Good results with Campath

[Birgitta-A]

Hi all,
Here is a study where 77 % of selected patients improved after treatment with Campath.
http://www.ncbi.nlm.nih.gov/pubmed/21041705
Kind regards
Birgitta-A

[cheri]

Hi Birgitta
When do you think it will be available? Worth trying to get into a clinical trial?
Sure seems so at 77% success rate!
I am not a candidate for transplant...
Thanks

[Greg H]

The trial that this abstract references is the one I will be participating in a week from today. The Principal Investigator sent me a copy of the full article; here are my notes:

Notes on the NIH Campath Study JCO Article


Overall, 68% hematologic improvement (HI) or complete response (CR)
Among INT-1, 77% HI or CR
Among INT-2, 57% HI or CR
81% with HLA-DR15+ responded vs 40% of HLA-DR15-

Among responders:
11% CR in 3 months
18% CR in 6 months
56% CR in 12 months
Median time to any response: 3 months

78% of RBC anemics in the trial were transfusion independent after one year.

Of 21 who responded, 71% are still responding.
6 relapsed and four of those responded to CsA

Temporary Impact on Blood Counts -
35% (11) Anemia
10% (3) neutropenia
39% (12) Thrombocytopenia
All resolved within three months.

75% (24) had infusion reactions -- rigors, malaise.

40% (13) Patients were hospitalized for infections (but the principle investigator in an email exchange told me these were largely folks who were neutropenic before the trial and, as a result, had already been hospitalized for infection before Campath. The post-trial hospitalization was only "possibly" related to Campth. Only one of the 32 patients had an infection "probably" related to the trial -- a reactivation of a prior case of shingles.

Epstein-Barr Virus was reactivated in 48% of those who were positive for it and CMV was reactivated in 23% of those positive for it, but no one got sick from either and both virus populations returned to normal in a median of a couple of weeks.

Those are the highlights. I'd attach a copy of the article, but I'm not sure I can do that given copyright restrictions. If you want a copy email me and I'll send it along. I'm sure that doesn't violate copyright.

Take Care!

Greg

[Greg H]

Originally Posted by cheri

Hi Birgitta
When do you think it will be available? Worth trying to get into a clinical trial?

Hey Cheri!

I am aware of two Campath trials for MDS that are currently underway:

This one at the National Institutes of Health, and

This one at MD Anderson in Houston.

Each has its own criteria for including patients, and they are trying different dosages and protocols for administering the drug.

Campath is FDA approved for the treatment of some CLL patients but not yet for MDS. That means your doc could get it, but getting insurance to cover it might be a problem.

Take Care!

Greg

[Birgitta-A]

Hi Cheri,
If you look at the links in Greg's post you will see that the trials are for patients with low risk MDS. You know I have seen still higher response rates (83 %) in patients treated with Vidaza and histone deacetylase inhibitors.
Kind regards
Birgitta-A

[cheri]

Hi All-
Thanks for your input...
Brigitta, what is your opinion on Vidaza overall? I am post cycle 3 and concerned about how many transfusions I am getting; platelets and now red blood cells. Yesterday's counts: WBC .09, Platelets 21; Hgb 7.9...literally getting transfused at the moment!
I had hoped to see my numbers on the upswing by this point in the process. I do realize Vidaza takes 4-6 months, and had planned to go the full 6 months into Jan before the next bmb...should I do it after 4? Do I really want to know?

Regarding CampathvClinical Trial, they say ineligible if my MDS is secondary to my AML treatment, but then they thought my AML may have started with MDS And how do I know if I have less than 6 months?

I am just wondering what would be the next step if I don't see progress with Vidaza.....

There isn't anyone I can speak with locally about this....I am grateful to have found this site and am telling the infusion dept about it!

[Birgitta-A]

Hi cheri,
You know as far as I understand Vidaza is supposed to be the first line drug for MDS patients. There is no need for a BMB now. Vidaza has to work on dividing cells - that's why the drug works so slowly.

Your WBCs are very low . When they are so low all kinds of bacteria, virus and fungi that we all have in our bodies can cause infections. I can't really understand why the doctors in the US don't treat their patients with Neupogen or a similar drug that increases the WBCs. In Sweden our doctors think it is OK to give Neupogen (I have had the drug more than 3 years now) and research has not showed increased risk for AML.

Be careful and avoid everything that can cause infections. Control your temperature morning and evening and if it is high don't take any drugs but go to the hospital for examination.

Many patients that don't respond when they get Vidaza try Dacogen and get a good response.
Kind regards
Birgitta-A

[Greg H]

Originally Posted by cheri

Regarding CampathvClinical Trial, they say ineligible if my MDS is secondary to my AML treatment, but then they thought my AML may have started with MDS. And how do I know if I have less than 6 months?

Hey Cheri!

If you are looking at the NIH trial criteria, I guess the question would be whether your MDS is actual secondary MDS (i.e., probably caused by your induction chemo) or if you are thought to have MDS now because your blast count has decreased enough that your disease has just fallen out of the AML category.

Do you know your IPSS score? Generally, immunosuppressant therapy (with ATG or Campath) has been more successful with lower risk patients.

Take care!

Greg