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Old Fri Jun 10, 2016, 09:07 PM
bailie bailie is offline
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Join Date: Dec 2013
Location: McMinnville,OR
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Another study

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Combination Of Vidaza And Donor Lymphocyte Infusions Shows Promise In Relapsed MDS Patients (ASH 2011)

By Jessica Langholtz
Published: Dec 19, 2011 3:14 pm

Combination Of Vidaza And Donor Lymphocyte Infusions Shows Promise In Relapsed MDS Patients (ASH 2011)
A treatment combining Vidaza and infusions of donor white blood cells may be effective in myelodysplastic syndromes patients who relapse after stem cell transplantation, according to results of a small Phase 2 clinical trial conducted in Germany.

In addition, the study authors found that patients who had a complete response to the combination therapy experienced significantly longer overall survival than those who did not.

Dr. Thomas Schroeder of Heinrich Heine University in Duesseldorf, Germany, presented the clinical trial findings at the 2011 American Society of Hematology (ASH) conference in San Diego last week.

In patients with myelodysplastic syndromes (MDS), relapse after stem cell transplantation is associated with a poor disease prognosis.

Previous research has shown that MDS and acute myeloid leukemia (AML) patients who relapse after transplant often respond to treatment with Vidaza (azacitidine).

Some retrospective studies also have shown encouraging results for combination therapy involving Vidaza and donor lymphocyte infusion.

Donor lymphocyte infusion, often abbreviated DLI, is a procedure in which a stem cell transplant patient receives an infusion of donated white blood cells. The cells usually are donated by the original stem cell transplant donor.

In the present study, German researchers evaluated the efficacy and safety of Vidaza and donor lymphocyte infusion in MDS and AML patients. The combination therapy was used as a salvage therapy after the patients relapsed following transplantation.

Of the 30 patients included in the study, 92 percent had AML and 8 percent had MDS. At a median of 160 days after transplant, all patients experienced relapse.

Patients received 100 mg/m2 of Vidaza daily on days 1 through 5 of a 28-day treatment cycle followed by donor lymphocyte infusion after every second treatment cycle.

Patients received a median of three treatment courses of Vidaza, and 73 percent of patients received a donor lymphocyte infusion, with a median of one infusion.

Overall, 47 percent of the patients responded to the treatment, with 23 percent achieving a complete response and 7 percent achieving a partial response. Of the patients who achieved a complete response, 71 percent maintained long-term complete response (median of 605 days) without any additional therapies.

At a median follow-up period of 645 days, 17 percent of the patients are still alive. The median overall survival time is 117 days. Patients who achieved a complete response to the trial regimen had significantly longer survival times than those who did not (not yet reached versus 83 days).

The primary causes of death were progressive disease (40 percent), infection (13 percent), and bleeding (7 percent). Five patients underwent a second stem cell transplant, but all have died.

Graft-versus-host disease, a common transplant-related complication in which the donor immune cells recognize the recipient’s cells as foreign and attack them, occurred in 42 percent of patients (37 percent acute, 5 percent chronic).

All patients in the trial experienced serious to life-threatening low blood cell counts, but only 37 percent were considered to be treatment-related. Other common side effects included infection and bleeding.

For more information, please see abstract 656 at the ASH 2011 meeting website.
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age 70, dx RAEB-2 on 11-26-2013 w/11% blasts. 8 cycles Vidaza 3w/Revlimid. SCT 8/15/2014, relapsed@Day+210 (AML). Now(SCT-Day+1005). Prepping w/ 10 days Dacogen for DLI on 6/9/2017.

Last edited by bailie : Fri Jun 10, 2016 at 09:21 PM.
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