Diffuse Large B Cell LymphomaPhase 2BrUOG-377NCT03719560
Early Systemic Central Nervous System Prophylaxis in Diffuse Large B-cell Lymphoma
A Phase 2 study testing Methotrexate and Cytarabine in people with Diffuse Large B Cell Lymphoma, run by Brown University at 1 site in United States.
Trial summary
Phase 2 single-institution trial of early systemic central nervous system prophylaxis in high-risk diffuse large B-cell lymphoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- What is being tested?
- Methotrexate and Cytarabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 31 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New diagnosis of diffuse large B-cell lymphoma, planned first-line therapy using the standard rituximab- and anthracycline-containing regimens
- No central nervous system involvement on initial staging
- Performance status of 0 or 1 (Eastern Cooperative Oncology Group scale)
- Renal function: creatinine clearance >45 ml/min
- Not pregnant; agreeable to contraception
- Written informed consent
Show all 12Show fewer
- High risk for central nervous system recurrence as determined by one of the following high-risk features:
- high central nervous system International Prognostic Index,
- testicular, breast, or uterine involvement,
- dual expresser or double/triple-hit status,
- HIV positive status, or
- Molecularly defined high-risk subtype.
Who cannot join
- pregancy
- unable to provide informed consent
- significant comorbidity in the investigator's judgement
Trial locations and contacts
1 site in 1 country.
About this study
Phase 2 single-institution trial of early systemic central nervous system prophylaxis in high-risk diffuse large B-cell lymphoma
Read the detailed description
This is a prospective phase 2 clinical trial of systemic central nervous system prophylaxis among patients with diffuse large B-cell lymphoma at high risk of central nervous system recurrence. The main objective is to evaluate safety and efficacy of early institution of intensive central nervous system prophylaxis in a high-risk group to minimize the risk of a devastating central nervous system recurrence. Patients receive standard primary immunochemotherapy with an addition of planned central nervous system prophylaxis courses on or around day 15 of cycles 2, 4, and 6. Growth factor support and Pneumocystis jirovecii prophylaxis is required. The primary endpoint of this pilot study is protocol-defined toxicity, whereas efficacy (cumulative incidence of central nervous system recurrence) will be a secondary endpoint.
- Conditions
- Diffuse Large B Cell Lymphoma
- Being tested
- Methotrexate, Cytarabine
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Also called Methotrexate sodium
Systemic methotrexate
CytarabineDrug
Also called Cytosar-U
Systemic cytarabine
| Study group | Role | What they receive |
|---|---|---|
| CNS prophylaxis protocol | Experimental | Patients will receive central nervous system prophylaxis protocol using high-dose methotrexate and cytarabine. Receives: Drug: Methotrexate; Drug: Cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion with clinically significant toxicity
Clinically significant toxicity as defined in the protocol
Measured: 1 year
Secondary outcomes (1)
Cumulative incidence of central nervous system recurrence
Cumulative incidence of central nervous system recurrence
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 posted25 Oct 2018
- Study start1 Jul 2019 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam J Olszewski, MD, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03719560
- Sponsor's protocol ID
- BrUOG-377
- Acronym
- BrUOG-377
- Status last verified
- Apr 2020
- First submitted
- 23 Oct 2018
- Last updated
- 13 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Systemic Central Nervous System Prophylaxis in Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT03719560
- Acronym / sponsor ID
- BrUOG-377 / BrUOG-377
- Conditions
- Diffuse Large B Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 Oct 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.
Phase 2 single-institution trial of early systemic central nervous system prophylaxis in high-risk diffuse large B-cell lymphoma
Detailed description
This is a prospective phase 2 clinical trial of systemic central nervous system prophylaxis among patients with diffuse large B-cell lymphoma at high risk of central nervous system recurrence. The main objective is to evaluate safety and efficacy of early institution of intensive central nervous system prophylaxis in a high-risk group to minimize the risk of a devastating central nervous system recurrence. Patients receive standard primary immunochemotherapy with an addition of planned central nervous system prophylaxis courses on or around day 15 of cycles 2, 4, and 6. Growth factor support and Pneumocystis jirovecii prophylaxis is required. The primary endpoint of this pilot study is protocol-defined toxicity, whereas efficacy (cumulative incidence of central nervous system recurrence) will be a secondary endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CNS prophylaxis protocol | Experimental | Drug: Methotrexate, Drug: CytarabinePatients will receive central nervous system prophylaxis protocol using high-dose methotrexate and cytarabine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- New diagnosis of diffuse large B-cell lymphoma, planned first-line therapy using the standard rituximab- and anthracycline-containing regimens
- No central nervous system involvement on initial staging
- Performance status of 0 or 1 (Eastern Cooperative Oncology Group scale)
- Renal function: creatinine clearance >45 ml/min
- Not pregnant; agreeable to contraception
Key exclusion criteria (3 listed)
- pregancy
- unable to provide informed consent
- significant comorbidity in the investigator's judgement
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 |
|---|---|---|
| MethotrexateAlso: Methotrexate sodiumSystemic methotrexate | Drug | CNS prophylaxis protocol |
| CytarabineAlso: Cytosar-USystemic cytarabine | Drug | CNS prophylaxis protocol |
Primary outcome
Proportion with clinically significant toxicity
Time frame: 1 year
Clinically significant toxicity as defined in the protocol
1 secondary outcome
Cumulative incidence of central nervous system recurrence
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
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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.
Adam J Olszewski, MD principal investigator
Rhode Island Hospital
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 Methotrexate and Cytarabine in people with Diffuse Large B Cell Lymphoma, run by Brown University at 1 site in United States.
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 12 inclusion and 3 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: withdrawn, as of the sponsor's last update on 13 Apr 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Proportion with clinically significant toxicity (time frame: 1 year). 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 Apr 2020.