High-grade B-cell LymphomaDIRECTNCT04226937
DLBCL Interim Response Evaluation for Customised Therapy
An observational study of High-grade B-cell Lymphoma, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The aim of the DIRECT Study is to establish a robust pipeline to identify those patients with high-grade B cell lymphoma most suitable for novel agent clinical trials based upon genomic subtype and an integrated response evaluation determined early in first-line therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High-grade B-cell Lymphoma
- What is being tested?
- Not Applicable as this is a translational, sample collection study.
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Sep 2020to 1 Sep 2025
- Phase
- Observational
- 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
Study population: Patients with diffuse Large B Cell Lymphoma (DLBCL) or closely related high-grade B cell lymphomas including, but not limited to: * DLBCL NOS * Transformed follicular lymphoma * High grade B cell lymphoma with rearrangement of BCL2/BCL6 and MYC * Plasmablastic lymphoma * Primary Mediastinal Large Cell lymphoma * Burkitt lymphoma * Primary Central Nervous System lymphoma * High grade B cell lymphoma NOS Undergoing Standard of Care treatment for their lymphoma.
Who may be able to join
None listed.
Who cannot join
- Unable to receive immunochemotherapy as first-line therapy due to co-morbidity or personal choice.
- Patients who have already started high dose steroids as a treatment for their lymphoma.
- Known diagnosis of infectious blood-borne virus e.g. Hep B, Hep C or HIV.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, CB2 0QQ
Phil Barry, PhD, philip.barry@addenbrookes.nhs.uk
Daniel Hodson, PhD MRCP FRCPath
About this study
The aim of the DIRECT Study is to establish a robust pipeline to identify those patients with high-grade B cell lymphoma most suitable for novel agent clinical trials based upon genomic subtype and an integrated response evaluation determined early in first-line therapy.
Read the detailed description
This will be done by integrating data and samples collected from patients undergoing standard of care treatment for high-grade B cell lymphoma
Data will be integrated from
- Clinical risk factors from the International Prognostic Index (IPI)
- Up-front genomic subtype based on molecular profiling of diagnostic biopsy
- Serial ctDNA monitoring during treatment.
- Radiological response imaging
- Conditions
- High-grade B-cell Lymphoma
- Being tested
- Not Applicable as this is a translational, sample collection study.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not Applicable as this is a translational, sample collection study.Other
Patients will take their normal standard of care treatment for their lymphoma, as per agreed with the patient's doctor.
Blood samples will be collected at Baseline, during the first 3 cycles of Treatment, at End of Treatment, at 6- and 12-months after End of Treatment and at relapse/progression if applicable.
Surplus Tissue biopsy will be collected at Baseline and at relapse/progression if applicable. In rare cases research-specific tissue biopsy may be collected if appropriate.
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish a robust molecular monitoring pipeline.
Measured: 3-5 years
Successful identification of trackable mutations in collected samples. Feasibility will be met if more than 75% of the samples yield trackable mutations across the whole study.
Measured: 3-5 years
Secondary outcomes (3)
Assess the utility of serial ctDNA assessment as a predicator of clinical outcome in high-grade B cell lymphoma.
Measured: 5 years
Assess the utility of integrated data from clinical risk factors (IPI), up-front genotype, serial ctDNA response and radiological assessment (CT or PET-CT).
Measured: 3-5 years
When the pipeline is optimised can these 4 parameters be available within 6 weeks, i.e. by completion of Cycle 2.
- Clinical risk factors from the International Prognostic Index (IPI)
- Up-front genomic subtype based on molecular profiling of diagnostic biopsy
- Serial ctDNA monitoring during treatment.
- Radiological response imaging
Measured: 3-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start17 Sep 2020
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-grade B-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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Cancer Research UK Cambridge Institute
- Responsible party
- Principal investigator, Daniel Hodson, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Daniel Hodson, PhD MRCP FRCPath, Principal investigator, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04226937
- Sponsor's protocol ID
- DIRECT
- Acronym
- DIRECT
- Status last verified
- Aug 2022
- First submitted
- 6 Jan 2020
- Last updated
- 5 Aug 2022
- 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 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DLBCL Interim Response Evaluation for Customised Therapy
- ClinicalTrials.gov ID
- NCT04226937
- Acronym / sponsor ID
- DIRECT / DIRECT
- Conditions
- High-grade B-cell Lymphoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- AstraZeneca, Cancer Research UK Cambridge Institute
- Study start
- 17 Sep 2020 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 13 Jan 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.
The aim of the DIRECT Study is to establish a robust pipeline to identify those patients with high-grade B cell lymphoma most suitable for novel agent clinical trials based upon genomic subtype and an integrated response evaluation determined early in first-line therapy.
Detailed description
This will be done by integrating data and samples collected from patients undergoing standard of care treatment for high-grade B cell lymphoma
Data will be integrated from
- Clinical risk factors from the International Prognostic Index (IPI)
- Up-front genomic subtype based on molecular profiling of diagnostic biopsy
- Serial ctDNA monitoring during treatment.
- Radiological response imaging
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diffuse Large B Cell Lymphoma (DLBCL) or closely related high-grade B cell lymphomas including, but not limited to: * DLBCL NOS * Transformed follicular lymphoma * High grade B cell lymphoma with rearrangement of BCL2/BCL6 and MYC * Plasmablastic lymphoma * Primary Mediastinal Large Cell lymphoma * Burkitt lymphoma * Primary Central Nervous System lymphoma * High grade B cell lymphoma NOS Undergoing Standard of Care treatment for their lymphoma.
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Unable to receive immunochemotherapy as first-line therapy due to co-morbidity or personal choice.
- Patients who have already started high dose steroids as a treatment for their lymphoma.
- Known diagnosis of infectious blood-borne virus e.g. Hep B, Hep C or HIV.
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 |
|---|---|---|
| Not Applicable as this is a translational, sample collection study.Patients will take their normal standard of care treatment for their lymphoma, as per agreed with the patient's doctor. Blood samples will be collected at Baseline, during the first 3 cycles of Treatment, at End of Treatment, at 6- and 12-months after End of Treatment and at relapse/progression if applicable. Surplus Tissue biopsy will be collected at Baseline and at relapse/progression if applicable. In rare cases research-specific tissue biopsy may be collected if appropriate. | Other | – |
Primary outcome
Establish a robust molecular monitoring pipeline.
Time frame: 3-5 years
Successful identification of trackable mutations in collected samples. Feasibility will be met if more than 75% of the samples yield trackable mutations across the whole study.
Time frame: 3-5 years
3 secondary outcomes
Assess the utility of serial ctDNA assessment as a predicator of clinical outcome in high-grade B cell lymphoma.
Time frame: 5 years
Assess the utility of integrated data from clinical risk factors (IPI), up-front genotype, serial ctDNA response and radiological assessment (CT or PET-CT).
Time frame: 3-5 years
When the pipeline is optimised can these 4 parameters be available within 6 weeks, i.e. by completion of Cycle 2.
Time frame: 3-5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for High-grade B-cell Lymphoma
Active, not recruitingPhase 1/2
First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
DLBCL, High-grade B-cell Lymphoma (HGBCL)
Active, not recruitingPhase 1/2
Trial of the Safety and Efficacy of Epcoritamab in Japanese Subjects With Relapsed or Refractory (R/R) B-Cell Non-Hodgkin Lymphoma (R/R B-NHL)
Diffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma
RecruitingObservational study
Pivotal Study to Validate a Novel System to Non-Invasively Detect Severe Neutropenia
Diffuse Large B Cell Lymphoma, Multiple Myeloma
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
RecruitingPhase 2
Personalized NK Cell Therapy in CBT
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Biphenotypic Leukemia
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.
Daniel Hodson, PhD MRCP FRCPath principal investigator
Cambridge University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High-grade B-cell Lymphoma, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 0 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: status not confirmed, as of the sponsor's last update on 5 Aug 2022. 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 Kingdom. 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.
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 Silvia Tarantino (+44(0)122325634, silvia.tarantino@addenbrookes.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish a robust molecular monitoring pipeline. (time frame: 3-5 years). 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 5 Aug 2022.