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.

Maintenance pemetrexed 500 mg/m2 every 3 weeks for six cycles

Maintenance pemetrexed 500 mg/m2 every 3 weeks until disease progression

Blood hemoglobin, white blood cell, absolute neutrophil count, platelet count, total bilirubin, aspartate aminotransferase, alanine aminotransferase, creatinine

Non-Small Cell Lung Cancer

National Cheng Kung University Hospital

Comparison of Cost-effectiveness of Continuation Maintenance Therapy With Six Cycles of Pemetrexed Versus Pemetrexed Until Disease Progression for Metastatic Non-squamous Non-small-cell Lung Cancer

Quality-adjusted progression-free survival (QA-PFS)

National Cheng-Kung University Hospital

Determine if the immunogenicity of oral typhoid can be enhanced in children by introducing zinc supplementation: Our recent studies on the interactions of oral cholera vaccine with breast milk and zinc provide some basis for improving immunogenicity, but additional work is needed to improve many of the oral vaccines. In this study we also plan to evaluate if the immune response to Cholera and Vivotif can be enhanced by supplementation with zinc using methods described earlier. We would like to study children, 2-5 years of age for this purpose.

There is a high burden of enteric parasites in the gut of people living in densely populated areas of less developed countries. The effect of concurrent parasitic infestations on immune responses has not been studied widely, although it is an area of utmost importance for natural protection as well as vaccine immuno-prophylaxis. In this study we plan to determine the impact of pretreatment with antiparasitic agents (albendazole and secnidazole) on the immunogenicity of the oral cholera and typhoid vaccines in children, 2-5 years of age

In this study, we aim to evaluate if immunogenicity of the oral cholera vaccine is modified in children living in a high arsenic contaminated area in Bangladesh. The plan is to study children 2-5 year old living in Shahrasti thana near Matlab where the tubewell water is highly contaminated with arsenic and this study will not be randomized double-blind, and compare their responses with responses of age matched children living in arsenic free area, such as in Mirpur area of Dhaka city. We only plan to study the effect of Dukoral vaccinees since this vaccine has been widely studied in Bangladesh. If an impact of arsenic is seen on immune response to this vaccine, future studies could be done with other vaccines including Vivotif.

Cholera

Typhoid

Placebo will be given according to randomization list

Placebo

Control will be selected from the Arsenic non contaminated Area

Control

Zinc Sulphate will be given according to randomization list

Zinc Sulphate

Albendazole and Secnidazole will be given according to randomization list

Albendazole and Secnidazole

Participant will be selected from the Arsenic Contaminated Area

Arsenic

Firdausi Qadri

Studies of Immune Responses to Orally Administered Vaccines in Developing Country

Studies of Acute and Memory Immune Responses to Orally Administered Vaccines in Developing Country Children and Factors That May Augment Such Responses

skin neoplasms/diarrhea

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

Comparison of Cost-effectiveness of Continuation Maintenance Therapy With Six Cycles of Pemetrexed Versus Pemetrexed Until Disease Progression for Metastatic Non-squamous Non-small-cell Lung Cancer

Studies of Immune Responses to Orally Administered Vaccines in Developing Country

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