Diffuse Intrinsic Pontine GliomaPhase 3NCT04532229
Nimotuzumab in Combined With Chemoradiotherapy to Treat the Newly Diagnosed Diffuse Intrinsic Pontine Glioma in Children
A Phase 3 study testing Nimotuzumab+CRT(concurrent IMRT and TMZ) in people with Diffuse Intrinsic Pontine Glioma, run by Biotech Pharmaceutical Co., Ltd. at 8 sites in China.
Trial summary
This is a prospective, open-label, single arm, multicenter clinical study. The purpose of the study is to evaluate the clinical efficacy and safety of combination Nimotuzumab with concurrent radiochemotherapy in children with newly diagnosed diffuse intrinsic pontine glioma(DIPG). Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Diffuse Intrinsic Pontine Glioma
- What is being tested?
- Nimotuzumab+CRT(concurrent IMRT and TMZ)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 8 sitesChina
- Study dates
- 3 Apr 2021to 8 Dec 2023
- Phase
- Phase 3
- 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 3 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Voluntary and sign a consent form;
- Age 3-15 years old, gender unlimited;
- Histology or imaging diagnosed as diffuse intrinsic pontine glioma, patients haven't received any anti-tumor treatment;
- According to the RANO criteria, at least one measurable lesion;
- Before enrollment, the results of laboratory examination are in accordance with:
- Blood routine test: platelet count ≥ 100 × 10^9/L; absolute neutrophil count ≥ 1.5 × 10^9/L or leukocyte count ≥ 3.0 × 10^9/L; hemoglobin ≥ 90g/L; Blood biochemistry: aspartate aminotransferase#AST# ≤ 3 ×Upper Limit Of Normal#ULN#; alanine aminotransferase#ALT# ≤ 3 × ULN; total bilirubin ≤ 1.5 × ULN; serum creatinine ≤ 1.5 × ULN;
Show all 9Show fewer
- Lansky score ≥ 60;
- Expected survival time ≥ 3 months;
- Fertile subjects are willing to take contraceptive measures during the study period.
Who cannot join
- Recurrent DIPG;
- Have received any other anti-tumor treatment for DIPG, including surgical treatment (except biopsy), chemotherapy, radiotherapy, targeted drugs, immunotherapy, etc;
- Uncontrollable infection, epilepsy and / or hypertension and / or hyperglycemia;
- Human immunodeficiency virus #HIV# infection or active hepatitis B infection or hepatitis C infection;
- Active hemorrhage found by CT or MRI before inclusion and / or inability to carry out CT and MRI examination;
- Major operation (except biopsy) were performed within four weeks before inclusion;
Show all 11Show fewer
- Decompensated heart failure (NYHA grades III and IV), unstable angina, acute myocardial infarction, persistent and clinically significant arrhythmia within three months of inclusion;
- Have other malignant tumor history;
- Known allergy to Nimotuzumab, temozolomide or its analogues or any component of the prescription;
- Unable to tolerate radiotherapy;
- Other reasons that are not suitable to participate in this study according to the researcher's judgment.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites, 8 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing
Xiaoguang Qiu, 13701009917, ttyy6611@126.com
- Not yet recruiting
Peking Union Medical College Hospital
Beijing
Wenbin Ma, 13701364566, MAWB2001@hotmail.com
- Recruiting
Xuanwu Hospital Capital Medical University
Beijing
Qingtang Lin, 15801588169, kingsang2002@hotmail.com
- Not yet recruiting
Xiangya Hospital of Centre-south University
Changsha, Hunan
Liangfang Shen, 13975805137, slf1688@sina.com
- Not yet recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan
Qing Mao, 18980601506, qingmao2000@163.com
- Not yet recruiting
Shandong Cancer Hospital
Jinan
Rongjie Tao, 13969191909, 053113969191909@163.com
- Recruiting
Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine
Shanghai
Xiaojun Yuan
- Recruiting
The Third People's Hospital of Zhengzhou
Zhengzhou, Henan
Gang Wang, 18037791710, z214023wanggang@126.com
About this study
Official title: A Multicenter, Prospective, Open and Single Arm Clinical Study of Nimotuzumab Combined With Concurrent Radiochemotherapy in the Treatment of Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) in Children
This is a prospective, open-label, single arm, multicenter clinical study. The purpose of the study is to evaluate the clinical efficacy and safety of combination Nimotuzumab with concurrent radiochemotherapy in children with newly diagnosed diffuse intrinsic pontine glioma(DIPG).
Read the detailed description
This clinical study is designed as a prospective, open-label, single arm, multicenter study to evaluate the clinical efficacy and safety of combination Nimotuzumab with concurrent radiochemotherapy in children with newly diagnosed diffuse intrinsic pontine glioma(DIPG). The main endpoint is objective response rate, 1-year overall survival rate is also observed.
- Conditions
- Diffuse Intrinsic Pontine Glioma
- Being tested
- Nimotuzumab+CRT(concurrent IMRT and TMZ)
- Keywords
- Nimotuzumab, Temozolomide, DIPG
- Medical subject headings
- Diffuse Intrinsic Pontine Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nimotuzumab+CRT(concurrent IMRT and TMZ)Drug
Also called h-R3
Drug: Nimotuzumab Concurrent radiochemotherapy period, 150mg/m2, weekly, for 6 weeks; Maintenance period, from the 7th to the 52nd week, 150mg/m2, every two weeks until disease progression or intolerable toxicity.
Other Names: h-R3
Drug: Temozolomide Concurrent radiochemotherapy period, 75mg/m2, daily, for 6 weeks; Maintenance period, rest from the 7th to 10th weeks, from the 11th week, 150-200mg/m2, day1 to day5, 21 days for a cycle, for 6 cycles.
Other Names: TMZ
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Nimotuzumab+CRT(concurrent IMRT and TMZ) Receives: Drug: Nimotuzumab+CRT(concurrent IMRT and TMZ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate #ORR# assessed by the Independent Review Committee
Proportion of patients with partial or complete response in tumor burden as defined by RECIST.
Measured: Up to 12 months
Secondary outcomes (3)
1-year overall survival
The possibility that a patient who has lived for 1 year after treatment will still survive. OS is defined as the time from enrollment to death.
Measured: Up to 12 months
Progression-free survival#PFS#
PFS is defined as the time from enrollment to disease progression or death from any cause.
Measured: Up to 12 months
Incidence of adverse events
An adverse event is any adverse event that occurs in a patient or subject of a drug clinical study.
Measured: Up to 30 days after last administration of Nimotuzumab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start3 Apr 2021
- Primary completion8 Oct 2023 (estimated)
- Study completion8 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Intrinsic Pontine GliomaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biotech Pharmaceutical Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaojun Yuan, Study chair, Xinhua Hospital, Shanghai Jiao Tong University School of MedicineXiaoguang Qiu, Study chair, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04532229
- Sponsor's protocol ID
- BPL-Nim-DIPG-1
- Status last verified
- Feb 2023
- First submitted
- 26 Aug 2020
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Open and Single Arm Clinical Study of Nimotuzumab Combined With Concurrent Radiochemotherapy in the Treatment of Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) in Children
- ClinicalTrials.gov ID
- NCT04532229
- Acronym / sponsor ID
- BPL-Nim-DIPG-1
- Conditions
- Diffuse Intrinsic Pontine Glioma
- Keywords
- Nimotuzumab, Temozolomide, DIPG
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Biotech Pharmaceutical Co., Ltd.University, hospital or other
- Study start
- 3 Apr 2021 (actual)
- Primary completion
- 8 Oct 2023 (estimated)
- Study completion
- 8 Dec 2023 (estimated)
- First posted
- 31 Aug 2020 (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.
This is a prospective, open-label, single arm, multicenter clinical study. The purpose of the study is to evaluate the clinical efficacy and safety of combination Nimotuzumab with concurrent radiochemotherapy in children with newly diagnosed diffuse intrinsic pontine glioma(DIPG).
Detailed description
This clinical study is designed as a prospective, open-label, single arm, multicenter study to evaluate the clinical efficacy and safety of combination Nimotuzumab with concurrent radiochemotherapy in children with newly diagnosed diffuse intrinsic pontine glioma(DIPG). The main endpoint is objective response rate, 1-year overall survival rate is also observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Nimotuzumab+CRT(concurrent IMRT and TMZ)Nimotuzumab+CRT(concurrent IMRT and TMZ) |
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Voluntary and sign a consent form;
- Age 3-15 years old, gender unlimited;
- Histology or imaging diagnosed as diffuse intrinsic pontine glioma, patients haven't received any anti-tumor treatment;
- According to the RANO criteria, at least one measurable lesion;
- Before enrollment, the results of laboratory examination are in accordance with:
Key exclusion criteria (11 listed)
- Recurrent DIPG;
- Have received any other anti-tumor treatment for DIPG, including surgical treatment (except biopsy), chemotherapy, radiotherapy, targeted drugs, immunotherapy, etc;
- Uncontrollable infection, epilepsy and / or hypertension and / or hyperglycemia;
- Human immunodeficiency virus #HIV# infection or active hepatitis B infection or hepatitis C infection;
- Active hemorrhage found by CT or MRI before inclusion and / or inability to carry out CT and MRI examination;
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 |
|---|---|---|
| Nimotuzumab+CRT(concurrent IMRT and TMZ)Also: h-R3Drug: Nimotuzumab Concurrent radiochemotherapy period, 150mg/m2, weekly, for 6 weeks; Maintenance period, from the 7th to the 52nd week, 150mg/m2, every two weeks until disease progression or intolerable toxicity. Other Names: h-R3 Drug: Temozolomide Concurrent radiochemotherapy period, 75mg/m2, daily, for 6 weeks; Maintenance period, rest from the 7th to 10th weeks, from the 11th week, 150-200mg/m2, day1 to day5, 21 days for a cycle, for 6 cycles. Other Names: TMZ | Drug | Experimental |
Primary outcome
Objective response rate #ORR# assessed by the Independent Review Committee
Time frame: Up to 12 months
Proportion of patients with partial or complete response in tumor burden as defined by RECIST.
3 secondary outcomes
1-year overall survival
Time frame: Up to 12 months
Progression-free survival#PFS#
Time frame: Up to 12 months
Incidence of adverse events
Time frame: Up to 30 days after last administration of Nimotuzumab
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Diffuse Intrinsic Pontine Glioma
RecruitingPhase 1
PEACH TRIAL- Precision Medicine and Adoptive Cellular Therapy
Neuroblastoma, Diffuse Intrinsic Pontine Glioma
Active, not recruitingPhase 1/2
A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)
Malignant Glioma
Active, not recruitingPhase 2
Pediatric Trial of Indoximod With Chemotherapy and Radiation for Relapsed Brain Tumors or Newly Diagnosed DIPG
Glioblastoma, Medulloblastoma
Not yet recruitingPhase 1
IL-8 Receptor-modified CD70 CAR T Cell Therapy in CD70+ Newly Diagnosed and Recurrent Pediatric High-grade Glioma (pHGG) and Newly Diagnosed Diffuse Intrinsic Pontine Glioma (ndDIPG)
High-grade Glioma, Diffuse Intrinsic Pontine Glioma
RecruitingPhase 2
A Study of VRT106 in Combination With Radiotherapy in Adult Patients With Diffuse Midline Glioma / Diffuse Intrinsic Pontine Glioma
Diffuse Midline Glioma, H3 K27M-Mutant, Diffuse Intrinsic Pontine Glioma
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.
Xiaojun Yuan study chair
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Xiaoguang Qiu study chair
Beijing Tiantan Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nimotuzumab+CRT(concurrent IMRT and TMZ) in people with Diffuse Intrinsic Pontine Glioma, run by Biotech Pharmaceutical Co., Ltd. at 8 sites 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 9 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaojun Yuan (13817266192, 13651718916@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate #ORR# assessed by the Independent Review Committee (time frame: Up to 12 months). 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 27 Jul 2023.