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Clinical study of cladribine combined with BEAC regimen in the treatment of peripheral T-cell lymphoma

Efficacy and safety of cladribine combined with BEAC regimen in the treatment of peripheral T-cell lymphoma: a multicenter randomized controlled clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039137
Enrollment
Unknown
Registered
2020-10-18
Start date
2020-10-17
Completion date
Unknown
Last updated
2021-01-18

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

Conditions

peripheral T-cell lymphoma

Interventions

Experimental group:Cla+BEAC
Control group:BEAC

Sponsors

Department of Hematology, Xinqiao Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Male and female aged 18-60 years; 2. ECoG score was 0-2 , Estimated lifetime>3months; 3. Patients with PTCL (except ALK + anaplastic large cell lymphoma) who were newly diagnosed by histopathology, and those who achieved PR after 6 courses of induction chemotherapy; 4.Within 14 days before admission, the blood routine test met the following requirements: HB >= 80g / L, ANC >= 1.0 x 10^9 / L, PLT >= 75 x 10^9 / L; liver and kidney function: TBIL = 3 x 10^8/kg and / or CD34+cells >= 2 x 10^6/kg; 7. Voluntary participants, informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with severe cardiac insufficiency and ejection fraction (EF) less than 60%; or severe arrhythmias, who can not tolerate the preconditioning; 2. Patients with severe pulmonary insufficiency (obstructive and or restrictive ventilation disorder) who could not tolerate the pretreatment regimen were evaluated by the researchers; 3. With severe liver function impairment, liver function indexes (alt, TBIL) were more than 3 times higher than the upper limit of normal value; 4. Patients with severe renal insufficiency, renal function index (CR) more than 2 times of the upper limit of normal value; or 24-hour urinary creatinine clearance rate (CCR) less than 50 ml / min, the researchers evaluated that they could not tolerate the pretreatment program; 5. Severe active infection before transplantation, and the researchers evaluated those who could not tolerate the pretreatment; 6. Patients with clinical symptoms of brain dysfunction or severe mental illness can not understand or follow the research protocol; 7. Pregnant, preparing for pregnancy or lactation women; 8. Patients with other malignant tumors requiring treatment; 9. Patients who cannot be guaranteed to complete the necessary treatment plan and follow-up observation.

Design outcomes

Primary

MeasureTime frame
2 year progress free survival after auto transplantation;

Secondary

MeasureTime frame
2 year oversurvival after auto transplantation;overall remission rate, ORR;Transplantation related adverse reactions;Patient tolerance;relapse rate;

Countries

China

Contacts

Public ContactZhang Xi

183 Xinqiao Main Street, Shapingba District, Chongqing, China

zhangxxi@sina.com+86 023-68774509

Outcome results

None listed

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