Efficacy and safety of CABA+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 relapsed and refractory 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

ChiCTR1900028164

Enrollment

Unknown

Registered

2019-12-14

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

Hematopoietic stem cell transplantation group :CABA+rATG reduced intensity conditioning haplo-identical high dose non T cell depleted peripheral blood stem cell transplantation

Eligibility

Sex/Gender

All

Age

55 Years to 69 Years

Inclusion criteria

Inclusion criteria: 1) Aged 55-69 years; 2) Patients with refractory relapsed AML and MDS: A. Patients with initial intermediate or high-risk AML who attained CR1 by standard induction chemotherapy but MRD is detectable, or MRD is still detectable after the standard or intensity chemotherapy for 1-2 courses; B. Patients with initial intermediate or high-risk AML who failed to attain CR1 by standard induction chemotherapy but attained CR2 after intensity chemotherapy, whether the MRD is detectable or not; C. Patients with initial low-risk AML failed to attain CR after 2 courses of standard induction chemotherapy or MRD is detectable when attained CR. Even after 2 courses of same or intensity chemotherapy. D. Patients with initial intermediate, high, and very high-risk myelodysplastic syndrome (graded according to IPSS-R system, <= 10% blasts) progress and do not response after 1-2 courses of chemotherapy; Patients with initial or relapsed low intermediate risk of high AML do not response to any kinds of chemotherapy.( <= 30% blasts) E. Patients with high-risk or very high-risk MDS (graded according to IPSS-R system 10-20%), who do not response or progress after 1-2 courses of chemotherapy; 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 who do not response to the CLAG regimen chemotherapy and/or azacitidine treatment; 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

Measure	Time frame
Engraft rate;Acute graft versus host disease;relapse rate;	—

Secondary

Measure	Time frame
Non-relapse mortality;Disease-free survival;Overall survival;Chronic graft versus host disease;	—

Countries

China

Contacts

Public ContactMing Jiang

Hematologic Disease Center, the 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