Combining stem cell transplantation with CD19-CART for treating high-risk leukemia in adults
Clinical Study of Autologous Hematopoietic Stem Cell Transplantation Combined With CD19-CART Treatment for Adult High-risk Acute Lymphoblastic Leukemia
This study is testing a new treatment that combines stem cell transplant with a special type of immune therapy to see if it helps adults with high-risk leukemia feel better and stay in remission.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Drugs / interventions | CAR-T, chemotherapy, CART |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT06608342 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of autologous hematopoietic stem cell transplantation combined with CD19-CART therapy in adults diagnosed with high-risk acute lymphoblastic leukemia (ALL). Participants who have achieved complete remission after induction chemotherapy and have successfully prepared autologous CD19-CAR-T will receive this combined treatment. The study aims to observe both the efficacy and potential side effects of this innovative approach in managing ALL.
Who should consider this trial
Good fit: Ideal candidates are adults with high-risk acute B-lymphoblastic leukemia who have achieved complete remission and are eligible for stem cell transplantation.
Not a fit: Patients with other malignant tumors, uncontrolled serious infections, or significant organ dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for adults with high-risk acute lymphoblastic leukemia.
How similar studies have performed: Other studies have shown promise with similar approaches, indicating potential for success in this novel treatment strategy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients with high-risk acute B-lymphoblastic leukemia * Complete remission was achieved after induction chemotherapy, and autologous CD19-CAR-T was successfully prepared * Eligible for autologous hematopoietic stem cell transplantation * No major organ dysfunction Exclusion Criteria: * Combined with malignant tumors of other organs * With a serious infection that is not under control * Syphilis, AIDS, hepatitis B, hepatitis C, any one of them positive * Patients who have had an allergic reaction to the drugs used in this study or similar drugs * Other patients deemed unsuitable for inclusion by the investigators
Where this trial is running
Tianjin, Tianjin Municipality
- NO.288 Nanjing Road，Heping District，Tianjin, Tianjin, — Tianjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Study coordinator: erlie EL Jiang
- Email: jiangerlie@ihcams.ac.cn
- Phone: +86-15122538106
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.