Lenalidomide, Rituximab, Gemcitabine, Oxaliplatin and Dexamethasone in Relapse and Refractory DLBCL

Diffuse Large B-cell Lymphoma Recurrent Clinical Trial

— R2-GOD  

Official title:

Lenalidomide, Rituximab, Gemcitabine, Oxaliplatin and Dexamethasone (R2-GOD) in Treatment of Relapse/Refractory DLBCL:A Phase I Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03795571
• Other study ID #: R2-GOD regimen
• Status: Recruiting
• Phase: Phase 1
• Start date: January 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2019
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Huayuan Zhu, PhD& MD
• Phone: 86 25 68306034
• Email: huayuan.zhu[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Previous study showed that Lenalidomide or R-GDP could achieve response in Relapse and Refractory DLBCL.The investigators therefore design this phase I study to investigate the safety and efficacy of R2-GOD in relapsed diffuse large-cell lymphoma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 18-65 years old;

• ECOG PS 0- 2;

• Histologically confirmed diffuse large B cell lymphoma(With exception of Primary mediastinal large B cell lymphoma?Primary central nervous system lymphoma?HIV-related lymphoma),relapse or refractory,defined as:

• relapse after standard first-line immunochemotherapy( R-CHOP or R-CHOP like)

• SD as best response after 4 cycles or PD after 2 cycles of first-line immunochemotherapy;

• a measurable or evaluable disease at the time of enrollment(diameter = 1.5cm);

• Eligible for subsequent autologous stem cell transplantation;

• Female subjects in childbearing age, their serum or urine pregnancy test must be negative. All patients must agree to take effective contraceptive measures during the trial measures

• Expected survival = 12 weeks;

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

Exclusion Criteria:

• Women who are pregnant or lactating. Patients have breeding intent in 12 months or cannot take effective contraceptive measures during the trial measures;

• Uncontrollable active infection within four week. Prophylactic antibiotic, antiviral and antifungal treatment is permissible. Active hepatitis B or hepatitis C virus infection, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV-infected persons;

• Used of systemic anti-tumor treatment within four weeks;

• CNS or meningeal involvement;

• Poor hepatic and/or renal function, defined as total bilirubin, ALT, AST, Cr more than two fold of upper normal level,Ccr< 50 mL/min unless these abnormalities were related to the lymphoma;

• 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;

• 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;

• Known sensitivity or allergy to investigational Product;

• Major surgery within three weeks;

• Presence of Grade III nervous toxicity within past two weeks;

• Active and severe infectious diseases;

• History of DVT or PE within past 12 months;

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

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

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma Refractory
• Diffuse Large B-cell Lymphoma Recurrent
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• Rituximab
Rituximab 375mg/m2,d0
• Gemcitabine
Gemcitabine 1000mg/m2,d1,d5
• Oxaliplatin
Oxaliplatin 75mg/m2,d1
• Dexamethasone
Dexamethasone 40mg/d,d1~d4
• Lenalidomide Oral Capsule
Lenalidomide 10mg/d?15mg/d?20mg/d?25mg/d d1~d10; 21days a cycle

Locations

Country	Name	City	State
China	The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (4)

Crump M, Kuruvilla J, Couban S, MacDonald DA, Kukreti V, Kouroukis CT, Rubinger M, Buckstein R, Imrie KR, Federico M, Di Renzo N, Howson-Jan K, Baetz T, Kaizer L, Voralia M, Olney HJ, Turner AR, Sussman J, Hay AE, Djurfeldt MS, Meyer RM, Chen BE, Shepherd LE. Randomized comparison of gemcitabine, dexamethasone, and cisplatin versus dexamethasone, cytarabine, and cisplatin chemotherapy before autologous stem-cell transplantation for relapsed and refractory aggressive lymphomas: NCIC-CTG LY.12. J Clin Oncol. 2014 Nov 1;32(31):3490-6. doi: 10.1200/JCO.2013.53.9593. Epub 2014 Sep 29. — View Citation

Feldman T, Mato AR, Chow KF, Protomastro EA, Yannotti KM, Bhattacharyya P, Yang X, Donato ML, Rowley SD, Carini C, Valentinetti M, Smith J, Gadaleta G, Bejot C, Stives S, Timberg M, Kdiry S, Pecora AL, Beaven AW, Goy A. Addition of lenalidomide to rituximab, ifosfamide, carboplatin, etoposide (RICER) in first-relapse/primary refractory diffuse large B-cell lymphoma. Br J Haematol. 2014 Jul;166(1):77-83. doi: 10.1111/bjh.12846. Epub 2014 Mar 25. — View Citation

Martín A, Redondo AM, Dlouhy I, Salar A, González-Barca E, Canales M, Montes-Moreno S, Ocio EM, López-Guillermo A, Caballero D; Spanish Group for Lymphomas and Autologous Bone Marrow (GELTAMO). Lenalidomide in combination with R-ESHAP in patients with relapsed or refractory diffuse large B-cell lymphoma: a phase 1b study from GELTAMO group. Br J Haematol. 2016 Apr;173(2):245-52. doi: 10.1111/bjh.13945. Epub 2016 Feb 5. — View Citation

Shen QD, Zhu HY, Wang L, Fan L, Liang JH, Cao L, Wu W, Xia Y, Li JY, Xu W. Gemcitabine-oxaliplatin plus rituximab (R-GemOx) as first-line treatment in elderly patients with diffuse large B-cell lymphoma: a single-arm, open-label, phase 2 trial. Lancet Haematol. 2018 Jun;5(6):e261-e269. doi: 10.1016/S2352-3026(18)30054-1. Epub 2018 May 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximum tolerated dose and dose limited toxicity		28 days after first cycle of R2-GOD regimen
Secondary	Overall response rate,	overall response rate after treated by R-GemOx or R-miniCHOP overall response rate after treated by R2-GOD regimen regimen	6 months
Secondary	Progressive free survival	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	2 years
Secondary	Overall survival	from the date of inclusion to date of death, irrespective of cause	2 years