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A randomized multicenter clinical trial of medium dose cytarabine based CEAC regimen combined with cratripine preconditioning in the treatment of high-risk NHL

A randomized multicenter clinical trial of medium dose cytarabine based CEAC regimen combined with cratripine preconditioning in the treatment of high-risk NHL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800015922
Enrollment
Unknown
Registered
2018-04-29
Start date
2018-05-01
Completion date
Unknown
Last updated
2018-04-30

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

Conditions

lymphoma

Interventions

test group:CEAC+Cla
control group:CEAC

Sponsors

The Second Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Aged 18-60 years old male and female; (2) ECOG score was 0-2 points (Annex 1), and the estimated survival time was more than 6 months; (3) patients with newly diagnosed high-risk NHL (stage III/IV, or other molecular biological markers are at high risk) or premenstrual induction therapy for patients whose efficacy is less than CR; (4) in the 14 day before the group, the blood routine was satisfied: Hb>80g/L, ANC>1x10^9/L, PLT>75x10^9/L; the function of liver and kidney was satisfied: TBIL < 1.5xULN, ALT, AST<2 x ULN, Cr<1.5xULN; (5) no radiotherapy, chemotherapy, targeted therapy or stem cell transplantation were included in the first 4 weeks; (6) voluntary subjects and signed informed consent.

Exclusion criteria

Exclusion criteria: (1) those with severe heart failure and ejection fraction of EF were less than 60%; or severe arrhythmia, the researchers could not tolerate preconditioning; (2) with severe pulmonary insufficiency (obstructive or restrictive ventilatory disorders), the researchers evaluated those who could not tolerate pre conditioning; (3) severe liver function damage and liver function index (ALT, TBIL) were more than 3 times higher than the upper limit of normal value (ULN); the researchers evaluated the patients who could not tolerate the preconditioning regimen; (4) with severe renal insufficiency, renal function index (Cr) was more than 2 times higher than the upper limit of normal value (ULN); or the urinary creatinine clearance rate of 24 hours was lower than 50ml/min, the researchers evaluated the patients who could not tolerate the preconditioning regimen; (5) severe active infection before transplantation; (6) the clinical symptoms or serious mental disorders with cerebral dysfunction can not understand or follow the research plan; (7) women in pregnancy, preparation for pregnancy or lactation; (8) patients with other malignant tumors need to be treated; (9) there is no guarantee of completing the necessary treatment plan and follow-up observation.

Design outcomes

Primary

MeasureTime frame
overall survival;progress free survival;

Secondary

MeasureTime frame
Transplantation related adverse reactions;Patient tolerance;the ratio of relapse;overall objective disease response rate;complete remission;Partial remission;

Countries

China

Contacts

Public ContactLiu Yao

The Second Affiliated Hospital of Army Medical University

648283926@qq.com+86 13228684685

Outcome results

None listed

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