Last updated: January 11, 2024
Sponsor: Wuhan Union Hospital, China
Overall Status: Active - Recruiting
Phase
2
Condition
Lymphocytic Leukemia, Acute
Leukemia
Treatment
Mitoxantrone hydrochloride liposome Injection-based bridging therapy+ Fludarabine-based chemotherapy +CD19 CAR-T Cells
Clinical Study ID
NCT06220097
bridging regimen of CD19CAR-T
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 refersto "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 bystandard chemotherapy but relapses within six months, (3) 2 or more recurrences afterCR, (4) recurrence after hematopoietic stem cell transplantation"; B-cell malignanciesinclude 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 tumorcells;
- Organ function needs to meet the following conditions:
- EF >50%, and there is no obvious abnormality on ECG; 2) SpO2≥90%; 3) Cr≤2.5 ULN; 4) ALTand AST≤5 ULN, TBil≤3 ULN; 6. Negativity of blood pregnancy test for women, andparticipants use effective methods of contraception until the last follow-up. 7. Thepatient or his or her legal guardian voluntarily participates in and signs an informedconsent form.
Exclusion
Exclusion Criteria:
- Prior treatment with doxorubicin or other anthracyclines with a total cumulative doseof doxorubicin >360 mg/m2 (other anthracyclines convert 1 mg of doxorubicin to 2 mgepirubicin).
- Hypersensitivity to any of the study drugs or their components.
- Concomitant other diseases that are not effectively controlled, including but notlimited to persistent or poorly controlled infections, symptomatic congestive heartfailure, unstable angina, cardiac arrhythmias, poorly controlled pulmonary diseases,or psychiatric disorders.
- Investigators judge patients with central nervous system involvement who may be athigh 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 whohave 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 theresults of the trial by the researcher.
Study Design
Total Participants: 28
Treatment Group(s): 1
Primary Treatment: Mitoxantrone hydrochloride liposome Injection-based bridging therapy+ Fludarabine-based chemotherapy +CD19 CAR-T Cells
Phase: 2
Study Start date:
February 01, 2024
Estimated Completion Date:
December 30, 2025
Study Description
Connect with a study center
Union Hospital, Huazhong University of Science and Technology
Wuhan, Hubei 430022
ChinaActive - Recruiting
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