BridgeMD
A phase II trial investigating Gemcitabine/Oxaliplatin/Rituximab with Tafasitamab (MOR208) for patients aggressive Lymphoma.
EU CTIS ID: 2024-514775-17-00
What this study is testing
Determination of the ORR in the experimental arm and comparison to historic results (Analysis will be based on Lugano -Criteria ).
- 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
- Histologically proven diagnosis of a) diffuse large cell B-cell lymphoma, and other aggressive B-cell lymphomas according to the WHO 2016 revision (specified in detail in the protocol) b) follicular lymphoma grade 3B and c) transformed indolent B-cell lymphoma (not more than 20 % of the patient population) according to the WHO classification (central pathology review)
- Signed informed consent
- Adequate contraception (if needed)
- Relapsed disease or refractory disease, at least one but no more than two prior treatment lines
- age ≥ 18 years
- No curative option available (age ≥ 65yr and/or HCT-CI Score > 2) or s.p. HDT
You likely can't join if
- CNS involvement (brain MRI is required only in cases of clinically suspicious involvement)
- Hepatitis C
- active Hepatitis B, patients with HBs-Ag positivity and no measurable HBV-DNA are eligible
- Medical or psychological condition that would not permit completion of the trial or signing of informed consent
- Diagnosed or treated for a malignancy other than NHL except: a) adequately treated non-melanoma skin cancer b) curatively treated in-situ cancer of the cervix c) ductal carcinoma in situ (DCIS) of the breast d) other solid tumors curatively treated with no evidence of disease for >2 years e) prostate cancer with a life expectancy of more than 2 years
- Concurrent treatment with another investigational agent or within the last 6 weeks prior to treatment initiation. Concurrent participation in non-treatment studies is not excluded
See the full eligibility criteria
Who can join
- Histologically proven diagnosis of a) diffuse large cell B-cell lymphoma, and other aggressive B-cell lymphomas according to the WHO 2016 revision (specified in detail in the protocol) b) follicular lymphoma grade 3B and c) transformed indolent B-cell lymphoma (not more than 20 % of the patient population) according to the WHO classification (central pathology review)
- Signed informed consent
- Adequate contraception (if needed)
- Relapsed disease or refractory disease, at least one but no more than two prior treatment lines
- age ≥ 18 years
- No curative option available (age ≥ 65yr and/or HCT-CI Score > 2) or s.p. HDT
- At least 1 measurable tumor mass (>1.5 cm x >1.0 cm) or bone marrow infiltration
- Adequate bone marrow reserve: a) Platelets of at least 100 000/μl b) absolute neutrophil count of at least 1000/μl
- Adequate hepatic and renal function: a) Alanine aminotransferase (ALT) <2.5 x upper limit of normal (ULN) b) Aspartate aminotransferase (AST) <2.5 x upper limit of normal (ULN) c) Total bilirubin <1.5 x upper limit of normal (ULN) unless related to lymphoma
- Measured or calculated eGFR >50 ml/min (institutional standard)
- Eastern Cooperative Oncology Group (ECOG) performance Status ≤2, unless tumor associated and expected to improve on treatment
What rules you out
- CNS involvement (brain MRI is required only in cases of clinically suspicious involvement)
- Hepatitis C
- active Hepatitis B, patients with HBs-Ag positivity and no measurable HBV-DNA are eligible
- Medical or psychological condition that would not permit completion of the trial or signing of informed consent
- Diagnosed or treated for a malignancy other than NHL except: a) adequately treated non-melanoma skin cancer b) curatively treated in-situ cancer of the cervix c) ductal carcinoma in situ (DCIS) of the breast d) other solid tumors curatively treated with no evidence of disease for >2 years e) prostate cancer with a life expectancy of more than 2 years
- Concurrent treatment with another investigational agent or within the last 6 weeks prior to treatment initiation. Concurrent participation in non-treatment studies is not excluded
- Known intolerance to any of the study drugs or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
- no adequate pretreatment (R-CHOP-like, or BR for initial indolent lymphoma)
- systemic treatment within last 6 weeks, steroids for bridging are allowed
- prior allogeneic transplantation prior anti CD19 CAR T-cell therapy or prior Tafasitamab therapy
- pregnant or breast-feeding women
- severe concomitant disease (e.g. uncontrolled arterial hypertension, heart failure (NYHA III-IV), uncontrolled diabetes mellitus, pulmonary fibrosis, uncontrolled hyperlipoproteinemia)
- Prolongation of QTc interval > 450 ms, demonstrated in electrocardiogramm (two separate or one in triplicate) or family history for Long QT-syndrome
- active uncontrolled infections
- HIV positivity
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, 65+ years, 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.