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

NCT03795571 | Unknown Phase 1

• 1 other identifier: R2-GOD regimen
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diffuse Large B-cell Lymphoma Recurrent; Diffuse Large B Cell Lymphoma Refractory

Keywords

lenalidomide; R-GOD; DLBCL

Outcome Measures

Primary Outcomes (1)

• maximum tolerated dose and dose limited toxicity

  28 days after first cycle of R2-GOD regimen

Secondary Outcomes (3)

• Overall response rate,

  6 months

• Progressive free survival

  2 years

• Overall survival

  2 years

Study Arms (1)

R2-GOD

EXPERIMENTAL

Drug: Rituximab; Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Dexamethasone; Drug: Lenalidomide Oral Capsule

Interventions

Rituximab DRUG

Rituximab 375mg/m2，d0

R2-GOD

Gemcitabine DRUG

Gemcitabine 1000mg/m2，d1，d5

R2-GOD

Oxaliplatin DRUG

Oxaliplatin 75mg/m2，d1

R2-GOD

Dexamethasone DRUG

Dexamethasone 40mg/d，d1\~d4

R2-GOD

Lenalidomide Oral Capsule DRUG

Lenalidomide 10mg/d、15mg/d、20mg/d、25mg/d d1\~d10； 21days a cycle

R2-GOD

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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 1.5×10⁹/L or platelet count less than 75×10⁹/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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 24661044 BACKGROUND

• Martin A, Redondo AM, Dlouhy I, Salar A, Gonzalez-Barca E, Canales M, Montes-Moreno S, Ocio EM, Lopez-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.

  PMID: 26847165 BACKGROUND

• 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.

  PMID: 25267740 BACKGROUND

• 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.

  PMID: 29752199 BACKGROUND

MeSH Terms

Interventions

Rituximab; Gemcitabine; Oxaliplatin; Dexamethasone; Lenalidomide

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Wei Xu, PhD& MD

  The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huayuan Zhu, PhD& MD

CONTACT

86 25 68306034; huayuan.zhu@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 1, 2019
• First Posted: January 7, 2019
• Study Start: January 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

CN (1)