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Clinical Trials in China / NCT04210791
Enrolling by invitation Observational

Autologous Stem Cell Transplantation for Patients With AL Amyloidosis

NCT04210791 · tracked via the Priya Life Science China tracker
Sponsor
Nanjing University School of Medicine
Phase
Observational
Started
2010-07-01
Last updated
2024-02-26

Condition(s) studied

AL AmyloidosisPlasma Cell Dyscrasia

Study summary

This study mainly evaluated the efficacy and safety of autologous stem cell transplantation for the treatment of AL amyloidosis, the role of induction and maintenance therapy in autologous stem cell transplantation, and the long-term efficacy and prognosis risk factors of autologous stem cell transplantation for the treatment of AL amyloidosis.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Male or female; * aged 18-75 years; * Patients with newly diagnosed AL; * Appropriate for autologous hematopoietic stem cell transplantation; * Abnormal M protein or free light chain detected in serum and/or urine * ECOG score 0-2 points; * Subjects (or their legal representatives) must sign an informed consent document indicating understanding the purpose of and procedures required for the study and willingness to participate in the study. Exclusion Criteria: * Pregnant and breastfeeding women; * Subjects suffering from multiple myeloma; * hypersensitivity to any treatment drugs; * Subjects have severe cardiovascular disease; * Subjects have a serious physical disease and mental illnesses; * Other conditions that researchers consider are not suitable for transplantation.

Primary outcome measure(s)

  • overall survival — 5 years
    the 5 years overall survival after autologous stem cell transplantation.
  • progression-free survival — 5 years
    the 5 years progression-free survival after autologous stem cell transplantation.
  • hematological complete response rate — 1 year
    the 1 year hematologic complete response rate after autologous stem cell transplantation.
  • organ response rate — 1 year
    the 1 years organ response rate after autologous stem cell transplantation.

Trial sites (1)

FacilityCityRegionStatus
National Clinical Research Center of Kidney Diseases, Jinling Hospital Nanjing Jiangsu

More Nanjing University School of Medicine trials in China

The BCMA/CD19 Dual Targeted CAR-T Cell in Participants With Autoimmune Kidney Diseases Recruiting
The Efficacy and Safety of Biologics (Belimumab/ Telitacicept) Induction Therapy in Proliferative Lupus Nephritis Patients for 6 Months Compared With Mycophenolate Mofetil Treatment Recruiting
Daratumumab for Patients With Light Chain Amyloidosis Recruiting

Other trials for the same condition

A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIb AL Amyloidosis (CARES) Active, not recruiting
Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis Recruiting
Optimize First-line Treatment for AL Amyloidosis With t (11; 14) Recruiting
Teclistamab in Newly Diagnosed Mayo Stage IIIB AL Amyloidosis Recruiting
BCMA/GPRC5D Trispecific Antibody Treatment for Newly Diagnosed Amyloidosis (AL-004) Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04210791 on ClinicalTrials.gov ↗ ← All trials in China