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

Sponsor
Fudan University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03318835
Collaborator
(none)
162
Enrollment
1
Location
2
Arms
36
Anticipated Duration (Months)
4.5
Patients Per Site Per Month

Study Details

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)

Condition or DiseaseIntervention/TreatmentPhase
Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
162 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Aug 22, 2017
Anticipated Primary Completion Date :
Aug 22, 2020
Anticipated Study Completion Date :
Aug 22, 2020

Arms and Interventions

ArmIntervention/Treatment
Experimental: Thalidomide combined with R-CHOP

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
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
Other Names:
  • RT-CHOP
  • Active Comparator: R-CHOP

    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
    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

    Outcome Measures

    Primary Outcome Measures

    1. 3 year PFS [3 years]

      3 year progression free survival

    Secondary Outcome Measures

    1. ORR [6 weeks,12 weeks,18weeks]

      overall response rate

    2. OS [3 years]

      overall survival

    3. adverse event [throughout the treatment period,up to 6 months]

      adverse event related to treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Age range ≥18 years old

    2. Eastern Cooperative Oncology Group performance status 0 to 2;

    3. Newly diagnosed, untreated, histological confirmed diffuse large B cell lymphoma, non-GCB subtype, and Myc≥40% as well as Bcl-2≥70% through immunohistochemistry;

    4. Measurable disease was defined as at least one lesion ≥1.5 cm in length-diameter and ≥0.5 cm in short-diameter by CT.

    5. Patients have written informed consent to participate in the study.

    6. Ultrasonic cardiogram showed left ventricle ejection fraction ≥ 50%, EKG showed on signs of myocardial ischemia, with no previous arrhythmia which need pharmacological intervention.

    7. White blood cell ≥ 3.5×109/L, absolute neutrophil count ≥ 1.5×109/L,platelet ≥ 80×109/L,hemoglobin ≥ 90 g/L

    8. total bilirubin < 1.5×upper limit of normal(ULN), ALT and AST < 1.5× ULN

    9. serum creatine <1.5×ULN, and creatinine clearance rate (CCR) ≥ 30 ml/min

    Exclusion Criteria:
    1. Presence of CNS involvement

    2. Particular kind of DLBCL,such as primary mediastinal/thymic B-cell lymphoma, elderly EBV positive DLBCL, primary cutaneous large B lymphoma.

    3. History of myocardial diseases, such as congenital heart disease, pericardial disease, heart failure, myocardial infarction, coronary heart disease, valvular heart disease, myocardosis, arrhythmia.

    4. History of severe chronic cutaneous diseases.

    5. History of allergic asthma or severe allergic diseases.

    6. Uncontrolled hypertension and diabetes.

    7. History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix

    8. HIV, HCV, or syphilis infection;

    9. Presence of active HBV infection(HBV-DNA≥104);

    10. Pregnant or lactating women

    11. Previously received organ transplant

    12. Having usage of Thalidomide;

    13. History of deep vein thrombosis

    14. Serious uncontrolled infection

    15. Having contraindications to the use of large doses of hormone, such as uncontrolled hyperglycemia, gastric ulcer, mental disorder.

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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Fudan University Cancer HospitalShanghaiShanghaiChina200032

    Sponsors and Collaborators

    • Fudan University

    Investigators

    • Principal Investigator: Fang-Fang Lv, Fudan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fangfang Lv, MD, principle investigator, Fudan University
    ClinicalTrials.gov Identifier:
    NCT03318835
    Other Study ID Numbers:
    • FDSCC LYM2017-01
    First Posted:
    Oct 24, 2017
    Last Update Posted:
    Oct 24, 2017
    Last Verified:
    Oct 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fangfang Lv, MD, principle investigator, Fudan University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 24, 2017