EUCTR2019-002373-59-DE
Active, not recruiting
Phase 1
A prospective, multicenter phase II trial investigating Gemcitabine/Oxaliplatin/Rituximab with Tafasitamab (MOR208) for patients with relapsed/refractory transformed or Aggressive Lymphoma (GOAL II). - GOAL II
niversity Medical Center of the Johannes Gutenberg University Mainz0 sites64 target enrollmentJuly 21, 2020
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Malignant B-cell lymphoma
- Sponsor
- niversity Medical Center of the Johannes Gutenberg University Mainz
- Enrollment
- 64
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects meeting all of the following criteria will be considered for enrollment to the trial:
- •\- 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:
Exclusion Criteria
- •\- CNS involvement (brain MRI is required only in cases of clinically suspicious involvement)
- •\- 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
- •\- Hepatitis C
Outcomes
Primary Outcomes
Not specified
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