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DLBCLPhase 2O-GemoxNCT05381506

Study of Orelabrutinib in Combination With Gemox in Refractory / Relapsed Diffuse Large B-cell Lymphoma

A Phase 2 study testing Orelabrutinib and Gemox in people with DLBCL, run by Sun Yat-sen University at 8 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study aims to investigate the treatment of refractory or relapsed DLBCL with orelabrutinib and gemox. The primary endpoint is response rate (complete response rate and overall response rate), and the second endpoints are survival time (OS and PFS) and toxicities. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
DLBCL
What is being tested?
Orelabrutinib and Gemox
Could I receive a placebo?
No, everyone receives an active treatment
How many people
77 participants
Where
8 sitesChina
Study dates
Jul 2022to Dec 2025
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed relapsed or refractory Diffuse Large B-cell Lymphoma. There must be at least one evaluate able or measurable lesion that meets the Lugano criteria
  • Age beyond18 years old;
  • ECOG performance status 0-2.
  • Estimated survival time > 12 weeks.
  • Adequate first-line treatment with CD20-containing monoclonal antibody
  • DLBCL patients confirmed as non-GCB by Han's classification
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  • The main organs function well, namely, the following requirements were met one week before admission: Blood routine ANC ≥ 1.5×109/L, Hb ≥ 100g/L and PLT ≥ 100×109/L; liver function were normal (total bilirubin ≤1.5×ULN, ALT and AST ≤ 2.5×ULN), renal function was normal (serum creatinine ≤1×upper limitation of normal (ULN)), and without abnormal coagulation function.
  • Pregnant women of childbearing age must have a pregnancy test (serum or urine) within 14 days before enrollment and the result is negative, and they are willing to use reliable methods of contraception during the test.
  • The subjects who volunteer to join the study and sign the informed consent form, have good compliance and cooperate with the follow-up.

Who cannot join

  • Patients with central nervous system involvement
  • Patients with Myc gene and BCL2/BCL6 gene rearrangement at the same time;
  • Patients who have received BTK inhibitor therapy in the past;
  • Patients who have received Gemox or GDP chemotherapy in the past;
  • History of other malignancy within the last 5 years prior to enrollment, except for cured basal cell carcinoma of skin, cervix in situ carcinoma and superficial bladder cancer;
  • Suffering from the following cardiovascular diseases: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia (including QTc interval ≥ 450 ms for men and ≥ 470 ms for women); according to NYHA standards, grades III to IV cardiac function Incomplete, or echocardiography showed left ventricular ejection fraction (LVEF) <50%;
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  • Abnormal coagulation function (INR>1.5 or prothrombin time (PT)>ULN+4 seconds or APTT>1.5 ULN), with bleeding tendency or receiving thrombolysis or anticoagulation therapy;
  • Arterial/venous thrombotic events, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism, that occurred within 12 months before enrollment;
  • Known hereditary or acquired bleeding and thrombotic tendencies (such as hemophiliacs, coagulation disorders, thrombocytopenia, hypersplenism, etc.);
  • Received major surgical operation or suffered severe traumatic injury, fracture or ulcer within 4 weeks of enrollment;
  • There are factors that obviously affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea and intestinal obstruction;
  • Active infection requires antimicrobial treatment (for example, antibiotics and antiviral drugs are required, excluding chronic hepatitis B, anti-hepatitis B treatment, and antifungal drug treatment);
  • Active hepatitis B (HBV DNA ≥ 2000IU/mL or 104 copies/mL) or hepatitis C (positive hepatitis C antibody, and HCV RNA is higher than the detection limit of the analytical method);
  • Those who have a history of psychotropic substance abuse and cannot quit or have mental disorders;
  • Participated in clinical trials of other anti-tumor drugs within 4 weeks before enrollment;
  • Received strong CYP3A4 inhibitor treatment within 7 days before enrollment, or received strong CYP3A4 inducer treatment within 12 days before participating in the study;
  • Pregnant or breastfeeding women; fertile patients who are unwilling or unable to take effective contraceptive measures;
  • The investigator judges other circumstances that may affect the conduct of clinical research and the judgment of research results.

Trial locations and contacts

8 sites in 1 country.

Zhiming Li, Dr. contact

+86-020-87343765

lizhm@sysucc.org.cn

8 sites in 1 country

China8 sites

  • Hunan Cancer Hospital

    Changsha, Hunan

    Hui Zhou

  • West China Hospital.Sichuan University

    Chengdu, Sichuan

    Liqun Zou

  • Chongqing Cancer Hospital

    Chongqing, Chongqing Municipality

    Yao Liu

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

    Haiyan Yang

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan

    Zeping Zhou

  • Guangxi Medical University Cancer Hospital

    Naning, Guangxi

    Hong Cen

  • Tianjin Medical University Cancer Hospital

    Tianjin, Tianjin Municipality

    Huilai Zhang

  • Hubei Cancer Hospital

    Wuhan, Hubei

    Huijing Wu

Other trials in China

About this study

Official title: A Phase II, Prospective, Multicenter Study Ofrelabrutinib in Combination With Gemox in Refractory / Relapsed Diffuse Large B-cell Lymphoma

This study aims to investigate the treatment of refractory or relapsed DLBCL with orelabrutinib and gemox. The primary endpoint is response rate (complete response rate and overall response rate), and the second endpoints are survival time (OS and PFS) and toxicities.

Conditions
DLBCL
Being tested
Orelabrutinib and Gemox
Keywords
Orelabrutinib, Gemox

What participants receive

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

  • Orelabrutinib and GemoxDrug

    Also called O-Gemox

    Drug: Orelabrutinib Orelabrutinib 200mg, po, qd

    Drug: Gemox14 Gemcitabine, Oxaliplatin

Study groups in NCT05381506
Study groupRoleWhat they receive
Orelabrutinib and GemoxExperimentalOrelabrutinib and Gemox for 6 cycles
Receives: Drug: Orelabrutinib and Gemox

What is being measured

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

  1. Overall response rate

    overall response rate after treated by Orelabrutin and Gemox

    Measured: 12 weeks after the initiation of the treatment

Secondary outcomes (4)

  1. Progression Free Survival (PFS)

    PFS was defined as time from study registration to first disease progression or death whichever occurred first, otherwise subject data were censored at time last known disease free

    Measured: Up to two years after the start of the study

  2. Overall Survival (OS)

    OS was defined as time from study registration to death, and otherwise censored at time last known alive

    Measured: Up to two years after the start of the study

  3. Duration of Response（DOR）

    The time from the first assessment of CR or PR to PD (progressive disease) or death from any cause

    Measured: Up to three years after the start of the study

  4. Adverse events

    All the adverse events of the patients related will be assessed and graded by NCI CTCAE v5.0

    Measured: Up to one year after the start of the study

Timeline

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

  1. First posted19 May 2022
  2. Study startJul 2022 (estimated)
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2025 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
77 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05381506
Sponsor's protocol ID
2022-FXY-102-内科
Acronym
O-Gemox
Status last verified
May 2022
First submitted
15 May 2022
Last updated
8 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Orelabrutinib and Gemox in people with DLBCL, run by Sun Yat-sen University at 8 sites 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 9 inclusion and 18 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 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Zhiming Li, Dr. (+86-020-87343765, lizhm@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (time frame: 12 weeks after the initiation of the treatment). 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 NCT05381506.

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 8 Jul 2022.

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