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Hyper-CVAD/MA for high-risk aggressive B-cell lymphomas: a single-centre academic phase II trial (HYPERION)
EU CTIS ID: 2023-505990-34-00
What this study is testing
The primary objective is to evaluate the efficacy of R-Hyper-CVAD/R-MA
- 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
- Written informed consent according to ICH-GCP guidelines
- Age ≥ 18 and < 65 years
- Eligible to receive at least 4 courses of R-Hyper-CVAD/R-MA per investigator determination (a compound clinical judgement based on all available information, in which the clinical performance, comorbidity, biological age, the patient’s social situation and lymphoma status are considered.)
- Aggressive, untreated, de novo CD20+ aggressive B-cell lymphoma, including: Diffuse large B-cell lymphoma (NOS, GCB, non-GCB or ABC); Large B-cell lymphoma with 11q aberration; Primary diffuse large B-cell lymphoma of the testis; Primary cutaneous diffuse large B-cell lymphoma, leg type; Intravascular large B-cell lymphoma; HHV-8 and EBV-negative primary effusion-based lymphoma; EBV-positive diffuse large B-cell lymphoma, NOS; High-grade B-cell lymphoma, NOS; High-grade B-cell lymphoma with MYC and BCL2 rearrangements; High-grade B-cell lymphoma with MYC and BCL6 rearrangements; Primary mediastinal B-cell lymphoma; T cell/histiocyte-rich B-cell lymphoma; Follicular lymphoma grade 3B; Lymphomatoid granulomatosis grade 3; Mediastinal gray-zone lymphoma; Aggressive B-cell lymphoma, NOS or unclassifiable
- At least one of four, as per protocol defined, high-risk criteria must be fufilled
- Women of child-bearing potential, only after using a acceptable effective method of contraception (defined in the study protocol) during treatment and for six months after completion of treatment.
You likely can't join if
- Pregnant or breast-feeding mother
- Evidence of significant, uncontrolled concomitant disease(s) that could affect compliance with the protocol or interpretation of results
- Previous chemotherapy for any malignancy
- Estimated glomerular filtration rate <60 ml/min (unless due to lymphoma)
- Impaired liver function, defined as serum total bilirubin > 2 x ULN (> 3 x ULN if Gilbert’s syndrome) or serum ALT and AST ˃ 3 x ULN (unless due to lymphoma)
- Unstable angina pectoris, cardiac infarction within 3 months or congestive heart failure New York Heart Association Class II-IV (unless due to lymphoma)
See the full eligibility criteria
Who can join
- Written informed consent according to ICH-GCP guidelines
- Age ≥ 18 and < 65 years
- Eligible to receive at least 4 courses of R-Hyper-CVAD/R-MA per investigator determination (a compound clinical judgement based on all available information, in which the clinical performance, comorbidity, biological age, the patient’s social situation and lymphoma status are considered.)
- Aggressive, untreated, de novo CD20+ aggressive B-cell lymphoma, including: Diffuse large B-cell lymphoma (NOS, GCB, non-GCB or ABC); Large B-cell lymphoma with 11q aberration; Primary diffuse large B-cell lymphoma of the testis; Primary cutaneous diffuse large B-cell lymphoma, leg type; Intravascular large B-cell lymphoma; HHV-8 and EBV-negative primary effusion-based lymphoma; EBV-positive diffuse large B-cell lymphoma, NOS; High-grade B-cell lymphoma, NOS; High-grade B-cell lymphoma with MYC and BCL2 rearrangements; High-grade B-cell lymphoma with MYC and BCL6 rearrangements; Primary mediastinal B-cell lymphoma; T cell/histiocyte-rich B-cell lymphoma; Follicular lymphoma grade 3B; Lymphomatoid granulomatosis grade 3; Mediastinal gray-zone lymphoma; Aggressive B-cell lymphoma, NOS or unclassifiable
- At least one of four, as per protocol defined, high-risk criteria must be fufilled
- Women of child-bearing potential, only after using a acceptable effective method of contraception (defined in the study protocol) during treatment and for six months after completion of treatment.
- Sexually active male participants must agree to use barrier prevention (condom) to ensure that embryos/fetuses are not exposed to study drugs via sperm, during treatment and for six months after completion of treatment; non-pregnant, fertile female partners to male participants are also recommended to use an acceptable method of birth control to avoid accidental pregnancy.
What rules you out
- Pregnant or breast-feeding mother
- Evidence of significant, uncontrolled concomitant disease(s) that could affect compliance with the protocol or interpretation of results
- Previous chemotherapy for any malignancy
- Estimated glomerular filtration rate <60 ml/min (unless due to lymphoma)
- Impaired liver function, defined as serum total bilirubin > 2 x ULN (> 3 x ULN if Gilbert’s syndrome) or serum ALT and AST ˃ 3 x ULN (unless due to lymphoma)
- Unstable angina pectoris, cardiac infarction within 3 months or congestive heart failure New York Heart Association Class II-IV (unless due to lymphoma)
- Psychiatric disorder or dementia which make the patient unable to give an informed consent and/or adhere to the schedule
- TdT-positive lymphoma
- CD34-positive lymphoma
- Previous organ transplantation
- Men and women of reproductive potential not agreeing to use an acceptable method of birth control (defined in study protocol) during treatment and for six months after completion of treatment
- Excluded diagnoses: CD20 negative lymphoma; Primary CNS lymphoma; Mantle cell lymphoma, including blastic/pleiomorphic types; Transformed lymphoma; Plasmablastic lymphoma; Lymphoblastic lymphoma; Post-transplant lymphoproliferative disorder; Burkitt leukaemia (≥25% Burkitt cells in bone marrow); Burkitt lymphoma
- Previous or concomitant diagnosis of another hematological malignancy
- Previous or concomitant diagnosis of another malignancy which is likely to cause death within 3 years
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. 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.