BL-M08D1 and Oxaliplatin and Rituximab in Diffuse Large B-Cell Lymphoma - Clinical Trials Registry

Study Overview

Status

Not yet recruiting

Conditions

Diffuse Large B-Cell Lymphoma

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

204

Phase

Phase 2
Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Sa Xiao, PHD
Phone Number: +86 15013238943
Email: xiaosa@baili-pharm.com

Study Locations

China
- Guangdong
  - Guangzhou, Guangdong, China
    - Sun Yat-sen University Cancer Center
    - Contact:
      
      Qingqing Cai
- Jiangsu
  - Suzhou, Jiangsu, China
    - The First Affiliated Hospital of Soochow University
    - Contact:
      
      Depei Wu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Voluntarily sign the informed consent form and comply with the protocol requirements;
No gender restriction;
Age ≥18 years and ≤75 years;
Expected survival time ≥3 months;
Patients with diffuse large B-cell lymphoma;
Agree to provide archived tumor tissue specimens within 3 years or fresh tissue samples;
Must have at least one measurable lesion;
Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;
Organ function levels must meet the requirements;
Urine protein ≤1+ or <1000 mg/24h;
For premenopausal women with childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, and the serum pregnancy test must exclude pregnancy; patients must not be breastfeeding; all enrolled trial participants must take adequate barrier contraceptive measures throughout the entire treatment period and for 6 months after treatment completion;
Trial participants must be able and willing to comply with the visit schedule, treatment plan, laboratory tests, and other study-related procedures specified in the protocol.

Exclusion Criteria:

Use of chemotherapy, biological therapy, immunotherapy, etc., within 4 weeks or 5 half-lives prior to the first dose;
History of severe heart disease or cerebrovascular disease within 6 months before screening;
Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;
Active autoimmune diseases and inflammatory diseases;
Diagnosis of active malignancy within 5 years prior to the first dose;
Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;
Hypertension inadequately controlled by antihypertensive medications;
Trial participants with poorly controlled blood glucose;
History of interstitial lung disease requiring corticosteroid therapy, or current ILD, or radiation pneumonitis of grade ≥2;
Use of glucocorticoids at a dose >30 mg/day prednisone or equivalent, for purposes other than control of lymphoma symptoms;
Concurrent pulmonary diseases resulting in clinically severe impairment of respiratory function;
Patients with central nervous system involvement;
Previous or current central nervous system disorders;
Contraindications to any component of the study intervention, including but not limited to previous allergic reactions;
Receipt of autologous hematopoietic stem cell transplantation or CAR-T cell therapy, etc., within 12 weeks prior to the first dose;
Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
Active infection requiring systemic therapy within 4 weeks prior to the first study drug administration;
Pleural, abdominal, or pelvic effusion or pericardial effusion requiring drainage and/or accompanied by symptoms within 4 weeks prior to the first study drug administration;
Imaging findings indicating that the tumor has invaded or encased major blood vessels in the abdomen, chest, neck, pharynx, etc., or the pericardium or heart;
Use of another investigational drug within 4 weeks or 5 half-lives prior to the first dose;
Pregnant or breastfeeding women;
Other conditions that, in the investigator's opinion, make the participant unsuitable for enrollment in this clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BL-M08D1+R-GemOx or BL-M08D1+R-CHOP Participants receive BL-M08D1+R-GemOx or BL-M08D1+R-CHOP for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.	Drug: BL-M08D1 Administration by intravenous infusion for a cycle of 3 weeks. Drug: Oxaliplatin Administration by intravenous infusion for a cycle of 3 weeks. Drug: Rituximab Administration by intravenous infusion for a cycle of 3 weeks. Drug: Gemcitabine Hydrochloride Administration by intravenous infusion for a cycle of 3 weeks. Drug: Cyclophosphamide Administration by intravenous infusion for a cycle of 3 weeks. Drug: Doxorubicin Hydrochloride Liposome Administration by intravenous infusion for a cycle of 3 weeks. Drug: Vincristine Sulfate Administration by intravenous infusion for a cycle of 3 weeks. Drug: Prednisone Acetate Tablets Oral administration for a cycle of 3 weeks.
Active Comparator: R-GemOx or R-CHOP Participants receive R-GemOx or R-CHOP for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.	Drug: Oxaliplatin Administration by intravenous infusion for a cycle of 3 weeks. Drug: Rituximab Administration by intravenous infusion for a cycle of 3 weeks. Drug: Gemcitabine Hydrochloride Administration by intravenous infusion for a cycle of 3 weeks. Drug: Cyclophosphamide Administration by intravenous infusion for a cycle of 3 weeks. Drug: Doxorubicin Hydrochloride Liposome Administration by intravenous infusion for a cycle of 3 weeks. Drug: Vincristine Sulfate Administration by intravenous infusion for a cycle of 3 weeks. Drug: Prednisone Acetate Tablets Oral administration for a cycle of 3 weeks.

Participant Group / Arm

Intervention / Treatment

Experimental: BL-M08D1+R-GemOx or BL-M08D1+R-CHOP

Participants receive BL-M08D1+R-GemOx or BL-M08D1+R-CHOP for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Drug: BL-M08D1