis (eg, hemophilia or von Willebrand disease).
  • •11. Uncontrolled AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenic purpura).
  • •12. Requires treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor/inducer.
  • •NLG-MCL8 v 1.8 – 2020-12-18 13
  • •13. Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon) within 7 days of first dose of study drug.
  • •14. Prothrombin time/INR or aPTT (in the absence of Lupus anticoagulant) > 2x ULN.
  • •15. Requires treatment with proton pump inhibitors (eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Patients receiving proton pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrollment to this study.
  • •16. History of significant cerebrovascular disease or event, including stroke or intracranial hemorrhage, within 6 months before the first dose of study drug.
  • •17. Breastfeeding or pregnant women
  • •18. Concurrent participation in another therapeutic clinical trial.

Investigators

Sponsor
ordic Lymphoma Group

Similar Trials

Active, not recruiting
Phase 1
Acalabrutinib and rituximab in elderly patients with untreated mantle cell lymphomaMantle Cell Lymphoma (MCL)
EUCTR2018-001850-80-NOordic Lymphoma Group80
Active, not recruiting
Phase 1
Acalabrutinib and rituximab in elderly patients with untreated mantle cell lymphomaMantle Cell Lymphoma (MCL)
EUCTR2018-001850-80-SESkåne University Hospital80
Recruiting
Phase 2
Acalabrutinib and rituximab in elderly patients with untreated mantle cell lymphoma (ALTAMIRA)
2023-509864-96-00Region Skane80
Active, not recruiting
Phase 2
Acalabrutinib and Rituximab in Elderly Patients With Untreated Mantle Cell LymphomaMCLMantle Cell Lymphoma
NCT05214183Nordic Lymphoma Group81
Recruiting
Not Applicable
Acalabrutinib with rituximab and lenalidomide in relapsed/refractory B-cell non-Hodgkin lymphoma
KCT0003724Seoul National University Hospital66
Acalabrutinib and rituximab in elderly... | Clinical Trial