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Aktuelle klinische Studien, Stand: Juni 2022

Leukämien, Myelodysplastisches Syndrom und Myeloproliferative Neoplasien

AMLKB-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, MDSCa-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
AMLHOVON 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)
APLAPOLLO 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
CLLCLL16  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)

ITPLUNA 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)
MDSCOMMANDS 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
MDSIDEAL 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

MDSLUCAS 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)
MDSVerbundprojekt 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 LymphomALTERNATIVE-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-CaHIOB  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-CaCIRCULATE Evaluierung der adjuvanten Therapie beim Dickdarmkrebs im Stadium II nach ctDNA-Bestimmung (CIRCULATE) AIO-KRK-0217
Kolon-CaFire-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-CaColopredict Plus Retro- und prospektive Erfassung der Rolle von MSI und KRAS für die Prognose beim Kolonkarzinom im Stadium II + III
Kolon-CaColopredict 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

 

Alle Studien sind offen.

Registerteilnahmen bleiben bestehen.

Registerteilnahmen : GMALL (Frankfurt), AML BiO-Register (Ulm), Marginalzell-Lymphom (Münster), MDS-Register (UK Düsseldorf), MPN (Aachen)

Weitere Informationen bekommen Sie gerne von uns:

Studiendokumentation
Frau Heinze/Frau Kravchenko/Frau Lohrbacher
Telefon (02 11) 44 00 - 2079

E-Mail:

linda.heinze(at)vkkd-kliniken.de

olga.kravchenko(at)vkkd-kliniken.de

vera.lohrbacher(at)vkkd-kliniken.de

Aktuelles Studientelegramm als PDF