Phase
Condition
Lymphocytic Leukemia, Acute
Leukemia
Treatment
Mitoxantrone hydrochloride liposome Injection-based bridging therapy+ Fludarabine-based chemotherapy +CD19 CAR-T Cells
Clinical Study ID
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"; refractoryrefers to "diagnosis can be made if any of the following are met:(1) tumor shrinkageof <50% or disease progression (PD) after standard chemotherapy; (2) CR is achievedby standard chemotherapy but relapses within six months, (3) 2 or more recurrencesafter CR, (4) recurrence after hematopoietic stem cell transplantation"; B-cellmalignancies include the following 3 categories: (1) B-cell acute lymphoblasticleukemia (B-ALL); (2) indolent B-cell lymphoma (CLL, FL, MZL); (3) aggressive B-celllymphoma (DLBCL, BL, MCL).
Flow cytometry (FCM) or immunohistochemistry showed positive CD19 expression intumor cells;
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)ALT and 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 aninformed consent form.
Exclusion
Exclusion Criteria:
Prior treatment with doxorubicin or other anthracyclines with a total cumulativedose 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 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 withthe results of the trial by the researcher.
Study Design
Study Description
Connect with a study center
Union Hospital, Huazhong University of Science and Technology
Wuhan, Hubei 430022
ChinaSite Not Available

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