Vinorelbine for Recurrent ACLC

NCT03397953 | Completed Phase 2 DMC

• 1 other identifier: CCGChina-ALCL-ABANDONED
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the efficiency and safety of vinorelbine in the treatment of relapsed / advanced ALCL in children and adolescents.

Conditions

Anaplastic Large Cell Lymphoma; Vinorelbine

Keywords

Anaplastic Large Cell Lymphoma; Childhood; Adolescent; Recurrent; Treatment

Outcome Measures

Primary Outcomes (1)

• Event free survival

  5 years

Secondary Outcomes (1)

• Overall survival

  5 years

Other Outcomes (1)

• Safety statistics: adverse reactions during the trial through NCI CTCAE version 4.0.

  2 years

Study Arms (1)

Vinorelbine monotherapy treatment

EXPERIMENTAL

Patients will be treated by Vinorelbine. Four weeks as a course. There are 20 courses in total.

Drug: Vinorelbine

Interventions

Vinorelbine DRUG

Vinorelbine will be used 25mg/m2/week, rest for 1 week after 3 weeks of continuous use, 4 weeks will be a course. After 1 week there will be a simple assessment, after 2 weeks will be a comprehensive assessment. If the patient got disease progression or partial response/stable disease, he/she would be removed from this trial.

Vinorelbine monotherapy treatment

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children and adolescents with a clear diagnosis of recurrent / progressive ALCL at Shanghai Children's Medical Center or other centers since September 2017 include:
• Diagnosed as ALCL, already received first-line treatment, but get disease progression;
• After receiving ALCL treatment has got CR then diagnosed relapse, need for pathological diagnosis.

You may not qualify if:

• Patients with other systemic diseases, severe infections or critically illness.

Sponsors & Collaborators

• Children's Cancer Group, China: lead

Study Sites (1)

Shanghai Children's Medical Center

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Lymphoma, Large-Cell, Anaplastic; Recurrence

Interventions

Vinorelbine

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Yijin Gao, MD

  Shanghai Children's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2018
• First Posted: January 12, 2018
• Study Start: November 1, 2016
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: July 26, 2022

Record last verified: 2022-07

Locations

CN (1)