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Status unknownNCT03795571R2-GODUpdated Feb 15, 2019

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

A Phase 1 interventional study of Rituximab and Gemcitabine in Diffuse Large B-cell Lymphoma Recurrent and Diffuse Large B Cell Lymphoma Refractory, sponsored by The First Affiliated Hospital with Nanjing Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-02-15.

Sponsored by The First Affiliated Hospital with Nanjing Medical University · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

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Conditions studied

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

Keywords

  • lenalidomide
  • R-GOD
  • DLBCL
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In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 12 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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 1.5×10⁹/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.
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    R2-GOD

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

Interventions

  • DrugRituximab

    Rituximab 375mg/m2，d0

  • DrugGemcitabine

    Gemcitabine 1000mg/m2，d1，d5

  • DrugOxaliplatin

    Oxaliplatin 75mg/m2，d1

  • DrugDexamethasone

    Dexamethasone 40mg/d，d1\~d4

  • DrugLenalidomide Oral Capsule

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

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What researchers measure

Primary outcomes

  1. maximum tolerated dose and dose limited toxicity

    Time frame: 28 days after first cycle of R2-GOD regimen

Secondary outcomes

  1. Overall response rate,

    overall response rate after treated by R-GemOx or R-miniCHOP overall response rate after treated by R2-GOD regimen regimen

    Time frame: 6 months

  2. 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

    Time frame: 2 years

  3. Overall survival

    from the date of inclusion to date of death, irrespective of cause

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital
    Nanjing, Jiangsu 210000, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 24661044 ↗
  • 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. PubMed 26847165 ↗
  • 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. PubMed 25267740 ↗
  • 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. PubMed 29752199 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03795571
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Responsible party
WEI XU (Professor, The First Affiliated Hospital with Nanjing Medical University) — Principal investigator
First posted
Jan 7, 2019
Start date
Jan 1, 2019
Primary completion
Dec 31, 2019 (estimated)
Completion
Dec 31, 2019 (estimated)
Last update
Feb 15, 2019

Study contacts

Huayuan Zhu, PhD& MD
Contact
huayuan.zhu@hotmail.com
86 25 68306034
Wei Xu, PhD& MD
principal investigator · The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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