Personalized Reduction of Chemotherapy Intensity Through ctDNA Evaluation for the Treatment of Patients With Advanced Hodgkin Lymphoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Washington

About this trial

This phase II trial tests how well personalized reduction of chemotherapy (nivolumab, doxorubicin, vinblastine and dacarbazine) based on circulating tumor deoxyribonucleic acid (ctDNA) evaluation works for treating patients with Hodgkin lymphoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Chemotherapy drugs, such as nivolumab, doxorubicin, vinblastine and dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Many types of tumors tend to lose cells or release different types of cellular products including their DNA, which is referred to as ctDNA, into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids and, based on the result, assign patients to a reduced number of chemotherapy treatments or the standard number of chemotherapy treatments. Using ctDNA to assign a personalized reduction of chemotherapy may be effective in treating patients with advanced Hodgkin lymphoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Classical Hodgkin lymphoma without prior systemic therapy, stage 3 or 4. Corticosteroids for symptom relief are allowed

Measurable disease per Lugano criteria

Patients must be appropriate candidates for 6 cycles of combination chemotherapy including an anthracycline

No evidence of active central nervous system lymphoma

Disqualifiers

Patients known positive for HIV or infectious hepatitis type B or C with a detectable viral load may not participate. Hepatitis B/C, and HIV testing are not required at screening unless mandated by local health authority.

Patients living with HIV, on anti-viral treatment and undetectable viral load are allowed

Patients with positive hepatitis (hep) B core antibody are allowed on study with an undetectable viral load and appropriate prophylaxis

Patients with positive hepatitis C antibody are allowed with undetectable viral load

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Computed Tomography

    Procedure/Surgery

    Undergo CT scan

  • Dacarbazine

    Drug

    Given IV

  • Doxorubicin

    Drug

    Given IV

  • Echocardiography Test

    Procedure/Surgery

    Undergo echocardiography

  • Multigated Acquisition Scan

    Procedure/Surgery

    Undergo MUGA scan

  • Nivolumab

    Biological/Vaccine

    Given IV

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET scan

  • Vinblastine

    Drug

    Given IV

  • Questionnaire

    Other intervention

    Complete questionnaire

Treatment groups

125 Participants
are divided into 2 treatment groups
Group A: Arm I (MRD negative)Experimental treatment 10 interventions
Group B: Arm II (MRD positive)Experimental treatment 10 interventions

Trial outcomes

Primary outcomes

1

Progression free survival (PFS) in patients with undetectable minimal residual disease (MRD) after 2 cycles of treatment

Time frame
At 1 year

Secondary outcomes

1

PFS in MRD positive patients after 2 cycles of treatment

Time frame
At 1 year
2

PFS in the overall cohort

Time frame
At 2 years
3

Best response

Time frame
Up to 5 years

Other outcomes

Sponsors and contacts

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