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

CTTQ

Status and phase: Completed; Phase 2

Conditions: Indolent B-Cell Non-Hodgkin's Lymphomas

Treatments: Drug: Bendamustine hydrochloride injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT04569838

BDMS-C10IICS-PRT

Details and patient eligibility

About

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.

Enrollment: 91 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Inert lymphoma, including follicular lymphoma (FL), extranodal marginal zone B-cell lymphomas of the mucosa-associated lymphoid tissue (MALT), lymphoplasmacytic lymphoma, mantle cell lymphoma, small lymphocyte B-cell lymphoma and chronic lymphoblastic leukemia (CLL).

  2. At least one measurable lesion with the longest diameter > 1.5 cm and the short diameter > 1.0 cm, or the peripheral blood B lymphocyte ≥ 5.0×109/L.

  3.Adequate laboratory indicators. 4. Has received one to three chemotherapy regimens (with or without rituximab) before enrollment.

  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.

  6. Understood and signed an informed consent form.

Exclusion criteria

• 1. Patients who could not tolerate bendamustine treatment according to the investigators' judgment.

  2. Has received anti-tumor treatment (including major surgery) in the last 4 weeks.

  3. Transformed into high malignant lymphoma (secondary to low-grade follicular lymphoma); grade 3B follicular lymphoma.

  4. Has received corticosteroids regularly in the last 4 weeks. 5. Has a history of central nervous system disease or central nervous system disease.

  5. Has other tumors. 7. Has suffered from serious infection and other drugs or mental illness,which affects signing informed consent form and follow-up visit.

  6. Pregnant or breastfeeding women. 9. Has participated in other clinical trials within three months.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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91 participants in 1 patient group

Bendamustine hydrochloride injection

Experimental group

Description:

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.

Treatment:

Drug: Bendamustine hydrochloride injection