Vinorelbine for Recurrent ALCL-2017

NCT03443128 | Completed Phase 2 DMC

• 1 other identifier: CCGChina-R-ALCL-2017
• 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; Recurrent; Childhood; Adolescent; Treatment

Outcome Measures

Primary Outcomes (2)

• Progression Rate

  The progression rate will be obtained from the results of simple assessment after one course.

  4 weeks

• CR/CRu Rate

  The CR/CRu rate will be obtained from the results of simple assessment, CT and FDG-PET after two courses.

  8 weeks

Secondary Outcomes (2)

• Progression-free Survival

  2 years

• Overall Survival

  2 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 with Vinorelbine. Four weeks as a course. There are 20 courses in total.

Drug: Vinorelbine

Interventions

Vinorelbine DRUG

During each course, patients will be treated with vinorelbine (25mg/m2/week on weeks 1-3). After 1 course(4 weeks) of vinorelbine, response will be evaluated by simple assessment: clinical symptoms, signs, B ultrasound, chest X-ray, peripheral blood test and bone marrow smear(if needed). After 2 courses, response will be evaluatedy by simple assessment, CT and FDG-PET. The CR/CRu was defined by anatomic tumour shrinkage more than 75% after 2 courses based on CT with negative PET assessment, with negative bone marrow PCR(if needed) and without CNS involvement. Patients who achieved a CR/CRu after two courses either will proceed to stem cell transplantation (SCT) or will receive additional courses of therapy while awaiting SCT. Response was re-evaluated at the end of every 2 courses. Patients with progressive disease at any time during treatment will be removed from protocol therapy.

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: February 17, 2018
• First Posted: February 22, 2018
• Study Start: November 1, 2016
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

CN (1)