acalabrutinib
acalabrutinib: sourced relationships with 1 company · 37 clinical trials tracked · 2 FDA decisions.
acalabrutinib evidence translation
What we can confirm
2 FDA records · 37 tracked trials
What it means
What to watch
Prepared research question
How could acalabrutinib → AZN affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence7 indications · 2 study sponsors
Related indications
Dated Pipeline Records (2)
| Company | Dated record stage |
|---|---|
| ASTRAZENECA PLC (AZN) Reported 2017-10-31 · Current development: unknownSource Mantle-cell Lymphoma | Phase 4 |
| ASTRAZENECA PLC (AZN) Reported 2017-10-31 · Current development: unknownSource Phase I: Relapsed or Refractory B-cell Malignancies; Chronic… | Phase 4 |
Clinical Trial Registry Records (37)showing 10 most recent
The MAVRiC Study: A Phase II Study of Disease Risk Mutation Guided Finite Duration Acalabrutinib Plus Venetoclax for Relapse in CLL/SLL After First-line Finite Covalent BTKi Plus BCL2i Combination, With or Without Obinutuzumab
Primary endpoint: Overall Response Rate (ORR)
A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Patients With Previously Untreated Chronic Lymphocytic Leukemia
Primary endpoint: Progression-Free Survival (PFS) as Determined by Independent Review Committee (IRC)
The SOUND-MCL Study: A Single-arm, Open-label, Multicenter, Phase II Study of Acalabrutinib, in Combination With the R-CHOP Standard of Care, for Previously Untreated Mantle Cell Lymphoma in Spain
Primary endpoint: Best Overall Response Rate (ORR)
A Multicentre, Open-label, Randomised Phase IV Study to Investigate Acalabrutinib Monotherapy Compared to Investigator's Choice of Treatment in Adults (> 18 Years) With Chronic Lymphocytic Leukaemia and Moderate to Severe Cardiac Impairment
Primary endpoint: Safety endpoints 1: To evaluate the incidence of CV (CardioVascular) adverse events leading to drug discontinuation after acalabrutinib treatment compared to investigators choice of treatment.
A Phase I/II Open-Label Multi-Centre Master Protocol to Evaluate the Safety and Efficacy of AZD0486 Monotherapy or in Combination With Other Anticancer Agents in Participants With Mature B-Cell Malignancies
Primary endpoint: Number of Participants with Adverse Events, Serious Adverse Events and Adverse Events of Special Interest
A Phase 2 Study of Glofitamab With Acalabrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma
Primary endpoint: Incidence of unacceptable adverse events (AEs) (safety lead-in)
A Prospective, Open-Label, Phase IIb/III Study to Evaluate the Risk of TLS and Optimization of the Initiation of Venetoclax in Combination With Obinutuzumab or Acalabrutinib With Different Ramp- Up Periods in Previously Untreated Subjects With CLL
Primary endpoint: Part 1: Percentage of Participants with Treatment-Emergent Laboratory Tumor Lysis Syndrome (TLS)-Venetoclax
A Prospective, Open-Label, Single-Arm, Phase II Study of Acalabrutinib and Rituximab in Untreated Elderly and/or Frail Patients With Diffuse Large B-Cell Lymphoma (ACRUE)
Primary endpoint: Percentage of patients with Grade 3 to 4 treatment emergent adverse events (TEAEs)
A Global Multicenter Open Label Randomized Phase III Confirmatory Study of Lisaftoclax (APG-2575) in Combination With Acalabrutinib vs Immunochemotherapy in Patients With Newly Diagnosed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma.
Primary endpoint: Progress Free Survival (PFS)
A Multicentre, Phase II, Open-label Study to Evaluate the Efficacy of Acalabrutinib in Combination With Venetoclax and Rituximab in Participants With Treatment Naïve Mantle Cell Lymphoma (TrAVeRse)
Primary endpoint: MRD-negative CR rate
FDA Decisions2 records
Frequently asked questions
Which companies have sourced relationships with acalabrutinib?
acalabrutinib has dated SEC/FDA relationship records for ASTRAZENECA PLC.
How many clinical trials involve acalabrutinib?
BioSniper tracks 37 clinical trials involving acalabrutinib.
What is acalabrutinib's latest FDA decision?
The most recent tracked FDA decision for acalabrutinib is Approval for 1 INDICATIONS AND USAGE CALQUENCE is a kinase inhibitor indicated: • In combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). (1.1 ) • For the treatment of adult patients with MCL who have received at least one prior therapy. ( 1.2 ) • For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). ( 1.3 ) 1.1 Previously Untreated Mantle Cell Lymphoma CALQUENCE in combination with bendamustine and rituximab is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). 1.2 Previously Treated Mantle Cell Lymphoma CALQUENCE is indicated for the treatment of adult patients with MCL who have received at least one prior therapy. 1.3 Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma CALQUENCE is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)., dated August 3, 2022.