randomized phase ii
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ESMO Open ◽  
2022 ◽  
Vol 7 (1) ◽  
pp. 100314
Author(s):  
M.M. Javle ◽  
D.-Y. Oh ◽  
M. Ikeda ◽  
W.-P. Yong ◽  
K. Hsu ◽  
...  

2021 ◽  
Vol 148 (12) ◽  
pp. 68-77
Author(s):  
Pham Thi Van Anh ◽  
Nguyen Phuong Thanh ◽  
Dau Thuy Duong ◽  
Nguyen Thi Thuy ◽  
Dang Thi Ngoc Mai ◽  
...  

A double-blind, randomized, phase II clinical trial was conducted within a 14-week follow-up including 2 weeks of the non-drug run-in period, 8 weeks of medication, and 4 weeks of follow-up after discontinuation. The objective of the study was to evaluate the efficacy and safety of Trang Phuc Linh Plus in irritable diarrhea syndrome patients. Group I took Trang Phuc Linh Plus 3 tablets/time x 2 times/day for 8 weeks; Group II took placebo 3 tablets/time x 2 times/day for 8 weeks. Patients will be re-examined, tested, and evaluated over the phone for symptom recurrence and adverse events (AEs). This study showed that the Trang Phuc Linh Plus tablets tended to improve symptoms in patients suffering from irritable bowel syndrome with diarrhea, suggesting its safety and tolerability.


2021 ◽  
Vol 131 (24) ◽  
Author(s):  
Mark Yarchoan ◽  
Leslie Cope ◽  
Amanda N. Ruggieri ◽  
Robert A. Anders ◽  
Anne M. Noonan ◽  
...  

Author(s):  
Vincent T Ho ◽  
Haesook T Kim ◽  
Jennifer Brock ◽  
Ilene Galinsky ◽  
Heather Daley ◽  
...  

Vaccination using irradiated, adenovirus transduced autologous myeloblasts to secrete GM-CSF (GVAX) early after allogeneic hematopoietic stem cell transplantation (HSCT) can induce potent immune responses. We conducted a randomized phase II trial of GVAX after HSCT for MDS-EB or relapsed/refractory AML. Myeloblasts were harvested before HSCT to generate the vaccine. Randomization to GVAX vs. placebo (1:1) was stratified by disease, transplant center, and conditioning. GVHD prophylaxis included tacrolimus and methotrexate. GVAX or placebo started between day +30-45 if there was engraftment and no GVHD. Vaccines were administered SC/ID weekly x 3, then q2 wks x 3. Tacrolimus taper began after vaccine completion. 123 patients enrolled, 92 proceeded to HSCT, and 57 (GVAX 30, Placebo 27) received at least 1 vaccination. No CTC grade ≥ 3 vaccine related adverse events were reported, but injection site reactions were more common after GVAX (10 vs. 1, p=0.006). With a median follow up of 39 months (range, 9-89), 18-month PFS, OS and relapse incidence were 53% vs 55% (p=0.79), 63% vs. 59% (p= 0.86), and 30% vs. 37% (p=0.51) for GVAX and placebo, respectively. NRM at 18 months was 17% vs. 7.7% (p=0.18), Grade II-IV aGVHD at 12 months 34% vs. 12% (p=0.13), and cGVHD at 3 years 49% vs. 57% for GVAX and placebo, respectively, p=0.26. Reconstitution of T, B, and NK cells were not decreased or enhanced by GVAX. There were no differences in serum MICA/B or other immune biomarkers between GVAX and placebo. GVAX does not improve survival after HSCT for MDS/AML. (Clinicaltrials.gov identifier: NCT01773395)


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