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

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 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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral T-cell Lymphoma
• Intervention / Treatment: Drug: BEAC; Drug: Cladribine combined with BEAC

Detailed Description

Peripheral T-cell lymphomas (PTCL) is a group of highly heterogeneous aggressive non-Hodgkin lymphomas originating from mature post-thymic T lymphocytes or NK/T cells. The treatment effect of patients receiving autologous hematopoietic stem cell transplantation (ASCT) is better than traditional chemotherapy, but the recurrence after transplantation is still as high as 50%. It is an urgent clinical problem to reduce the recurrence after PTCL transplantation. Cladribine can kill quiescent tumor cells, which is the main reason of tumor recurrence. Since 2018, our center has used cladribine combined with BEAC pretreatment regimen to treat 20 patients with PTCL. The PFS reached 68% at 2 years, which is about 15% higher than the previous classic BEAC regimen. This multi-center clinical study will further evaluate the efficacy and safety of Cladribine combined with BEAC pretreatment regimen in the Treatment of Peripheral T-cell Lymphoma.

• Study Type: Interventional
• Enrollment (Anticipated): 266
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Ruijin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: BEAC; Patients in this arm will receive BEAC (Semustine, Etoposide, Cytarabine, Cyclophosphamide) as pretreatment regimen of ASCT	Drug: BEAC; Semustine, 300 mg/m2，-6d； Etoposide, 100 mg/m2，-5～-2d； Cytarabine, 100mg/m2，q12h，-5～-2d； Cyclophosphamide, 1.5g/m2，-5～-2d
EXPERIMENTAL: Cladribine combined with BEAC; Patients in this arm will receive Cladribine combined with BEAC (Semustine, Etoposide, Cytarabine, Cyclophosphamide) as pretreatment regimen of ASCT	Drug: Cladribine combined with BEAC; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival was defined as the time from the date of ASCT to the date of death from any cause.	Baseline up to data cut-off (up to approximately 2 years)
Overall remission rate	Percentage of participants with overall response was determined on the basis of Revised Standards for Efficacy Evaluation of Malignant Lymphoma in 2007.	3 months after the transplantation
Transplantation-related adverse reactions	Transplantation-related adverse reactions are any untoward medical occurrence in a participant which is related to ASCT	Baseline up to data cut-off (up to approximately 5 years)
Patient tolerance	Percentage of participants who can tolerate the whole treatment of ASCT	Through the whole course of ASCT, an average of one month
Relapse rate	Percentage of participants who relapse determined on the basis of Revised Standards for Efficacy Evaluation of Malignant Lymphoma in 2007.	Baseline up to data cut-off (up to approximately 5 years)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 17, 2020
• Primary Completion (ANTICIPATED): October 17, 2024
• Study Completion (ANTICIPATED): October 17, 2025

Study Registration Dates

• First Submitted: April 17, 2021
• First Submitted That Met QC Criteria: May 9, 2021
• First Posted (ACTUAL): May 11, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 11, 2021
• Last Update Submitted That Met QC Criteria: May 9, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Cladribine; Autologous stem cell transplantation; Peripheral T-cell lymphoma; BEAC
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Physiological Effects of Drugs; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Cladribine
• Other Study ID Numbers: ASCT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No