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A prospective, multicenter phase II trial investigating Gemcitabine/Oxaliplatin/Rituximab with Tafasitamab (MOR208) for patients with relapsed/refractory transformed or Aggressive Lymphoma (GOAL II)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514775-17-00
Acronym
19-00153
Enrollment
64
Registered
2024-08-22
Start date
2021-02-10
Completion date
Unknown
Last updated
2024-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant B-cell lymphoma

Brief summary

ORR of the regimen within the first 8 treatment cycles

Detailed description

ORR (Cheson 2007-criteria), Progression free survival (Lugano), Overall survival, CR-Rate (Lugano), Best response (Lugano), Quality of Life measured with EORTC QLQ C30 and NHL-HG29 (global QoL, physical functioning, fatigue), ORR in separate GCB vs. non GCB-analysis is planned, Safety Endpoints: Safety and tolerability as measured by rate of AE, SAE compared between Arm A and B

Interventions

DRUGRITUXIMAB
DRUGOXALIPLATIN
DRUGGEMCITABINE

Sponsors

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Secondary

MeasureTime frame
ORR (Cheson 2007-criteria), Progression free survival (Lugano), Overall survival, CR-Rate (Lugano), Best response (Lugano), Quality of Life measured with EORTC QLQ C30 and NHL-HG29 (global QoL, physical functioning, fatigue), ORR in separate GCB vs. non GCB-analysis is planned, Safety Endpoints: Safety and tolerability as measured by rate of AE, SAE compared between Arm A and B

Primary

MeasureTime frame
ORR of the regimen within the first 8 treatment cycles

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026