Safety and Efficacy Study of Bendamustine to Treat Non-Hodgkin Lymphoma

NCT01570049 | Unknown Phase 3 DMC

• 1 other identifier: RGB-NHL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine whether bendamustine HCl for injection is safe and effective in the treatment of Rituximab refractory or relapsed B-cell indolent lymphoma.

Conditions

Non-Hodgkin Lymphoma by Clinical Course

Keywords

Single arm; Open label; Bendamustine HCl; Non-hodgkin's lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR=CR+PR) of bendamustine hydrochloride in patients who are refractory to rituximab therapy.

  18 months

Secondary Outcomes (3)

• Safety profile of Bendamustine hydrochloride in this patient population

  18 months

• Progression free survival (PFS)

  18 months

• Overall survival (OS)

  18 months

Study Arms (1)

Bendamustine

EXPERIMENTAL

Dose of 120 mg/m2/day on Day 1 and Day 2 of each treatment cycle (every 21 days), to a maximum of 8 cycles.

Drug: Bendamustine

Interventions

Bendamustine DRUG

for injection

Bendamustine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 75 years
• B-cell indolent lymphoma proved by biopsy, exclude CLL/SLL
• Rituximab refractory or relapsed lymphoma patients
• At least 1 measurable tumor with shortest diameter being of \> 1.0cm and longest diameter being of \> 1.5cm
• ECOG PS ≤ 2
• Anticipated Survival is more than 3 months
• Hematopoietic function is normal during 14 days before enrollment (unless those abnormities related to lymphoma aggression), including: hemoglobin (Hb) ≥ 8.0g/dl (5.0mmol/L); absolute neutrophil count (ANC) ≥ 1.5X109/L; Platelet count (PLT) ≥ 80X109/L. Acceptable range for abnormities related to lymphoma aggression: Platelet count (PLT) ≥ 50X109/L; White blood cell count (WBC) ≥ 3.5X109/L; Absolute neutrophil count (ANC) ≥ 1.0X109/L
• Female subjects should not be pregnant and breast-feed, should have contraceptive method during the clinical trial and 12 months thereafter.
• Subject (or his/her legal representative) agrees to participate the trial and sign the informed consent form

You may not qualify if:

• Those who can not tolerate bendamustine treatment according to investigators view
• Transferred to high grade malignant lymphoma (from low grade follicular lymphoma)
• b grade follicular lymphoma
• With central nervous system diseases or medical history (e.g., central nervous system lymphoma or lymphoma related meningitis )
• With other anticancer treatment during the last 4 weeks
• Regularly administrated corticosteroid during the last 4 weeks, unless the dose is less or equivalent to 20mg/d prednisone
• Had tumors or have other tumors, not including non-melanoma skin cancers and cervical carcinoma in situ be treated properly
• Underwent surgical operation within 28 days before enrollment (exclude lymph node biopsy)
• Renal disfunction: serum creatinine is more than 1.5 times of upper limit of normal value
• Hepatic insufficiency: serum total bilirubin is \> 1.5 times of upper limit of normal value; AST, ALT is \> 2.5 times of upper limit of normal value
• Known HIV infection or HBV, HCV related active infections; HBsAg is positive; HBcAb is positive and virus copy number is \> 1000
• For patients with other severe medical diseases interfering with their participations of this study(e.g., infections and diabetes not controlled well, gastric ulcer, other lung diseases, active autoimmune diseases), the suitability of participation is judged by investigators
• Patients participated in other clinical studies and got medical treatments within 30 days prior to enrollment of this trial
• Other medical and psychological conditions that influence the patients participation or signing of informed consent form

Sponsors & Collaborators

• Shandong Lanjin Pharmaceuticals Co.,Ltd: lead

Study Sites (2)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Bendamustine Hydrochloride

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Huaqing Wang, master

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huaqing Wang, Master

CONTACT

+86-022-2334-0123

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2012
• First Posted: April 4, 2012
• Study Start: April 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 2, 2012

Record last verified: 2012-08

Locations

CN (2)