Dose-adjusted EPOCH-R in MYC Positive DLBCL

NCT01914718 | Terminated Phase 2

• 1 other identifier: LMTG 13-02
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the efficacy and toxicity of dose-adjusted EPOCH-R in patients with MYC positive diffuse large B-cell lymphoma.

Conditions

Diffuse Large B-cell Lymphoma

Keywords

DLBCL; DA-EPOCH-R

Outcome Measures

Primary Outcomes (1)

• 3-year progression-free survival

  3 years

Secondary Outcomes (3)

• Objective response rate

  4 months

• 3-year overall survival

  3 years

• Toxicity

  6 months

Study Arms (1)

DA-EPOCH-R

EXPERIMENTAL

rituximab 375mg/m2 IV day 0, etoposide 50mg/m2/d CIV days 1-4, doxorubicin 10mg/m2/d CIV days 1-4, vincristine 0.4mg/m2/d CIV days 1-4, cyclophosphamide 750mg/m2 IV day 5, prednisone 50mg PO days 1-5 twice per day

Drug: DA-EPOCH-R

Interventions

DA-EPOCH-R DRUG

rituximab 375mg/m2 IV day 0, etoposide 50mg/m2/d CIV days 1-4, doxorubicin 10mg/m2/d CIV days 1-4, vincristine 0.4mg/m2/d CIV days 1-4, cyclophosphamide 750mg/m2 IV day 5, prednisone 50mg PO days 1-5 twice per day

Also known as: mabthera

DA-EPOCH-R

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previously untreated MYC positive diffuse large B-cell lymphoma
• Age range 18-70 years old
• Eastern Cooperative Oncology Group performance status 0-2
• Life expectancy of more than 3 months
• Adequate organ function

You may not qualify if:

• Primary or secondary central nervous system involvement
• Previous serious cardiac disease
• History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
• Pregnant or lactating women
• Serious uncontrolled diseases and intercurrent infection

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Rituximab

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Ye Guo, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 2, 2013
• First Posted: August 2, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2017
• Last Updated: August 20, 2014

Record last verified: 2014-08

Locations

CN (1)