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AzTrials

Diffuse Large B-cell Lymphoma RecurrentPhase 1R2-GODNCT03795571

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

A Phase 1 study testing Rituximab, Gemcitabine and Oxaliplatin in people with Diffuse Large B-cell Lymphoma Recurrent and Diffuse Large B Cell Lymphoma Refractory, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Rituximab, Gemcitabine and Oxaliplatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
1 Jan 2019to 31 Dec 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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）；
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  • 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

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

Huayuan Zhu, PhD& MD contact

86 25 68306034

huayuan.zhu@hotmail.com

China1 site, 1 recruiting

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

    Nanjing, Jiangsu, 210000

    Huayuan Zhu, PhD，MD, +86 68136034, huayuan.zhu@hotmail.com

    Recruiting

Other trials in China

About this study

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

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.

Being tested
Rituximab, Gemcitabine, Oxaliplatin, Dexamethasone, Lenalidomide Oral Capsule
Keywords
lenalidomide, R-GOD, DLBCL

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RituximabDrug

    Rituximab 375mg/m2，d0

  • GemcitabineDrug

    Gemcitabine 1000mg/m2，d1，d5

  • OxaliplatinDrug

    Oxaliplatin 75mg/m2，d1

  • DexamethasoneDrug

    Dexamethasone 40mg/d，d1~d4

  • Lenalidomide Oral CapsuleDrug

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

Study groups in NCT03795571
Study groupRoleWhat they receive
R2-GODExperimentalNot described
Receives: Drug: Rituximab; Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Dexamethasone; Drug: Lenalidomide Oral Capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. maximum tolerated dose and dose limited toxicity

    Measured: 28 days after first cycle of R2-GOD regimen

Secondary outcomes (3)

  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

    Measured: 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

    Measured: 2 years

  3. Overall survival

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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2019
  2. Study start1 Jan 2019
  3. Primary completion31 Dec 2019 (estimated)
  4. Study completion31 Dec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03795571
Sponsor's protocol ID
R2-GOD regimen
Acronym
R2-GOD
Status last verified
Feb 2019
First submitted
1 Jan 2019
Last updated
15 Feb 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Rituximab, Gemcitabine and Oxaliplatin in people with Diffuse Large B-cell Lymphoma Recurrent and Diffuse Large B Cell Lymphoma Refractory, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Huayuan Zhu, PhD& MD (86 25 68306034, huayuan.zhu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

maximum tolerated dose and dose limited toxicity (time frame: 28 days after first cycle of R2-GOD regimen). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03795571, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.

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