Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Bendamustine Hydrochloride

Rituximab

Antineoplastic Agents, Alkylating

Alkylating Agents

Participants will receive bendamustine hydrochloride administered at 120 milligrams (mg)/square meter (m\^2) intravenously (IV) as a 60-minute infusion, and not more than 120 minutes, on Days 1 and 2 in each 21-day treatment cycle for 6 planned cycles and up to 8 total cycles.

Bendamustine will be be administered per dose and schedule specified in the arm description.

Bendamustine hydrochloride

Teva Medical Expert, MD

The primary objective of the study is to determine the overall response rate (ORR), which includes complete response (CR) and partial response (PR), to bendamustine treatment in participants with indolent non-Hodgkin lymphoma (NHL) that has progressed after rituximab or a rituximab-containing therapy.

This is a multicenter, nonrandomized, open-label, single-agent clinical study conducted in China, and is designed to investigate the use of bendamustine in the treatment of Chinese participants with relapsed, rituximab-refractory indolent NHL. The study consists of a screening period of up to 4 weeks, a treatment period of approximately 24 weeks (up to eight 21-day cycles), and a long-term follow-up period for up to 2 years after the last dose of study drug. Participants are expected to participate in this study for approximately 2.5 years.

A Study of Bendamustine in the Treatment of Chinese Participants With Indolent Non-Hodgkin Lymphoma Refractory to Rituximab Treatment

An Open-Label Study to Evaluate Bendamustine Hydrochloride in the Treatment of Chinese Patients With Indolent Non-Hodgkin Lymphoma (NHL) Refractory to Rituximab Treatment

The ORR was defined as the percentage of participants who achieved a best response of complete response (CR) or partial response (PR) during the study based on the modified International Workshop Response Criteria. CR: disappearance of all evidence of disease; nodal masses regression on normal size on computed tomography (CT); spleen and liver not palpable and nodule disappeared; bone marrow infiltrate cleared on repeat biopsy. PR: Regression of measurable disease and no new sites; nodal masses ≥50% decrease in sum of the product of the diameters (SPD) of up to 6 largest dominant masses and no increase in size of other nodes; spleen and liver ≥50% decrease in SPD of nodules and no increase in size of liver or spleen.

Duration of response was defined as the time from the date of first documentation of response to the first documentation of disease progression, new anticancer therapy, or death (regardless of cause), whichever occurred first for participants with a best response of CR or PR determined by the modified International Workshop Response Criteria. CR: disappearance of all evidence of disease; nodal masses regression on normal size on CT; spleen and liver not palpable and nodule disappeared; bone marrow infiltrate cleared on repeat biopsy. PR: Regression of measurable disease and no new sites; nodal masses ≥50% decrease in SPD of up to 6 largest dominant masses and no increase in size of other nodes; spleen and liver ≥50% decrease in SPD of nodules and no increase in size of liver or spleen. Disease progression: any new lesion or increase by ≥50% of previously involved sites from nadir.

Progression free survival was defined as the time from the date of the first administration of bendamustine to the first documentation of disease progression/relapse, new anticancer therapy, or death (regardless of cause), whichever occurred first for all participants. Disease progression/relapse: appearance of any new lesion or increase by ≥50% of previously involved sites from nadir.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.

Number of participants with WHO performance status (improved, stayed the same, and deteriorated) at the end of treatment have been reported.

Concomitant medications included all medications taken while the participant received study drug.

Teva Branded Pharmaceutical Products R&D, Inc.

Safety analysis set included all enrolled participants who were treated with any amount of study drug.

Participants received bendamustine hydrochloride administered at 120 mg/m\^2 IV as a 60-minute infusion, and not more than 120 minutes, on Days 1 and 2 in each 21-day treatment cycle for 6 planned cycles and up to 8 total cycles.

Bendamustine

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race/Ethnicity, Customized

The primary analysis set (PAS) included all enrolled participants who were treated with any amount of study drug.

Director, Clinical Research

Overall Response Rate (ORR) (Assessed by Independent Review Committee [IRC])

The PAS included all enrolled participants who were treated with any amount of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Duration of Response (DOR) (Assessed by IRC)

The PAS included all enrolled participants who were treated with any amount of study drug.

Progression-Free Survival (Assessed by IRC)

The pharmacokinetic analysis set included all enrolled participants who were treated with any amount of study drug and for whom at least 1 pharmacokinetic parameter was calculated.

Maximum Observed Plasma Concentration (Cmax) of Bendamustine

Time to Reach Cmax (Tmax) of Bendamustine

Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Drug Concentration (AUC0-t) of Bendamustine

The pharmacokinetic analysis set included all enrolled participants who were treated with any amount of study drug and for whom at least 1 pharmacokinetic parameter was calculated. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity (AUC0-∞) of Bendamustine

Rate Constant for Elimination (λz) of Bendamustine

Percentage of the AUC0-∞ Based on Extrapolation (%AUCext)

Half-Life (t½) of Bendamustine

Number of Participants With Adverse Events (AEs)

World Health Organization (WHO) Performance Status

Number of Participants Who Need At Least 1 Hematologic Supportive Care (Plasma, Blood Cells, or Cytokines)

Number of Participants With Concomitant Medication Usage

Participants received bendamustine hydrochloride administered at 120 milligrams (mg)/square meter (m\^2) intravenously (IV) as a 60-minute infusion, and not more than 120 minutes, on Days 1 and 2 in each 21-day treatment cycle for 6 planned cycles and up to 8 total cycles.

Spots Global Cancer Trial Database for treanda®

Every month we try and update this database with for treanda® cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for treanda®

Every month we try and update this database with for treanda® cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for treanda® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.