Status:
ACTIVE_NOT_RECRUITING
Mitoxantrone Hydrochloride Liposome Injection-containing Bridging Regimen and CD19-targeting CAR-T Therapies
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborating Sponsors:
CSPC Pharmaceutical Group Limited
Conditions:
B-cell Acute Lymphoblastic Leukemia
B-cell Lymphoma Refractory
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The goal of this open, single-arm practical, phase II, clinical study is to evaluate the efficacy and safety of the mitoxantrone hydrochloride liposome injection-containing regimens in bridging therap...
Detailed Description
Chimeric antigen receptor T-cell (CAR-T) therapy has been approved for a variety of relapsed/refractory hematologic malignancies and has significantly improved patient outcomes. The preparation of CAR...
Eligibility Criteria
Inclusion
- Aged ≥ 18 years and \<75 years.
- Eastern Cooperative Oncology Group score≤ 2.
- Clinically diagnosed refractory or relapsed B-cell malignancies. Relapse refers to "relapse after a complete response (CR) from initial chemotherapy"; refractory refers to "diagnosis can be made if any of the following are met:(1) tumor shrinkage of \<50% or disease progression (PD) after standard chemotherapy; (2) CR is achieved by standard chemotherapy but relapses within six months, (3) 2 or more recurrences after CR, (4) recurrence after hematopoietic stem cell transplantation"; B-cell malignancies include the following 3 categories: (1) B-cell acute lymphoblastic leukemia (B-ALL); (2) indolent B-cell lymphoma (CLL, FL, MZL); (3) aggressive B-cell lymphoma (DLBCL, BL, MCL).
- Flow cytometry (FCM) or immunohistochemistry showed positive CD19 expression in tumor cells;
- Organ function needs to meet the following conditions:
- 1\) EF \>50%, and there is no obvious abnormality on ECG; 2) SpO2≥90%； 3) Cr≤2.5 ULN; 4) ALT and AST≤5 ULN, TBil≤3 ULN; 6. Negativity of blood pregnancy test for women, and participants use effective methods of contraception until the last follow-up. 7. The patient or his or her legal guardian voluntarily participates in and signs an informed consent form.
Exclusion
- Prior treatment with doxorubicin or other anthracyclines with a total cumulative dose of doxorubicin \>360 mg/m2 (other anthracyclines convert 1 mg of doxorubicin to 2 mg epirubicin).
- Hypersensitivity to any of the study drugs or their components.
- Concomitant other diseases that are not effectively controlled, including but not limited to persistent or poorly controlled infections, symptomatic congestive heart failure, unstable angina, cardiac arrhythmias, poorly controlled pulmonary diseases, or psychiatric disorders.
- Investigators judge patients with central nervous system involvement who may be at high risk of receiving bridging therapy and CD19 CAR-T cell treatment.
- Participants with other active malignancies within five years.
- Patients with relapse after allogeneic hematopoietic stem cell transplantation who have had grade 3\~4 acute graft-versus-host response (GVHD).
- Patients who are pregnant or breast-feeding.
- Active autoimmune disease requiring systemic immunosuppressive therapy.
- Other conditions considered to increase the risk to the subject or interfere with the results of the trial by the researcher.
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06220097
Start Date
February 1 2022
End Date
December 30 2025
Last Update
July 17 2025
Active Locations (1)
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1
Union Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022