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

Primary Purpose

Peripheral T-cell Lymphoma

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

BEAC

Cladribine combined with BEAC

About this trial

This is an interventional treatment trial for Peripheral T-cell Lymphoma focused on measuring Peripheral T-cell lymphoma, Autologous stem cell transplantation, Cladribine, BEAC

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Ruijin HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

BEAC

Cladribine combined with BEAC

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall survival

Overall survival was defined as the time from the date of ASCT to the date of death from any cause.

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.

Transplantation-related adverse reactions

Transplantation-related adverse reactions are any untoward medical occurrence in a participant which is related to ASCT

Patient tolerance

Percentage of participants who can tolerate the whole treatment of ASCT

Relapse rate

Percentage of participants who relapse determined on the basis of Revised Standards for Efficacy Evaluation of Malignant Lymphoma in 2007.

Full Information

NCT ID

NCT04880746

First Posted

April 17, 2021

Last Updated

May 9, 2021

Sponsor

Ruijin Hospital

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04880746

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Recruiting

Study Start Date

October 17, 2020 (Actual)

Primary Completion Date

October 17, 2024 (Anticipated)

Study Completion Date

October 17, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ruijin Hospital

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral T-cell Lymphoma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

266 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

BEAC

Arm Type

Active Comparator

Arm Description

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

Arm Title

Cladribine combined with BEAC

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

BEAC

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cladribine combined with BEAC

Intervention Description

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

Primary Outcome Measure Information:

Title

Progression free survival

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Overall survival

Description

Overall survival was defined as the time from the date of ASCT to the date of death from any cause.

Time Frame

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

Title

Overall remission rate

Description

Percentage of participants with overall response was determined on the basis of Revised Standards for Efficacy Evaluation of Malignant Lymphoma in 2007.

Time Frame

3 months after the transplantation

Title

Transplantation-related adverse reactions

Description

Transplantation-related adverse reactions are any untoward medical occurrence in a participant which is related to ASCT

Time Frame

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

Title

Patient tolerance

Description

Percentage of participants who can tolerate the whole treatment of ASCT

Time Frame

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

Title

Relapse rate

Description

Percentage of participants who relapse determined on the basis of Revised Standards for Efficacy Evaluation of Malignant Lymphoma in 2007.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Weili Zhao

Phone

+862164370045

zwl_trial@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Pengpeng Xu

Phone

+862164370045

pengpeng_xu@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Weili Zhao

Organizational Affiliation

Ruijin Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Ruijin Hospital

City

Shanghai

State/Province

Shanghai

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Weili Zhao

Phone

+862164370045

zwl_trial@163.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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