Klinische Studien

Aktuelle klinische Studien, Stand: Juni 2022

Leukämien, Myelodysplastisches Syndrom und Myeloproliferative Neoplasien
AML	KB-ENTO-3001 A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Entospletinib in Combination With Intensive Induction and Consolidation Chemotherapy in Adults With Newly Diagnosed Nucleophosmin 1-mutated Acute Myeloid Leukemia
AML, MDS	M20-866 VALENCIA A Phase 1b Dose Escalation Study of Lemzoparlimab in Combination with Venetoclax and/or Azacitidine in Subjects with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
AML, MDS	Ca-4948-102 A Phase 1, Open Label Dose Escalation Trial Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Orally Administered CA-4948 in Patients with Acute Myelogenous Leukemia or Myelodysplastic Syndrome
AML	HOVON 150 AML/ AMLSG 29-18 Eine multizentrische, doppelblinde, randomisierte, placebokontrollierte, Phase 3 Studie zu Ivosidenib oder Enasidenib in Kombination mit Induktions- und Konsolidierungschemotherapie mit anschließender Erhaltungstherapie für Patienten mit neu-diagnostizierter akuter myeloischer Leukämie oder mit myelodysplastischem Syndrom mit Exzess von Blasten-2 (MDS-EB2), die eine IDH1 oder IDH2 Mutation aufweisen und für eine intensive Chemotherapie geeignet sind. (HOVON 150 AML/AMLSG 29-18)
APL	APOLLO A randomized Phase III study to compare arsenic trioxide (ATO) combined to ATRA and idarubicin versus standard ATRA and anthracycline-based chemotherapy (AIDA regimen) for patients with newly diagnosed, high-risk acute promyelocytic leukemia
CLL	CLL16 A PROSPECTIVE, OPEN-LABEL, MULTICENTER, RANDOMIZED, PHASE 3 TRIAL OF ACALABRUTINIB, OBINUTUZUMAB AND VENETOCLAX (GAVE) COMPARED TO OBINUTUZUMAB AND VENETOCLAX (GVE) IN PREVIOUSLY UNTREATED PATIENTS WITH HIGH RISK (17P-DELETION, TP53- MUTATION OR COMPLEX KARYOTYPE) CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)
ITP	CETB115JDE01 A Phase II, randomized (1:1) open label study to assess the efficacy and safety of eltrombopag in combination with dexamethasone compared to dexamethasone, as first-line treatment in adult patients with newly diagnosed immune thrombocytopenia (XPAG-ITP)
ITP	LUNA A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study with an Open-Label Extension to Evaluate the Efficacy and Safety of Oral Rilzabrutinib (PRN1008) in Adults and Adolescents with Persistent or Chronic Immune Thrombocytopenia (ITP)
MDS	COMMANDS A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) versus Epoetin alfa for the Treatment of Anemia due to IPSS-R Very Low, Low or Intermediate Risk Myelodysplastic Syndromes (MDS) in ESA Naïve Subjects who require Red Blood Cell Transfusions
MDS	IDEAL A single-arm phase II multicenter study of IDH2 (AG 221) inhibitor in patients with IDH2 mutated myelodysplastic syndrome
MDS	ENHANCE A Randomized, Double-blind, Multicenter Study Comparing Magrolimab in Combination with Azacitidine versus Azacitidine Plus Placebo in Treatment-naïve Patients with Higher Risk Myelodysplastic Syndrome
MDS	STIMULUS MDS-3 A single-arm, open-label, Phase II study of sabatolimab in combination with azacitidine and venetoclax in adult participants with high or very high risk myelodysplastic syndrome (MDS) as per IPSS-R criteria
MDS	ACE-536-LTFU-001 A PHASE 3B, OPEN-LABEL, SINGLE-ARM, ROLLOVER STUDY TO EVALUATE LONG-TERM SAFETY IN SUBJECTS WHO HAVE PARTICIPATED IN OTHER LUSPATERCEPT (ACE-536) CLINICAL TRIALS
MDS	LUCAS A Phase II, Open-Label, Multicenter Study of Orally Administered CA-4948 for the Treatment of Anemia in Patients with Very Low, Low or Intermediate Risk Myelodysplastic Syndromes (MDS)
MDS	Verbundprojekt MDS EU Registry Prof. Germing

Lymphome
Diffuses großzelliges B-Zell-Lymphom (DLBCL)	Pola-R-ICE An open-label, prospective Phase III clinical study to compare polatuzumab vedotin plus rituximab, ifosfamide, carboplatin and etoposide (Pola-R-ICE) with rituximab, ifosfamide, carboplatin and etoposide (R-ICE) alone as salvage therapy in patients with primary refractory or relapsed diffuse large B-cell lymphoma (DLBCL)
DLBCL	MOR208C310 A Phase 3, multicenter, open-label, randomized trial comparing the efficacy and safety of Tafasitamab plus Lenalidomide in addition to RCHOP versus R-CHOP in high-intermediate and high-risk patients with newly diagnosed Diffuse Large B-Cell Lymphoma
follikuläres Lymphom	ALTERNATIVE-C prospective multicenter Phase 2 Study of the Chemotherapy-free Combination of the intravenous Phosphatidylinositol-3-Kinase (PI3K) Inhibitor Copanlisib in Combination with Obinutuzumab in Patients with Previously Untreated Follicular Lymphoma (FL) and a High Tumor Burden
follikuläres Lymphom	Celestimo PHASE III RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY EVALUATING EFFICACY AND SAFETY OF MOSUNETUZUMAB IN COMBINATION WITH LENALIDOMIDE IN COMPARISON TO RITUXIMAB IN COMBINATION WITH LENALIDOMIDE IN PATIENTS WITH FOLLICULAR LYMPHOMA AFTER AT LEAST ONE LINE OF SYSTEMIC THERAPY

Solide Tumore
Mamma-Ca	HIOB IOERT als antizipiertes Boostverfahren beim Mammakarzinom des Stadiums I und II mit nachfolgender hypofraktionierter Ganzbrustbestrahlung: HIOB Eine neue Option für die brusterhaltendende Therapie Prospektive einarmige Multizenterstudie
Kolon-Ca	CIRCULATE Evaluierung der adjuvanten Therapie beim Dickdarmkrebs im Stadium II nach ctDNA-Bestimmung (CIRCULATE) AIO-KRK-0217
Kolon-Ca	Fire-4 Randomisierte Studie zur Wirksamkeit einer Cetuximab- Reexposition bei Patienten mit metastasiertem kolorektalem Karzinom (RAS Wildtyp), welche auf eine Erstlinien-Behandlung mit FOLFIRI plus Cetuximab ein Ansprechen zeigten
Kolon-Ca	Colopredict Plus Retro- und prospektive Erfassung der Rolle von MSI und KRAS für die Prognose beim Kolonkarzinom im Stadium II + III
Kolon-Ca	Colopredict Plus 2.0 Registerstudie Retro- und prospektive Erfassung der Rolle von MSI und KRAS für die Prognose beim Kolonkarzinom im Stadium I-III sowie prospektiv bei hochsitzendem Rektumkarzinom im Stadium I-III