Thalidomide Combined With R-CHOP in Newly Diagnosed，Untreated Double-expressor Diffuse Large B-Cell Lymphoma Patients

NCT03318835 | Unknown Phase 3 DMC

• 1 other identifier: FDSCC LYM2017-01
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy of Thalidomide combined with R-CHOP(RT-CHOP) in newly diagnosed，untreated double-expressor Diffuse Large B-Cell Lymphoma patients (DLBCL)

Conditions

Thalidomide

Keywords

Thalidomide; R-CHOP; diffuse large B-cell lymphoma

Outcome Measures

Primary Outcomes (1)

• 3 year PFS

  3 year progression free survival

  3 years

Secondary Outcomes (3)

• ORR

  6 weeks，12 weeks，18weeks

• OS

  3 years

• adverse event

  throughout the treatment period，up to 6 months

Study Arms (2)

Thalidomide combined with R-CHOP

EXPERIMENTAL

rituximab 375 mg/m2,ivgtt D1 cyclophosphamide 750 mg/m2 iv D2 vincristine 1.4 mg/m2 \[capped at 2.0 mg\], iv D2 doxorubicin 50 mg/m2 iv D2 prednisone 100 mg/m2 per day PO D2-6 Thalidomide 200mg PO QN D1-21

Drug: Thalidomide combined with R-CHOP

R-CHOP

ACTIVE COMPARATOR

rituximab 375 mg/m2,ivgtt D1 cyclophosphamide 750 mg/m2 iv D2 vincristine 1.4 mg/m2 \[capped at 2.0 mg\], iv D2 doxorubicin 50 mg/m2 iv D2 prednisone 100 mg/m2 per day PO D2-6

Drug: R-CHOP

Interventions

Thalidomide combined with R-CHOP DRUG

rituximab 375 mg/m2,ivgtt D1 cyclophosphamide 750 mg/m2 iv D2 vincristine 1.4 mg/m2 \[capped at 2.0 mg\], iv D2 doxorubicin 50 mg/m2 iv D2 prednisone 100 mg/m2 per day PO D2-6 Thalidomide 200mg PO QN D1-21

Also known as: RT-CHOP

Thalidomide combined with R-CHOP

R-CHOP DRUG

rituximab 375 mg/m2,ivgtt D1 cyclophosphamide 750 mg/m2 iv D2 vincristine 1.4 mg/m2 \[capped at 2.0 mg\], iv D2 doxorubicin 50 mg/m2 iv D2 prednisone 100 mg/m2 per day PO D2-6

R-CHOP

Eligibility Criteria

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

You may qualify if:

• Age range ≥18 years old
• Eastern Cooperative Oncology Group performance status 0 to 2;
• Newly diagnosed, untreated, histological confirmed diffuse large B cell lymphoma, non-GCB subtype, and Myc≥40% as well as Bcl-2≥70% through immunohistochemistry；
• Measurable disease was defined as at least one lesion ≥1.5 cm in length-diameter and ≥0.5 cm in short-diameter by CT.
• Patients have written informed consent to participate in the study.
• Ultrasonic cardiogram showed left ventricle ejection fraction ≥ 50%, EKG showed on signs of myocardial ischemia, with no previous arrhythmia which need pharmacological intervention.
• White blood cell ≥ 3.5×109/L, absolute neutrophil count ≥ 1.5×109/L，platelet ≥ 80×109/L，hemoglobin ≥ 90 g/L
• total bilirubin \< 1.5×upper limit of normal(ULN), ALT and AST \< 1.5× ULN
• serum creatine \<1.5×ULN, and creatinine clearance rate (CCR) ≥ 30 ml/min

You may not qualify if:

• Presence of CNS involvement
• Particular kind of DLBCL，such as primary mediastinal/thymic B-cell lymphoma, elderly EBV positive DLBCL, primary cutaneous large B lymphoma.
• History of myocardial diseases, such as congenital heart disease, pericardial disease, heart failure, myocardial infarction, coronary heart disease, valvular heart disease, myocardosis, arrhythmia.
• History of severe chronic cutaneous diseases.
• History of allergic asthma or severe allergic diseases.
• Uncontrolled hypertension and diabetes.
• History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
• HIV, HCV, or syphilis infection；
• Presence of active HBV infection（HBV-DNA≥104）；
• Pregnant or lactating women
• Previously received organ transplant
• Having usage of Thalidomide；
• History of deep vein thrombosis
• Serious uncontrolled infection
• Having contraindications to the use of large doses of hormone, such as uncontrolled hyperglycemia, gastric ulcer, mental disorder.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

R-CHOP protocol

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

• Fang-Fang Lv

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fang-Fang Lv

CONTACT

18017312613; lvff80@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: October 11, 2017
• First Posted: October 24, 2017
• Study Start: August 22, 2017
• Primary Completion: August 22, 2020
• Study Completion: August 22, 2020
• Last Updated: October 24, 2017

Record last verified: 2017-10

Locations

CN (1)