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

Primary Purpose

Thalidomide

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Thalidomide combined with R-CHOP

R-CHOP

About this trial

This is an interventional treatment trial for Thalidomide focused on measuring Thalidomide, R-CHOP, diffuse large B-cell lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.
Severe neurol of mental illness, including dementia and epilepsy.

Sites / Locations

Fudan University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Thalidomide combined with R-CHOP

R-CHOP

Arm Description

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

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

Outcomes

Primary Outcome Measures

3 year PFS

3 year progression free survival

Secondary Outcome Measures

ORR

overall response rate

overall survival

adverse event

adverse event related to treatment

Full Information

NCT ID

NCT03318835

First Posted

October 11, 2017

Last Updated

October 20, 2017

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT03318835

Brief Title

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

Official Title

An Randomized, Open-label, Phase III Study Comparing Thalidomide Combined With R-CHOP and R-CHOP in Newly Diagnosed Double-expressor Diffuse Large B-Cell Lymphoma Patients

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Unknown status

Study Start Date

August 22, 2017 (Actual)

Primary Completion Date

August 22, 2020 (Anticipated)

Study Completion Date

August 22, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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)

Detailed Description

Double expressor lymphoma is a subtype of diffuse large B-cell lymphoma defined as having increased expression of MYC and BCL-2 and/or BCL-6 by immunohistochemistry. Patients with double-expressor lymphomas have a poor prognosis when treated with standard chemoimmunotherapy and have increased risk of progression and recurrence. The investigators conducted this study to evaluate the efficacy of Thalidomide combined with R-CHOP(RT-CHOP) in newly diagnosed double-expressed, untreated Diffuse Large B-Cell Lymphoma patients (DLBCL). Thalidomide is a kind of glutamate derivatives, which can inhibit angiogenesis by blocking bFGF and VEGF, and it can also modulate the immune system by co-stimulating T cell proliferation. In addition, thalidomide can also inhibit the IKK activity and block the activation of NF-kB. In this open-label, randomized, phase III study, we are aiming to compare Thalidomide combined with R-CHOP(RT-CHOP) and R-CHOP in newly diagnosed double-expressor Diffuse Large B-Cell Lymphoma patients (DLBCL), in order to find a potential promising way to treat this subtype of lymphoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thalidomide

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

162 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Thalidomide combined with R-CHOP

Arm Type

Experimental

Arm Description

Arm Title

R-CHOP

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Thalidomide combined with R-CHOP

Other Intervention Name(s)

RT-CHOP

Intervention Description

Intervention Type

Drug

Intervention Name(s)

R-CHOP

Intervention Description

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

Primary Outcome Measure Information:

Title

3 year PFS

Description

3 year progression free survival

Time Frame

3 years

Secondary Outcome Measure Information:

Title

ORR

Description

overall response rate

Time Frame

6 weeks，12 weeks，18weeks

Title

Description

overall survival

Time Frame

3 years

Title

adverse event

Description

adverse event related to treatment

Time Frame

throughout the treatment period，up to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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. Severe neurol of mental illness, including dementia and epilepsy.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fang-Fang Lv

Phone

18017312613

lvff80@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fang-Fang Lv

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fudan University Cancer Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

FangFang Lv

Phone

18017312613

lvff80@163.com

12. IPD Sharing Statement

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

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