Reduced-dose Conditioning Regimen Containing TBI in HSCT Treating Elderly Patients With Aplastic Anemia

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

The TBI-containing reduced-dose conditioning regimen was used to treat elderly patients with aplastic anemia who received hematopoietic stem cell transplantation. The overall survival rate, GVHD-free survival rate, all-cause mortality,et al were studied. The modified conditioning regimen included TBI 2Gy, -7d, busulfan 3.2mg / kg-6d ; fludarabine 30mg / m2 / d-5 \~ -1d ; cyclophosphamide 25-30mg / kg / d-5 \~ -2d ; ATG ( rabbit ) 2 mg / kg / d-5 \~ -1d.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

( 1 ) Diagnosis of aplastic anemia, including very severe aplastic anemia, severe aplastic anemia, chronic aplastic anemia and hepatitis-associated aplastic anemia.

Disqualifiers

( 1 ) Patients who underwent more than one time of transplantation before enrollment ; ( 2 ) Uncontrolled infection, mechanical ventilation or hemodynamic instability at the time of enrollment ; ( 3 ) Diagnosis of clinically significant severe liver dysfunction ( defined as Child-Pugh C grade ) within 5 days before enrollment ; or within 5 days before enrollment, AST or ALT was 5 times higher than the upper limit of normal, or serum total bilirubin was 2 times higher than the upper limit of normal ; ( 4 ) End-stage renal insufficiency was diagnosed within 5 days before enrollment, and creatinine clearance rate was less than 10ML / min.

Trial design

Design model

Single group

Treatments tested in this trial

  • reduced-dose conditioning regimen containing TBI in hematopoietic stem cell transplantation treating elderly patients with aplastic anemia

    Drug

    reduced-dose conditioning regimen containing TBI in hematopoietic stem cell transplantation treating elderly patients with aplastic anemia

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: reduced-dose conditioning regimen containing TBI in hematopoietic stem cell transplantation treatingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

overall survival

2-year overall survival

Time frame
2 year after HSCT

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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