DRKS00023793
Active, not recruiting
Phase 2
A prospective, multicenter phase II trial investigating Gemcitabine/Oxaliplatin/Rituximab with Tafasitamab (MOR208) for patients with relapsed/refractory transformed aggressive Lymphoma - GOAL II
niversitätsmedizin der Johannes Gutenberg-Universität Mainz0 sites26 target enrollmentJanuary 11, 2021
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- C83.3
- Sponsor
- niversitätsmedizin der Johannes Gutenberg-Universität Mainz
- Enrollment
- 26
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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);
- •\- 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
Exclusion Criteria
- •CNS involvement (brain MRI is required only in cases of clinically suspicious involvement);
- •\- no adequate pretreatment (R\-CHOP\-like);
- •\- systemic treatment within last 6 weeks, steroids for bridging are allowed;
- •\- prior allogeneic transplantation and 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; Hepatitis C;
- •\- active Hep B, patients with HBs\-Ag positivity and no measurable HBV\-DNA are eligible;
Outcomes
Primary Outcomes
Not specified
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