Study of BEBT-908 in Subjects With Advanced Hematological Tumors (NCT06082596) | Clinical Trial Compass
CompletedPhase 1
Study of BEBT-908 in Subjects With Advanced Hematological Tumors
China32 participantsStarted 2016-03-02
Plain-language summary
The purpose of this study was to evaluate the safety and tolerance of BEBT-908 for injection in the treatment of recurrent refractory malignant lymphoma, multiple myeloma and chronic lymphoblastic leukemia, and to obtain the pharmacokinetic data and preliminary efficacy of BEBT-908 for injection, and to explore the relationship between the safety and efficacy of BEBT-908 for injection and related biomarkers.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥ 18 and ≤ 70 years old, both men and women.
. Tissue biopsy, bone marrow examination and / or hematological examination confirmed relapsed refractory （Note 1） malignant lymphoma, chronic lymphoblastic leukemia and multiple myeloma. （Note 2 and Note 3）
. With measurable lesions . (Note 4)
. Eastern Cooperative Oncology Group (ECOG) score≤2.
. The level of organ function must meet the following requirements:
. Absolute neutrophil count (ANC) ≥ 1000 /μL (if recent bone marrow biopsies or smears prove tumor progression, this index can be \< 1000/μL).
. Hemoglobin (HGB) ≥ 9g/dL.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
DLT
Timeframe: Dose escalation phase: a 6-day observation after a single administration, cycle 1st of continuous medication (21 days). Dose expansion phase: from date of administration until the date of disease progression or withdrawal, assessed up to 36 months.
2
MTD
Timeframe: Dose escalation phase: a 6-day observation after a single administration, cycle 1st of continuous medication (21 days). Dose expansion phase: from date of administration until the date of disease progression or withdrawal, assessed up to 36 months.
. Platelet count (PLT) ≥ 1000000/μL (if recent bone marrow biopsies or smears prove tumor progression, this index can be \< 1000000/μL).
Exclusion criteria
. Severe allergies to research drugs or any of their excipients are known.
. Because the research drugs may have genotoxicity, mutagenicity and teratogenicity, the following subjects should be excluded: men and women who plan to reproduce within 5 years without in vitro preservation of sperm or eggs before the trial, unless follow-up studies confirm reproductive safety; pregnant or lactating women.
. The treatment of the subjects before the trial:
. Bone marrow transplantation was performed within 3 months before enrolling the group.
. Received bone marrow inhibitory chemotherapy or biotherapy within 3 weeks before enrolling the group.
. Before enrolling the group, the subjects had been treated with any persistent or intermittent small molecular targeted drugs (Phosphoinositide 3-kinase (PI3K) inhibitors or Mammalian Target of Rapamycin (mTOR) inhibitors or Histone Deacetylase (HDAC) inhibitors). Subjects in the dose increasing phase of this study will not be subject to the exclusion criteria of this article if they participate in the expanded group phase screening.
. Within 3 months before enrolling the group, subjects received radiotherapy that affected the efficacy evaluation of this study, or local supportive radiotherapy that affected the bone marrow function of the subjects.
. Subjects received any hematopoietic colony stimulating factor therapy (such as granulocyte colony stimulating factor （G-CSF）, granulocyte macrophage colony stimulating factor（GM-CSF）) within 2 weeks before enrolling the group (Note 1).