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DLBCL Interim Response Evaluation for Customised Therapy (DIRECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04226937
Recruitment Status : Not yet recruiting
First Posted : January 13, 2020
Last Update Posted : January 13, 2020
Sponsor:
Collaborators:
AstraZeneca
Cancer Research UK Cambridge Institute
Information provided by (Responsible Party):
Daniel Hodson, Cambridge University Hospitals NHS Foundation Trust

Brief 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.

Condition or disease Intervention/treatment
High-grade B-cell Lymphoma Other: Not Applicable as this is a translational, sample collection study.

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

  1. Clinical risk factors from the International Prognostic Index (IPI)
  2. Up-front genomic subtype based on molecular profiling of diagnostic biopsy
  3. Serial ctDNA monitoring during treatment.
  4. Radiological response imaging

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: DLBCL Interim Response Evaluation for Customised Therapy
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : April 1, 2025
Estimated Study Completion Date : April 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma


Intervention Details:
  • Other: 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.



Primary Outcome Measures :
  1. Establish a robust molecular monitoring pipeline. [ Time Frame: 3-5 years ]
  2. 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 ]

Secondary Outcome Measures :
  1. Assess the utility of serial ctDNA assessment as a predicator of clinical outcome in high-grade B cell lymphoma. [ Time Frame: 5 years ]
  2. 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 ]
  3. 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 ]
    1. Clinical risk factors from the International Prognostic Index (IPI)
    2. Up-front genomic subtype based on molecular profiling of diagnostic biopsy
    3. Serial ctDNA monitoring during treatment.
    4. Radiological response imaging


Other Outcome Measures:
  1. Identification of the de novo somatic variants in high-grade B cell lymphoma from collected ctDNA and tissue samples. [ Time Frame: 3-5 years ]
  2. Assess the utility of ctDNA to track clonal evolution in patients undergoing treatment for high-grade B cell lymphoma. [ Time Frame: 3-5 years ]

Biospecimen Retention:   Samples With DNA
ctDNA and Biopsy Tissue


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.

Criteria
  • Have given written informed consent to participate.
  • Age ≥ 18 years at the time of consent.
  • Histologically confirmed diagnosis of previously untreated high-grade B cell lymphoma.
  • Planned to receive immunochemotherapy as first-line therapy, e.g. R-CHOP therapy.
  • Planned or completed standard of care imaging (CT or PET-CT)
  • Able to give blood.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04226937


Contacts
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Contact: Catia Caetano, PhD +44(0)122325634 catia.caetano@addenbrookes.nhs.uk
Contact: Richard Skells, BSc +44(0)1223349707 richard.skells@addenbrokes.nhs.uk

Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
AstraZeneca
Cancer Research UK Cambridge Institute
Investigators
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Principal Investigator: Daniel Hodson, PhD MRCP FRCPath Cambridge University Hospitals NHS Foundation Trust

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Responsible Party: Daniel Hodson, Dr, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04226937    
Other Study ID Numbers: DIRECT
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No