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Efficacy and safety of FAB-rATG reduced intensity conditioning haplo-identical high dose non T cell depleted peripheral blood stem cell transplantation(RIC-haplo-HDPBSCT)in treatment of in elderly patients with intermediate or high-risk acute myeloid leukemia or myelodysplastic syndrome: a prospective, single arm, multicenter study

Efficacy and safety of FAB-rATG reduced intensity conditioning haplo-identical high dose non T cell depleted peripheral blood stem cell transplantation(RIC-haplo-HDPBSCT)in treatment of in elderly patients with intermediate or high-risk acute myeloid leukemia or myelodysplastic syndrome: a prospective, single arm, multicenter study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900028197
Enrollment
Unknown
Registered
2019-12-15
Start date
2020-01-01
Completion date
Unknown
Last updated
2019-12-16

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

Conditions

acute myeloid leukemia or myelodysplastic, syndrome

Interventions

Case series:FAB-rATG reduced intensity conditioning haplo-identical high dose non T cell depleted peripheral blood stem cell transplantation

Sponsors

First Affiliated Hospital of Xinjiang Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
55 Years to 69 Years

Inclusion criteria

Inclusion criteria: 1. Aged 55-69 years; 2. Patients with intermediate or high-risk AML and MDS: (1) Patients with initial intermediate or high-risk AML who attained CR1 by standard induction chemotherapy and MRD is undetectable; (2) Patients mentioned above who relapse for any reasons of postponing HSCT attained CR2 and MRD is undetectable; (3) Patients with initial low-risk AML failed to attain CR after 2 courses of standard induction chemotherapy. Patients who attained CR with MRD detectable, after receiving 2 courses of same or intensity chemotherapy, the MRD is undetectable; (4) Patients with initial intermediate, high-risk myelodysplastic syndrome (graded according to IPSS-R system, <=10% blasts) response after 1-2 courses of chemotherapy or do not receive any treatment; (5) Patients with very high-risk MDS (graded according to IPSS-R system, 10-20% blasts) attain CR1 or PR(<=10% blasts) after chemotherapy; (6) Patients with MDS mentioned above who progressed for postponing HSCT attain CR2 or PR (<=10% blasts); 3. Patients important organs (heart, liver, kidney, brain, etc.) do not have severe complications, and patients are suitable for transplantation by HCT-CI and EBMT transplantation scoring system evaluation; 4. Patients have HLA mismatch related donors( 5/10-9/10); 5. Patients or family members agree to conduct this research.

Exclusion criteria

Exclusion criteria: 1. Patients with AML do not attain CR or/and MRD is detectable; 2. Patients with active uncontrollable infections; 3. Patients important organs (heart, liver, kidney, brain, etc.) have severe complications, and patients are not suitable for transplantation by HCT-CI (HCT-CI>=5); 4. Patients DSA titer is over 10,000; 5. Patients with mental disease.

Design outcomes

Primary

MeasureTime frame
Engraft rate;Acute graft versus host disease;relapse rate;

Secondary

MeasureTime frame
Non-relapse mortality;Disease-free survival;Overall survival;Chronic graft versus host disease;

Countries

China

Contacts

Public ContactMing Jiang

Hematologic Disease Center, First Affiliated Hospital of Xinjiang Medical University

jiangmingyy@126.com+86 13909910116

Outcome results

None listed

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