Patients assigned to arm A, will receive acalabrutinib as one capsule of 100 mg orally twice daily on a continuos schedule until disease progression, unacceptable toxicity or early withdrawal.

Patients assigned to arm B, will receive standard of care for the management of early Binet stage A patients "clinical observation (watch & wait)" until disease progression or early withdrawal.

Chronic Lymphocytic Leukemia- Binet Staging System

Patients in Arm A will receive acalabrutinib as one capsule of 100 mg orally twice daily on a continuos Schedule.

Acalabrutinib 100 MG Oral Capsule

Complejo Hospitalario Universitario A Coruña

ICO Badalona (Hospital Universitari Germans Trias i Pujol)

Hospital de la Santa Creu i Sant Pau

Hospital Universitari Vall d'Hebron

Hospital Clínic de Barcelona

ICO L´Hospitalet - Hospital Duran i Reynals

Hospital Universitario Reina Sofía

Hospital Universitario de La Princesa

Hospital Universitario Infanta Leonor

Hospital Universitario Fundación Jiménez Díaz

Hospital Universitario 12 de Octubre

Hospital Universitario La Paz

Hospital Costa del Sol

Hospital Universitario Central de Asturias

Hospital Universitario Son Espases

Hospital Universitario Salamanca

Hospital Universitario Marqués de Valdecilla

Hospital Universitario Virgen de Valme

Hospital Virgen de la Salud (Complejo Hospitalario de Toledo)

H Clínico Universitario Valencia

Hospital Universitari i Politecnic La Fe

Study to Investigate the Use of Acalabrutinib in the Treatment of Patients With Chronic Lymphocytic Leukemia

Phase III Randomized Study to Investigate the Use of Acalabrutinib in the Treatment of Patients With Early Stage CLL With High Risk of Early Disease Progression

EFS is defined as the time between the date of randomization and time point of symptomatic disease progression with treatment indication according to the iwCLL-Guidelines, initiation of subsequent treatment for CLL or death by any cause, whichever occurs first.

Time between the date of randomization and progression of disease or death from any cause, whichever occurs first.

Time between the date of randomization and death from may cause.

Time from randomization until the date of initiation of subsequent treatment for CLL or death from any cause.

Is defined as the proportion of patients who achieve a CR (Complete Remission), CRi (CR with incomplete bone marrow recovery), nPR (nodular Partial Remission) or PR (Partial Response) over the course of the study. Patients who achieve a PR with lymphocytosis will be included in the ORR. The rate of MRD-negative disease (MRD: Minimal Residual Disease) will also be calculated. The IWCLL guidelines (Hallek, 2018) will be used to measure response in CLL.

PETHEMA Foundation

Arm A (65 patients): Patients assigned to arm A, will receive acalabrutinib as one capsule of 100 mg orally twice daily on a continuos schedule until disease progression, unacceptable toxicity or early withdrawal.
Arm B (65 patients): Patients assigned to arm B, will remain on the w&w approach until disease progression or early withdrawal.

Symptomatic patients, with weakly positive serum anti-tTG and evidence of mild intestinal histology damage (grade 1-2) at first evaluation.

Symptomatic patients, with weakly positive serum anti-tTG and evidence of intestinal villous atrophy (intestinal histology damage grade 3) at first evaluation.

Celiac Disease

Internal Medicine Department of the Hospital of Sciacca (Agrigento)

Internal Medicine Department of the University Hospital of Palermo

Celiac Disease Diagnosis in Patients With Weakly Positive Serum Anti-Transglutaminase: Duodenal Anti-Endomysium Assay.

Antiendomysium Antibodies Assay in the Culture Medium of Intestinal Mucosa: an Accurate Method for Celiac Disease Diagnosis in Patients With Weakly Positive Serum Anti-transglutaminase Antibodies.

Intestinal histology re-evaluation after at least one year after the first evaluation for suspected CD, without any dietary restriction. Marsh-Oberhuber's classification will be adopted: change from baseline (1st evaluation) to 2nd evaluation

Evaluation of changes in serum levels of IgA anti-tTG antibodies after at least one year since the first evaluation for suspected CD, without any dietary restriction.

The evaluation of changes in symptoms/signs will be made according to the score calculated on the basis of the Visual Analogue Scale after at least one year since the first evaluation for suspected CD, without any dietary restriction.

EmA assay in the culture medium of duodenal biopsies will be performed in all the patients, both Study and Control group, at the time of the first duodenal histology evaluation.

All the patients will undergo human leucocyte antigen (HLA) typing for DQ2 and DQ8 alleles determination.

lymphocytosis/průjem

Study to Investigate the Use of Acalabrutinib in the Treatment of Patients With Chronic Lymphocytic Leukemia

Celiac Disease Diagnosis in Patients With Weakly Positive Serum Anti-Transglutaminase: Duodenal Anti-Endomysium Assay.

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