Hematologic Disease and DisordersPhase 2NCT06828796
Early Use of Tacrolimus in HLA-Mismatched Haploidentical Allogeneic Hematopoietic Transplantation With Post-Transplant Cyclophosphamide
A Phase 2 study testing Tacrolimus, Cyclophosphamide and Mycofenolate mofetil in people with Hematologic Disease and Disorders and Hematopoietic Cell Transplant, run by Northside Hospital, Inc. at 1 site in United States.
Trial summary
To evalute the safety and efficacy in reducing Cytokine Release Syndrome after hematopoietic stem cell transplantation by introducing immunosuppression earlier in the transplant process Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hematologic Disease and Disorders, Hematopoietic Cell Transplant
- What is being tested?
- Tacrolimus, Cyclophosphamide and Mycofenolate mofetil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2025to 30 Jun 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Availability of a 5/10-8/10 mismatched (HLA-A, B, DR) haploidentical related donor with a negative HLA cross-match in the host vs. graft direction and willing to provide peripheral blood stem cells
- Karnofsky status >/= 70%
- Hematologic malignancy requiring allogeneic transplantation
- First allogeneic transplant only. Prior autologous transplant is allowed.
Who cannot join
- Poor cardiac function: LVEF <40%
- Poor pulmonary function: FEV1 and FVC <50% predicted
- Poor liver function: bilirubin >/= 3mg/dL (not due to hemolysis, Gilbert's or primary malignancy)
- Poor renal function: Creatinine >/= 2mg/dL or creatinine clearance (calculated or measured creatinine clearance is permitted) <40mL/min based on Traditional Cockcroft-Gault formula
- Women of childbearing potential who currently are pregnant or who are not practicing adequate contraception
- Patients who have any debilitating medical or psychiatric illness that would preclude their giving informed consent or their receiving optimal treatment and follow up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northside Hospital
Atlanta, Georgia, 30342
Caitlin Guzowski, MBA, MHA, CCRC, 404-851-8523, caitlin.guzowski@northside.com
Melhem Solh, MD
About this study
To evalute the safety and efficacy in reducing Cytokine Release Syndrome after hematopoietic stem cell transplantation by introducing immunosuppression earlier in the transplant process
- Being tested
- Tacrolimus, Cyclophosphamide, Mycofenolate mofetil
- Medical subject headings
- Hematologic Diseases, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Begins Day -1 and continues to Day +90 or Day +180 after transplant
CyclophosphamideDrug
Given Days +3 and +4 after transplant
Mycofenolate mofetilDrug
Given Day 0 to Day +35 after transplant
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Tacrolimus; Drug: Cyclophosphamide; Drug: Mycofenolate mofetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (3)
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
Measured: 30 days
Safety of administering early immunosuppression
Record incidence of acute graft-versus-host disease at 6 months by using the NIH Grading Consensus system
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start3 Jul 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Hematologic Disease and DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northside Hospital, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melhem Solh, MD, Principal investigator, The Blood and Marrow Transplant Group of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828796
- Sponsor's protocol ID
- NSH 1420
- Status last verified
- Oct 2026
- First submitted
- 6 Feb 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results of the trial will be shared on clinicaltrials.gov
Publications
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.
PubMed 30953027Tang 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.
PubMed 38281591Abboud 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.
PubMed 34262142Abboud 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.
PubMed 27318038Ruggeri 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.
PubMed 32645444Chiusolo 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.
PubMed 29421292Bashey 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.
PubMed 23423745Mayumi 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.
PubMed 8877390Jones 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.
PubMed 7742535Fuchs 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.
PubMed 23233586