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Study Comparing BEBT-908 Combined With R to SOC for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma

ConditionRelapsed/Refractory Diffuse Large B-Cell Lymphoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeBetter Med Inc

About this trial

This is a multicenter, randomized, controlled, open-label Phase III clinical trial, aimed at evaluating the efficacy and safety of BEBT-908 combined with rituximab (R) compared to investigator-selected standard chemotherapy regimens \[Standard of Care (SOC)\] \[i.e., rituximab-gemcitabine-oxaliplatin (R-GemOx) or rituximab-ifosfamide-carboplatin-etoposide (R-ICE)\] for the treatment of relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The subject has been fully informed and is willing to sign the Informed Consent Form (ICF).

Age is ≥18 years and ≤75 years, both men and women are eligible.

Pathologically diagnosed as diffuse large B-cell lymphoma according to the 2022 World Health Organization classification, confirmed by central pathology review (Patients who relapse after more than one year need to undergo tissue biopsy again to confirm the pathological diagnosis.).

Measurable lesions [The criteria for measurable lesions are: the longest diameter of lymph node lesions measured by enhanced Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) is greater than 15 mm, and the longest diameter of extranodal lesions is greater than 10 mm.] assessed by Positron Emission Tomography/Computed Tomography (PET-CT) and Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) according to the Lugano 2014 criteria .

Disqualifiers

Known severe allergy to the study drug or any of its excipients;

Men and women who have not undergone in vitro preservation of sperm or oocytes and plan to have children within 5 years, unless subsequent studies confirm reproductive safety;

Pregnant or breastfeeding women;

Primary central nervous system lymphoma;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ifupinostat Hydrochloride for Injection

    Drug

    Ifupinostat Hydrochloride for Injection,dosage of administration:18.5mg/m\^2,frequency and duration of administration:Medication is administered on days 1, 3, 5, 8, 10, and 12 of each cycle,with a 21-day or 42-day cycle duration.

  • Rituximab Injection

    Drug

    Rituximab Injection,dosage of administration:375 mg/m\^2,frequency and duration of administration:Medication is administered on day 1 of each cycle or every third cycle, with a 21-day cycle duration.

  • Gemcitabine Hydrochloride for Injection

    Drug

    Gemcitabine Hydrochloride for Injection,dosage of administration:1g/m\^2,frequency and duration of administration:Medication is administered on day 2 of each cycle, with a 21-day cycle duration.

  • Oxaliplatin Injection

    Drug

    Oxaliplatin Injection,dosage of administration:100mg/m\^2,frequency and duration of administration:Medication is administered on day 2 of each cycle, with a 21-day cycle duration.

  • Etoposide Injection

    Drug

    Etoposide Injection,dosage of administration:100mg/m\^2,frequency and duration of administration:Medication is administered on days 1,2,and 3 of each cycle, with a 21-day cycle duration.

  • Ifosfamide for Injection

    Drug

    Ifosfamide for Injection,dosage of administration:5000mg/m\^2,frequency and duration of administration:Medication is administered on day 2 of each cycle, with a 21-day cycle duration.

  • Carboplatin Injection

    Drug

    Carboplatin Injection,,dosage of administration:single dose ≤800 mg (calculated based on AUC=5),frequency and duration of administration:Medication is administered on day 2 of each cycle, with a 21-day cycle duration.

Treatment groups

416 Participants
are divided into 2 treatment groups
Group A: Experimental Group (BEBT-908 Combined With R)Experimental treatment 2 interventions
Group B: Control Group (R-GemOx or R-ICE)Active comparator 6 interventions

Trial outcomes

Primary outcomes

1

Overall Survival (OS)

Defined as the time from the date of randomization to death due to any cause.

Time frame
Up to 48 months

Secondary outcomes

1

Progression-Free Survival (PFS)

Defined as the time from randomization to tumor progression or death, whichever occurs first.

Time frame
Up to 48 months
2

Overall Response Rate (ORR)

Defined as the proportion of subjects achieving complete response (CR) and partial response (PR) from the start of randomization to tumor progression among the total number of subjects.

Time frame
Up to 48 months
3

Overall Response Rate After Completion of Treatment (ORR-EoT)

Defined as the proportion of subjects achieving complete response (CR) and partial response (PR) after the subject has completed eight cycles of treatment among the total number of subjects.

Time frame
Up to 8 treatment cycles (Each cycle is 21 days.)
4

Clinical Benefit Rate (CBR)

Defined as the percentage of subjects achieving complete response (CR), partial response (PR), or stable disease (SD) from the start of randomization to the time of tumor progression.

Time frame
Up to 48 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BeBetter Med Inc

Lead sponsor

Source ClinicalTrials.gov
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