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Relapsed/Refractory Diffuse Large B-Cell LymphomaPhase 2NCT06601504

Study of HMPL-760 Plus R-GemOx Versus Placebo Plus R-GemOx in Relapsed/Refractory DLBCL

A Phase 2 study testing HMPL-760 planned dose 1, R-GemOx and HMPL-760 planned dose 2 in people with Relapsed/Refractory Diffuse Large B-Cell Lymphoma, run by Hutchmed at 16 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this study is to evaluate the efficacy of HMPL-760 in combination with R-GemOx versus placebo in combination with R-GemOx in patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
HMPL-760 planned dose 1, R-GemOx and HMPL-760 planned dose 2
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
61 participants
Where
16 sitesChina
Study dates
5 Nov 2024to 23 May 2026
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

  • Sign the Informed consent form(ICF) and be able to follow the requirements of study protocol;
  • Age ≥18 years;
  • Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2;
  • Histopathologically confirmed diagnosis of DLBCL;
  • The investigator judges that the patient's current condition requires further treatment;
  • Patients should have at least one bi-dimensionally measurable lesion;
  • Expected survival is more than 12 weeks;

Who cannot join

  • Patients with known primary or secondary central nervous system lymphoma (CNSL) or the presence of clinical symptoms suggestive of CNSL;
  • Women who are pregnant (positive pregnancy test during the screening period) or breastfeeding;
  • Organ insufficiency;
  • Currently known history of liver disease, including cirrhosis, alcoholic liver, known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV):
  • History of significant organ bleeding, including gastrointestinal bleeding, hematencephalon, haemoptysis, etc., within 8 weeks prior to the first dose of study drug;
  • Known risk of bleeding, such as coagulation factor deficiency, vascular hemophilia; or the patient is receiving vitamin K antagonist (warfarin);
  • Toxicities from prior anticancer therapy not resolved to Grade ≤ 1 (except for alopecia and decreased appetite);
  • Clinically significant active infection;

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

China16 sites

  • Hunan Cancer Hospital

    Changsha, Hunan

  • West China Hospital of Sichuan University

    Chengdu, Sichuan

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong

  • Harbin First Hospital

    Harbin, Heilongjiang

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang

  • Shandong Cancer Hospital & Institute

    Jinan, Shandong

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning

  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

    Tianjin, Tianjin Municipality

  • Wuhan Union Hospital of China

    Wuhan, Hebei

  • Henan Cancer Hospital

    Zhengzhou, Henan

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

Other trials in China

About this study

Official title: A Phase II Randomized, Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HMPL-760 Plus R-GemOx Versus Placebo Plus R-GemOx in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma(R/R DLBCL)

The goal of this study is to evaluate the efficacy of HMPL-760 in combination with R-GemOx versus placebo in combination with R-GemOx in patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL).

Read the detailed description

A Phase II Randomized, Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HMPL-760 in Combination with R-GemOx versus Placebo in Combination with R-GemOx in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL). The study phases include screening period, treatment period, safety observation period, PFS follow-up period, and OS follow-up period.

Being tested
HMPL-760 planned dose 1, R-GemOx, HMPL-760 placebo planned dose 1, HMPL-760 planned dose 2, HMPL-760 placebo planned dose 2
Keywords
R-GemOx, R/R DLBCL, HMPL-760
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

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

  • HMPL-760 planned dose 1Drug

    HMPL-760 planned dose 1 daily (QD) orally

  • R-GemOxDrug

    Also called Rituximab Injection, Gemcitabine Hydrochloride for Injection, Gemcitabine Hydrochloride for Injection

    R-GemOx regimen includes Rituximab Injection, Gemcitabine Hydrochloride for Injection, Gemcitabine Hydrochloride for Injection. R-GemOx regimen in 21-day cycle for a total of 6 cycles. Rituximab 375 mg/m^2 ivgtt is given on day 1 of each cycle, and gemcitabine 1000 mg/m^2 ivgtt is given, followed by oxaliplatin 100 mg/m^2 ivgtt on day 2 of each cycle.

  • HMPL-760 placebo planned dose 1Drug

    HMPL-760 placebo planned dose 1 daily (QD) orally

  • HMPL-760 planned dose 2Drug

    HMPL-760 planned dose 2 daily (QD) orally

  • HMPL-760 placebo planned dose 2Drug

    HMPL-760 placebo planned dose 2 daily (QD) orally

Study groups in NCT06601504
Study groupRoleWhat they receive
Group A: HMPL-760 planned dose 1 once daily (QD) in combination with R-GemOx regimenExperimentalGroup A: Patients will receive HMPL-760 planned dose 1 once daily (QD) orally from Cycle 1 Day 1 until disease progression(PD), patient death, intolerable toxicity, etc., in combination with R-GemOx regimen in 21-day cycle for a total of 6 cycles. Rituximab 375 mg/m^2 ivgtt is given on day 1 of each cycle, and gemcitabine 1000 mg/m^2 ivgtt is given, followed by oxaliplatin 100 mg/m^2 ivgtt on day 2 of each cycle.
Receives: Drug: HMPL-760 planned dose 1; Drug: R-GemOx
Group B: HMPL-760 placebo planned dose 1 once daily (QD) in combination with R-GemOx regimenPlacebo comparatorPatients will receive HMPL-760 placebo planned dose 1 once daily (QD) orally from Cycle 1 Day 1 until disease progression(PD), patient death, intolerable toxicity, etc., in combination with R-GemOx regimen in 21-day cycle for a total of 6 cycles. Rituximab 375 mg/m^2 ivgtt is given on day 1 of each cycle, and gemcitabine 1000 mg/m^2 ivgtt is given, followed by oxaliplatin 100 mg/m^2 ivgtt on day 2 of each cycle.
Receives: Drug: R-GemOx; Drug: HMPL-760 placebo planned dose 1
Group C: HMPL-760 planned dose 2 once daily (QD) in combination with R-GemOx regimenExperimentalPatients will receive HMPL-760 planned dose 2 once daily (QD) orally from Cycle 1 Day 1 until disease progression(PD), patient death, intolerable toxicity, etc., in combination with R-GemOx regimen in 21-day cycle for a total of 6 cycles. Rituximab 375 mg/m^2 ivgtt is given on day 1 of each cycle, and gemcitabine 1000 mg/m^2 ivgtt is given, followed by oxaliplatin 100 mg/m^2 ivgtt on day 2 of each cycle.
Receives: Drug: R-GemOx; Drug: HMPL-760 planned dose 2
Group D: HMPL-760 placebo planned dose 2 once daily (QD) in combination with R-GemOx regimenPlacebo comparatorPatients will receive HMPL-760 placebo planned dose 2 once daily (QD) orally from Cycle 1 Day 1 until disease progression(PD), patient death, intolerable toxicity, etc., in combination with R-GemOx regimen in 21-day cycle for a total of 6 cycles. Rituximab 375 mg/m^2 ivgtt is given on day 1 of each cycle, and gemcitabine 1000 mg/m^2 ivgtt is given, followed by oxaliplatin 100 mg/m^2 ivgtt on day 2 of each cycle.
Receives: Drug: R-GemOx; Drug: HMPL-760 placebo planned dose 2

What is being measured

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

  1. Progression-free survival (PFS)

    Progression-free survival (PFS): Efficacy is evaluated using the Lugano Efficacy Evaluation Criteria for Malignant Lymphoma (Cheson 2014).

    Measured: Up to approximately 2 years

Secondary outcomes (13)

  1. Objective Response Rate (ORR)

    Objective Response Rate (ORR) is defined as the ratio of patients who reached complete response (CR) or partial response (PR), as assessed by investigator.

    Measured: Up to approximately 2 years

  2. Complete response (CR) rate

    Complete response (CR) rate is defined as the ratio of patients with who reached complete response (CR), as assessed by investigator.

    Measured: Up to approximately 2 years

  3. Duration of response (DoR)

    For patients who reached complete response (CR) or partial response (PR), Duration of Response (DoR) is defined as the time from the first CR or PR until disease progression or death due to any cause, whichever occurs first, as assessed by investigator.

    Measured: Up to approximately 2 years

  4. Clinical benefit rate (CBR)

    Defined as the ratio of patients with complete response (CR), partial response (PR), or stable disease (SD).

    Measured: Up to approximately 2 years

  5. Time to response (TTR)

    Time To Response (TTR) is defined as the time from the start of treatment to the first objective response rate (ORR), as assessed by investigator.

    Measured: Up to approximately 2 years

  6. Overall survival (OS)

    Overall Survival (OS) is defined as the time from randomization to death due to any cause.

    Measured: Up to approximately 2 years

  7. Safety Endpoints of adverse events

    Incidence and severity of treatment-emergent adverse events (TEAEs), incidence of serious adverse events (SAEs), incidence of TEAEs leading to permanent discontinuation, dose interruption, and dose reduction, and their correlation to study drug. The severity is determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE 5.0).

    Measured: Up to approximately 2 years

  8. Pharmacokinetic(PK) profile of HMPL-760 in combination with R-GemOx

    Trough plasma concentration (Ctrough) of drug

    Measured: At the end of Cycle 7 (each cycle is 21 days)

  9. Pharmacokinetic(PK) profile of HMPL-760 in combination with R-GemOx

    Maximum observed concentration, occurring at time Tmax at steady-state (Cmax,ss) of drug

    Measured: At the end of Cycle 7 (each cycle is 21 days)

  10. Pharmacokinetic(PK) profile of HMPL-760 in combination with R-GemOx

    Time of maximum observed concentration at steady-state(Tmax,ss) of drug

    Measured: At the end of Cycle 7 (each cycle is 21 days)

  11. Pharmacokinetic(PK) profile of HMPL-760 in combination with R-GemOx

    The partial area from dosing time to dosing time plus Tau at steady-state (AUCss) of drug

    Measured: At the end of Cycle 7 (each cycle is 21 days)

  12. Pharmacokinetic(PK) profile of HMPL-760 in combination with R-GemOx

    Apparent clearance at steady-state (CLss/F) of drug (if applicable)

    Measured: At the end of Cycle 7 (each cycle is 21 days)

  13. Pharmacokinetic(PK) profile of HMPL-760 in combination with R-GemOx

    Apparent volume of distribution at steady-state (Vz,ss/F) of drug (if applicable)

    Measured: At the end of Cycle 7 (each cycle is 21 days)

Timeline

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

  1. First posted19 Sep 2024
  2. Study start5 Nov 2024
  3. Primary completion23 May 2026
  4. Study completion23 May 2026

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06601504
Sponsor's protocol ID
2024-760-00CH1
Status last verified
Sep 2026
First submitted
8 Sep 2024
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HMPL-760 planned dose 1, R-GemOx and HMPL-760 planned dose 2 in people with Relapsed/Refractory Diffuse Large B-Cell Lymphoma, run by Hutchmed at 16 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 7 inclusion and 8 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: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: Up to approximately 2 years). 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 NCT06601504.

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 24 Sep 2026.

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