Clinical Trials Azacitidine + PD 1 Inhibitor

[steve_ky]

Does anyone have experience with these recent phase #2 trials?

https://clinicaltrials.gov/ct2/show/...phase=1&rank=1

https://clinicaltrials.gov/ct2/show/NCT02530463

https://clinicaltrials.gov/ct2/show/NCT02599649

Thanks

[bailie]

Steve, I like the idea that they are constantly trying to combine 5-azacitidine with other various new drugs. For me it was Vidaza (azacitidine) and Revlimid (lenalidomide) that had positive effects. I also like that they are seemingly making progress with oral Vidaza.

Do you have a chance to participate in one of these trials?

[nshan]

Yes, my husband just recently tried ipilimumab(2rounds) and aza (1 round... After relapsing after the 13th round of only aza that had in remission for 7months), at MD Anderson Houston,unfortunately not successful and he currently is in induction chemo right now for a allogenic transplant. He had low risk mds since November 2014 and now has 55% blasts and full amp.

[nshan]

I meant he now has full aml, not amp

[bailie]

nshan, thank you for the information. What was the nature of the relapse? Were there genetic mutations along with the blasts? What was the goal of continuing with the Vidaza for so long and not going to transplant while in remission? I ask because I have had a similar route. I was on Vidaza for eight cycles and as soon as I got close to remission I had a stem cell transplant. About seven months after the transplant I relapsed with AML and 30 percent blasts. I was immediately put back on Vidaza and after 12 cycles I am doing well. Naturally, we don't know how long my remission will last.

[steve_ky]

Bailie > My father has been offered two treatment options. A trial of oral Vidaza + Opdivo (Nivolumab) from MD Anderson. Or the mini stem cell transplant. Transplant scares him so he's opted for the trial.

[steve_ky]

nshan > Sorry about his progression to AML. Were there any harsh side effects with the clinical trial? Does your husband plan to transplant at MD Anderson?

Our story...

My father was treated at MD Anderson in March - April this year. He originally came down for the same clinical trial as your husband but didn't qualify due to an acute complication. Instead, he received a round of low dose ara-c + clofarabine as in-patient. It reduced his blasts from 9% to 3% but he still couldn't make platelets & red blood. A second round was prescribed with a recommendation to be hospitalized.

Two weeks after the first round, my parents make a mistake and decided to return home. They arranged to take the 2nd round of chemo at remotely in an outpatient setting. This time he suffered from a severe infection in the mouth & throat. Couldn't eat for days and running high body temperature.

He was hospitalized and suffered a heart issue 2 days later. Luckily we were in the room with him when the event occurred. Help arrived quickly and the staff revived him.

Two weeks of ICU and now we are home. He's 30lbs lighter and still transfusion dependent. We don't know the current blast count but a BMB is scheduled for later this week.

[nshan]

Bailie-I don't really know why they didn't try to do a stem cell transplant when he was in remission from the aza, but he had only 1 %blasts until the aza quit working and then within a matter of weeks it went from 14 to 27 to 55%blasts, and not really sure what chromosomal abnormalities are showing now (originally he had the 5q neg and 12p? Before the aza he had tried revlimid for about three months and it almost killed him (constant infections requiring hospitalizations), so that wasn't an option anymore. The dr was trying to avoid going the induction route when the 14% blasts showed up and put him on just ipilimumab one round, and when the next BMW showed 27% shows up he tried adding in the aza per the protocol in the study, but after another aza round and another ipilimumab round and blasts at 55% he said forget the study we have to go for induction and allogenic transplant. He's in day 7 of the induction and doing ok so far. Holding out hope he goes into remission so he can have the transplant.

Steve, no bad side effects from the ipilimumab except for rash on upper body.

[nshan]

And yes, he is going to have the transplant at MD ANderson, I think it's the only place in Texas my insurance will let it be done anyway, so I'm glad he.s already a patient there.