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To evalute the safety and efficacy in reducing Cytokine Release Syndrome after hematopoietic stem cell transplantation by introducing immunosuppression earlier in the transplant process
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tacrolimus + MMF + Post-Transplant Cyclophosphamide | Experimental | Cyclophosphamide 50mg/kg/d Days +3 and +4 after transplant Tacrolimus Day -1 to Day +90 or Day +180 after transplant MMF 15mg/kg PO TID Day 0 to Day +35 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus | Drug | Begins Day -1 and continues to Day +90 or Day +180 after transplant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy in preventing CRS post transplant | Evaluate the incidence of CRS during the first 5 days following stem cell transplant by recording signs and symptoms based on CTCAE v5.0. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of CRS after stem cell transplant | Record incidence of CRS by grading signs and symptoms using the CTCAE v5.0, the day of onset of CRS, the duration of CRS, and admissions to the hospital for these events | 30 days |
| Safety of administering early immunosuppression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melh Solh, MD | Contact | 404-255-1930 | msolh@bmtga.com | |
| Caitlin Guzowski, MBA, MHA, CCRC | Contact | 404-851-8523 | caitlin.guzowski@northside.com |
| Name | Affiliation | Role |
|---|---|---|
| Melhem Solh, MD | The Blood and Marrow Transplant Group of Georgia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northside Hospital | Recruiting | Atlanta | Georgia | 30342 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30953027 | Result | Solh MM, Dickhaus E, Solomon SR, Morris LE, Zhang X, Holland HK, Bashey A. Fevers post infusion of T-cell replete hla mismatched haploidentical hematopoietic stem cells with post-transplant cyclophosphamide: risk factors and impact on transplant outcomes. Bone Marrow Transplant. 2019 Nov;54(11):1756-1763. doi: 10.1038/s41409-019-0522-4. Epub 2019 Apr 5. | |
| 38281591 |
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Results of the trial will be shared on clinicaltrials.gov
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| Cyclophosphamide | Drug | Given Days +3 and +4 after transplant |
|
| Mycofenolate mofetil | Drug | Given Day 0 to Day +35 after transplant |
|
Record incidence of acute graft-versus-host disease at 6 months by using the NIH Grading Consensus system |
| 6 months |
| Safety of administering early immunosuppression | Record incidence of chronic graft-versus-host disease at 1 year by using the NIH Grading Consensus system | 1 year |
| Tang J, Jensen RR, Bryan B, Hoda D, Hunter BD. Reduced Cytokine Release Syndrome and Improved Outcomes with Earlier Immunosuppressive Therapy in Haploidentical Stem Cell Transplantation. Transplant Cell Ther. 2024 Apr;30(4):438.e1-438.e11. doi: 10.1016/j.jtct.2024.01.076. Epub 2024 Jan 26. |
| 34262142 | Result | Abboud R, Wan F, Mariotti J, Arango M, Castagna L, Romee R, Hamadani M, Chhabra S. Cytokine release syndrome after haploidentical hematopoietic cell transplantation: an international multicenter analysis. Bone Marrow Transplant. 2021 Nov;56(11):2763-2770. doi: 10.1038/s41409-021-01403-w. Epub 2021 Jul 14. |
| 27318038 | Result | Abboud R, Keller J, Slade M, DiPersio JF, Westervelt P, Rettig MP, Meier S, Fehniger TA, Abboud CN, Uy GL, Vij R, Trinkaus KM, Schroeder MA, Romee R. Severe Cytokine-Release Syndrome after T Cell-Replete Peripheral Blood Haploidentical Donor Transplantation Is Associated with Poor Survival and Anti-IL-6 Therapy Is Safe and Well Tolerated. Biol Blood Marrow Transplant. 2016 Oct;22(10):1851-1860. doi: 10.1016/j.bbmt.2016.06.010. Epub 2016 Jun 16. |
| 32645444 | Result | Ruggeri A, Labopin M, Battipaglia G, Chiusolo P, Tischer J, Diez-Martin JL, Bruno B, Castagna L, Moiseev IS, Vitek A, Rovira M, Ciceri F, Bacigalupo A, Nagler A, Mohty M. Timing of Post-Transplantation Cyclophosphamide Administration in Haploidentical Transplantation: A Comparative Study on Behalf of the Acute Leukemia Working Party of the European Society for Blood and Marrow Transplantation. Biol Blood Marrow Transplant. 2020 Oct;26(10):1915-1922. doi: 10.1016/j.bbmt.2020.06.026. Epub 2020 Jul 6. |
| 29421292 | Result | Chiusolo P, Bug G, Olivieri A, Brune M, Mordini N, Alessandrino PE, Dominietto A, Raiola AM, Di Grazia C, Gualandi F, Van Lint MT, Ferrara F, Finizio O, Angelucci E, Bacigalupo A. A Modified Post-Transplant Cyclophosphamide Regimen, for Unmanipulated Haploidentical Marrow Transplantation, in Acute Myeloid Leukemia: A Multicenter Study. Biol Blood Marrow Transplant. 2018 Jun;24(6):1243-1249. doi: 10.1016/j.bbmt.2018.01.031. Epub 2018 Feb 5. |
| 23423745 | Result | Bashey A, Zhang X, Sizemore CA, Manion K, Brown S, Holland HK, Morris LE, Solomon SR. T-cell-replete HLA-haploidentical hematopoietic transplantation for hematologic malignancies using post-transplantation cyclophosphamide results in outcomes equivalent to those of contemporaneous HLA-matched related and unrelated donor transplantation. J Clin Oncol. 2013 Apr 1;31(10):1310-6. doi: 10.1200/JCO.2012.44.3523. Epub 2013 Feb 19. |
| 8877390 | Result | Mayumi H, Umesue M, Nomoto K. Cyclophosphamide-induced immunological tolerance: an overview. Immunobiology. 1996 Jul;195(2):129-39. doi: 10.1016/S0171-2985(96)80033-7. |
| 7742535 | Result | Jones RJ, Barber JP, Vala MS, Collector MI, Kaufmann SH, Ludeman SM, Colvin OM, Hilton J. Assessment of aldehyde dehydrogenase in viable cells. Blood. 1995 May 15;85(10):2742-6. |
| 23233586 | Result | Fuchs EJ. Haploidentical transplantation for hematologic malignancies: where do we stand? Hematology Am Soc Hematol Educ Program. 2012;2012:230-6. doi: 10.1182/asheducation-2012.1.230. |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D004194 | Disease |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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