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Single-center, open, nonrandomized, single-arm clinical trial of bridging allogeneic hematopoietic stem cell transplantation after CAR T cell remission in refractory/relapsed acute myeloid leukemia

Single-center, open, nonrandomized, single-arm clinical trial of bridging allogeneic hematopoietic stem cell transplantation after CAR T cell remission in refractory/relapsed acute myeloid leukemia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058978
Enrollment
Unknown
Registered
2022-04-21
Start date
2022-04-29
Completion date
Unknown
Last updated
2024-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory/recurrent acute myeloid leukemia

Interventions

Experimental group:Bridging allogeneic hematopoietic stem cell transplantation

Sponsors

Beijing GoBroad Boren Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 75 Years

Inclusion criteria

Inclusion criteria: 1. Relapsed/refractory acute myeloid leukemia patients in remission after treatment with CD33-CART, CD123-CART, or CD371-CART; 2. No gender limit; 3. Aged =60 days; 7. Children under 8 years old shall sign the informed consent voluntarily by their legal representatives (guardians); children between 8 and 18 years old who have the ability to know themselves and their legal representatives (guardians) shall sign the informed consent voluntarily; adults over 18 years old shall sign the informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1. Intracranial hypertension or cerebral disturbance of consciousness; 2. Symptomatic heart failure or severe arrhythmia; 3. Symptoms of severe respiratory failure; 4. With other types of malignant tumors; 5. Diffuse vascular intravascular coagulation; 6. Serum creatinine and/or urea nitrogen >= 1.5 times the normal value; 7. Suffering from sepsis or other hard-to-control infections; 8. Have uncontrolled diabetes; 9. Severe mental disorder; 10. Cranial MRI examination showed obvious lesions in the skull; 11. Have received organ transplantation (excluding bone marrow transplantation); 12. The blood HCG test of female patients (fertile patients) is positive; 13. Screening positive for hepatitis (including hepatitis B and C) and HIV/AIDS and syphilis.

Design outcomes

Primary

MeasureTime frame
Treatment-Related Mortality;Treatment-Related Adverse Events;

Secondary

MeasureTime frame
Objective Response Rate;Complete Remission;Partial Remission;Duration of Response;Progression-Free Survival;Overall Survival;

Countries

China

Contacts

Public ContactSong Yanzhi

Beijing GoBroad Boren Hospital

bjbrgcpll@gobroadhealthcare.com+86 13851534047

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026