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A phase II efficacy and safety study of cell-free circulating tumor DNA-guided commencement of second-line treatment in patients with DLBCL/HGBCL relapse
EU CTIS ID: 2024-518275-64-00
What this study is testing
The primary objective of the proposed phase 2 study is to evaluate the efficacy and safety of an intervention involving early implementation of second-line treatment in DLBCL/HGBCL patients, initiated based on eligibility including assessment of circulating tumor-derived DNA.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Stage I - prescreening 1. patients with a diagnosis of DLBCL or HGBCL, eligible for chemotherapy according to the R-CHOP or R-CHOP-like regimen (DLBCL) or Pola-R-CHP (DLBCL) or DA-EPOCH-R (HGBCL).
- Available results of the following tests: - quantitative and qualitative analysis of mutation assessment in peripheral blood by CAPP-Seq and ddPCR prior to the start of first-line treatment, or a secured blood sample allowing such analysis; - Quantitative assessment of circulating free DNA (cfDNA) of tumor origin during treatment (after the 2nd cycle of R-CHOP or R-CHOP-like in DLBCL patients, after the 2nd cycle of DA-EPOCH-R in HGBCL patients) and after completion of 1st line treatment or secured blood samples enabling such analysis; - PET-CT before inclusion of first-line treatment and after completion of first-line treatment - PET-CT or CT during 1st line treatment (after 2nd or 3rd cycle of R-CHOP or R-CHOP-like or Pola-R-CHP in DLBCL, after 2nd or 3rd cycle of DA-EPOCH-R for HGBCL).
- Signing informed consent to participate in Phase II clinical trial.).
- Age ≥18 years
- Perform a PET/CT scan to assess disease progression before starting treatment (a description of the result does not have to be available on the day the patient is included in the study).
- Age ≥18 years
You likely can't join if
- Stage I - prescreening Richter syndrome, transformation to DLBCL of indolent lymphomas, G3B follicular lymphoma, lymphomas with intermediate features between DLBCL and Hodgkin's lymphoma.
- Pregnancy and breastfeeding.
- Any other significant abnormality that, in the opinion of the Investigator, excludes the patient from participation in the study or prevents the application of the planned treatment regimens.
- inability of the patient to sign the informed consent form.
- Stage II Lack of CR after completion of first-line treatment.
- Active second primary malignancy other than basal cell carcinoma of the skin.
See the full eligibility criteria
Who can join
- Stage I - prescreening 1. patients with a diagnosis of DLBCL or HGBCL, eligible for chemotherapy according to the R-CHOP or R-CHOP-like regimen (DLBCL) or Pola-R-CHP (DLBCL) or DA-EPOCH-R (HGBCL).
- Available results of the following tests: - quantitative and qualitative analysis of mutation assessment in peripheral blood by CAPP-Seq and ddPCR prior to the start of first-line treatment, or a secured blood sample allowing such analysis; - Quantitative assessment of circulating free DNA (cfDNA) of tumor origin during treatment (after the 2nd cycle of R-CHOP or R-CHOP-like in DLBCL patients, after the 2nd cycle of DA-EPOCH-R in HGBCL patients) and after completion of 1st line treatment or secured blood samples enabling such analysis; - PET-CT before inclusion of first-line treatment and after completion of first-line treatment - PET-CT or CT during 1st line treatment (after 2nd or 3rd cycle of R-CHOP or R-CHOP-like or Pola-R-CHP in DLBCL, after 2nd or 3rd cycle of DA-EPOCH-R for HGBCL).
- Signing informed consent to participate in Phase II clinical trial.).
- Age ≥18 years
- Perform a PET/CT scan to assess disease progression before starting treatment (a description of the result does not have to be available on the day the patient is included in the study).
- Age ≥18 years
- ECOG 0-2 or ECOG 3, if the general condition is due to disease progression
- Consent to effective contraception during the trial with contraception for 14 months for women and 11 months for men after the last dose of immunochemotherapy 6 In women of childbearing age, a negative serum pregnancy test at screening and agreement to use highly effective contraception during the trial and for 14 months after the last dose of chemotherapy (except for patients over 50 years of age with natural amenorrhea for at least 12 months or after a bilateral salpingo-oophorectomy or hysterectomy).7. Signed consent to participate in the Phase I clinical trial.
- Signing consent to participate in Phase I clinical trial.
- Provide access to histopathological material from the disease diagnosis in case of technical difficulties in obtaining sufficient genetic material from cfDNA.
- In the case of planned treatment with Pola-R-CHP, meeting the general and specific eligibility criteria for first-line therapy according to drug program B.12.
- Stage II Patients diagnosed with DLBCL or HGBCL, in complete remission (CR) confirmed by PET-CT after completion of first-line treatment (R-CHOP or R-CHOP-like or Pola-R-CHP in DLBCL patients, DA-EPOCH-R in HGBCL patients). Modifications of standard R-CHOP immunochemotherapy to, for example, R-CHOP-14, addition of etoposide (R-CHOEP), dose changes due to comorbidities or side effects are allowed.
What rules you out
- Stage I - prescreening Richter syndrome, transformation to DLBCL of indolent lymphomas, G3B follicular lymphoma, lymphomas with intermediate features between DLBCL and Hodgkin's lymphoma.
- Pregnancy and breastfeeding.
- Any other significant abnormality that, in the opinion of the Investigator, excludes the patient from participation in the study or prevents the application of the planned treatment regimens.
- inability of the patient to sign the informed consent form.
- Stage II Lack of CR after completion of first-line treatment.
- Active second primary malignancy other than basal cell carcinoma of the skin.
- Treatment for malignant neoplasm other than basal cell carcinoma of the skin less than 5 years prior to study inclusion.
- Pregnancy and breastfeeding.
- Any other significant abnormality that, in the opinion of the Investigator, excludes the patient from participation in the study or prevents the application of the planned treatment regimens.
- inability of the patient to sign the informed consent form.
- For planned treatment with vedotin polatuzumab under drug program B.12: (a) active, severe infection; (b) bilirubin levels exceeding 1.5 times the upper limit of normal for the laboratory; (c) peripheral neuropathy ≥ grade 2; (d) presence of contraindications to the use of vedotin polatuzumab, bendamustine and rituximab, which are derived from the Summary Product Chracteristcs.
- The following test results are not available: - quantitative and qualitative analysis of peripheral blood mutation assessment by CAPP-Seq and ddPCR prior to initiation of first-line treatment, or a secured blood sample allowing such analysis; - quantitative assessment of circulating tumor-derived free DNA (cfDNA) during treatment (after the 2nd cycle of R-CHOP or R-CHOP-like or Pola-R-CHP in DLBCL patients, after the 2nd cycle of DA-EPOCH-R in HGBCL patients) and after completion of first-line treatment, or secured blood samples enabling such analysis;
- n addition, for treatment under drug program B.12: (a) disease progression during treatment; (b) occurrence of symptoms of hypersensitivity to any of the drugs used or to mouse proteins or any of the excipients of the formulations; (c) occurrence of intolerable or life-threatening toxicity despite adequate management; (d) diagnosis of progressive multifocal leukoencephalopathy (PML); (e) the occurrence of diseases or conditions that, in the judgment of the treating physician attending physician makes it impossible to continue treatment
- inability of the patient to sign the informed consent form.
- Stage III DLBCL/HGBCL lymphoma with secondary central nervous system involvement.
- creatinine clearance <30 ml/min.
- DLBCL lymphoma with primary central nervous system involvement.
- Creatinine clearance <30 ml/min.
- Active second primary malignancy other than basal cell carcinoma of the skin
- Treatmentdue due to malignant neoplasm other than basal cell carcinoma of the skin less than 5 years prior to study inclusion.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.