Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Buparlisib

Sarit Assouline

The purpose of this study is to find out what effects a new drug, buparlisib, has on chronic lymphocytic leukemia.

Buparlisib has been shown to shrink tumours in animals. It has been studied in some people and seems promising but it is not clear if it can offer better results than standard treatment.

The standard or usual treatment for this disease is chemotherapy, targeted therapy or radiation, either alone or in combination.

Buparlisib in Patients With Relapsed and Refractory Chronic Lymphocytic Leukemia

A Phase II Study of Buparlisib in Patients With Relapsed and Refractory Chronic Lymphocytic Leukemia

To determine the overall response rate (complete + partial response, as defined in the protocol) to oral buparlisib in patients with relapsed and refractory chronic lymphocytic leukemia.

Complete Response (CR): CR requires all of the criteria listed on page 31 of the protocol, maintained for a period of at least 8 weeks.

Partial Response (PR): To define a PR, at least 1 of the criteria of Group A plus 1 of the criteria of Group B listed on page 32 of the protocol must be met and persist for ≥ 8 weeks, in the absence of any criteria definitive of progressive disease.

Progression-free survival (PFS) is defined as the time in months from study entry until disease progression or death.

Novartis

Canadian Cancer Trials Group

100mg daily orally every 28 days

Buparlisib

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

The scale was developed by the Eastern Cooperative Oncology Group (ECOG)

Grade 0: Fully active, able to carry on all pre-disease performance without restriction Grade 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

Spots Global Cancer Trial Database for Buparlisib in Patients With Relapsed and Refractory Chronic Lymphocytic Leukemia

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial