cometadata/datacite-titles-descriptions-related-identifiers huggingface dataset:
DOI: 10.15468/dl.zmuswn
title: Occurrence Download

description: A dataset listing the 3556 species recorded in GBIF matching the query:
{
 "GadmGid" : [
 "is PRT.9.1_1"
 ]
}

 The dataset's 3556 records were derived from 135 constituent datasets; see https://api.gbif.org/v1/occurrence/download/0054855-251120083545085/datasets/export for details.
 
Data from some individual datasets included in this download may be licensed under less restrictive terms.
DOI: 10.25934/pr00012224
title: A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab in Autoinjectors to Demonstrate Efficacy After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability, Usability and Long-term Efficacy in Subjects With Chronic Plaque-type Psoriasis

description: The purpose of this study was to demonstrate efficacy of autoinjector administered secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.
DOI: 10.13130/rd_unimi/6np0bt/25mdub
title: Giugno_1894_Pagina_003.jpg

description: Bulletin of 1894/06/01
DOI: 10.13130/rd_unimi/awv4gb/elm66y
title: Gennaio_1896_Pagina_122.jpg

description: Bulletin of 1896/01/31
DOI: 10.13130/rd_unimi/cbrkhv/sh6mp6
title: Gennaio_1927_Pagina_035.jpg

description: Bulletin of 1927/01/09
DOI: 10.25934/pr00012225
title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Study to Demonstrate the Efficacy at 16 Weeks of Secukinumab 150 and 300 mg s.c. and to Assess Safety, Tolerability and Long-term Efficacy up to 132 Weeks in Subjects With Moderate to Severe Nail Psoriasis

description: This purpose of this study was to demonstrate the efficacy of secukinumab versus placebo on nail psoriasis and to assess long-term efficacy, safety and tolerability of secukinumab.
DOI: 10.25934/pr00012226
title: A Phase III, Randomized, Double-blind, Triple-dummy, Placebo Controlled, Multicenter, 5-period, Single-dose Complete Block Crossover Study to Determine the Onset of Action of Indacaterol (150 and 300 μg) in Patients With Moderate to Severe COPD Using Salbutamol (200 μg) and Salmeterol/Fluticasone (50/500 μg) as Active Controls

description: This study will evaluate the onset of action of indacaterol (150 and 300 µg) as compared to placebo, salbutamol 200 µg and salmeterol/fluticasone 50/500 µg
DOI: 10.13130/rd_unimi/gsbgp1/rndzi8
title: Giugno_1889_Pagina_061.jpg

description: Bulletin of 1889/06/16
DOI: 10.13130/rd_unimi/nsvbhr/wls6qw
title: Giugno_1890_Pagina_045.jpg

description: Bulletin of 1890/06/12
DOI: 10.13130/rd_unimi/v8alup/czt0s8
title: Giugno_1891_Pagina_042.jpg

description: Bulletin of 1891/06/11
DOI: 10.13130/rd_unimi/xu1sm0/i8ywew
title: Giugno_1893_Pagina_020.jpg

description: Bulletin of 1893/06/05
DOI: 10.15468/dl.bx27bx
title: Occurrence Download

description: A dataset containing 194197 species occurrences available in GBIF matching the query:
{
 "and" : [
 "TaxonKey is Tracheophyta",
 "DecimalLatitude is greater than or equal to -20.914722",
 "DecimalLatitude is less than or equal to -15.914722",
 "DecimalLongitude is greater than or equal to 140.0",
 "DecimalLongitude is less than or equal to 145.0",
 "HasCoordinate is TRUE",
 "HasGeospatialIssue is FALSE"
 ]
}

 The dataset includes 194197 records from 94 constituent datasets; see https://api.gbif.org/v1/occurrence/download/0054840-251120083545085/datasets/export for details.
 
Data from some individual datasets included in this download may be licensed under less restrictive terms.
DOI: 10.25574/03150
title: Chandra X-ray Observatory ObsId 03150

description: CHANDRA OBSERVATIONS OF TYPE-2 LINERS: STARBURSTS OR AGNS ?
DOI: 10.25934/pr00012227
title: A Phase I, Multi-center, Open Label Dose Escalation Study of LDK378, Administered Orally in Adult Patients With Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase (ALK)

description: This study assessed the safety and efficacy of LDK378 in adult patients with genetic abnormalities in anaplastic lymphoma kinase (ALK).
DOI: 10.13130/rd_unimi/jvs9pt/tmdzoy
title: Giugno_1892_Pagina_020.jpg

description: Bulletin of 1892/06/05
DOI: 10.13130/rd_unimi/rjrjox/ihyenp
title: Luglio_1895_Pagina_071.jpg

description: Bulletin of 1895/07/18
DOI: 10.25934/pr00012228
title: Efficacy and Safety Study Comparing Concentration-controlled Everolimus in Two Doses (1.5 and 3.0 mg/Day Starting Doses) With Reduced Cyclosporine Versus 1.44 g Mycophenolic Acid (as Sodium Salt) With Standard Dose Cyclosporine in de Novo Renal Transplant Recipients

description: The purpose of this study was to compare the safety and efficacy of three immunosuppressive treatment regimens following a kidney transplant.
DOI: 10.13130/rd_unimi/6np0bt/hsks7p
title: Giugno_1894_Pagina_004.jpg

description: Bulletin of 1894/06/01
DOI: 10.13130/rd_unimi/cbrkhv/gjsyhr
title: Gennaio_1927_Pagina_036.jpg

description: Bulletin of 1927/01/09
DOI: 10.25934/pr00012229
title: A 24 Month, Multicenter, Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients

description: This trial was designed to address important issues that impact recipients of liver allografts as well as clinicians, ie, renal function, reduction or discontinuation of tacrolimus early post-transplantation, and progression rate of fibrosis in hepatitis C virus (HCV) positive patients.
DOI: 10.13130/rd_unimi/nsvbhr/pubskr
title: Giugno_1890_Pagina_046.jpg

description: Bulletin of 1890/06/12
DOI: 10.13130/rd_unimi/v8alup/vlz7rj
title: Giugno_1891_Pagina_043.jpg

description: Bulletin of 1891/06/11
DOI: 10.13130/rd_unimi/xu1sm0/0enwth
title: Giugno_1893_Pagina_021.jpg

description: Bulletin of 1893/06/06
DOI: 10.25574/03151
title: Chandra X-ray Observatory ObsId 03151

description: A CHANDRA SURVEY OF THE MOST LUMINOUS QUASARS AT Z &gt; 4
DOI: 10.25934/pr00012230
title: HORIZON-PFT: Pivotal Fracture Trial

description: HORIZON-PFT (Pivotal Fracture Trial) will study the effect of zoledronic acid, given once per year, on the treatment of osteoporosis in women past menopause. Hip and vertebral fractures are the most devastating consequences of osteoporosis. HORIZON-PFT is designed to determine the benefits of zoledronic acid in fracture reduction at both the hip and spine.
DOI: 10.5281/zenodo.17404676
title: data and codes on Experimental evolution of plasmodium yoelii in single and helminth coinfected mice
DOI: 10.5281/zenodo.17953365
title: data and codes on Experimental evolution of plasmodium yoelii in single and helminth coinfected mice
DOI: 10.13130/rd_unimi/awv4gb/s7xx2j
title: Gennaio_1896_Pagina_123.jpg

description: Bulletin of 1896/01/31
DOI: 10.13130/rd_unimi/gsbgp1/fst6nb
title: Giugno_1889_Pagina_062.jpg

description: Bulletin of 1889/06/16
DOI: 10.13130/rd_unimi/rjrjox/qswty9
title: Luglio_1895_Pagina_061.jpg

description: Bulletin of 1895/07/16
DOI: 10.25934/pr00012231
title: A 3-year, Double-blind Extension to CZOL446H2301 to Evaluate the Long-term Safety and Efficacy of Zoledronic Acid in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D

description: This extension study is designed to assess the long term safety and efficacy of zoledronic acid in postmenopausal women with osteoporosis who have participated in the CZOL446H2301 (NCT00049829): HORIZON Pivotal Fracture Trial. This extension study began after the 3-year core study ended. Baseline is the same as Year 3.
DOI: 10.13130/rd_unimi/6np0bt/btptnu
title: Giugno_1894_Pagina_005.jpg

description: Bulletin of 1894/06/02
DOI: 10.13130/rd_unimi/cbrkhv/2kuqdp
title: Gennaio_1927_Pagina_037.jpg

description: Bulletin of 1927/01/10
DOI: 10.13130/rd_unimi/jvs9pt/4scknm
title: Giugno_1892_Pagina_021.jpg

description: Bulletin of 1892/06/06
DOI: 10.25934/pr00012232
title: A 3-year, Multicenter, Double-blind, Randomized, Placebo-controlled Extension to CZOL446H2301E1 to Evaluate the Efficacy and Long Term Safety of 6 and 9 Years Zoledronic Acid Treatment of Postmenopausal Women With Osteoporosis

description: This second extension will evaluate the efficacy and long term safety of zoledronic acid in women with post-menopausal osteoporosis
DOI: 10.25934/pr00012233
title: Evaluating the Ability of Zoledronic Acid to Reduce the Rate of Subsequent Osteoporotic Fractures After a Hip Fracture

description: The purpose of this study is to evaluate whether zoledronic acid given once yearly for two years to men and women after surgical repair of a recent hip fracture will significantly reduce the rate of all re-occurring (new) osteoporotic fractures. All patients will receive vitamin D and calcium.
DOI: 10.13130/rd_unimi/gsbgp1/5atxq9
title: Giugno_1889_Pagina_063.jpg

description: Bulletin of 1889/06/16
DOI: 10.13130/rd_unimi/nsvbhr/jaokiv
title: Giugno_1890_Pagina_047.jpg

description: Bulletin of 1890/06/12
DOI: 10.13130/rd_unimi/xu1sm0/5rivzz
title: Giugno_1893_Pagina_022.jpg

description: Bulletin of 1893/06/06
DOI: 10.25574/03152
title: Chandra X-ray Observatory ObsId 03152

description: A CHANDRA SURVEY OF THE MOST LUMINOUS QUASARS AT Z &gt; 4
DOI: 10.25934/pr00012234
title: A One-year Partial Double-blinded, Randomized, Multi-center, Multi-national Study to Assess the Effects of Combination Therapy of Annual Zoledronic Acid (5 mg) and Daily Subcutaneous Teriparatide (2mcrg) on Postmenopausal Women With Severe Osteoporosis

description: The purpose of this study is to assess the effects of zoledronic acid administered at the same time with teriparatide compared to zoledronic acid alone and teriparatide alone on bone mineral density (BMD) gain in the lumbar spine and total hip
DOI: 10.13130/rd_unimi/awv4gb/egcgfi
title: Gennaio_1896_Pagina_124.jpg

description: Bulletin of 1896/01/31
DOI: 10.13130/rd_unimi/v8alup/m2uqv4
title: Giugno_1891_Pagina_044.jpg

description: Bulletin of 1891/06/11
DOI: 10.25934/pr00012235
title: Efficacy and Safety of Zoledronic Acid for the Treatment of Osteoporosis in Men

description: The goal of this study is to determine the effectiveness and safety of an annual intravenous treatment of zoledronic acid for the treatment of osteoporosis in men. All patients will receive calcium and vitamin D supplements.
DOI: 10.13130/rd_unimi/6np0bt/kutfqp
title: Giugno_1894_Pagina_006.jpg

description: Bulletin of 1894/06/02
DOI: 10.13130/rd_unimi/jvs9pt/wo4m4u
title: Giugno_1892_Pagina_022.jpg

description: Bulletin of 1892/06/06
DOI: 10.13130/rd_unimi/rjrjox/igse8c
title: Luglio_1895_Pagina_074.jpg

description: Bulletin of 1895/07/19
DOI: 10.25934/pr00012236
title: A Two Year Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Fracture Efficacy and Safety of Intravenous Zoledronic Acid 5 mg Annually for the Treatment of Osteoporosis in Men

description: This study will investigate if the drug zoledronic acid given once yearly is safe and has beneficial effects in treating osteoporosis by reducing bone loss and fractures in men with osteoporosis.
DOI: 10.13130/rd_unimi/cbrkhv/meyv4t
title: Gennaio_1927_Pagina_038.jpg

description: Bulletin of 1927/01/10
DOI: 10.13130/rd_unimi/nsvbhr/smvhns
title: Giugno_1890_Pagina_048.jpg

description: Bulletin of 1890/06/12
DOI: 10.25574/03153
title: Chandra X-ray Observatory ObsId 03153

description: A CHANDRA SURVEY OF THE MOST LUMINOUS QUASARS AT Z &gt; 4
DOI: 10.25934/pr00012237
title: Efficacy and Safety of Zoledronic Acid in the Prevention and Treatment of Corticosteroid Induced Osteoporosis

description: The intake of high doses of corticosteroids is known to play an important role in the weakening of the bones and is thus an increasing fracture risk. Zoledronic acid (Aclasta) is a drug known for its protective effect in some bone diseases (tumors, paget). This study will test the safety and efficacy of zoledronic acid in the prevention and treatment of corticosteroid induced osteoporosis in male and female patients.
DOI: 10.13130/rd_unimi/gsbgp1/rbizeo
title: Giugno_1889_Pagina_064.jpg

description: Bulletin of 1889/06/16
DOI: 10.13130/rd_unimi/rjrjox/lqvil4
title: Luglio_1895_Pagina_075.jpg

description: Bulletin of 1895/07/19
DOI: 10.13130/rd_unimi/xu1sm0/ph25pl
title: Giugno_1893_Pagina_023.jpg

description: Bulletin of 1893/06/06
DOI: 10.25934/pr00012238
title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Psoriatic Arthritis

description: This study will assess the efficacy and safety of secukinumab in patients with active psoriatic arthritis who are intolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor therapy.
DOI: 10.13130/rd_unimi/awv4gb/cpxav0
title: Giugno_1896_Pagina_001.jpg

description: Bulletin of 1896/06/01
DOI: 10.13130/rd_unimi/jvs9pt/9ezecx
title: Giugno_1892_Pagina_023.jpg

description: Bulletin of 1892/06/06
DOI: 10.13130/rd_unimi/v8alup/sf6bdh
title: Giugno_1891_Pagina_045.jpg

description: Bulletin of 1891/06/12
DOI: 10.25934/pr00012239
title: A Phase II, Multicenter, Single-arm Study of Oral LDK378 in Adult Patients With ALK-activated Non-small Cell Lung Cancer Previously Treated With Chemotherapy and Crizotinib

description: A single-arm, open-label, multicenter, phase II study. Treatment with LDK378 750 mg qd continued until the patient experienced unacceptable toxicity that precluded further treatment, discontinued treatment at the discretion of the investigator or patient, started a new anti-cancer therapy and/or died. LDK378 could be continued beyond RECIST-defined progressive disease (PD) as assessed by the investigator if, in the judgment of the investigator, there was evidence of clinical benefit. In these patients tumor assessment would continue as per the schedule of assessments until treatment with LDK378 was permanently discontinued. Patients who discontinued the study medication in the absence of progression continued to be followed for tumor assessment until the time of PD as assessed by the investigator
DOI: 10.13130/rd_unimi/6np0bt/rgzwcv
title: Giugno_1894_Pagina_007.jpg

description: Bulletin of 1894/06/02
DOI: 10.13130/rd_unimi/cbrkhv/4kykz4
title: Gennaio_1927_Pagina_039.jpg

description: Bulletin of 1927/01/10
DOI: 10.25574/03154
title: Chandra X-ray Observatory ObsId 03154

description: A CHANDRA SURVEY OF THE MOST LUMINOUS QUASARS AT Z &gt; 4
DOI: 10.25934/pr00012240
title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Study Comparing GW572016 and Letrozole Versus Letrozole in Subjects With Estrogen/Progesterone Receptor- Positive Advanced or Metastatic Breast Cancer

description: This study evaluated and compared the efficacy and tolerability of lapatinib and letrozole, with letrozole and placebo in post-menopausal women with hormone receptor positive (ER positive and/or PgR positive) advanced or metastatic breast cancer, who had not received prior therapy for advanced or metastatic disease.
DOI: 10.13130/rd_unimi/nsvbhr/5g6hag
title: Giugno_1890_Pagina_049.jpg

description: Bulletin of 1890/06/13
DOI: 10.13130/rd_unimi/rjrjox/j4ak3m
title: Luglio_1895_Pagina_064.jpg

description: Bulletin of 1895/07/16
DOI: 10.13130/rd_unimi/xu1sm0/filejr
title: Giugno_1893_Pagina_024.jpg

description: Bulletin of 1893/06/06
DOI: 10.25934/pr00012241
title: A 26-week Treatment Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled (Open Label) Study to Assess the Efficacy, Safety and Tolerability of QVA149 (110/50 μg q.d.) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

description: The purpose of this study is to provide pivotal efficacy and safety data for QVA149 in patients with moderate to severe COPD.
DOI: 10.25934/pr00012242
title: A Placebo and Active Controlled Study to Assess the Long-term Safety of Once Daily QVA149 for 52 Weeks in Chronic Obstructive Pulmonary Disease (COPD) Patients With Moderate to Severe Airflow Limitation

description: The study will assess the long-term safety of the fixed combination product QVA149 versus placebo and a standard of care treatment (tiotropium) in Chronic Obstructive Pulmonary Disease (COPD) patients with moderate to severe airflow limitation.
DOI: 10.13130/rd_unimi/awv4gb/wfeavq
title: Giugno_1896_Pagina_002.jpg

description: Bulletin of 1896/06/01
DOI: 10.13130/rd_unimi/gsbgp1/qxrt7n
title: Giugno_1889_Pagina_065.jpg

description: Bulletin of 1889/06/17
DOI: 10.13130/rd_unimi/v8alup/isgji0
title: Giugno_1891_Pagina_046.jpg

description: Bulletin of 1891/06/12
DOI: 10.25934/pr00012243
title: A 12-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation.

description: This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to severe airflow limitation.
DOI: 10.13130/rd_unimi/6np0bt/nqbxvs
title: Giugno_1894_Pagina_008.jpg

description: Bulletin of 1894/06/02
DOI: 10.13130/rd_unimi/jvs9pt/ydsywe
title: Giugno_1892_Pagina_024.jpg

description: Bulletin of 1892/06/06
DOI: 10.25574/03155
title: Chandra X-ray Observatory ObsId 03155

description: A CHANDRA SURVEY OF THE MOST LUMINOUS QUASARS AT Z &gt; 4
DOI: 10.25934/pr00012244
title: A 12-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation

description: This study will assess the efficacy, safety and tolerability of indacaterol maleate/glycopyrronium bromide in patients with moderate to severe airflow limitation.
DOI: 10.13130/rd_unimi/cbrkhv/fzx0o5
title: Gennaio_1927_Pagina_040.jpg

description: Bulletin of 1927/01/10
DOI: 10.13130/rd_unimi/nsvbhr/47xrjw
title: Giugno_1890_Pagina_050.jpg

description: Bulletin of 1890/06/13
DOI: 10.13130/rd_unimi/xu1sm0/rdiysb
title: Giugno_1893_Pagina_025.jpg

description: Bulletin of 1893/06/07
DOI: 10.13130/rd_unimi/gsbgp1/6yquwr
title: Giugno_1889_Pagina_066.jpg

description: Bulletin of 1889/06/17
DOI: 10.13130/rd_unimi/rjrjox/yczdqw
title: Luglio_1895_Pagina_067.jpg

description: Bulletin of 1895/07/17
DOI: 10.25934/pr00012245
title: A Multicener, Randomised, Double-blind, Placebo-controlled Study, to Assess the Long Term Safety of 52 Weeks Treatment With QVA149 (110 ug Indacaterol/50ug Glycopyrrolate) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

description: The study is designed to provide long-term safety data for QVA149 in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
DOI: 10.25934/pr00012246
title: A Multi-centre Randomized Double Blind 52-week Study to Assess the Safety of QVA149 Compared to QAB149 in Patients With COPD Who Have Moderate to Severe Airflow Limitation

description: This study is to assess the safety and tolerability of two different doses of QVA149 and QAB149 in patients with moderate to severe airflow limitation.
DOI: 10.13130/rd_unimi/6np0bt/v5tmei
title: Giugno_1894_Pagina_009.jpg

description: Bulletin of 1894/06/03
DOI: 10.13130/rd_unimi/awv4gb/ynaj5d
title: Giugno_1896_Pagina_003.jpg

description: Bulletin of 1896/06/01
DOI: 10.13130/rd_unimi/jvs9pt/ghfjwa
title: Giugno_1892_Pagina_025.jpg

description: Bulletin of 1892/06/07
DOI: 10.13130/rd_unimi/v8alup/gfzogu
title: Giugno_1891_Pagina_047.jpg

description: Bulletin of 1891/06/12
DOI: 10.25574/03156
title: Chandra X-ray Observatory ObsId 03156

description: A CHANDRA SURVEY OF THE MOST LUMINOUS QUASARS AT Z &gt; 4
DOI: 10.25934/pr00012247
title: A Randomized, Double-blind, Placebo Controlled Study of Canakinumab in Patients With Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF), With Subsequent Randomized Withdrawal/Dosing Frequency Reduction and Open-label Long-term Treatment Epochs

description: This study is to determine whether canakinumab is able to induce and maintain a clinically meaningful reduction of disease activity in participants with Hereditary Periodic Fevers (HPF) compared to placebo.
DOI: 10.13130/rd_unimi/cbrkhv/sznhfd
title: Gennaio_1927_Pagina_041.jpg

description: Bulletin of 1927/01/11
DOI: 10.13130/rd_unimi/nsvbhr/6mojrg
title: Giugno_1890_Pagina_051.jpg

description: Bulletin of 1890/06/13
DOI: 10.13130/rd_unimi/xu1sm0/buzdoa
title: Giugno_1893_Pagina_026.jpg

description: Bulletin of 1893/06/07
DOI: 10.25934/pr00012248
title: A Multi-center, Randomized, Double-blind, 52-week Study to Assess the Safety of NVA237 Compared to QAB149 in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Have Moderate to Severe Airflow Limitation

description: The purpose of the study is to provide long term safety data of NVA237. This study will assess the safety and tolerability of a single dose strength of NVA237.
DOI: 10.13130/rd_unimi/awv4gb/gbr8jr
title: Giugno_1896_Pagina_004.jpg

description: Bulletin of 1896/06/01
DOI: 10.13130/rd_unimi/gsbgp1/rjvqlz
title: Giugno_1889_Pagina_067.jpg

description: Bulletin of 1889/06/17
DOI: 10.13130/rd_unimi/rjrjox/2b7txx
title: Luglio_1895_Pagina_080.jpg

description: Bulletin of 1895/07/20
DOI: 10.25934/pr00012249
title: A Phase II, Multi-centre Study Investigating the Safety and Efficacy of Ofatumumab and Bendamustine Combination in Patients With Untreated or Relapsed Chronic Lymphocytic Leukaemia (CLL)

description: This is a Phase II, open label, single arm, multi-centre study investigating the safety and efficacy of ofatumumab plus bendamustine in subjects with untreated or relapsed CLL.Each subject from the screening phase who is willing to participate in the study and is found eligible according to the inclusion and exclusion criteria will enter the treatment phase and will receive a maximum of 6 Cycles of study treatment (ofatumumab plus bendamustine). All subjects will receive 3 Cycles of study treatment (Cycles 1, 2 and 3). Eligibility to receive study treatment for Cycles 4, 5 and 6 will be assessed following the 3rd Cycle. Subjects who have achieved at least stable disease with acceptable toxicity following 3 Cycles of treatment will be eligible to continue to receive study treatments for a maximum of 3 further Cycles. In case of progressive disease, at, or at any time after the start of Cycle 4, subjects must discontinue further study treatment and move into the study's follow-up period.During the treatment phase, all eligible subjects will be allocated to receive the following study treatments:1. Subjects with Untreated CLL: Up to 6 monthly intravenous infusions of ofatumumab (Cycle 1: 300 mg Day 1 and 1000 mg Day 8; subsequent Cycles: 1000 mg at Day 1 every 28 Days) in combination with up to 6 Cycles of intravenously infused bendamustine (90 mg/m2, Days 1 and 2, every 28 Days).2. Subjects with Relapsed CLL: Up to 6 monthly intravenous infusions of ofatumumab (Cycle 1: 300 mg Day 1 and 1000 mg Day 8; subsequent Cycles: 1000 mg at Day 1 every 28 Days) in combination with up to 6 Cycles of intravenously infused bendamustine (70 mg/m2, Days 1 and 2, every 28 Days).The studies primary endpoint is overall response rate (ORR) as determined by Investigator evaluation. The ORR is the percentage of subjects achieving an objective response (i.e., partial response or better), using the IWCLL updated NCI-WG guidelines. Response assessments are planned at the following time-points: After 3 Cycles of ofatumumab plus bendamustine treatment, after 6 Cycles of ofatumumab plus bendamustine treatment and after the last dose, if not after 6 cycles, of ofatumumab plus bendamustine treatment.Follow-up assessments will be performed every 3 months following the last study treatment. The follow-up period will last for a maximum of 3 years. Response evaluation assessments to determine subject response or progression will be performed during the follow-up period, according to the IWCLL updated NCI-WG guidelines. Following progression, only survival status and details concerning the subject's next CLL therapy will be recorded.