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Comparison of the curative efficacy and safety of allo-HSCT by using conditioning regiment of modified BUCY or CLAG combined with modified BUCY for refractory and relapsed patients with acute myelocytic leukemia: a sigle-center prospective randomized controlled clinical trial

Comparison of the curative efficacy and safety of allo-HSCT by using conditioning regiment of modified BUCY or CLAG combined with modified BUCY for refractory and relapsed patients with acute myelocytic leukemia: a sigle-center prospective randomized controlled clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-16009917
Enrollment
Unknown
Registered
2016-11-18
Start date
2017-01-01
Completion date
Unknown
Last updated
2017-04-18

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

Control Group:Modified BUCY
Experimental Group:GLAG combined with BUCY

Sponsors

Aerospace Center Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Agree to sign informed consent; 2. Aged 3-59 years; 3. Diagnosed with AML according to MICM and meet the 2016 NCCN criteria of relapse/refractory disease; 4. > 10% blasts on a bone marrow suggested by cell morphology and immunophenotyping analysis; 5. Receive matched sibling or unrelated donor hematopoietic stem cell transplantation.

Exclusion criteria

Exclusion criteria: 1. Mixed acute leukemia(MAL) or blastic crisis of chronic myelogenous leukemia (CML-BC) or blastic crisis of chronic myelomonocytic leukemia(CMML-BC) or MDS-RAEB; 2. Severe heart function insufficiency, EF<60% or arrhythmia, and cannot tolerate intense conditioning regiment; 3. Severe lung function insufficiency (obstructive ventilatory dysfunction), and cannot tolerate intense conditioning regiment; 4. Severe liver function insufficiecy with abnormal ALT and TBIL (3 times over ULN), and cannot tolerate intense conditioning regiment; 5. Severe kidney function insufficiency with abnormal Cr (3 times over ULN), or Ccr <50ml/min within 24 hours, and cannot tolerate intense conditioning regiment; 6. Severe active infection before tansplantation, and cannot tolerate intense conditioning regiment; 7. Previously treated with similar conditioning regiment, but severe AE or allergy occur; 8. Pregnancy or ready for pregnancy or lactation; 9. Others. .

Design outcomes

Primary

MeasureTime frame
Overal Survival (3 years);Leukemia Free Survival (3 years);Recovery of platelet;—

Secondary

MeasureTime frame
Complete Remission (28 days after transplantation);Toxicity of the conditioning regimens;Recovery of neutrocyte ;Donor chimerism;Transplantation-realted mortality(1,2 and 3 year(s) after transplantation respectively);Relapse Rate;Cronic&Aute GVHD (rate & severity);Infection rate;—

Countries

China

Contacts

Public ContactJingbo Wang

Aerospace Center Hospital

dpwangjingbo@sina.com+86 13693587668

Outcome results

None listed

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