Matched group comparison of GLA-R to GOAL-II - GLA 2021-1 (A prospective, multicenter phase II trial investigating Gemcitabine/Oxaliplatin/Rituximab with Tafasitamab (MOR208) for patients with relapsed/refractory transformed or Aggressive Lymphoma (GOAL II))
Frau Dr. med. Stephanie Herold
stephanie.herold@unimedizin-mainz.de
Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Mainz (Prüfzentrum (CAR-T), 11520)
III. Medizinische Klinik und Poliklinik
Langenbeckstr. 1
55131 Mainz
| Beschreibung | In later treatment lines of diffuse large B-cell lymphoma (DLBCL), effective and safe treatment options are urgently needed. While young and fit patients receive CAR-T cells or a salvage chemotherapy followed by autologous stem cell transplantation (ASCT) depending on the time to relapse, options for older or unfit patients remain limited. The combination of Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) has shown acceptable efficacy with good tolerability in a cohort not suitable for ASCT (El Gnaoui, T et al. Annals of Oncology, 2007). Tafasitamib in combination with lenalidomide represents another approved, chemo-free approach in the elderly cohort, based on the data of the L-Mind study (Salles, Gilles et al. The Lancet Oncology, 2020). However, real-world data dampened optimism with lower response rates and progression free survival in patients without exclusion of various risk factors (David A. Qualls et al. Blood, 2023).
Study objective of GOAL-II was to investigate safety and efficacy of the combination of R-GemOx and Tafasitamab in the elderly cohort with relapsed/refractory DLBCL. GOAL-II recruited 26 patients and was closed early due to slow patient recruitment. 20 patients received R-GemOx plus tafasitamab in the experimental arm and 6 patients received R-GemOx. To allow a more balanced consideration of the data, we would like to analyze 20 additional matched patients who received R-GemOx as a historical control arm. | |
| Indikation | DLBCL | |
| Patientenpopulation | 20 matched patients with relapsed/refractory DLBCL who received R-GemOx. Matching parameters will be gender, age, initial IPI and lines of prior therapy. The matched cohort resembles the cohort of the experimental GOAL-II arm (Tafasitamab R-GemOx) that included 60% male patients with a median age of 79 years and a median of 1 prior therapy. 25% of patients had an IPI of 1-2 and 75% an IPI of 3-5. | |
| Statistische Annahmen | Data will be analyzed descriptively. For categorical / binary variables counts and percentages will be calculated. For continuous variables mean, standard deviation, median, first and third quartile, minimum, and maximum will be calculated. In addition, for primary and secondary endpoints, 95% confidence intervals for proportions and means will be calculated (if applicable). All data will be analyzed as observed, i.e. no imputation of missing data will be performed.
For the comparison of the response rates between the two groups (experimental arm and historical cohort), Fisher's Exact Test will be used. A statistical significant difference requires a p-value < 0,05. | |
| Primäre Endpunkte | Overall response rate (ORR) (defined as proportion of patients who achieved best overall response of complete response (CR) or partial response (PR)) according to physician’s assessment. | |
| Sekundäre Endpunkte | • Complete response (CR) rate (defined as proportion of patients with CR) according to physician’s assessment (continuously documented by cycle)
• Partial response (PR) rate (defined as proportion of patients with PR) according to physician’s assessment (continuously documented by cycle) • Duration of response (DoR) and duration of complete response (DoCR) (defined as the time from the first documentation of response / CR to the date of PD or death, whichever occurs earlier) • Time to next treatment (TTNT) (defined as the time from Day 1 of Cycle 1 to first recorded administration of subsequent anti-lymphoma therapy or death due to any cause, whichever occurs earlier.) • Overall survival (OS) (defined as the time from Day 1 of Cycle 1 to death) (continuously documented) • Progression-free survival (PFS) (defined as the time from Day 1 of Cycle 1 to first documented PD or death due to any cause, whichever occurs earlier) (continuously documented) Exploratory endpoints: Comparison of the ORR between the historical cohort who received R-GemOx from the GLA registry and the experimental cohort who received Tafasitamab plus R-GemOx from the GOAL-II trial. | |
| Geplante Projektdauer (Projektstart, Projektende) | Project starts in Q2/2025 and will be completed in Q4/2025 | |
| Projekt finanziert durch | Costs of statistical evaluation will be covered through the GOAL-II trial, Mainz.
Data export based on matching parameters and analysis will be performed by IZKS Mainz. | |
| Geschätzte Kosten | none for the GLA | |
| Biometrische Analyse | Datenexport und eigene Analyse | |
| Ist eine Erweiterung des Datensatzes projektspezifisch notwendig? | Nein | |
| Ist eine direkte Interaktion (über die Vertrauenstelle) mit den Patienten geplant? | Nein | |
