Oversigt opdateret d. 6. januar 2020

Leukæmier

ALLTogether. A Treatment study protocol of the ALLTogether Consortium for children and young adults (1-45 years of age) with newly diagnosed acute lymphoblastic leukaemia (ALL). Ingolf Mølle, Lene Ebbesen.

AML17. Trial in Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome 17. Ingolf Mølle, Hans Beier Ommen. 

AML18. A Trial For Older Patients With Acute Myeloid Leukaemia and High Risk Myelodysplastic Syndrome. Hans Beier Ommen, Ingolf Mølle, Mette Skov Holm, Lene Ebbesen.

AML19. Adults with Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome (AML19). Ingolf Mølle, Hans Beier Ommen. 

BosuPeg. A Study of Efficacy and Safety of Long-Acting Low Dose Ropeginterferon in Patients with Chronic Myeloid Leukemia Treated with Bosutinib from Diagnosis: A Randomized Prospective Trial. Jesper Stentoft, Peter Niekerk.

DAstop2. Persistence of Major Molecular Remission in Chronic Myeloid Leukemia After a second Stop of TKI Treatment in patients who failed an initial stop attempt: a Multicenter Prospective Trial. Jesper Stentoft, Marie Bill.

ENEST Freedom. A single-arm, multicenter, nilotinib treatment-free remission study in patients with BCR-ABL1 positive Chronic Myelogenous Leukemia in chronic phase who have achieved durable minimal residual disease (MRD) status on first line nilotinib treatment. Jesper Stentoft. 

EVI-3. Combining Active and Passive DNA Hypomethylation. Anne Stidsholt Roug, Lene Hyldahl Ebbesen.

GOSSAMER. A Phase 2, Multicenterm Randomized, Double-Blind, Placebo-Controlled Trial of the FLT3 Inhibitor Gilteritinib (ASP2215) Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects with FLT/ITD AML in First Complete Remission. Ingolf Mølle, Hans Beier Ommen.

IDHENTIFY. A phase 3, Multicenter, Open-label, Randomized Study Comparing the Efficacy and Safety of AG-221 CC-90007) Versus Conventional Care Regimens in Older Subjects With Late Stage Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation. Hans Beier Ommen, Ingolf Mølle.

NOPHO – ALL 2008. Treatment Protocol for Children (1.0 – 17.9 years of age) and young adults (18 – 45 years of age) with Acute Lymphoblastic Leukemia. Lene Hyldahl Ebbesen & Mette Skov Holm.

MICRO-CARE. A multicenter, randomized, placebo-controlled, parallel-arm clinical trial to evaluate the efficacy of DAV132 in preventing Clostridioides difficile infection in patients with newly diagnosed Acute Myeloid Leukemia or high-risk Myelodysplastic Syndrome treated with intensive chemotherapy. Peter Asdahl, Ingolf Mølle, Hans Beier Ommen, Anne Stidsholt Roug, Marie Bill.

PTH. Målrettet behandling af patienter med blodsygdomme. Hans Beier Ommen.

Maligne lymfomer

ACE-CL-311. A Randomized, Multicenter, Open-Label, Phase 3 Study to Compare the Efficacy and Safety of
Acalabrutinib (ACP-196) in Combination with
Venetoclax with and without Obinutuzumab Compared
to Investigator’s Choice of Chemoimmunotherapy in
Subjects with Previously Untreated Chronic
Lymphocytic Leukemia Without del(17p) or TP53
Mutation. Hans Bentzen, Peter Asdahl.

ARROVEN (PASS). An Observational Cohort Study of the Safety of Brentuximab Vedotin in the Tretment of Relapsed or Refractory CD30+ Hodgkin Lymphoma and Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma. Francesco d´Amore.

B-CAP. Brentuximab vedotin or B-CAP in the treatment of older patients with newly diagnosed classical Hodgkin Lymphoma – a GHSG-NLG Intergroup Phase II trial.
Peter Kamper, Ida Blok Sillesen, Francesco d’Amore.

BIO-CHIC. Biomarker driven and dose intensified chemoimmunotherapy with early CNS prophylaxis in patients less than 65 years with high risk diffuse large
B-cell lymphoma. Judit Meszaros Jørgensen, Dorte Balle Gilstrøm.

CHIC. ”Intensiveret dosering af kemoterapi med tidlig CNS-profylakse hos patienterunder 65 årmed diffust storcellet B-cellelymfom i højrisikogruppen (aaIPI≥2) (NLG-LBC05)”. Judit Jørgensen.

Citadel 102. An Open-Label, Dose-Finding, and Cohort-Expansion Phase 1 Study Evaluating Safety and Efficacy of INCB050465 in Combination With Bendamustine and Obinutuzumab in Subjects With Relapsed or Refractory Follicular Lymphoma. Francesco d'Amore, Ida Blok Sillesen.

Citadel 205. A Phase 2, Open-Label, 2-Cohort, Multicenter Study of INCB050465, a PI3Kδ Inhibitor, in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a BTK Inhibitor.Francesco d'Amore, Hans Bentzen.

CLL13. A Phase 3 Multicenter, Randomized, Prospective, Open-LabeL Trial Of Standard Chemoimmunotherapy (FCR/BR) versus Rituximab plus Venetoclax (RVE) versus Obinutuzumab (GA101) PLUS VENETOCLAX (GVE) versus Obinutuzumab plus Ibrutinib plus Venetoclax (GIVE) in fit Patitens with previously untreated Chronic Lymphocytic Leukemia (CLL) without DEL(17P) OR TP53 Mutation. Dorte Balle Gilstrøm.

ECHELON-1. A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma. Francesco d´Amore & Ida Blok Sillesen.

ECHELON-2. A randomized, double blind, ploacebo-controlled, phase 3 study of brentuximab vedotin and CHP (A+CHP) versus CHOP in the frontline treatment of patients with CD30-positive mature T-cell lymphomas. Francesco d´Amore & Ida Blok Sillesen.

ENRICH. Randomised, open label study of Rituximab/Ibrutinib vs Rituximab/Chemotherapy in older patients with untreated mantle cell lymphoma. Hans Bentzen.

FIORELLA. Randomized Phase II Trial on Fitness- and Comorbidity- Tailored Treatment in Elderly Patients with Newly Diagnosed Primary CNS Lymphoma. Michael Thorsgaard.

GCT3013-02. Phase 1b/2, Open-Label Trial to Assess the Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Combination with Other Agents in Subjects with B-cell Non-Hodgkin Lymphoma. Judit Jørgensen, Hans Bentzen.

GCT3013-03. A Phase 1b/2, Open-Label, Safety and Efficacy Study of Epcoritamab (GEN3013; DuoBody®
-CD3 X CD20) in Relapsed/Refractory Chronic Lymphocytic Leukemia. Hans Bentzen, Peter Asdahl.

GCT3013-05. A Randomized, Open-Label, Phase 3 Trial of Epcoritamab vs Investigator’s Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma. Judit Jørgensen, Hans Bentzen, Peter Kamper, Charlotte Madsen, Martin Bjerregård Petersen, Ida Blok Sillesen, Francesco d'Amore.

GLOW. A Randomized, Open-label, Phase 3 study of the Combination of Ibrutinib plus Venetoclax
versus Chlorambucil plus Obinutuzumab for the First-line Treatment of Subjects with
Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL). Hans Bentzen, Dorte Balle Gilstrøm.

HD21. Treatment optimization trial in the first-line treatment of advanced stage Hodgkin lymphoma; comparison of 4-6 cycles of escalated BEACOPP with 4-6 cycles of BrECADD. Peter Kamper.

IELSG43 (MATRIX). High-dose chemotherapy and autologous stem cell transplant or consolidating conventional chemotherapy in primary CNS lymphoma - randomized phase III trial. Michael Thorsgaard.

ILIAD. A Phase II Trial of Idealisib in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma. Judit Meszaros Jørgensen

LYMRIT 37-01. A phase I/II study of lutetium (177Lu)-lilotomab satetraxetan (Betalutin®) antibodyradionuclide-conjugate for treatment of relapsed non-Hodgkin lymphoma. Francesco d’Amore, Ida Blok Sillesen, Hans Bentzen.

NP39488. AN OPEN-LABEL, MULTI-CENTER, PHASE IB STUDY OF GLOFITAMAB AND ATEZOLIZUMAB OR POLATUZUMAB VEDOTIN (PLUS A SINGLE PRE-TREATMENT DOSE OF OBINUTUZUMAB) IN ADULT PATIENTS WITH RELAPSED / REFRACTORY B-CELL NON-HODGKIN’S LYMPHOMA. Judt Jørgensen, Peter Kamper, Hans Bentzen, Charlotte Madsen

PHOENIX. A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma. Francesco d´Amore, Søren Ramme Nielsen & Peter Kamper.

PREBEN. A Phase 1/2 study of the combination of pixantrone, etoposide, bendamustine and, in CD-20 positive tumors, rituximab in patients with relapsed aggressive non-Hodgkin lymphomas of B- or T-cell phenotype – The P[R]EBEN study. 
Judit Meszaros Jørgensen, Peter Kamper, Francesco d’Amore.

SAKK 35-14. Rituximab with or without Ibrutinib for untreated patients with advanced follicular lymphoma in need of therapy. A randomized, double-blinded, SAKK and NLG collaborative Phase II trial. Ida Blok Sillesen

SGN35-031. A Randomized, Double-blind, Placebo-Controlled, Active-Comparator, Multicenter, Phase 3 Study of Brentuximab Vedotin or Placebo in Combination With Lenalidomide and Rituximab in Subjects with Relapsed or Refractory Diffuse Large B-cell Lymphoma. Judit Jørgensen, Peter Kamper, Hans Bentzen

STARGLO. A PHASE III, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY EVALUATING THE EFFICACY AND SAFETY OF GLOFITAMAB IN COMBINATION WITH GEMCITABINE PLUS OXALIPLATIN VERSUS RITUXIMAB IN COMBINATION WITH GEMCITABINE AND OXALIPLATIN IN PATIENTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA. Judit Jørgensen, Charlotte Madsen, Hans Bentzen, Peter Kamper.

TRIANGLE. autologous Transplantation after a Rituximab/Ibrutinib/Ara-c containing iNduction
in Generalized mantle cell Lymphoma – a randomized European mcl network trial. Hans Bentzen, Dorte Balle Gilstrøm.

VENICE-1 (M15-550). Open-Label, Single Arm, Phase 3b, Multi-Center Study Evaluating the Efficacy of Venetoclax (ABT-199) in Relapsed/Refractory Subjects with Chronic Lymphocytic Leukemia (CLL) Including Those with the 17p Deletion or TP53 Mutation OR Those Who Are Refractory or Intolerant to B-Cell Receptor Inhibitors.
Dorte Balle Gilstrøm, Hans Bentzen.

Myelodysplastiske syndromer

EVI-3. A multicenter, randomized, parallel-group, placebo-controlled phase II study of the efficacy and safety of oral vitamin C supplement in combination with azacitidine in higher-risk MDS, CMML, and lowblast-count AML. Jan Maxwell Nørgaard.

NMDSG14B. Individual molecular minimal residual disease monitoring for patients with MDS and mixed MDS/MPN treated with allogenic stem cell transplantation. Gitte Olesen.

PTH. Målrettet behandling af patienter med blodsygdomme. Hans Beier Ommen.

Kroniske myeloproliferative syndromer

GERON. A Randomized, Open-Label, Phase 3 Study to Evaluate Imetelstat (GRN163L) versus Best Available Therapy (BAT) in Myelofibrosis. Hans Beier Ommen, Jespar Stentoft, Peter Niekerk.

Myelomatose

Artemids. A non-interventional post authorisation registry of patients treated with pomalidomide for relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy. Niels Frost Andersen.

C16019. A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Patients With Multiple Myeloma Following Autologous Stem Cell Transplant. Niels Frost Andersen, Anja Klostergaard, Trine Silkjær.

C16021. A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Maintenance Therapy After Initial Therapy in Patients With Multiple Myeloma Not Treated with Stem Cell Transplantation. Niels Frost Andersen, Anja Klostergaard, Trine Silkjær.

CC-92480-MM-001. A Phase 1/2 Multicenter Open-Label Study to Assess the Safety, Pharmacokinetics and Efficacy of CC-92480 Monotherapy and in Combination with Dexamethasone in Subjects with Relapsed and Refractory Multiple Myeloma. Maja Ølholm Vase, Anja Klostergaard, Trine Silkjær.

HOVON 95. A randomized phase III study to compare Bortezomib, Melphalan, Prednisone (VMP) with High Dose Melphalan followed by Bortezomib, Lenalidomide, Dexamethasone (VRD) consolidation and Lenalidomide maintenance in patients with newly diagnosed multiple myeloma. The European Intergroup Trial of the European Myeloma Network EMN (HOVON 95 MM). Niels Frost Andersen, Anja Klostergaard.

HOVON 129. Carfilzomib and Lenalidomide-based treatment for younger and elderly newly diagnosed primary plasma cell leukemia patients. Trine Silkjær.

ITHACA. A Phase 3 randomized, open-label, multicenter study of isatuximab (SAR650984) in combination with
lenalidomide and dexamethasone versus lenalidomide
and dexamethasone in patients with high-risk
smoldering multiple myeloma. Anja Klostergaard, Trine Silkjær, Maja Ølholm Vase.

LYNX. A Phase 2 Study of Daratumumab Subcutaneous (Dara-SC) Administration in Combination with Carfilzomib and Dexamethasone (DKd) Compared with Carfilzomib and Dexamethasone (Kd) in Participants with Multiple Myeloma who have been Previously Treated with Daratumumab Intravenous (Dara-IV) to Evaluate Daratumumab Retreatment. Trine Silkjær, Maja Ølholm Vase, Anja Klostergaard.

Magnolia. Prolonged Protection from Bone Disease in Multiple Myeloma. An open label phase 4 multicenter international randomised trial. Trine Silkjær, Niels Frost Andersen.

MAIA. A Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects with Previously Untreated Multiple Myeloma who are Ineligible for High Dose Therapy.
Niels Frost Andersen, Anja Klostergaard, Trine Silkjær.

Perseus. A Phase 3 Study Comparing Daratumumab, VELCADE (bortezomib), Lenalidomide, and Dexamethasone (D-VRd) vs VELCADE, Lenalidomide, and Dexamethasone (VRd) in Subjects with Previously Untreated Multiple Myeloma who are Eligible for High-dose
Therapy. Anja Klostergaard, Maja Ølholm Vase, Trine Silkjær.

QoL MM. Livskvalitet hos danske patienter med myelomatose. Anja Klostergaard, Trine Silkjær, Niels Frost Andersen.

Amyloidose

Andromeda. A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared with CyBorD Alone i Newly Diagnosed Systemic AL Amyloidosis. Maja Ølholm Vase, Anja Klostergaard, Trine Silkjær.

Øvrige

GVH 2448. A Randomized Phase III Study to Determine the Most Promising Postgrafting Immunosuppression
for Prevention of Acute GVHD after Unrelated Donor Hematopoietic Cell Transplantation using Nonmyeloablative Conditioning for Patients with Hematologic Malignancies: A Multi-Center Trial. Gitte Olesen, Irma Petruskevicius.

MICRO. MethylphenIdate for fatigue in haematological cancer. A randomized, double-blind, placebo-controlled, CROssover trial. Dorte Balle Gilstrøm, Mie Sand Hougaard.