Primary Central Nervous System LymphomaPhase 2/3NCT02657785
Treatment of PCNSL With R-IDARAM and Intrathecal Immunochemotherapy
A Phase 2/3 study testing R-IDARAM plus intrathecal chemotherapy in people with Primary Central Nervous System Lymphoma, run by Navy General Hospital, Beijing at 1 site in China.
Trial summary
This study suggests that R-IDARAM combined with intrathecal immunochemotherapy may be high effective in primary central nervous system lymphoma (PCNSL) patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Central Nervous System Lymphoma
- What is being tested?
- R-IDARAM plus intrathecal chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Sep 2010to Dec 2030
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
- Newly diagnosed histologically proven non-Hodgkin's lymphoma (NHL).
Who cannot join
- Involved sites other than the brain, meninges, CSF, or the eyes.
- Age less than 18 years or greater than 75 years.
- Inadequate bone marrow capacity (defined as neutrophils<1.5 ×10^9/L, platelets <100 ×10^9/L, and hemoglobin level< 8 g/dL).
- Known cause of immunosuppression (ie, HIV type I infection).
- Any previous malignancy.
- Creatinine clearance below 60 mL/min.
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- Heart insufficiency (NYHA IIIB or IV).
- Uncontrolled infection.
- Noncompensated active pulmonary or liver disease.
- Previously treated for PCNSL, except by corticosteroids.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Navy General Hospital
Beijing, Beijing Municipality, 100048
Liren Qian, M.D., +861066957676, qlr2007@126.com
About this study
Official title: Treatment of Primary CNS Lymphoma With Systemic R-IDARAM Chemotherapy and Intrathecal Immunochemotherapy
This study suggests that R-IDARAM combined with intrathecal immunochemotherapy may be high effective in primary central nervous system lymphoma (PCNSL) patients.
Read the detailed description
The investigators will evaluate response rate, progression free survival (PFS), overall survival (OS), and toxicity in primary central nervous system lymphoma (PCNSL) after systemic and intrathecal immunochemotherapy with deferred radiotherapy.
- Conditions
- Primary Central Nervous System Lymphoma
- Being tested
- R-IDARAM plus intrathecal chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-IDARAM plus intrathecal chemotherapyDrug
Also called R-IDARAM plus intrathecal immuochemotherapy
R-IDARAM comprised of rituximab 375 mg/m2 (day 1), idarubicin 10 mg/m2(day 2 and 3); dexamethasone 100 mg/m2 (12 h.infusion in day 2, 3 and 4); cytarabine 1 g/m2 (1 h. infusion in day 2 and 3); methotrexate 2 g/m2 (6 h. infusion in day 4 with folinic acid rescue). Intrathecal Immunochemotherapy comprised of rituximab 10mg, MTX 15mg, dexamethasone 5mg and Ara-c 50mg once a week.
| Study group | Role | What they receive |
|---|---|---|
| R-IDARAM plus intrathecal chemotherapy | Experimental | Patients will be treated with systemic R-IDARAM plus intrathecal immunochemotherapy Receives: Drug: R-IDARAM plus intrathecal chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
3 year Overall survival
Measured: 3 year Overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2016 (estimated)
- Study startSep 2010
- Primary completionDec 2028 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Central Nervous System 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Navy General Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liren Qian, Navy General Hospital, Beijing
- Investigators
- Liren Qian, M.D., Study chair, Navy General Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657785
- Sponsor's protocol ID
- NavyGHB-001
- Other IDs
- 001
- Status last verified
- Sep 2020
- First submitted
- 23 Apr 2014
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Primary CNS Lymphoma With Systemic R-IDARAM Chemotherapy and Intrathecal Immunochemotherapy
- ClinicalTrials.gov ID
- NCT02657785
- Acronym / sponsor ID
- NavyGHB-001
- Conditions
- Primary Central Nervous System Lymphoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Navy General Hospital, BeijingUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 18 Jan 2016 (estimated)
- 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 study suggests that R-IDARAM combined with intrathecal immunochemotherapy may be high effective in primary central nervous system lymphoma (PCNSL) patients.
Detailed description
The investigators will evaluate response rate, progression free survival (PFS), overall survival (OS), and toxicity in primary central nervous system lymphoma (PCNSL) after systemic and intrathecal immunochemotherapy with deferred radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| R-IDARAM plus intrathecal chemotherapy | Experimental | Drug: R-IDARAM plus intrathecal chemotherapyPatients will be treated with systemic R-IDARAM plus intrathecal immunochemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Newly diagnosed histologically proven non-Hodgkin's lymphoma (NHL).
Key exclusion criteria (10 listed)
- Involved sites other than the brain, meninges, CSF, or the eyes.
- Age less than 18 years or greater than 75 years.
- Inadequate bone marrow capacity (defined as neutrophils<1.5 ×10^9/L, platelets <100 ×10^9/L, and hemoglobin level< 8 g/dL).
- Known cause of immunosuppression (ie, HIV type I infection).
- Any previous malignancy.
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 |
|---|---|---|
| R-IDARAM plus intrathecal chemotherapyAlso: R-IDARAM plus intrathecal immuochemotherapyR-IDARAM comprised of rituximab 375 mg/m2 (day 1), idarubicin 10 mg/m2(day 2 and 3); dexamethasone 100 mg/m2 (12 h.infusion in day 2, 3 and 4); cytarabine 1 g/m2 (1 h. infusion in day 2 and 3); methotrexate 2 g/m2 (6 h. infusion in day 4 with folinic acid rescue). Intrathecal Immunochemotherapy comprised of rituximab 10mg, MTX 15mg, dexamethasone 5mg and Ara-c 50mg once a week. | Drug | R-IDARAM plus intrathecal chemotherapy |
Primary outcome
Overall survival
Time frame: 3 year Overall survival
3 year Overall survival
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- 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.
Liren Qian, M.D. study chair
Navy General Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing R-IDARAM plus intrathecal chemotherapy in people with Primary Central Nervous System Lymphoma, run by Navy General Hospital, Beijing 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 1 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 9 Sep 2020. 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 combined 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.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liren Qian, M.D. (+861066957676, qlr2007@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 3 year Overall survival). 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 9 Sep 2020.