NCT06608342 Autologous Hematopoietic Stem Cell Transplantation Combined With CD19-CART Treatment of Adult High-risk Acute Lymphoblastic Leukemia
| NCT ID | NCT06608342 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Acute Lymphoblastic Leukemia ALL |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-06-25 |
| Primary Completion | 2026-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2024-06-25 with a primary completion date of 2026-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To observe the efficacy and side effects of autologous hematopoietic stem cell transplantation combined with CD19-CART for adult acute lymphoblastic leukemia, and to evaluate the safety and efficacy of this regimen in the treatment of acute lymphoblastic leukemia.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06608342 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Acute Lymphoblastic Leukemia ALL. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06608342 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06608342 currently recruiting?
Yes, NCT06608342 is actively recruiting participants. Contact the research team at jiangerlie@ihcams.ac.cn for enrollment information.
Where is the NCT06608342 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT06608342 clinical trial?
NCT06608342 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The trial plans to enroll 20 participants.
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