Click
Chat
 
Du kan vedhæfte PDF, JPG, PNG, DOC(X), XLS(X) og TXT-filer. Klik på ikonet, vælg fil og vent til upload er færdig før du indsender eller uploader endnu en fil.
60
Vedhæft Send
DANMARKS STØRSTE INVESTORSITE MED DEBAT, CHAT OG NYHEDER

OFATUMUMAB RITUXIMAB !


33561 gentogen 16/9 2010 15:45
1
Oversigt

Single Agent Ofatumumab Vs. Single Agent Rituximab in Follicular Lymphoma Relapsed After Rituximab-Containing Therapy
This study is not yet open for participant recruitment.
Verified by GlaxoSmithKline, September 2010
First Received: September 10, 2010 No Changes Posted

This is a multi-center, parallel, active comparator controlled, open-label, randomized (1:1) phase III study of single agent ofatumumab compared to single agent rituximab in subjects with rituximab-sensitive grade 1, 2, and 3A follicular lymphoma that has relapsed at least 6 months after completing treatment with single agent rituximab or a rituximab-containing regimen. Subjects must have attained a Complete Response or Partial Response to their last prior rituximab containing therapy lasting at least six months beyond the end of rituximab therapy. Subjects will receive four weekly doses of single agent ofatumumab (1000 mg) or rituximab (375 mg/m2), followed by ofatumumab (1000 mg) or rituximab (375 mg/m2) every 2 months for four additional doses. Therefore, subjects will receive a total of eight doses of anti-CD20 antibody over 9 months. Subjects will be evaluated for response after completion of the first four doses of therapy, after six doses of therapy, and after completion of study therapy. Subjects will be followed until the end of the designated follow-up period (total study duration of 200 weeks) or until they meet the withdrawal criteria.



16/9 2010 15:49 033562



Yes sir. Head to Head is the name of the game!



16/9 2010 16:26 srdjan 033563



All or nothing

sent from iPhone



16/9 2010 16:26 srdjan 033564



All or nothing

sent from iPhone



16/9 2010 16:31 gentogen 033565



Estimated Enrollment: 516
Study Start Date: November 2010
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)



16/9 2010 16:48 colombuss 033567



Det er dejligt GSK bruger de ressourcer, men det give lidt gaasehud naar man ser paa completion data, 9 aar, er lang tid at vente..



16/9 2010 16:50 033568



men dog kan man registrerer det på data November 2015.



16/9 2010 17:17 troldmanden 033569



Ja det er det ufede ved cancer studier. De er afsindig langvarige. Så som investor skal man være meeeeeget tålmodigt.

Bavarian Nordic som f.eks står foran deres første fase 3 forsøg med Prostvac kan man nok med fordel sælge ud kort efter den nyhed for så at afvente et nyt entry punkt


Så er det noget hurtiger i f.eks en række CNS studier hvor det ofte kun er 8 uger til måske 6 mdr studier.



17/9 2010 14:42 gentogen 033614



De får vel en milestone?(minus 50%)



18/9 2010 09:40 gentogen 433646



Eftersom det jo er gået stærkt på det sidste med nye ofatumumab studier, så kiggede jeg lige på listen over samarbejdspartnere vedrørende finansiering af projekterne. Jeg får det til, at Genmab/GSK alene finansierer 11 rekrutterende studier (plus diverse ikke afsluttede),G/G plus partner 10 studier og 3. part alene finansierer 9 studier. Det er dog tegn på temmelig stor interesse for ofa! Når man dertil lægger, at GSK mod tidligere vorventning satster på de autoimmune, så synes jeg egentlig, at det ser ret fornuftigt ud...



Recruiting Ofatumumab Cardiac Repolarization (QTc) Study in Fludarabine-Refractory Chronic Lymphocytic Leukemia Subjects Condition: Leukaemia, Lymphocytic, Chronic
Intervention: Biological: Ofatumumab
Sponsor: GlaxoSmithKline

2 Not yet recruiting PH2 Trial in Patietns With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) With a Combination of Bendamustine & Ofatumumab Condition: Chronic Lymphocytic Leukemia (CLL)
Intervention: Drug: ofatumumab + bendamustine
Sponsors: Nevada Cancer Institute; Cephalon; GlaxoSmithKline

3 Recruiting Clinical Protocol for the Treatment of Patients With Previously Untreated Chronic Lymphocytic Leukemia With a Combinaton of Bendamustine and Ofatumumab Condition: Chronic Lymphocytic Leukemia (CLL)
Intervention: Drug: ofatumumab + bendamustine
Sponsors: Nevada Cancer Institute; GlaxoSmithKline; Cephalon

4 Recruiting Ofatumumab and High-dose Methylprednisolone in Patients With Chronic Lymphocytic Leukemia (CLL) Condition: CLL
Intervention: Drug: Ofatumumab/HDMP
Sponsors: Chronic Lymphocytic Leukemia Research Consortium; GlaxoSmithKline

5 Not yet recruiting Ofatumumab Versus Rituximab Salvage Chemoimmunotherapy Followed by Autologous Stem Cell Transplant in Relapsed or Refractory Diffuse Large B Cell Lymphoma Condition: Lymphoma, Large-Cell, Diffuse
Interventions: Drug: RITUXIMAB + DHAP; Drug: RITUXIMAB + DVD; Drug: OFATUMUMAB + DVD; Drug: OFATUMUMAB + DHAP
Sponsor: GlaxoSmithKline

6 Not yet recruiting Single Agent Ofatumumab Vs. Single Agent Rituximab in Follicular Lymphoma Relapsed After Rituximab-Containing Therapy Condition: Lymphoma, Follicular
Interventions: Biological: Ofatumumab; Biological: Rituximab
Sponsor: GlaxoSmithKline

7 Recruiting Ofatumumab, Pentostatin, and Cyclophosphamide in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Conditions: Hematopoietic/Lymphoid Cancer; B-cell Chronic Lymphocytic Leukemia; Contiguous Stage II Small Lymphocytic Lymphoma; Noncontiguous Stage II Small Lymphocytic Lymphoma; Stage 0 Chronic Lymphocytic Leukemia; Stage I Chronic Lymphocytic Leukemia; Stage I Small Lymphocytic Lymphoma; Stage II Chronic Lymphocytic Leukemia; Stage III Chronic Lymphocytic Leukemia; Stage III Small Lymphocytic Lymphoma; Stage IV Chronic Lymphocytic Leukemia; Stage IV Small Lymphocytic Lymphoma
Interventions: Drug: pentostatin; Drug: cyclophosphamide; Biological: ofatumumab; Procedure: laboratory biomarker analysis; Other: flow cytometry; Genetic: protein expression analysis
Sponsor: Mayo Clinic

8 Recruiting A Phase II Study of Ofatumumab-Based Induction Chemoimmunotheraphy Followed by Consolidation Ofatumumab Immunotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Conditions: Small Lymphocytic Lymphoma; CLL (Chronic Lymphocytic Leukemia)
Interventions: Drug: Fludarabine Phosphate; Biological: Ofatumumab; Drug: Cyclophosphamide
Sponsors: National Heart, Lung, and Blood Institute (NHLBI); University of Virginia; GlasoSmithKline

9 Not yet recruiting Study of Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone (CHOP) With Ofatumumab in Patients With Richter's Syndrome Condition: Richter's Syndrome
Intervention: Drug: Ofatumumab
Sponsors: University of Oxford; GlaxoSmithKline; Oxford Radcliffe Hospitals NHS Trust; NCRI CLL Subgroup

10 Recruiting Ofatumumab and Bendamustine for Previously Treated Chronic Lymphocytic Leukemia (CLL) Conditions: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
Intervention: Drug: Ofatumumab and Bendamustine
Sponsors: Georgetown University; GlaxoSmithKline; Cephalon

11 Not yet recruiting Ofatumumab and Bendamustine Combination Therapy Compared With Bendamustine Monotherapy in Indolent B-cell Non-Hodgkin's Lymphoma (NHL) Unresponsive to Rituximab or a Rituximab-Containing Regimen Conditions: Lymphoma, Non-Hodgkin; Lymphoma, Follicular
Interventions: Drug: Ofatumumab and Bendamustine infusions (Arm A); Drug: Bendamustine infusion (Arm B)
Sponsor: GlaxoSmithKline

12 Recruiting Ofatumumab Maintenance Treatment vs No Further Treatment in Relapsed CLL Responding to Induction Therapy Condition: Leukaemia, Lymphocytic, Chronic
Interventions: Other: No Intervention; Biological: Ofatumumab
Sponsor: GlaxoSmithKline

13 Recruiting Phase II Study of Ofatumumab Plus ICE or DHAP Chemotherapy Regimen in Relapsed/ Refractory DLBCL Conditions: Diffuse Large B Cell Lymphoma (DLBCL); Non-Hodgkin's Lymphoma; Grade 3b Follicular Lymphoma; Transformed Follicular Lymphoma
Interventions: Drug: ofatumumab + DHAP; Drug: ofatumumab + ICE
Sponsor: GlaxoSmithKline

14 Recruiting Investigating Clinical Efficacy of Ofatumumab in Adult RA Patients Who Had an Inadequate Response to TNF-α Antagonist Therapy Conditions: Arthritis, Rheumatoid; Rheumatoid Arthritis
Interventions: Drug: Ofatumumab; Drug: Placebo
Sponsors: Genmab; GlaxoSmithKline

15 Recruiting Ofatumumab + Chlorambucil vs. Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia Condition: Chronic Lymphocytic Leukemia
Interventions: Drug: chlorambucil, tablets; Drug: ofatumumab (GSK1841157) infusion
Sponsor: GlaxoSmithKline

16 Recruiting A Phase II Trial of Ofatumumab in Subjects With Waldenstrom's Macroglobulinemia Condition: Waldenstrom's Macroglobulinemia
Intervention: Biological: Ofatumumab
Sponsor: GlaxoSmithKline

17 Recruiting Lenalidomide and Ofatumumab in Previously Treated Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (CLL/SLL) Conditions: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
Interventions: Drug: Lenalidomide; Drug: Ofatumumab
Sponsors: M.D. Anderson Cancer Center; GlaxoSmithKline; Celgene Corporation

18 Recruiting A Phase I/II, a Single Arm, Open-label Study of Ofatumumab (GSK1841157) in Patients With Previously Treated Chronic Lymphocytic Leukemia Condition: Leukaemia, Lymphocytic, Chronic
Intervention: Drug: ofatumumab 100 mg, 1000 mg / vial
Sponsor: GlaxoSmithKline

19 Recruiting Ofatumumab for Patients With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Conditions: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
Intervention: Drug: Ofatumumab
Sponsors: Sarah Cannon Research Institute; GlaxoSmithKline

20 Recruiting Trial of Intracycle Sequential Ofatumumab and Lenalidomide for the Treatment of Chronic Lymphocytic Leukemia in Patients Previously Exposed to Rituximab Condition: Chronic Lymphocytic Leukemia
Intervention: Drug: Ofatumumab, Lenalidomide
Sponsors: Medical University of South Carolina; GlaxoSmithKline; Celgene Corporation

21 Not yet recruiting Ofatumumab in Treating Patients With Previously Untreated Stage II, III, or IV Follicular Non-Hodgkin Lymphoma Condition: Lymphoma
Intervention: Biological: ofatumumab
Sponsors: Cancer and Leukemia Group B; National Cancer Institute (NCI)

22 Recruiting Study of Lenalidomide and Ofatumumab for the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma Condition: Non-Hodgkin's Lymphoma
Interventions: Drug: Lenalidomide; Drug: ofatumumab
Sponsors: University of Nebraska; Celgene Corporation; GlaxoSmithKline

23 Recruiting Patients With Relapsed or Refractory Diffuse Large B Cell Non Hodgkin Lymphomas Condition: Non-Hodgkin Lymphomas
Intervention: Drug: Ofatumumab
Sponsor: Oncology Specialists, S.C.

24 Recruiting Study to Evaluate the Efficacy and Safety of Treatment With Bendamustine in Combination With Ofatumumab in Previously Untreated Patients With Indolent B-Cell Non-Hodgkin's Lymphoma (NHL) Condition: Non-Hodgkin's Lymphoma (NHL)
Intervention: Drug: Bendamustine and Ofatumumab
Sponsor: Cephalon

25 Not yet recruiting Ofatumumab in Nodular Lymphocyte Predominant Hodgkin Lymphoma (NLPHL) Condition: Relapsed NLPHL
Intervention: Drug: Ofatumumab
Sponsor: University of Cologne

26 Recruiting Ofatumumab Added to Fludarabine-Cyclophosphamide vs. Fludarabine-Cyclophosphamide Combination in Relapsed Subjects With Chronic Lymphocytic Leukemia Condition: Chronic Lymphocytic Leukemia
Interventions: Drug: OFC Infusion; Drug: FC infusion
Sponsor: GlaxoSmithKline

27 Recruiting Study of Ofatumumab and ESHAP for the Treatment of Hodgkin's Lymphoma Condition: Hodgkin Disease
Intervention: Drug: Ofatumumab
Sponsor: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

28 Recruiting Ofatumumab and Bortezomib for Patients With Low-grade B-cell Non-hodgkin Lymphoma That Relapse After Rituximab Condition: Lymphoma, Non-Hodgkins
Intervention: Drug: Ofatumumab and Bortezomib
Sponsors: Brown University; Rhode Island Hospital; The Miriam Hospital; Memorial Hospital of Rhode Island

29 Recruiting Study of Mini-Chop Plus Ofatumumab To Treat Cd 20+ Diffuse Large B-Cell Lymphoma In Patients Aged Over 80 Years Condition: Non Previously Treated CD20+ Diffuse Large B-cell Lymphoma
Intervention: Drug: Ofatumumab
Sponsor: Groupe d'Etude des Lymphomes de l'Adulte - Recherche Clinique

30 Recruiting Study to Investigate CAL-101 in Combination With Bendamustine and CD20 mAb in Patients With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia Conditions: Indolent Non-Hodgkin's Lymphoma; Chronic Lymphocytic Leukemia
Interventions: Drug: CAL-101; Drug: Rituximab; Drug: Bendamustine; Drug: Ofatumumab
Sponsor: Calistoga Pharmaceuticals, Inc.




18/9 2010 10:11 colombuss 033647



Ja det begynder at ligne en ret fantastisk case. har du nogen sinde kikket paa lcp, vil gerne hoere dine views..



20/9 2010 08:49 gentogen 033689



Jeg er kun forelsket i Gen....
Bemærk forresten, at de eksternt finansierede i ofatumumab tæller cirka 500 patienter. Det er da noget.



20/9 2010 09:02 colombuss 033690



Så har vi det på samme måde

Det må koste kassen for partnerne, og viser potentialet..

Jeg syntes dog alk og Lun, også er smækre, men de spiller bare lidt for kostbare....endnu



20/9 2010 09:34 MaxProfit 033691



Gentogen.

At være forelsket i en aktie=gift med en aktie=stuck i en aktie er det man skal undgå som trader.En ægte trader er inde for den mulige gevinst der er og ud igen!Ingen aktier er altid spændende.....



20/9 2010 10:07 colombuss 033692



Jo den her er Max, potentialet er så stort, at man godt kan blive gift godt med den...Tjeck lige min tråd Gentanker....ikke giftetanker..dog



20/9 2010 12:55 gentogen 133701



Opdatering af foråret Zalu studie.

Nyt:

Estimated Study Completion Date: December 2010



TRÅDOVERSIGT