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DLBCLPhase 2NCT06569485

A Study of Trilaciclib Combined With Chemotherapy in the Treatment of Diffuse Large B-Cell Lymphoma Patients

A Phase 2 study testing Trilaciclib+R-CHOP in people with DLBCL, run by Sun Yat-sen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a prospective, single-arm, multi-center, phase II clinical study to evaluate the efficacy and safety of Trilaciclib in DLBCL patients treated with R-CHOP. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
DLBCL
What is being tested?
Trilaciclib+R-CHOP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteChina
Study dates
23 May 2024to 1 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Having sufficient understanding of this study and being willing to sign the informed consent form (ICF);
  • Age above 18 years old (including 18 years old)，regardless of gender;
  • Treatment-naive, histologically confirmed DLBCL, at least one tumor lesion that could be measured accurately at baseline according to RECIST1.1 criteria;
  • IPI score 0-2;
  • ECOG score of 0-2；
  • No prophylactic G-CSF, TPO, IL-11, ESA, iron within 1 week of screening hematology test, and no platelet transfusion or blood transfusion；
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  • Estimated survival greater than 3 months；
  • Adequate organ function；
  • Being willing and able to comply with the visits, treatment plan, laboratory examinations and other study procedures scheduled in the study;
  • Women of childbearing potential must undergo a serum pregnancy test within 3 days prior to the first dose and the result must be negative. Female patients of childbearing potential and male subjects whose partners are women of childbearing potential must agree to use highly effective contraceptive methods during the study period and within 3 months after the last dose of study drug.

Who cannot join

  • The subject is participating in other interventional clinical studies;
  • The subject has previous or concurrent other malignancies;
  • Lymphoma bone marrow invasion;
  • The presence of symptomatic brain metastases requiring immediate radiotherapy or steroid therapy;
  • Known hypersensitivity to the applied drugs or any excipients；
  • Previous hematopoietic stem cell or bone marrow transplantation；
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  • Active infection requiring systemic treatment;
  • Patients with uncontrolled cardiac clinical symptoms or diseases;
  • The subject has severe active infection or unexplained fever > 38.5 degrees during screening or before the first dose (the subject can be enrolled due to tumor fever as judged by the investigator);
  • Radiotherapy or radiotherapy at any site within 2 weeks before study medication;
  • Any investigational drug within 4 weeks before study medication;
  • Live attenuated vaccine within 4 weeks before study medication or possibly during the study period, influenza vaccine can be administered during the influenza season;
  • Pregnant or lactating women;
  • Any reasons that the investigator believes that it should be excluded from this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

  • Department of Medical Oncology, Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Zhiming Li, MD, +86-13719189172, lizhm@sysucc.org.cn

    Recruiting

Other trials in China

About this study

Official title: Phase 2 Study Evaluating Efficacy and Safety of Trilaciclib In Diffuse Large B-Cell Lymphoma Patients Receiving The Standard Chemotherapy R-CHOP.

This is a prospective, single-arm, multi-center, phase II clinical study to evaluate the efficacy and safety of Trilaciclib in DLBCL patients treated with R-CHOP.

Read the detailed description

This is a prospective, single-arm, multi-center, phase II clinical study to investigate the myeloprotection efficacy, antitumor efficacy, and safety of Trilaciclib in DLBCL patients treated with R-CHOP (rituximab, cyclophosphamide, doxorubicin or Epirubicin, vincristine, and prednisone). 38 eligible subjects who met the inclusion criteria were screened and given a treatment regimen of Trilaciclib before chemotherapy R-CHOP, after signing informed consent. The incidence of Grade ≥ 3 neutropenia was used as the primary endpoint to observe whether Trilaciclib could reduce the occurrence or degree of chemotherapy-induced myelosuppression (CIM). Researchers will monitor potential adverse events (AEs) throughout the entire trial and grade the severity of adverse events according to the guidelines of the National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) 5.0.

Conditions
DLBCL
Being tested
Trilaciclib+R-CHOP

What participants receive

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

  • Trilaciclib+R-CHOPDrug

    Also called G1T28

    This is a prospective, single-arm, multi-center, phase II clinical study to evaluate the efficacy and safety of Trilaciclib in DLBCL patients treated with R-CHOP.

Study groups in NCT06569485
Study groupRoleWhat they receive
Intervention/TreatmentExperimentalExperimental: Trilaciclib+R-CHOP Patients with DLBCL were treated with Trilaciclib (240mg/m2, d1, within 4 hours before each chemotherapy) combined with Rituximab (375 mg/m2，d0), Cyclophosphamide (50 mg/m2，d1), Doxorubicin (50 mg/m2，d1) or Epirubicin（60 mg/m2，d1）, Vincristine (1.4 mg/m2), and Prednisone (100 mg，d1-5). A total of 6 cycles of treatment were performed every 21 days as a cycle.
Receives: Drug: Trilaciclib+R-CHOP

What is being measured

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

  1. Occurrence of Grade 3/4 neutropenia

    Proportion of subjects with at least one absolute neutrophil count (ANC) < 1.0 × 10^9/L enrolled and treated with at least one dose of trilaciclib

    Measured: Up to 6 months

Secondary outcomes (13)

  1. ORR

    Objective Response Rate (ORR) is defined as the percentage of participants achieving complete response (CR) and partial response (PR) for tumor volume reduction and maintaining the minimum duration requirement based on RECIST v1.1

    Measured: Up to 6 months

  2. 2y-PFS

    Progression-free survival (PFS per RECIST 1.1) is defined as the time until the first imaging disease progression or death (whichever occurs first)

    Measured: Up to 2 years

  3. 2y-OS

    Overall survival (OS) is defined as the time until the subject's death due to any reason

    Measured: Up to 2 years

  4. Neutrophil-related myeloprotection efficacy

    Occurrence of febrile neutropenia adverse events(AEs)

    Measured: Up to 6 months

  5. Neutrophil-related myeloprotection efficacy

    Occurrence of Granulocyte colony-stimulating factor(G-CSF) administration

    Measured: Up to 6 months

  6. RBC related myeloprotection efficacy

    Occurrence of Grade 3/4 decrease of hemoglobin, occurrence and number of RBC transfusions on/after Week 5

    Measured: Up to 6 months

  7. RBC related myeloprotection efficacy

    Occurrence of erythropoiesis-stimulating agent(ESA) administration

    Measured: Up to 6 months

  8. Platelet related myeloprotection efficacy

    Occurrence of Grade 3/4 decrease of platelets

    Measured: Up to 6 months

  9. Platelet related myeloprotection efficacy

    Occurrence and number of platelet transfusions

    Measured: Up to 6 months

  10. Platelet related myeloprotection efficacy

    Occurrence of rhTPO/Recombinant human interleukin-11(rhIL-11) administration

    Measured: Up to 6 months

  11. Myeloprotection efficacy

    Hospitalization due to chemotherapy-induced myelosuppression

    Measured: Up to 6 months

  12. Chemotherapy dosing

    Chemotherapy dose reductions and delays due to chemotherapy-induced myelosuppression

    Measured: Up to 6 months

  13. Incidence of Treatment-Emergent Adverse Events

    To assess the effects of trilaciclib administered prior to chemotherapy on the occurrence and severity of adverse events by CTCAE 5.0, study treatment discontinuation due to adverse events, and trilaciclib adverse events of special interest.

    Measured: Up to 6 months

Timeline

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

  1. First posted26 Aug 2024
  2. Study start23 May 2024
  3. Primary completion30 Dec 2024 (estimated)
  4. Study completion1 Dec 2027 (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
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06569485
Sponsor's protocol ID
B2024-253-01
Status last verified
Aug 2024
First submitted
7 Aug 2024
Last updated
26 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trilaciclib+R-CHOP in people with DLBCL, run by Sun Yat-sen 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: looking for participants now, as of the sponsor's last update on 26 Aug 2024. 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 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?

This study is still under way. Results are not available in the source record yet.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of Grade 3/4 neutropenia (time frame: Up to 6 months). 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 NCT06569485.

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 26 Aug 2024.

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