Treatment of Elderly Patients With Diffuse Large B-cell Lymphoma

To explore the clinical features and efficacy evaluation of large b-cell lymphoma in old age.

Study Overview

• Status: Unknown
• Conditions: Diffuse Large B Cell Lymphoma
• Intervention / Treatment: Drug: (R)-CHOP regimen; Drug: (R)-CVP regimen

Detailed Description

The results of the analysis of the treatment of large b-cell lymphoma in old age were analyzed, and the treatment of large B cell lymphoma was provided.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450052
      • Recruiting
      • Oncology Department of The First Affiliated Hospital of Zhengzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years to 85 years (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Above 70 years old，Pathology proved to be diffuse large B cell lymphoma，Estimated survival time > 3 months，None of chemotherapy contraindication;At least one measurable lesion according to RECIST;None of other serious diseases;Patients could be followed up;None of other relative treatments including the traditional Chinese medicine, immunotherapy,biotherapy except anti-bone metastasis therapy and other symptomatic treatments.

volunteers who signed informed consent.

Exclusion Criteria:

• Currently undergoing chemotherapy, radiotherapy and targeted therapy (received chemotherapy within 3 weeks, received radiotherapy within 2 weeks, or has not recovered from any previous treatment of acute toxicity);Patients with uncontrolled medical problems (including active infection, uncontrolled diabetes, severe heart, liver, kidney dysfunction and interstitial pneumonia, etc.); Pregnant or lactating women;Serious medical illness likely to interfere with participation;Chemotherapy contraindication such as cachexia; patients with other malignancies previously;Serious infection;The evidence of peripheral nervous disorder or dysphrenia; patients estimated to be unsuitable by investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: (R)-CHOP regimen; (R)-CHOP regimen((rituximab)，cyclophosphamide，epirubicin，vincristine and prednisone)，(rituximab 375mg/m2 d0 ivgtt),cyclophosphamide 750mg/m2 d1、8 ivgtt,epirubicin 50mg/m2 d1、8 ivgtt,vincristine 2mg d1、8 ivgtt,prednisone 60mg d1-5 po.Every 21 days for one cycle and six cycles are required. Efficacy was evaluated every two cycles.	Drug: (R)-CHOP regimen; (rituximab 375mg/m2 d0 ivgtt),cyclophosphamide 750mg/m2 d1、8 ivgtt,epirubicin 50mg/m2 d1、8 ivgtt,vincristine 2mg d1、8 ivgtt,prednisone 60mg d1-5 po.Every 21 days for one cycle and six cycles are required. Efficacy was evaluated every two cycles.; Other Names: (rituximab)，CTX，VCR，EPI，PDN
EXPERIMENTAL: (R)-CVP regimen; (R)-CVP regimen((rituximab)，cyclophosphamide，vincristine and prednisone) The dose of the chemical was reduced by 20%，(rituximab 375mg/m2 d0 ivgtt),cyclophosphamide 750mg/m2 d1、8 ivgtt,vincristine 2mg d1、8 ivgtt,prednisone 60mg d1-5 po.Every 21 days for one cycle and one or two cycles are required. Efficacy was evaluated every two cycles. Subsequent (rituximab 375mg/m2 d0 ivgtt)， oral cyclophosphamide .	Drug: (R)-CVP regimen; The dose of the chemical was reduced by 20%，(rituximab 375mg/m2 d0 ivgtt),cyclophosphamide 750mg/m2 d1、8 ivgtt,vincristine 2mg d1、8 ivgtt,prednisone 60mg d1-5 po.Every 21 days for one cycle and one or two cycles are required. Efficacy was evaluated every two cycles. Subsequent (rituximab 375mg/m2 d0 ivgtt)， oral cyclophosphamide .; Other Names: (rituximab)，CTX，VCR，PDN,20 percent reduction in chemical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	Progression-free survival	up to end of follow-up-phase(approximately 24 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	overall survival	up to the date of death (approximately 5 years)
disease control rate	disease control rate	every 6 weeks,up to completion of treatment(approximately 18 weeks )]
objective remission rate	objective remission rate	every 6 weeks,up to completion of treatment(approximately 18 weeks )]

Collaborators and Investigators

• Sponsor: Mingzhi Zhang

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2017
• Primary Completion (ANTICIPATED): May 1, 2019
• Study Completion (ANTICIPATED): May 1, 2019

Study Registration Dates

• First Submitted: October 31, 2017
• First Submitted That Met QC Criteria: April 30, 2018
• First Posted (ACTUAL): May 1, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 1, 2018
• Last Update Submitted That Met QC Criteria: April 30, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: PFS; OS; Adverse reactions; Clinical characteristics; PR; Curative effect evaluation
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Rituximab
• Other Study ID Numbers: hnslblzlzx2017-10

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes