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.

Breast Cancer

Bone Metastasis

Pain

chemoradiation

Rabin Medical Center, Beilinson Campus

Chemoradiation for Bone Metastasis

Chemoradiation With Capecitabine for Palliation of Pain From Bone Metastasis

Patients were asked to score their pain on a scale of 0 (no pain) to 10 (worst possible pain) before treatment and at 1, 2, 4, 8 and 12 weeks after treatment initiation.

Consumption of analgesics was evaluated by the physician using the 5-point WHO score, as follows: level 0, no analgesics required; level 1, non-narcotic analgesics required occasionally; level 2, non-narcotic analgesics required regularly; level 3, narcotic analgesics required occasionally; level 4, narcotic analgesics required regularly

Rabin Medical Center

Sheba Medical Center

Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg and Temozolomide 150-200 mg/m2/day (PO divided BID).

Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg and Temozolomide 150-200 mg/m2/day (PO divided BID).
Capecitabine: Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles
After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.
Temozolomide: Temozolomide 150-200 mg/m2/day (PO divided BID).
Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles
After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.

Capecitabine and Temozolomide

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

PR according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, which is defined as a reduction of ≥ 30% in the sum of the longest diameter for all target lesions lasting > 4 weeks, during which no new lesions may appear, when compared with with pretreatment measurements.

Number of Participants With Partial Response (PR)

CR according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, which is defined as disappearance of all target lesions (primary and metastases), signs, symptoms, and biochemical changes related to the tumor for >4 weeks, during which no new lesions may appear and no existing lesion may enlarge.

Number of Participants With Complete Response (CR)

Overall Study

Dr. Paul Oberstein

Neuroendocrine Tumors

Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles
After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.

Capecitabine

Temozolomide 150-200 mg/m2/day (PO divided BID).
Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles
After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.

thymidine/erbrechen

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

Chemoradiation for Bone Metastasis

Capecitabine and Temozolomide for Neuroendocrine Cancers

Combination of Carboplatin, Gemcitabine, and Capecitabine in Patients With Carcinoma of Unknown Primary Site

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