NCT04883749 (CLL-Frail) is a Phase 2 clinical trial of Acalabrutinib in Chronic Lymphoid Leukemia, sponsored by German CLL Study Group.

Who is sponsoring NCT04883749?

NCT04883749 is sponsored by German CLL Study Group.

What drugs are being tested in NCT04883749?

Interventions in NCT04883749: Acalabrutinib.

What condition does NCT04883749 study?

NCT04883749 studies Chronic Lymphoid Leukemia.

Is NCT04883749 still recruiting?

NCT04883749 is currently completed. Last updated 8 June 2025.

Last reviewed 2025-06-08 · How we verify

NCT04883749: CLL-Frail

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Efficacy of Acalabrutinib in Very Old or Frail Patients With Treatment-naïve or Relapsed/Refractory CLL

Completed Phase 2 Last updated 8 June 2025

What this trial tests

Phase 2 trial testing Acalabrutinib in Chronic Lymphoid Leukemia in 53 participants. Completed in 8 May 2025.

Timeline

1 June 2021

Primary endpoint
8 May 2025

8 May 2025

Quick facts

Lead sponsor	German CLL Study Group
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	53
Start date	1 June 2021
Primary completion	8 May 2025
Estimated completion	8 May 2025
Sites	20 locations across Austria, Germany

Drugs / interventions tested

Acalabrutinib (ACALABRUTINIB) — full drug profile →

Conditions studied

Chronic Lymphoid Leukemia — all drugs for Chronic Lymphoid Leukemia →

Sponsor

German CLL Study Group — full company profile →

Who can join

18 and older, any sex, with Chronic Lymphoid Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this trial is to show the efficacy, safety and feasibility of acalabrutinib in a cohort of CLL-patients ≥80 years or with a FRAIL scale score \>2 (5-item questionnaire to be filled out by the patient)

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Acalabrutinib treatment for older (aged ≥80 years) and/or frail patients with CLL: primary end point analysis of the CLL-Frail trial.
Simon F, Ligtvoet R, Bohn JP, Nösslinger T, et al · · 2025 · cited 5× · PMID 40906922 · DOI 10.1182/blood.2025028550

Verify or expand the search:

Other trials of Acalabrutinib

Trials testing the same drug.

NCT07257055 — Phase 2 Study of BTKi-Rituximab Induction Followed by Glofitamab Consolidation in High Risk Untreated MCL Patients - WIN · Phase 2 · recruiting
NCT07377578 — A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cel · Phase 3 · recruiting
NCT07024706 — Phase 2 Study of Disease Risk Mutation-Guided Finite Acalabrutinib+Venetoclax for Relapsed CLL Post-1L Finite cBTKi+BCL2 · Phase 2 · not yet recruiting
NCT07283965 — Zanubrutinib and Acalabrutinib Use and Risk of Atrial Fibrillation in Patients With Chronic B-cell Malignancies · not yet recruiting
NCT07014917 — Intermittent Versus Continuous Venetoclax With Acalabrutinib for CLL/SLL · Phase 2 · recruiting

Other recruiting trials for Chronic Lymphoid Leukemia

Currently open trials in the same condition.

NCT03766763 — Preemptive Therapy for High Risk Chronic Lymphoid Leukemia Stage A · Phase 2 · active not recruiting
NCT03852407 — Allogeneic Hematopoietic Cell Transplantation From HLA-matched Donor After Flu-Mel-PTCy Versus Flu-Mel-ATG Reduced-inten · Phase 2 · recruiting

Other German CLL Study Group trials

Trials by the same sponsor.

NCT06792994 — A Prospective Observational Trial to Assess Treatment Sequences and Factors That Impact Overall Sur-vival in Patients Wi · not yet recruiting
NCT03787264 — Sequential Regimen of Bendamustin-Debulking Followed by Obinutuzumab, Acalabrutinib and Venetoclax in Patients With Rela · Phase 2 · completed
NCT03153514 — Obinutuzumab Containing Conditioning Regimen for Patients With Poor Risk CLL or Richter's Transformation Requiring Allog · Phase 2 · terminated
NCT02950051 — Standard Chemoimmunotherapy (FCR/BR) Versus Rituximab + Venetoclax (RVe) Versus Obinutuzumab (GA101) + Venetoclax (GVe) · Phase 3 · completed
NCT02689141 — Sequential Regimen of Bendamustin-Debulking Followed by Ofatumumab and Ibrutinib in CLL Patients (CLL2-BIO) · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04883749 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by German CLL Study Group
Last refreshed: 8 June 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04883749.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing