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Low-dose TBI combined with flundarabine, arabinoside and cyclophosphamide (FACT) for allogeneic hematopoietic stem cell transplantation in the treatment of recurrent and refractory acute leukemia- A multicenter, single-arm clinical trial

Low-dose TBI combined with flundarabine, arabinoside and cyclophosphamide (FACT) for allogeneic hematopoietic stem cell transplantation in the treatment of recurrent and refractory acute leukemia- A multicenter, single-arm clinical trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035111
Enrollment
Unknown
Registered
2020-08-01
Start date
2021-01-01
Completion date
Unknown
Last updated
2020-08-03

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

Conditions

Acute leukemia

Interventions

Case series:Low-dose TBI combined with flundarabine, arabinoside and cyclophosphamide (FACT) for allogeneic hematopoietic stem cell transplantation

Sponsors

Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Basic standard 1. Aged 14 to 65 years; 2. ECOG score =2 times; 3. Patients with persistent extramedullary leukemia and persistent positive MRD; 4. Relapsed ALL was defined as the reappearance of primary cells in blood or bone marrow (>.5%), or any other extramedullary tissue, in patients who had achieved CR.

Exclusion criteria

Exclusion criteria: 1. New or active infection as determined by fever, unexplained pulmonary infiltrate or sinusitis on radiographic assessment which cannot be controlled. Infections diagnosed within 4 weeks of registration must be determined to be controlled or resolving prior to treatment. 2. Suffering from severe heart, liver, renal insufficiency and other diseases; 3.Severe autoimmune disease or immunodeficiency disease; 4. Severe allergic constitution; 5. Severe mental disorders; 6. Have participated in or are currently participating in other clinical trial investigators within the past 3 months. 7.Active CNS leukemia within two weeks of registration. Patients with a history of CNS leukemia must have adequate treatment as defined by at least two negative spinal fluid assessments separated by at least one week. Patients who have received cranial XRT must still be eligible to receive total body irradiation to 4 Gy. 8. Patients planning pregnancy, pregnancy or lactation; 9. The investigator determined that fertile subjects were not using adequate contraceptive methods; 10. The investigator determined that the patient was not suitable for the study.

Design outcomes

Primary

MeasureTime frame
The overall survival at day 100 after transplantation;

Secondary

MeasureTime frame
Neutrophil recovery time;Platelet recovery time;Primary implantation failed;Acute graft-versus-host disease;Complete remission after transplantation;Relapse after transplantation;Transplantation related mortality;Overall Survival;Progression free survival;

Countries

China

Contacts

Public ContactQian Shenxian

Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine

sysxqian@163.com+86 13750887628

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026