Combining Cladribine with BEAC for treating Peripheral T-cell Lymphoma

Efficacy and Safety of Cladribine Combined With BEAC ( Semustine, Etoposide, Cytarabine, Cyclophosphamide) Pretreatment Regimen in the Treatment of Peripheral T-cell Lymphoma: a Multicenter Clinical Study

This study is testing if combining Cladribine with a specific treatment plan can help people with Peripheral T-cell Lymphoma have better outcomes and lower chances of their cancer coming back.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 266 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Ruijin Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT04880746 on ClinicalTrials.gov

What this trial studies

This multicenter clinical study aims to evaluate the efficacy and safety of Cladribine combined with the BEAC pretreatment regimen in patients with Peripheral T-cell Lymphoma (PTCL). PTCL is an aggressive form of non-Hodgkin lymphoma, and while autologous stem cell transplantation (ASCT) improves treatment outcomes, recurrence rates remain high. The study builds on previous findings where Cladribine showed promise in reducing tumor recurrence. By assessing a larger patient population, the study seeks to confirm the benefits of this combined treatment approach.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with newly diagnosed PTCL who have achieved partial or complete remission after induction chemotherapy.

Not a fit: Patients with severe cardiac or pulmonary insufficiencies or those who have received prior hematopoietic stem cell transplantation may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce recurrence rates in patients with Peripheral T-cell Lymphoma after transplantation.

How similar studies have performed: Previous studies have shown promising results with similar approaches, indicating a potential for success in this trial.

Eligibility criteria

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×ULN in 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 Criteria:

* Accompanied by severe cardiac insufficiency, cardiac ejection fraction \<60%; or severe arrhythmia, intolerance of pretreatment;
* Accompanied by severe pulmonary insufficiency (obstructive and or restrictive ventilatory 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 of pretreatment;
* 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 Ccr is 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 or follow 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 and follow-up observation.

Where this trial is running

Shanghai, Shanghai

• Ruijin Hospital — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Weili Zhao

Conditions Peripheral T-cell Lymphoma; Peripheral T-cell lymphoma; Autologous stem cell transplantation; Cladribine; BEAC