Vinorelbine for Recurrent ALCL-2017

NCT ID: NCT03443128

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2025-02-28

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.

Detailed Description

Anaplastic large cell lymphoma (ALCL) is a rare non-Hodgkin's lymphoma, around 30% patients would get relapse. Vinorelbine(Navelbine) is a third-line treatment option for Hodgkin's disease(HD) after transplantation failed, while both HD and ALCL express CD30. When ALCL recurred, vinblastine monotherapy was used and the 5-year EFS up to 30%, 5-year OS up to 60%. In China vinblastine is unavailable. Vinorelbine is very similar to vinblastine in molecular formula, and is available in China. From November 2016 to March 2017, two patients with recurrent ALCL were recruited in the Department of Hematology and Oncology, Shanghai Children's Medical Center. They received vinorelbine monotherapy and achieved clinical remission (PET CR) at 8 weeks. One patient with bone marrow recurrence showed negative ALK / NPM by PCR . Based on this, the investigators will expand the sample to further investigate the therapeutic efficiency and safety of vinorelbine in children and adolescents with ALCL.

Conditions

Anaplastic Large Cell Lymphoma; Vinorelbine

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vinorelbine monotherapy treatment

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

Group Type: EXPERIMENTAL

Vinorelbine

Intervention Type: 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.

Interventions

Vinorelbine

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Cancer Group, China

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yijin Gao, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Children's Medical Center

Locations

Shanghai Children's Medical Center

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

CCGChina-R-ALCL-2017

Identifier Type: -

Identifier Source: org_study_id