Treatment of Elderly Patients With Diffuse Large B-cell Lymphoma

NCT03513601 | Unknown Phase 4 FDA Drug

• 1 other identifier: hnslblzlzx2017-10
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diffuse Large B Cell Lymphoma

Keywords

Curative effect evaluation; Adverse reactions; Clinical characteristics; PR; PFS; OS

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Progression-free survival

  up to end of follow-up-phase(approximately 24 months)

Secondary Outcomes (3)

• overall survival

  up to the date of death (approximately 5 years)

• disease control rate

  every 6 weeks,up to completion of treatment(approximately 18 weeks )]

• objective remission rate

  every 6 weeks,up to completion of treatment(approximately 18 weeks )]

Study Arms (2)

(R)-CHOP regimen

EXPERIMENTAL

(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

(R)-CVP regimen

EXPERIMENTAL

(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

Interventions

(R)-CHOP regimen DRUG

(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.

Also known as: (rituximab)，CTX，VCR，EPI，PDN

(R)-CHOP regimen

(R)-CVP regimen DRUG

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 .

Also known as: (rituximab)，CTX，VCR，PDN,20 percent reduction in chemical therapy

(R)-CVP regimen

Eligibility Criteria

• Age: 70 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mingzhi Zhang: lead

Study Sites (1)

Oncology Department of The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Mingzhi zhang

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingzhi zhang, Pro,Dr

CONTACT

13838565629; Mingzhi_zhang@126.com

Mingzhi zhang

CONTACT

13838565629; Mingzhi_zhang@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: the director of oncology department of the first affiliated hospital

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: May 1, 2018
• Study Start: July 1, 2017
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: May 1, 2018

Record last verified: 2018-04

Locations

CN (1)