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Vinorelbine for Recurrent ALCL-2017

C

Children's Cancer Group, China

Status and phase

Enrolling
Phase 2

Conditions

Vinorelbine
Anaplastic Large Cell Lymphoma

Treatments

Drug: Vinorelbine

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT03443128
CCGChina-R-ALCL-2017

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Vinorelbine monotherapy treatment
Experimental group
Description:
Patients will be treated with Vinorelbine. Four weeks as a course. There are 20 courses in total.
Treatment:
Drug: Vinorelbine

Trial contacts and locations

1

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Central trial contact

Yijin Gao, MD; Xingwei Wang, MD

Data sourced from clinicaltrials.gov

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