CCCG-ALCL-2020 for Chinese Children and Adolescents With Newly Diagnosed High-risk ALCL
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: High risk group Stage I, unresected; Stage I with "B" syndrome Stage II Stage III 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.
|
Outcome Measures
Primary Outcome Measures
- 3-year event free survival (EFS) [Up to 3 years]
Calculated from the time of diagnosis to the first of the following events: progression, relapse, secondary ,malignancy or death
Secondary Outcome Measures
- Treatment-related adverse events [Up to 3 years]
Number of participants with treatment-related adverse events as assessed by CTCAEv5.0
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shanghai Children's Medical Center | Shanghai | China |
Sponsors and Collaborators
- Children's Cancer Group, China
- Shanghai Children's Medical Center
- Nanjing Children's Hospital
- Qilu Hospital of Shandong University
- Tianjin Cancer Hospital
- West China Second University Hospital
- Xiangya Hospital
- 1st Affiliated Hospital of Zhengzhou University
Investigators
- Principal Investigator: Yijin Gao, MD, Shanghai Children's Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CCCG-ALCL-2020