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A multicenter, open, prospective controlled clinical study comparing the efficacy and safety of CLAG regimen combined with modified BUCY and modified BUCY regimen in allogeneic hematopoietic stem cell transplantation in the treatment of relapsed and refractory AML

A multicenter, open, prospective controlled clinical study comparing the efficacy and safety of CLAG regimen combined with modified BUCY and modified BUCY regimen in allogeneic hematopoietic stem cell transplantation in the treatment of relapsed and refractory AML

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049606
Enrollment
Unknown
Registered
2021-08-06
Start date
2021-08-31
Completion date
Unknown
Last updated
2022-04-19

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

Conditions

Relapse and Refractory Acute Myelocytic Leukemia

Interventions

Experimental Group:GLAG combined with modified BUCY

Sponsors

Aerospace Center Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 59 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily sign the informed consent; 2. Aged 3-59 years; 3. MICM is diagnosed as acute myeloid leukemia (AML), and meets the criteria for patients with relapsed or refractory AML (2016 NCCN guidelines); 4. Morphological or immunophenotyping of bone marrow cells of AML suggests that blast cells exceed 10%; 5. Receive allogeneic hematopoietic stem cell transplantation from a relative or unrelated donor.

Exclusion criteria

Exclusion criteria: 1. Patients with severe cardiac insufficiency and cardiac ejection fraction EF less than 60%; or severe arrhythmia, who cannot tolerate super preconditioning according to the investigator's evaluation; 2. With severe pulmonary insufficiency (obstructive and/or restrictive ventilation disorder), the investigator evaluates those who cannot tolerate super-strong conditioning regimens; 3. Accompanied by severe liver function impairment, liver function indexes (ALT, TBIL) are more than 3 times higher than the upper limit of normal (ULN); the investigators evaluate those who cannot tolerate super-strong conditioning regimens; 4. With severe renal insufficiency, the renal function index (Cr) is more than 2 times the upper limit of normal (ULN); or the 24-hour urinary creatinine clearance Ccr is lower than 50ml/min, and the investigators evaluate those who cannot tolerate the super-strong conditioning regimen; 5. Severe active infection before transplantation, and the investigators evaluate those who cannot tolerate preconditioning; 6. Allergic reactions or serious adverse reactions have occurred in the previous use of pretreatment-related drugs, and those who cannot be enrolled in the evaluation of the investigator; 7. Patients who are pregnant, planning to become pregnant or breastfeeding; 8. The investigator evaluates other reasons for not being selected.

Design outcomes

Primary

MeasureTime frame
1-year overall survival (OS) after transplantation;Leukemia free survival;

Secondary

MeasureTime frame
Toxicity of the conditioning regimens;Recovery of neutrocyte;Recovery of platelet;Donor chimerism;Complete remission rate on day 28 after transplantation;Transplantation-realted mortality(1 year after transplantation);Relapse rate;Acute and chronic graft-versus-host disease (incidence and severity);

Countries

China

Contacts

Public ContactWang Jingbo

Aerospace Center Hospital

zhangweijie0626@sina.com+86 13693587668

Outcome results

None listed

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