Study of Ixazomib to Prevent Recurrent or Late Acute and Chronic Graft-versus-Host Disease 1-year After Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Hematologic Malignancies
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|ClinicalTrials.gov Identifier: NCT03082677|
Recruitment Status : Recruiting
First Posted : March 17, 2017
Last Update Posted : February 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Myeloid Hematologic Malignancy Lymphoid Hematologic Malignancy||Drug: Ixazomib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a single arm phase 2 study to evaluate a post-transplant proteasome inhibitor, ixazomib, as prophylaxis against recurrent or late acute and chronic GVHD. Ixazomib will be initiated within days 100 to 150 post-transplant in patient's ≥ 18 years-old with either myeloid or lymphoid hematologic malignancy treated with a RI or NMA HSCT and will have received calcineurin inhibitor based drug (tacrolimus or cyclosporin) and methotrexate as part of their initial GVHD prophylaxis.|
|Masking:||None (Open Label)|
|Official Title:||Open Label Phase II Study of Ixazomib for the Prevention of Recurrent or Late Acute and Chronic Graft-versus-Host Disease at 1-year After Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Hematologic Malignancies|
|Actual Study Start Date :||March 10, 2017|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2020|
Ixazomib beginning between day +100 to +150 at a dose of 4 mg orally once per week (3 weeks on/ 1 week off). The patients will continue on this same dose until taper off from immunosuppressants or 1 year post-HSCT is reached (whichever occurs first) or until the patient develops GVHD or malignant disease relapse/progression occurs.
Ixazomib beginning between day +100 to +150 at a dose of 4 mg orally once per week (3 weeks on/ 1 week off).
Other Name: MLN 9708
- number of patients absence of grade II-IV aGVHD or chronic GVHD diagnostic features [ Time Frame: 1 year ]Therapeutic response will be determined by the absence of grade II-IV aGVHD or chronic GVHD diagnostic features.
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): NCT03082677
|Contact: Doris M Ponce, MDfirstname.lastname@example.org|
|Contact: Craig Sauter, MD||212-639-3460|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Doris M Ponce, MD 212-639-4838|
|Contact: Craig Sauter, MD 212-639-3460|
|Principal Investigator: Doris M Ponce, MD|
|Principal Investigator:||Doris M Ponce, MD||Memorial Sloan Kettering Cancer Center|