Anaplastic Lymphoma, Lymphoma, Nonhodgkin, MDD, MRD, Pediatric Cancer
Conditions
Brief summary
With the development of molecular biology and precise medical treatment, new challenges have been raised in the diagnosis and treatment of non-Hodgkin lymphoma (NHL) in children. In recent years, the criteria for clinical staging and efficacy evaluation of NHL in children have been updated. Studies in Germany and the United States have shown that pathological types of systemic anaplastic large cell lymphoma (ALCL) in children and adolescents, minimal disseminated disease (MDD) in peripheral blood or bone marrow and minimal residual disease (MRD) are significantly associated with prognosis, suggesting that these factors need to be combined in risk stratification of ALCL patients. Recent studies have also suggested that PET/CT is helpful in evaluating residual lesions in patients with lymphoma after chemotherapy. In order to keep pace with the times in the diagnosis, clinical staging, risk stratification, efficacy evaluation and treatment of NHL in children. We adjusted the original NHL-BFM-90/95 regimen, mainly in the aspects of clinical staging, efficacy evaluation, risk stratification and treatment regimen，etc.
Detailed description
Research purpose: 1. To study the efficacy and safety of SCCCG-ALCL-2017 regimen in children with systemic ALK-positive anaplastic large cell lymphoma. 2. To explore the correlation between MDD or MRD in peripheral blood or bone marrow and the treat response and survival. 3. To explore the feasibility of risk stratification combined with adverse pathological types, dangerous organ invasion and MDD. 4. To investigate the effect of vinblastine maintenance chemotherapy on survival of patients with MRD-positive in peripheral blood after treatment.
Interventions
None listed
Sponsors
Sun Yat-sen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Age \< 18 years old 2. Pathologically confirmed systemic ALK-positive anaplastic large cell lymphoma 3. Newly diagnosed patients 4. Informed consent of guardian of children patients
Exclusion criteria
1. Secondary immunodeficiency disease 2. Second neoplasm 3. Primary cutaneous anaplastic large cell lymphoma 4. Recurrent and progressive patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Event-free survival (EFS) | through study completion, maximal eight years | EFS is defined as time from start of treatment/randomization up to event or to date of last contact for patients without event. The following occurrences are defined as an event: non-response, progressive disease or relapse, treatment related death, death of any other cause or diagnosis of secondary malignancies |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | through study completion, maximal eight years | OS is defined as time from start of treatment/randomization up to death of any |
| Relapse-free survival (RFS) | through study completion, maximal eight years | RFS is defined as time from start of treatment/randomization up to event or to date of last contact for patients without event. The following occurrences are defined as an event: non-response, progressive disease, or relapse. |
| Response rate (RR) | on an average 3 weeks after finish of treatment | Complete response, partial remission, objective effect, stable disease or progressive disease |
| Adverse event rate | from the first day of protocol defined treatment until two years after start of protocol defined treatment | Rate of patients with acute toxicity defined as grade III/IV/V AE |
Countries
China
Contacts
Primary ContactSun Xiao-Fei
Backup ContactZhen Zi-Jun
Outcome results
None listed