CCCG-ALCL-2020 for Chinese Children and Adolescents With Newly Diagnosed High-risk ALCL

February 9, 2024 updated by: Children's Cancer Group, China

Using a Modified ALCL99 Regimen for Chinese Children With Newly Diagnosed High-risk Anapestic Large Cell Lymphoma

A prospective study on the efficacy of modified ALCL99 regimens in the treatment of the current Chinese pediatric and adolescent high-risk ALCL and compared with our historical data.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Anaplastic large cell lymphoma (ALCL) accounts for 15% of pediatric and adolescent non-Hodgkin lymphomas (NHLs). In our historical study (retrospective multicenter study), the 3-year event-free survival (EFS) was 65% for 80 eligible patients treated in 10 centers between January 2009 and June 2014.

The ALCL99 trial reported a 2-year overall survival of 92% and 2-year event-free survival of 74% then become the current standard frontline treatment for pediatric ALCL. The recent long-term follow-up data from ALCL99 trial highlighted its excellent outcome. A less toxic schedule of methotrexate (MTX) 3g/m2 in a 3-hour infusion without intrathecal therapy reproduced the favorable results from previous reports of NHL-BFM90 protocol with MTX at 1g/m2 in a 3-hour infusion. Additionally, a prospective ALCL-Relapse trial by the European Inter-Group for Childhood Non-Hodgkin Lymphoma demonstrated 80% of patients with a late relapse can be cured by 24 months of vinblastine monotherapy. However, vinblastine would not be advised as a treatment option in mainland China due to its inaccessibility. A pilot experience using single-drug vinorelbine in 4 pediatric patients with relapsed ALCL with satisfactory outcome provides the rational for studying vinorelbine as a front line drug option.

Study Type

Interventional

Enrollment (Estimated)

172

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Shanghai Children's Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient must be ≤ 18 years at the time of diagnosis
  • Newly diagnosed patients with histologically confirmed high-risk anaplastic large cell lymphoma
  • No congenital immunodeficiency, HIV infection, or prior organ transplant

Exclusion Criteria:

  • Patients have received prior cytotoxic chemotherapy/target therapy/radiation, if any steroid applied, total prior steroids dosage > Dexamethasone 40 mg/m2 for the current diagnosis or any cancer
  • Patients have overwhelming infection, and a life expectancy of < 2 weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High risk group
  1. Stage I, unresected; Stage I with "B" syndrome
  2. Stage II
  3. Stage III
  4. Stage IV without CNS involvement
Drug: P regimen
Dexamethasone 5 mg/m2 Days 1 and 2; 10mg/m2 Day 3 to 5; Cyclophosphamide 200 mg/m2 Days 1 and 2 Intrathecal therapy Day 1
Drug: Course A1 + Vin
vinorelbine 25 mg/m2, Day 1 Dexamethasone 10 mg/m2 Days 1 to 5; Methotrexate 3g/m2, 3-hour infusion Day 1; Etoposide 100mg/m2, Days 4 to 5; Ifosfamide 800 mg/m2, Days 1 to 5; Cytarabine 150 mg/m2, q12h Days 4 to 5;
Drug: Course B1 +Vin
vinorelbine 25 mg/m2, Day 1; Dexamethasone 10 mg/m2 Days 1 to 5; Methotrexate 3g/m2, 3-hour infusion Day 1; Cyclophosphamide 200 mg/m2, Days 1 to 5; Doxorubicin 25 mg/m2, Days 4 to 5;
Drug: Course A2 + Vin
vinorelbine 25 mg/m2, Day 1 Dexamethasone 10 mg/m2 Days 1 to 5; Methotrexate 3g/m2, 3-hour infusion Day 1; Etoposide 100mg/m2, Days 4 to 5; Ifosfamide 800 mg/m2, Days 1 to 5; Cytarabine 150 mg/m2, q12h Days 4 to 5;
Drug: Course B2 +Vin
vinorelbine 25 mg/m2, Day 1; Dexamethasone 10 mg/m2 Days 1 to 5; Methotrexate 3g/m2, 3-hour infusion Day 1; Cyclophosphamide 200 mg/m2, Days 1 to 5; Doxorubicin 25 mg/m2, Days 4 to 5;
Drug: Course A3 + Vin
vinorelbine 25 mg/m2, Day 1 Dexamethasone 10 mg/m2 Days 1 to 5; Methotrexate 3g/m2, 3-hour infusion Day 1; Etoposide 100mg/m2, Days 4 to 5; Ifosfamide 800 mg/m2, Days 1 to 5; Cytarabine 150 mg/m2, q12h Days 4 to 5;
Drug: Course B3 +Vin
vinorelbine 25 mg/m2, Day 1; Dexamethasone 10 mg/m2 Days 1 to 5; Methotrexate 3g/m2, 3-hour infusion Day 1; Cyclophosphamide 200 mg/m2, Days 1 to 5; Doxorubicin 25 mg/m2, Days 4 to 5;
Drug: Maintenance therapy
Vinorelbine 25 mg/m2 IV, weekly for 3 consecutive weeks followed by 1-week rest. Totally 80 cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year event free survival (EFS)
Time Frame: Up to 3 years
Calculated from the time of diagnosis to the first of the following events: progression, relapse, secondary ,malignancy or death
Up to 3 years
Treatment-related adverse events
Time Frame: Up to 3years
Number of participants with treatment-related adverse events as assessed by CTCAEv5.0
Up to 3years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient compliance
Time Frame: Up to 3years
the percentage of patients who complete the maintenance therapy of this modified ALCL99 regimens
Up to 3years
Value of early PET/CT in pediatric ALCL
Time Frame: Up to 3 years
Prognostic value of early remission of PET/CT after 2 cycles of chemotherapy in pediatric ALCL
Up to 3 years
Value of peripheral blood or bone marrow NPM-ALK or ALK-variants level in pediatric ALCL
Time Frame: Up to 3 years
Prognostic value of peripheral blood/bone marrow NPM-ALK or ALK-variants level (qPCR) at diagnosis in pediatric ALCL
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Cancer Group, China

Collaborators

Qilu Hospital of Shandong University
Shanghai Children's Medical Center
West China Second University Hospital
Shenzhen Children's Hospital
Nanjing Children's Hospital
Sun Yat-Sen Memorial Hospital Zhongshan University
Tianjin Cancer Hospital
Xiangya Hospital
1st Affiliated Hospital of Zhengzhou University

Investigators

  • Principal Investigator: Yijin Gao, MD, Shanghai Children's Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

May 10, 2021

First Submitted That Met QC Criteria

May 10, 2021

First Posted (Actual)

May 11, 2021

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCCG-ALCL-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study protocol, SAP and ICF were shared before study initiation. Patient data and the information about the process of the study will be shared within the all participants annually after enrollment patients.

IPD Sharing Time Frame

The data will be shared within the all hospitals every 12 months after enrollment of patients.

IPD Sharing Access Criteria

Scheduled meeting and paper transferring.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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