Anaplastic Large Cell LymphomaPhase 2NCT03443128
Vinorelbine for Recurrent ALCL-2017
A Phase 2 study testing Vinorelbine in people with Anaplastic Large Cell Lymphoma and Vinorelbine, run by Children's Cancer Group, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Anaplastic Large Cell Lymphoma, Vinorelbine
- What is being tested?
- Vinorelbine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Feb 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Patients with other systemic diseases, severe infections or critically illness.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Children's Medical Center
Shanghai, Shanghai Municipality, 200127
About this study
Official title: Phase II Study of Vinorelbine for Children with Recurrent Anaplastic Large Cell Lymphoma
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.
Read the 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
- Being tested
- Vinorelbine
- Keywords
- Anaplastic Large Cell Lymphoma, Recurrent, Childhood, Adolescent, Treatment
- Medical subject headings
- Lymphoma, Large-Cell, Anaplastic, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VinorelbineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Vinorelbine monotherapy treatment | Experimental | Patients will be treated with Vinorelbine. Four weeks as a course. There are 20 courses in total. Receives: Drug: Vinorelbine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Rate
The progression rate will be obtained from the results of simple assessment after one course.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (2)
Progression-free Survival
Measured: 2 years
Overall Survival
Compared with historical data.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study startNov 2016
- Primary completionDec 2024
- Study completionFeb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anaplastic Large Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Cancer Group, China
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Yijin Gao, MD, Principal investigator, Shanghai Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443128
- Sponsor's protocol ID
- CCGChina-R-ALCL-2017
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2018
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Vinorelbine for Children with Recurrent Anaplastic Large Cell Lymphoma
- ClinicalTrials.gov ID
- NCT03443128
- Acronym / sponsor ID
- CCGChina-R-ALCL-2017
- Conditions
- Anaplastic Large Cell Lymphoma, Vinorelbine
- Keywords
- Anaplastic Large Cell Lymphoma, Recurrent, Childhood, Adolescent, Treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Children's Cancer Group, ChinaResearch network
- Study start
- Nov 2016 (actual)
- Primary completion
- Dec 2024 (actual)
- Study completion
- Feb 2025 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vinorelbine monotherapy treatment | Experimental | Drug: VinorelbinePatients will be treated with Vinorelbine. Four weeks as a course. There are 20 courses in total. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with other systemic diseases, severe infections or critically illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VinorelbineDuring 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. | Drug | Vinorelbine monotherapy treatment |
Primary outcome
Progression Rate
Time frame: 4 weeks
The progression rate will be obtained from the results of simple assessment after one course.
CR/CRu Rate
Time frame: 8 weeks
The CR/CRu rate will be obtained from the results of simple assessment, CT and FDG-PET after two courses.
2 secondary outcomes
Progression-free Survival
Time frame: 2 years
Overall Survival
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yijin Gao, MD principal investigator
Shanghai Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vinorelbine in people with Anaplastic Large Cell Lymphoma and Vinorelbine, run by Children's Cancer Group, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Rate (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025; AzTrials last refreshed its copy on 28 Oct 2026.