Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04123392
Other study ID # TP53+ Myeloid tumors
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date October 2019
Est. completion date September 2023

Study information

Verified date October 2019
Source Nanfang Hospital of Southern Medical University
Contact Qifa Liu
Phone 020-61641611
Email liuqifa628@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Recent studies have demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for TP53+ myeloid tumors, such as acute myeloid leukemia and myelodysplastic syndrome. Unfortunately, some patients relapsed after allo-HSCT. In this prospective randomized controlled study, the safety and efficacy of Decitabine + BUCY and BUCY myeloablative conditioning regimens in TP53+ myeloid tumors undergoing allo-HSCT are evaluated.


Description:

Recent studies have demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for TP53+ myeloid tumors, such as acute myeloid leukemia and myelodysplastic syndrome. BUCY conditioning regimen is the standard myeloablative regimen for TP53+ myeloid tumors undergoing allo-HSCT. However, it appears to have higher relapse rate and lower survival. To reduce the relapse rate and improve the survival, decitabine is added in the conditioning regimen. In this prospective randomized controlled study, the safety and efficacy of Decitabine + BUCY and BUCY myeloablative conditioning regimens in TP53+ myeloid tumors undergoing allo-HSCT are evaluated.


Recruitment information / eligibility

Status Recruiting
Enrollment 196
Est. completion date September 2023
Est. primary completion date September 2022
Accepts healthy volunteers No
Gender All
Age group 14 Years to 65 Years
Eligibility Inclusion Criteria:

- TP53+ Myeloid tumors undergoing allo-HSCT

- 14-65 years

Exclusion Criteria:

- Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)

- Patients with any conditions not suitable for the trial (investigators' decision)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Decitabine
Decitabine was administered at 20mg/m2/day on days -14 and -10.
Busulfan (BU)
Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.
Cyclophosphamide (CY)
Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.

Locations

Country Name City State
China Department of Hematology,Nanfang Hospital, Southern Medical University Guangzhou Guangdong

Sponsors (5)

Lead Sponsor Collaborator
Nanfang Hospital of Southern Medical University Peking University People's Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary relapse rate relapse rate 1 year
Secondary overall survival (OS) overall survival (OS) 1 year
Secondary disease-free survival (DFS) disease-free survival (DFS) 1 year
Secondary transplant-related mortality (TRM) transplant-related mortality (TRM) 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT03294824 - Non Randomized Comparative Study With Control
Recruiting NCT04098653 - Decitabine + BUCY vs BUCY Conditioning Regimen for Myeloid Tumors Undergoing Allo-HSCT Phase 2/Phase 3
Recruiting NCT03256071 - Low Dose Decitabine + Modified BUCY Conditioning Regimen for High Risk Acute Myeloid Leukemia Undergoing Allo-HSCT Phase 2/Phase 3
Terminated NCT02653196 - A Multi-Institutional Pilot Study of Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Malignant Neuro-Epithelial and Other Solid Tumors Early Phase 1
Terminated NCT00429039 - A Study to Accelerate Immune System Recovery Following Stem Cell Transplantation Phase 2
Recruiting NCT06028828 - Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation Phase 2
Recruiting NCT05084027 - Venetoclax Combining With Fludarabine and Melphalan as Conditioning Regimen for Allo-HSCT Phase 2
Recruiting NCT05601895 - The Gut Microbiome in FLT3- AL Undergoing Allo-HSCT With Or Without Sorafenib Maintenance
Recruiting NCT05596981 - The Gut Microbiome in FLT3-ITD+ AML Undergoing Allo-HSCT With Or Without Sorafenib Maintenance After Allo-HSCT
Recruiting NCT05596968 - The Gut Microbiome and Sorafenib Maintenance Therapy in FLT3-ITD Positive AML After Allo-HSCT
Recruiting NCT03357172 - Determination of Factors Involved in the Regulation of Immune Responses After Allogeneic Hematopoietic Stem Cell Transplantation N/A
Active, not recruiting NCT04995653 - A Multiple Dose Study to Evaluate Safety, Tolerability, PK, and Efficacy of SER-155 in Adults Undergoing HSCT Phase 1
Completed NCT02250300 - MLN9708 for the Prophylaxis of Chronic Graft-versus-host Disease in Patient Undergoing Allogeneic Transplantation Phase 1/Phase 2
Recruiting NCT04372524 - Biomarker Verification in Pediatric Chronic GvHD: ABLE 2.0 / PTCTC GVH 1901 Study
Recruiting NCT03593161 - Humor Therapy and Distress After Allogeneic Stem Cell Transplantation N/A
Recruiting NCT05379569 - Comparative Study of BFC and BuCy Conditioning Regimen for Allo-PBSCT in Acute B-cell ALL Phase 4
Not yet recruiting NCT03902041 - The Prospective Randomized Controlled Study of Eltrombopag on Hematopoietic Reconstruction After Allogeneic HSCT
Completed NCT02270346 - Inspiratory Muscle Training in Allogeneic Hematopoietic Stem Cell Transplantation Recipients N/A
Recruiting NCT03297528 - Chemotherapy and DLI for Prevention of Second Relapse in Patients With Relapsed Acute Leukemia After Allotransplant Phase 2
Completed NCT01879072 - Prospective Cohort for the Evaluation of Biomarkers Following HCT (BMT CTN 1202)