Efficacy and Safety of Cladribine Combined With BEAC Pretreatment Regimen in the Treatment of Peripheral T-cell Lymphoma: a Multicenter Clinical Study

NCT04880746 | Unknown Phase 3 DMC

• 1 other identifier: ASCT-001
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

Brief Summary

This multi-center clinical study will evaluate the efficacy and safety of Cladribine Combined With BEAC Pretreatment Regimen in the Treatment of Peripheral T-cell Lymphoma.

Conditions

Peripheral T-cell Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Progression-free survival was defined as the time from the date of ASCT until the date of the first documented day of disease progression or relapse, using Revised Standards for Efficacy Evaluation of Malignant Lymphoma in 2007, or death from any cause, whichever occurred first.

  Baseline up to data cut-off (up to approximately 2 years)

Secondary Outcomes (5)

• Overall survival

  Baseline up to data cut-off (up to approximately 2 years)

• Overall remission rate

  3 months after the transplantation

• Transplantation-related adverse reactions

  Baseline up to data cut-off (up to approximately 5 years)

• Patient tolerance

  Through the whole course of ASCT, an average of one month

• Relapse rate

  Baseline up to data cut-off (up to approximately 5 years)

Study Arms (2)

BEAC

ACTIVE COMPARATOR

Patients in this arm will receive BEAC (Semustine, Etoposide, Cytarabine, Cyclophosphamide) as pretreatment regimen of ASCT

Drug: BEAC

Cladribine combined with BEAC

EXPERIMENTAL

Patients in this arm will receive Cladribine combined with BEAC (Semustine, Etoposide, Cytarabine, Cyclophosphamide) as pretreatment regimen of ASCT

Drug: Cladribine combined with BEAC

Interventions

BEAC DRUG

Semustine, 300 mg/m2，-6d； Etoposide, 100 mg/m2，-5～-2d； Cytarabine, 100mg/m2，q12h，-5～-2d； Cyclophosphamide, 1.5g/m2，-5～-2d

BEAC

Cladribine combined with BEAC DRUG

Cladribine, 6mg/m2，-5～-2d, two hours before Cytarabine Semustine, 300 mg/m2，-6d； Etoposide, 100 mg/m2，-5～-2d； Cytarabine, 100mg/m2，q12h，-5～-2d； Cyclophosphamide, 1.5g/m2，-5～-2d

Cladribine combined with BEAC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead
• Xinqiao Hospital of Chongqing: collaborator
• The First Affiliated Hospital of Anhui Medical University: collaborator
• Harbin Hematology and Oncology Institute: collaborator
• Affiliated Zhongshan Hospital of Dalian University: collaborator
• Qilu Hospital of Shandong University: collaborator
• Fujian Medical University Union Hospital: collaborator
• Shanxi Province Cancer Hospital: collaborator
• RenJi Hospital: collaborator
• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Huashan Hospital: collaborator

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

BAEC protocol

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Weili Zhao

  Ruijin Hospital

  STUDY CHAIR

Central Study Contacts

Weili Zhao

CONTACT

+862164370045; zwl_trial@163.com

Pengpeng Xu

CONTACT

+862164370045; pengpeng_xu@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: First Deputy Director, Hematology Department

Study Record Dates

• First Submitted: April 17, 2021
• First Posted: May 11, 2021
• Study Start: October 17, 2020
• Primary Completion: October 17, 2024
• Study Completion: October 17, 2025
• Last Updated: May 11, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)