Trial of R-GemOx Versus R-miniCHOP Regimen in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma

Diffuse Large B Cell Lymphoma Clinical Trial

Official title:

Phase III,Randomized Controlled Trial of R-GemOx Versus R-miniCHOP Regimen in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02767674
• Other study ID #: JSPH-002
• Status: Recruiting
• Phase: Phase 3
• Start date: May 2016
• Est. completion date: December 2020

Study information

• Verified date: January 2019
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Huayuan Zhu, M.D., Ph.D.
• Phone: +86 68136034
• Email: huayuan.zhu[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate efficacy and safety of R-GemOx Versus R-miniCHOP as first-line treatment of elderly patients with Diffuse large B cell lymphoma

Description:

Gemcitabine and Oxaliplatin(GemOx) shows effective activity in patients with relapsed diffuse large-cell lymphoma and other solid tumors. Our Previous study showed that two-weekly regimen of rituximab combined with GemOx regimen acheived comparable response rate to R-miniCHOP.The investigators therefore design this open-label,phase III and random trial to compared the safety and efficacy of R-Gemox versus R-miniCHOP as first-line treatment of elderly patients with diffuse large B cell lymphoma.

Primary Outcome Measures:

• 2-year overall survival rate

Secondary Outcome Measures:

• 2-year progression free survival rate

• overall response rate

• safety and toxicity Enrollment:258 Study Start Date: June 2016 Primary Completion Date:

June 2019

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 258
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Histologically confirmed diffuse large B cell lymphoma(With exception of Primary mediastinal large B cell lymphoma?Primary central nervous system lymphoma?HIV-related lymphoma);

2. New-diagnosed and untreated;

3. Age older than 80 years or older than 70 years with ECOG PS = 2;

4. Ann Arbor stage I to stage IV disease;

5. Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

1. Poor hepatic and/or renal function, defined as total bilirubin, ALT, AST, Cr more than two fold of upper normal level, unless these abnormalities were related to the lymphoma;

2. Poor bone-marrow reserve, defined as neutrophil count less than 1.5×10?/L or platelet count less than 75×10?/L, unless caused by bone marrow infiltration;

3. Presence of Grade III nervous toxicity with two weeks;

4. New York Heart Association class III or IV cardiac failure; or Ejection fraction less than 50%;or history of following disease in past 6 months: acute coronary syndrome?acute heart failure?severe ventricular arrhythmia

5. Positive HIV, syphilis,HCV, or HBV virus load(HBV DNA)> 1×10'4copies/ml;

6. CNS or meningeal involvement;

7. Concomitant malignancy other than aggressive B cell lymphoma and need to Treat, with the exception of non-melanoma skin tumours or stage 0 (in situ) cervical carcinoma,or history of cancer more than 5 years;

8. Concomitant with other hematologic diseases(such as leukemia, hemophilia primary myelofibrosis) which investigator it unsuitable to be enrolled into this clinical trial;

9. Active and severe infectious diseases;

10. Major surgery within three weeks;

11. Any potential drug abuse, medical, psychological or social conditions which may disturb this investigation and assessment.

12. In any conditions which investigator considered ineligible for this study.

13. Known sensitivity or allergy to investigational Product.

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• Rituximab
375 mg/m2 IVD day0
• Gemcitabine
Gemcitabine 1 g/m2 IVD day 1
• Oxaliplatin
Oxaliplatin 100 mg/m2 IVD day1
• Cyclophosphamide
Cyclophosphamide 400 mg/m2 IVD d1
• Epirubicin Injectable Product
Epirubicin 35 mg/m2 IVD d1
• Vindesine
Vindesine 2 mg IVP d1
• Prednisone
Prednisone 40mg/m2 PO d1-5

Locations

Country	Name	City	State
China	QiLu Hospital of Shandong University	Jinan	Shandong
China	Shandong Province Hospital	Jinan	Shandong
China	The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)	NanJing	Jiangsu
China	Rui Jin Hospital Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Sudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Tongji Medical College of HUST	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (6)

Cabanillas F. Rituximab in DLBCL: 6 years on. Lancet Oncol. 2011 Oct;12(11):984-5. doi: 10.1016/S1470-2045(11)70251-0. Epub 2011 Sep 21. — View Citation

Coiffier B, Lepage E, Briere J, Herbrecht R, Tilly H, Bouabdallah R, Morel P, Van Den Neste E, Salles G, Gaulard P, Reyes F, Lederlin P, Gisselbrecht C. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cel — View Citation

López A, Gutiérrez A, Palacios A, Blancas I, Navarrete M, Morey M, Perelló A, Alarcón J, Martínez J, Rodríguez J. GEMOX-R regimen is a highly effective salvage regimen in patients with refractory/relapsing diffuse large-cell lymphoma: a phase II study. Eu — View Citation

Oyama T, Yamamoto K, Asano N, Oshiro A, Suzuki R, Kagami Y, Morishima Y, Takeuchi K, Izumo T, Mori S, Ohshima K, Suzumiya J, Nakamura N, Abe M, Ichimura K, Sato Y, Yoshino T, Naoe T, Shimoyama Y, Kamiya Y, Kinoshita T, Nakamura S. Age-related EBV-associat — View Citation

Park S, Lee J, Ko YH, Han A, Jun HJ, Lee SC, Hwang IG, Park YH, Ahn JS, Jung CW, Kim K, Ahn YC, Kang WK, Park K, Kim WS. The impact of Epstein-Barr virus status on clinical outcome in diffuse large B-cell lymphoma. Blood. 2007 Aug 1;110(3):972-8. Epub 200 — View Citation

Peyrade F, Jardin F, Thieblemont C, Thyss A, Emile JF, Castaigne S, Coiffier B, Haioun C, Bologna S, Fitoussi O, Lepeu G, Fruchart C, Bordessoule D, Blanc M, Delarue R, Janvier M, Salles B, André M, Fournier M, Gaulard P, Tilly H; Groupe d'Etude des Lymph — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-year overall survival rate	from the date of inclusion to date of death, irrespective of cause	One year
Secondary	2-year progression free survival rate	from date of inclusion to date of progression, relapse, or death from any causePFS:from date of inclusion to date of progression, relapse, or death from any cause	One year
Secondary	overall response rate	overall response rate after treated by R-GemOx or R-miniCHOP overall response rate after treated by R-GemOx or R-miniCHOP regimen	One year