1.B cell Acute lymphoblastic leukemia. 2.Indolent B cell lymphoma (CLL, FL, MZL, LPL, HCL ). 3.Aggressive B cell lymphoma (DLBCL, BL, MCL). 4.Multiple myeloma (MM).
Conditions
Interventions
Intervention Group:autologous Car-T cells
Control Group:regular chemotherapy or transplantation
Sponsors
Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
6 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary participation in the clinical trials and sign the informed consent; 2. To be aged 6 to 70 years, no gender limited; 3. Patients with CD19+ leukemia or lymphoma diagnosed by pathology and histology, and have no effective treatment by now, including patients who are with relapsed disease after chemotherapy or hematopoietic stem cell transplantation (HSC); or patients are voluntary to accept Anti-CD19 CAR-T cell therapy as the first-line therapy; 4. 4 types of B cell malignancy are included: B cell Acute lymphoblastic leukemia; Indolent B cell lymphoma (CLL, FL, MZL, LPL, HCL); Aggressive B cell lymphoma (DLBCL, BL, MCL); Multiple myeloma; 5. Patients enrolled in are meeting the following criteria: (1) Present residual disease after main therapy but not eligible for HSCT; (2) Relapse after CR1 but not eligible for HSCT; (3) Patients with high risk factors; (4) Failure to achieve remission or relapse after HSCT; (5) Patients with measurable lesions; 6. Multiple organ function assessment: Creatinine =95%; Bilirubin 40%; 7. Karnofsky performance status >= 60; 8. Adequate venous access for apheresis; 9. Without history of accepting anti-cancer therapy, including chemotherapy, radiotherapy, immunotherapy(immune suppressive drugs treatment) within 4 weeks of screening.
Exclusion criteria
Exclusion criteria: 1. Pregnancy and nursing females; 2. Planning pregnancy within 1 year; 3. Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening; 4. Systemic fungal, bacterial, viral, or other infection that is not controlled, at the time of screening; 5. Presence of Grade II-IV (Glucksberg) or B-D (IBMTR) acute or extensive chronic GVHD at the time of screening; 6. Participation in an investigational research study within 6 weeks before enrolled; 7. Presence of severe autoimmune disease or immune deficiency disease; 8. Diagnosed with primary tumor other than leukemia or lymphoma by pathology; 9. History of accepting systemic steroids treatments within 4 weeks; 10. Allergic to any cytokines or antibodies; 11. History of mental disorders; 12. Drug abuse and addiction; 13. Other situations we think improper for the research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival;Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Remission rate;Adverse effects rate; | — |
Countries
China
Contacts
Public ContactZhou Jian-feng
Outcome results
None listed