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

Antineoplastic Agents

All Drugs and Chemicals

Bendamustine Hydrochloride

Chlorambucil

Antineoplastic Agents, Alkylating

Alkylating Agents

d1-2, i.v.gtt, 100mg/m2, 28 days per cycle, at most 6 cycles

Bendamustine hydrochloride injection

d1-d2, d15-d16, p.o., 0.4mg/kg/day, 28 days per cycle, at most 6 cycles

Zhixiang Shen, Dr.

To compare the clinical efficacy and safety of bendamustine hydrochloride versus chlorambucil for initial treatment of chronic lymphocytic leukemia

Patients will be assessed for response after three cycles of treatment. Two additional cycles are recommended for CR, PR or SD patients, up to a maximum limit of six cycles in total. Patients will be followed up every three months until disease progression or death.

Bendamustine Hydrochloride Injection for Initial Treatment of Chronic Lymphocytic Leukemia

Study of Bendamustine Hydrochloride Injection in Previously Untreated Chronic Lymphocytic Leukemia Patients

Jiangsu Simcere Pharmaceutical Co., Ltd.

Lymphoma

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin

Lymphosarcoma

B-cell Lymphoma

Antirheumatic Agents

Rituximab

Bendamustine hydrochloride injection 120 mg/m² or 100 mg/m² intravenously (IV) on Day 1 and Day 2 of 21-day cycle (6-8 cycles maximum) for non-hodgkin's lymphomas or chronic lymphocytic leukemia. After 6-8 cycles, the course of treatment could be added based on patient's benefit and investigator's determination.

Bendamustine is a bifunctional alkylating agent. It cross-links DNA single strand and double strand by alkylation,then destroys the function and synthesis of DNA, and makes the DNA and protein, protein and protein cross-linking, has potential to treat various tumors

This is a study to evaluate the efficacy and safety of Bendamustine Hydrochloride Injection in subjects with Rituximab-resistant Indolent B-Cell Non-Hodgkin's Lymphomas.

A Study to Evaluate the Efficacy and Safety of Bendamustine Hydrochloride Injection

A Multicenter, Single-arm Phase II Study to Evaluate the Efficacy and Safety of Bendamustine Hydrochloride Injection in Subjects With Rituximab-resistant Indolent B-Cell Non-Hodgkin's Lymphomas

Percentage of participants achieving complete response (CR) and partial response (PR).

DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.

PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.

OS defined as the time from randomization to death from any cause. Subjects who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Bendamustine Hydrochloride Injection for Initial Treatment of Chronic Lymphocytic Leukemia	NCT01109264	Chronic Lymphoc...	Bendamustine hy... Chlorambucil	18 Years - 75 Years	Jiangsu Simcere Pharmaceutical Co., Ltd.
A Study to Evaluate the Efficacy and Safety of Bendamustine Hydrochloride Injection	NCT04569838	Indolent B-Cell...	Bendamustine hy...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Study to Evaluate the Efficacy and Safety of Bendamustine Hydrochloride Injection	NCT04569838	Indolent B-Cell...	Bendamustine hy...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Study to Evaluate the Efficacy and Safety of Bendamustine Hydrochloride Injection	NCT04569838	Indolent B-Cell...	Bendamustine hy...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Bendamustine Hydrochloride Injection for Initial Treatment of Chronic Lymphocytic Leukemia	NCT01109264	Chronic Lymphoc...	Bendamustine hy... Chlorambucil	18 Years - 75 Years	Jiangsu Simcere Pharmaceutical Co., Ltd.

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