Last updated: May 9, 2021
Sponsor: Ruijin Hospital
Overall Status: Active - Recruiting
Phase
3
Condition
Lymphoma
T-cell Lymphoma
Non-hodgkin's Lymphoma
Treatment
N/AClinical Study ID
NCT04880746
ASCT-001
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 18-65 years old, no gender limit;
- ECOG 0-2, estimated survival time ≥ 3 months;
- Pathologically newly diagnosed with PTCL (except ALK+ anaplastic large cell lymphoma),with PR or CR after 6 cycles of induction chemotherapy;
- Hb≥80g/L, ANC≥1.0×10^9/L, PLT≥75×10^9/L; TBIL≤1.5×ULN, ALT/AST≤2.0× ULN, Cr ≤1.5×ULNin the 14 days before enrollment
- Have not received hematopoietic stem cell transplantation and other treatments within 4 weeks before enrollment;
- The number of hematopoietic stem cells requires MNC ≥3×10^8/kg and/or CD34 cells ≥2×10^6/kg;
- Informed consented
Exclusion
Exclusion Criteria:
- Accompanied by severe cardiac insufficiency, cardiac ejection fraction <60%; or severearrhythmia, intolerance of pretreatment;
- Accompanied by severe pulmonary insufficiency (obstructive and or restrictiveventilatory disorders), intolerance of pretreatment;
- Accompanied by severe liver function impairment, liver function indexes (ALT, TBIL)are more than 3 times higher than the upper limit of normal, intolerance ofpretreatment;
- Accompanied by severe renal insufficiency, the renal function index (Cr) is more than 2 times the upper limit of normal; or the 24-hour urine creatinine clearance rate Ccris less than 50ml/min, intolerance of pretreatment;
- Severe active infection before transplantation, intolerance of pretreatment;
- Accompanied by brain dysfunction or severe mental illness, unable to understand orfollow the research plan;
- Pregnant or lactation;
- Accompanied by other malignant tumors in need of treatment;
- Patients who cannot guarantee the completion of the necessary treatment plan andfollow-up observation.
Study Design
Total Participants: 266
Study Start date:
October 17, 2020
Estimated Completion Date:
October 17, 2025
Study Description
Connect with a study center
Ruijin Hospital
Shanghai, Shanghai
ChinaActive - Recruiting

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