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Active clinical trials in the Department of Haematology, University Hospital of Ioannina
(presented by disease)
Myelodysplastic syndromes (MDS)
ASPIRE (phase II clinical trial)
Official title: A Three-part Study of Eltrombopag in Thrombocytopenic Subjects With Myelodysplastic Syndromes or Acute Myeloid Leukemia (Part 1: Open-label, Part 2: Randomized, Double-blind, Part 3: Extension) - NCT01440374 Adult subjects (18 years of age or older) MDS intermediate-II or high risk patients or patients with acute myelogenous leukemia and bone marrow blast<50% and with platelet (PLT) count < 25 x 109/L
Main inclusion Criteria:
- Adult subjects (18 years of age or older) with MDS or AML (bone marrow blasts ≤50%) with thrombocytopenia due to bone marrow insufficiency from the disease or prior treatment, with ECOG Status 0-2.
- Subjects must have Grade 4 thrombocytopenia (platelet counts <25 x109/L) due to bone marrow insufficiency (or platelet count ≥25 x109/L due to platelet transfusion). In addition, subjects must have had at least one of the following during the 4 week screening period: platelet transfusion, or symptomatic bleeding or platelet count <10 x109/L
- Subjects with a prior stem cell transplant (SCT) must have relapsed after the SCT.
- Subjects must have stable disease
Treatment within the clinical trial: eltrombopag per os daily
Relevant link – clinicaltrials.gov
TELESTO (phase III clinical trial)
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial of Deferasirox in Patients With Myelodysplastic Syndromes (Low/Int-1 Risk) and Transfusional Iron Overload-NCT00940602
Low risk or intermediate–I MDS patients that are being transfused and need chelation therapy
Treatment within the clinical trial: Deferasirox or placebo for as long as needed
Relevant link – clinicaltrials.gov
ARCADE (phase III clinical trial)
Official title: A Multicenter, Randomised, Double-blind, Placebo-controlled Study of Darbepoetin Alfa for the Treatment of Anaemic Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) - NCT01362140
Low risk or intermediate –I MDS patients with anemia that need treatment with an erythropoietic stimulating agent (ESA)
Inclusion Criteria
- Hb <10 gr/dl over the last week
- Need for transfusion no more than every 15 days over the last two months
- No previous or ongoing use of an ESA
Treatment within the clinical trial: Darbepoetin alpha 500 μg sc Q3W or placebo sc Q3W
Relevant link – clinicaltrials.gov
Acute Myelogenous Leukemia
ASPIRE (phase II clinical trial)
(as above)
POLO-AML2 Clinical Trial 1230.14
A phase III randomised, double-blind, controlled, parallel group study of intravenous volasertib in combination with subcutaneous low-dose cytarabine vs. placebo + low-dose cytarabine in patients ≥ 65 years with previously untreated acute myeloid leukaemia, who are ineligible for intensive remission induction therapy.
Relevant link – clinicaltrialsregister.eu
Acute Lymphoblastic Leukemia
AMG103_Blinatumomab Study 00103311
A Phase 3, Randomized, Open Label Study Investigating the Efficacy of the BiTE Antibody Blinatumomab Versus Standard of Care Chemotherapy in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)
Relevant link – clinicaltrials.gov
Chronic Myeloid Leukemia
ENESTPath
A clinical research study evaluating the possibility to suspend the drug nilotinib (Tasigna) in chronic myeloid leukemia (CML) patients who have been for two different durations on Tasigna with a predifined level of molecular response.
Relevant link – clinicaltrialsregister.eu
Non-Hodgkin Lymphomas
ASSIST-FL
A randomized Phase III clinical trial to compare the efficacy and safety of the biosimilar rituximab GP2013 in combination with a standard chemotherapy (CVP) or rituximab MabThera in combination with a standard chemotherapy (CVP), including GP2013/MabThera maintenance therapy in patient with previously untreated advanced stage follicular lymphoma.
Relevant link – clinicaltrialsregister.eu
Pillar (phase III clinical trial)
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Phase III Study of RAD001 Adjuvant Therapy in Poor Risk Patients With Diffuse Large B-Cell Lymphoma (DLBCL) of RAD001 Versus Matching Placebo After Patients Have Achieved Complete Response With First-line Rituximab-chemotherapy-NCT00790036
For patients with diffuse large B cell lymphoma with stage 3 or 4 disease at diagnosis who have received rituximab-CHOP and have achieved complete response
Treatment within the clinical trial: Everolimus or placebo per os for one year
Relevant link – clinicaltrials.gov
COMPLEMENT (phase III clinical trial)
Official title: A Randomized, Open Label Study of and Bendamustine Combination Therapy Compared With Bendamustine Monotherapy in Indolent B-cell Non-Hodgkin's Lymphoma Unresponsive to Rituximab or a Rituximab-Containing Regimen During or Within Six Months of Treatment-NCT01077518
For patients with indolent lymphoma (follicular lymphoma, small cell lymphocytic lymphoma, Waldenstrom’s Macroglobulinemia) who received Ritiximab as monotherapy or in combination with chemotherapy and with one of the following
- Have not achieved partial response
- Have relapsed within 6 months after the last rituximab infusion
- Have relapsed during rituximab treatment
Treatment within the clinical trial:Bendamustine (2 infusions every 21 days) for a maximum of 8 cycles +/- ofatumumab (1 infusion every 21 days for a maximum of 12 infusions)
Relevant link – clinicaltrials.gov
Chronic Lymphocytic Leukemia
Green
International study evaluating safety of Obinutuzumab alone or in combination with chemotherapy in patients with Chronic Lymphocytic Leukemia.
Relevant link – clinicaltrials.gov
Relevant link – clinicaltrialsregister.eu
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