Hvis nogen følger David Arensons blog (CLL Patient) så roser han Revlimid til skyerne men skriver om Arzerra:
"I also have been on monthly doses of Arzerra during some of this period (ending two months ago). It is possible that the anti-CD20 monoclonal antibody also contributed to my progress, although it appeared to have little effect on the disease and we have now suspended its use. The fact that I was refractory to a similar drug, Rituxan, may explain why Arzerra (ofatumumab) appeared to be providing me with little benefit.
Altså han mener at fremgangen skyldes Revlimid, men hvordan kan han egentlig vide det, når han det seneste års tid har været gennem så mange forskellige medikamenter?
link til blog: (link)
"I also have been on monthly doses of Arzerra during some of this period (ending two months ago). It is possible that the anti-CD20 monoclonal antibody also contributed to my progress, although it appeared to have little effect on the disease and we have now suspended its use. The fact that I was refractory to a similar drug, Rituxan, may explain why Arzerra (ofatumumab) appeared to be providing me with little benefit.
Altså han mener at fremgangen skyldes Revlimid, men hvordan kan han egentlig vide det, når han det seneste års tid har været gennem så mange forskellige medikamenter?
link til blog: (link)
Det indsatte link til bloggen virker ikke helt for mig, så jeg fandt det via google.
Linket er: http://clldiary.blogspot.com/
Linket er: http://clldiary.blogspot.com/
18/11 2010 16:00 gentogen 0
36185 Det er der helt styr på:
Fra Genmabs hjemmeside:
Thus far 26 of the 40 planned patients have been accrued to this study and we present an analysis of response and toxicity for the first 16 patients that have been on study for at least 3 months. The median age of the patients is 62 yrs (45-82). Eight patients (50%) had Rai stage III-IV disease. The median Beta-2M level was 4.4 mg/dL (2-6.1). The median number of prior treatments was 2 (1-8). Four patients (25%) were refractory to fludarabine and all pts had received prior rituximab. Nine patients (56%) had unmutated IGHV genes, 5 patients (31%) had chromosome 17p deletion and 3 patients (19%) had 11q deletion as detected by FISH analysis. Responses were evaluated according to the 2008 IWCLL criteria: 10 of the 16 evaluable patients achieved a response [2 CR (13%), 8 PR (50%)] for an ORR of 63%. Four patients with stable disease are continuing on treatment. One patient discontinued therapy and did not return for response assessment and another patient progressed. All patients are alive.
The most common grade 3-4 treatment related adverse events observed were: neutropenia (8 pts, 50%) and anemia (2 pts, 13%). One patient (6%) developed grade 2 superficial vein thrombosis. Lenalidomide-associated tumor flare reaction was limited to grade 1 in 2 patients (13%) while a grade 3 infusion reaction was observed in 1 patient (6%) during the first ofatumumab administration. Three grade 3 infectious episodes occurred: 2 cases of pneumonia and 1 case of parotiditis. None of the patients received routine antibiotic prophylaxis. The median daily dose of lenalidomide tolerated was 5 mg/day (2.5-10 mg).
In conclusion, our initial analysis indicates that the combination of ofatumumab and lenalidomide is therapeutically active in patients with relapsed CLL. This treatment is well tolerated. Neutropenia is the most common toxicity observed. Enrollment is ongoing, and updated results will be provided.
Fra Genmabs hjemmeside:
Thus far 26 of the 40 planned patients have been accrued to this study and we present an analysis of response and toxicity for the first 16 patients that have been on study for at least 3 months. The median age of the patients is 62 yrs (45-82). Eight patients (50%) had Rai stage III-IV disease. The median Beta-2M level was 4.4 mg/dL (2-6.1). The median number of prior treatments was 2 (1-8). Four patients (25%) were refractory to fludarabine and all pts had received prior rituximab. Nine patients (56%) had unmutated IGHV genes, 5 patients (31%) had chromosome 17p deletion and 3 patients (19%) had 11q deletion as detected by FISH analysis. Responses were evaluated according to the 2008 IWCLL criteria: 10 of the 16 evaluable patients achieved a response [2 CR (13%), 8 PR (50%)] for an ORR of 63%. Four patients with stable disease are continuing on treatment. One patient discontinued therapy and did not return for response assessment and another patient progressed. All patients are alive.
The most common grade 3-4 treatment related adverse events observed were: neutropenia (8 pts, 50%) and anemia (2 pts, 13%). One patient (6%) developed grade 2 superficial vein thrombosis. Lenalidomide-associated tumor flare reaction was limited to grade 1 in 2 patients (13%) while a grade 3 infusion reaction was observed in 1 patient (6%) during the first ofatumumab administration. Three grade 3 infectious episodes occurred: 2 cases of pneumonia and 1 case of parotiditis. None of the patients received routine antibiotic prophylaxis. The median daily dose of lenalidomide tolerated was 5 mg/day (2.5-10 mg).
In conclusion, our initial analysis indicates that the combination of ofatumumab and lenalidomide is therapeutically active in patients with relapsed CLL. This treatment is well tolerated. Neutropenia is the most common toxicity observed. Enrollment is ongoing, and updated results will be provided.
18/11 2010 19:37 gentogen 036199 NYT OFA studie igen igen!
Ofatumumab for High-Risk Chronic Lymphocytic Leukemia (CLL)
This study is not yet open for participant recruitment.
Verified by M.D. Anderson Cancer Center, November 2010
First Received: November 12, 2010 Last Updated: November 17, 2010 History of Changes
Sponsor: M.D. Anderson Cancer Center
Collaborator: GlaxoSmithKline
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01243190
Ofatumumab for High-Risk Chronic Lymphocytic Leukemia (CLL)
This study is not yet open for participant recruitment.
Verified by M.D. Anderson Cancer Center, November 2010
First Received: November 12, 2010 Last Updated: November 17, 2010 History of Changes
Sponsor: M.D. Anderson Cancer Center
Collaborator: GlaxoSmithKline
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01243190
18/11 2010 20:31 leoloo 036200 jo.. det er jeg såmænd helt med på. Det der undrer/skuffer mig er at Arenson, formentlig i samråd med hans læge, vælger at droppe Arzerra behandlingen i deres formodning om at det er Revlimid der virker bedst.
Det var ellers senest nu, her i 5. kvartal fra lanceringen, at jeg havde forventet blogs eller anden form for tilbagemeldinger -fra patienter, pårørende eller læger - der roser arzerra til skyerne...
Ikke at det nødvendigvis ændrer noget grundlæggende omkring vores forventninger til arzerras fortræffeligheder som sådan, men det var alligevel en forventning jeg havde..
Er der nogen der har tilgængeligt feed-back fra 2010 der giver udtryk for det modsatte af Arensons konklusion?
Nok er CLL Refrac patienterne ikke de mest bloggende, både når man tager deres forløb, tilstand og alder i betragtning, men jeg undrer mig alligevel.
vh
Det var ellers senest nu, her i 5. kvartal fra lanceringen, at jeg havde forventet blogs eller anden form for tilbagemeldinger -fra patienter, pårørende eller læger - der roser arzerra til skyerne...
Ikke at det nødvendigvis ændrer noget grundlæggende omkring vores forventninger til arzerras fortræffeligheder som sådan, men det var alligevel en forventning jeg havde..
Er der nogen der har tilgængeligt feed-back fra 2010 der giver udtryk for det modsatte af Arensons konklusion?
Nok er CLL Refrac patienterne ikke de mest bloggende, både når man tager deres forløb, tilstand og alder i betragtning, men jeg undrer mig alligevel.
vh
19/11 2010 00:02 gentogen 036205 Nu har jeg ikke læst op på hele blog forhistorien igen, men jeg mener umiddelbart, at du lægger for meget i hans formuleringer. Så vidt jeg husker har han fået Arzerra i så mange måneder, at det er almindelig standard praksis at stoppe. Hans udlægning (eller lægens), at det ikke var Arzerra, der hjalp ham, tror jeg ikke rigtig, at nogen kan afgøre rigtigheden af. I tidligere indlæg har han skrevet ret positivt om Arzerra.Nu er jeg ikke nok inde i det medicinske til helt at gennemskue indholdet i mit eget ovenstående indlæg fra kommende ASH fremlæggelse, men det fremgår jo, at der er temmelig gode resultater ved at kombinere Arzerra og LEN. Og det er vel trods alt bedre dokumentation end mere eller mindre tilfældige blog indlæg (med al respekt). I øvrigt fremgår det vel, at de reelt ikke ved det: "It is possible that the anti-CD20 monoclonal antibody also contributed to my progress". Behandlinger af den art er tilsyneladende rene eksperimenter.
19/11 2010 16:28 gentogen 036228 Det fortsætter med nye studier i OFA!
GIMEMA CLL0809 Study (BendOfa)
This study is not yet open for participant recruitment.
Verified by Gruppo Italiano Malattie EMatologiche dell'Adulto, November 2010
First Received: November 18, 2010 No Changes Posted
Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Information provided by: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT01244451
Purpose
In the last ten years there have been significant developments in CLL treatment. The advent of fludarabine, rituximab and the association of chemo-immunotherapy have substantially increased overall response rate, CR rate, time to progression and may also have an impact on overall survival.
Even though, CLL remains incurable and all patients eventually relapse and progressively become resistant to treatment. The development of an effective therapy that is not cross-resistant with the ones currently available as front-line treatment, is one of the clinical unmet needs within CLL.
BendOfa is a non comparative phase II trial designed to determine the therapeutic benefit of bendamustine given together to ofatumumab in relapsed or resistant patients with CLL.
Bendamustine is approved by FDA for CLL treatment, it is an hybrid drug with alkylating agents and purine analogue properties that may lack of cross resistance with fludarabine. It was utilized in CLL as a single agent and its association with rituximab is currently under clinical investigation.
Ofatumumab is a new fully human anti-CD20 monoclonal antibody with high in vitro efficacy on CD20 low-expressing CLL cells. An early report showed that ofatumumab in single therapy is effective in highly pre-treated refractory CLL patients.
Both drugs were generally well tolerated without unexpected untoward toxicity. On the basis of these data, bendamustine and ofatumumab could be a new effective and well tolerated combination for patients with relapsed and refractory CLL.
GIMEMA CLL0809 Study (BendOfa)
This study is not yet open for participant recruitment.
Verified by Gruppo Italiano Malattie EMatologiche dell'Adulto, November 2010
First Received: November 18, 2010 No Changes Posted
Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Information provided by: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT01244451
Purpose
In the last ten years there have been significant developments in CLL treatment. The advent of fludarabine, rituximab and the association of chemo-immunotherapy have substantially increased overall response rate, CR rate, time to progression and may also have an impact on overall survival.
Even though, CLL remains incurable and all patients eventually relapse and progressively become resistant to treatment. The development of an effective therapy that is not cross-resistant with the ones currently available as front-line treatment, is one of the clinical unmet needs within CLL.
BendOfa is a non comparative phase II trial designed to determine the therapeutic benefit of bendamustine given together to ofatumumab in relapsed or resistant patients with CLL.
Bendamustine is approved by FDA for CLL treatment, it is an hybrid drug with alkylating agents and purine analogue properties that may lack of cross resistance with fludarabine. It was utilized in CLL as a single agent and its association with rituximab is currently under clinical investigation.
Ofatumumab is a new fully human anti-CD20 monoclonal antibody with high in vitro efficacy on CD20 low-expressing CLL cells. An early report showed that ofatumumab in single therapy is effective in highly pre-treated refractory CLL patients.
Both drugs were generally well tolerated without unexpected untoward toxicity. On the basis of these data, bendamustine and ofatumumab could be a new effective and well tolerated combination for patients with relapsed and refractory CLL.
