GPS Compared With BAT in AML CR2/CR2p
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|ClinicalTrials.gov Identifier: NCT04229979|
Recruitment Status : Unknown
Verified February 2020 by Sellas Life Sciences Group.
Recruitment status was: Recruiting
First Posted : January 18, 2020
Last Update Posted : February 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Biological: Galinpepimut-S Drug: Best Available Therapy||Phase 3|
This is an open-label, multicenter, randomized, parallel groups study of GPS vs. best available treatment (BAT) in patients with AML in second complete remission (CR2) or in second complete remission with incomplete platelet recovery (CRp2). All patients will have bone marrow samples stained for WT1 via IHC by central pathology review. The primary goal of the study will be to demonstrate an advantage for GPS in overall survival in these patient populations. The study will enroll approximately 116 patients and will be conducted at up to 50 investigational sites. Patients will be randomized 1:1 to GPS or BAT stratified by whether they are in CR2 or CRp2.
Patients on the BAT arm may be treated with 1. observation (whereby palliative management with hydroxyurea is allowed), 2. a hypomethylating agent (decitabine or azacitidine), 3. Venetoclax monotherapy or 4. low-dose ara-C monotherapy. Patients whose remission is maintained with other agents (e.g. FLT-3 or IDH inhibitors) will not be eligible.
Patients on the GPS arm will receive 70 μg of sargramostim (GM- CSF) on Day -2 and Day 1 before each injection of GPS. The first two administrations of GM-CSF will take place at the same anatomical site as the planned administration of GPS within each treatment cycle. GPS will be administered as an immunization induction every 2 weeks for 6 administrations (Weeks 0 - 10); this will be followed by a 4-week period of no treatment. Treatment will then resume for 6 administrations as an initial booster phase every 4 weeks (Weeks 14 - 34) which will again be followed by a period of no treatment lasting 6 weeks. GPS will be resumed after this period as a second booster phase and will be administered every 6 weeks for 3 administrations (Weeks 40 - 52). Following each administration of GM-CSF or GPS, patients will remain in the clinic for approximately 30 minutes for observation. An End of Treatment visit will be conducted 30 days following the last dose of GPS. Patients will then enter the long-term follow-up portion of the trial where they will be followed for recurrence of leukemia and overall survival.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||116 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Open-label, multicenter, randomized, parallel group study|
|Masking:||None (Open Label)|
|Official Title:||Randomized, Open-Label Study of the Efficacy and Safety of Galinpepimut-S Maintenance Therapy Compared to Best Available Therapy in Acute Myeloid Leukemia Patients Who Have Achieved Complete Remission After Second-Line Salvage Therapy|
|Estimated Study Start Date :||February 2020|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||April 2022|
A maximum of 15 total injections will be administered as follows:
Mixture of four peptides supplied at a concentration of 0.2 mg/vial
Other Name: SLS-001
Active Comparator: Best Available Therapy
Four options (per treating investigator's choice):
Drug: Best Available Therapy
Investigator's choice of 4 options:
Other Name: Investigator's choice: observation OR [decitabine or azacitidine] OR venetoclax OR low-dose cytarabine)
- Overall survival [ Time Frame: Up to 52 weeks ]The primary objective of the trial is to compare the efficacy of GPS to Investigator's choice of BAT on OS in subjects with AML who are in CR2/CR2p.
- LFS [ Time Frame: at 6, 9, and 12 months ]Leukemia Free Survival
- OS rate (%) [ Time Frame: At 6, 9 and 12 months ]Percentage of patients surviving
- LFS rate (%) [ Time Frame: At 6, 9, and 12 months ]Percentage of patients surviving and being free of leukemic relapse
- MRD [ Time Frame: Up to 52 weeks ]Minimum residual disease by multigene assay
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04229979
|Contact: Gurpeet Brar, MD, MBAfirstname.lastname@example.org|
|Contact: Mireille Cantarini, MBChB,MRCPemail@example.com|
|United States, Arizona|
|HonorHealth Virginia G. Piper Cancer Care Network||Recruiting|
|Scottsdale, Arizona, United States, 85258|
|Contact: Jeffrey R Schriber, MD 480-323-1587 firstname.lastname@example.org|
|United States, Texas|
|University of Texas - MD Anderson Cancer Center||Not yet recruiting|
|Houston, Texas, United States, 77030|
|Contact: Hagop M Kantarjian, MD 713-792-7026 email@example.com|
|Contact: Tapan M Kadia, MD 713-792-7305 firstname.lastname@example.org|
|Study Director:||Nicholas J Sarlis, MD, PhD||Sellas Life Sciences Group|