NHLPhase 1NCT03535753
Safety and Efficacy Evaluation of Decitabine With R-GDP
A Phase 1 study testing Decitabine and R-GDP in people with NHL, run by Beijing Immunochina Medical Science & Technology Co., Ltd. at 1 site in China.
Trial summary
Assessment of the Safety and efficacy of Administering decitabin plus R-GDP to NHL patients Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NHL
- What is being tested?
- Decitabine and R-GDP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 1 Nov 2020
- Phase
- Phase 1
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Relapsed or refractory Non-Hodgkin's lymphoma(NHL) patiens.
- Eastern Cooperative Oncology Group(ECOG) score 0-2
- Expected survival >3 months
- Measurable disease.
Who cannot join
- Patients who needs treatment with immunosuppressive agents
- Hematosepsis or Uncontrolled active infection
- History of epilepsy or other CNS disease.
- Active hepatitis B , hepatitis C or HIV infection or any other uncontrolled active infection.
- Pregnancy or breast-feeding women.
- Any uncontrolled medical disorders that the researchers considered are not suitable to participate the clinical trial.
- Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluatio
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking university third hospital
Beijing, Beijing Municipality, 010
Xinan Lu, Dr
About this study
Official title: Safety and Efficacy Evaluation of Decitabine With R-GDP on Refractory or Relapsed NHL Patients
Assessment of the Safety and efficacy of Administering decitabin plus R-GDP to NHL patients
Read the detailed description
RR NHL patients will be treated with decitabin plus R-GDP , safety and efficacy will be assessed.
- Conditions
- NHL
- Being tested
- Decitabine and R-GDP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decitabine and R-GDPDrug
Also called DR
Decitabine and R-GDP
| Study group | Role | What they receive |
|---|---|---|
| Decitabine and R-GDP | Experimental | ALL patients will be treated with Decitabine and R-GDP Receives: Drug: Decitabine and R-GDP |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
Overall survival
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 posted24 May 2018
- Study start1 Sep 2017
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NHLStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hongmei Jing, MD, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03535753
- Sponsor's protocol ID
- M201791
- Status last verified
- Sep 2017
- First submitted
- 14 May 2018
- Last updated
- 24 May 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Evaluation of Decitabine With R-GDP on Refractory or Relapsed NHL Patients
- ClinicalTrials.gov ID
- NCT03535753
- Acronym / sponsor ID
- M201791
- Conditions
- NHL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 24 May 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.
Assessment of the Safety and efficacy of Administering decitabin plus R-GDP to NHL patients
Detailed description
RR NHL patients will be treated with decitabin plus R-GDP , safety and efficacy will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decitabine and R-GDP | Experimental | Drug: Decitabine and R-GDPALL patients will be treated with Decitabine and R-GDP |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Relapsed or refractory Non-Hodgkin's lymphoma(NHL) patiens.
- Eastern Cooperative Oncology Group(ECOG) score 0-2
- Expected survival >3 months
- Measurable disease.
Key exclusion criteria (7 listed)
- Patients who needs treatment with immunosuppressive agents
- Hematosepsis or Uncontrolled active infection
- History of epilepsy or other CNS disease.
- Active hepatitis B , hepatitis C or HIV infection or any other uncontrolled active infection.
- Pregnancy or breast-feeding women.
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 |
|---|---|---|
| Decitabine and R-GDPAlso: DRDecitabine and R-GDP | Drug | Decitabine and R-GDP |
Primary outcome
OS
Time frame: 2 years
Overall survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2018.
- Individual participant dataSharing planned: No
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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.
Hongmei Jing, MD principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Decitabine and R-GDP in people with NHL, run by Beijing Immunochina Medical Science & Technology Co., Ltd. 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 4 inclusion and 7 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 24 May 2018. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 xian lu, Dr (86 ext. 189-1157-6946, luxinan@immunochina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS (time frame: 2 years). 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 24 May 2018.