Severe Aplastic AnemiaPhase 2NCT06412497
MT2023-20: Hematopoietic Cell Transplant With Reduced Intensity Conditioning and Post-transplant Cyclophosphamide for Severe Aplastic Anemia and Other Forms of Acquired Bone Marrow Failure.
A Phase 2 study testing Rituximab, Rabbit ATG and Cyclophosphamide in people with Severe Aplastic Anemia and Acquired Amegakaryocytic Thrombocytopenia, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
A phase II trial of a reduced intensity conditioned (RIC) allogeneic hematopoietic cell transplant (HCT) with post-transplant cyclophosphamide (PTCy) for idiopathic severe aplastic anemia (SAA), paroxysmal nocturnal hemoglobinuria (PNH), acquired pure red cell aplasia (aPRCA), or acquired amegakaryocytic… Read more about this study
- Who is it for?
- Ages 0 to 75 years
- Conditions the study is for
- Severe Aplastic Anemia, Acquired Amegakaryocytic Thrombocytopenia, Acquired Pure Red Cell Aplasia
- What is being tested?
- Rituximab, Rabbit ATG and Cyclophosphamide
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2024to 1 May 2036
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 0 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Idiopathic Severe Aplastic Anemia (SAA), characterized by one of the following:
- Refractory cytopenia(s), with 1+ of the following:
- Platelets <20,000/uL or transfusion dependent
- Absolute neutrophil count <500/uL without hematopoietic growth factor support
- Absolute reticulocyte count <60,000/uL AND bone marrow cellularity <50% (with < 30% residual hematopoietic cells)
- Early myelodysplastic features (bone marrow (BM) blasts <5%), without history of MDS/AML pre-treatment.
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- Idiopathic SAA with post-HCT graft failure (blood/marrow donor chimerism <5%) requiring a 2nd allogeneic HCT
- Paroxysmal Nocturnal Hemoglobinuria (PNH), including AA-PNH overlap syndrome, acquired pure red cell aplasia (aPRCA), or acquired amegakaryocytic thrombocytopenia (aAT), characterized by one of the following:
- Refractory cytopenia(s), with 1+ of the following:
- Platelets <20,000/uL or transfusion dependent
- Absolute neutrophil count <500/uL without hematopoietic growth factor support
- Absolute reticulocyte count <60,000/uL or red cell transfusion dependent AND Bone marrow evidence of 1 to 3-lineage aplasia OR peripheral blood PNH clone >/= 10%
- Early myelodysplastic features (bone marrow (BM) blasts <5%) without history of MDS/AML pre-treatment.
- Idiopathic PNH, aPRCA, or aAT with post-HCT graft failure (blood/marrow donor chimerism <5%) requiring a 2nd allogeneic HCT
- Adequate organ function within 30 days of conditioning regimen
Who cannot join
- Pregnant, breastfeeding or intending to become pregnant during the study. Persons of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days of the start of treatment
- Uncontrolled infection
- Evidence of moderate or severe portal fibrosis or cirrhosis on biopsy
- Known allergy to any of the study components
- Prior radiation therapy deemed excessive by radiation therapist for proposed low dose TBI exposure on this protocol
- Diagnosis of an inherited bone marrow failure disorder such as Fanconi anemia, Telomere biology disorder, or Schwachman-Diamond syndrome, unless reviewed by the principal investigator and deemed appropriate for this approach (e.g. GATA2 deficiency)
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- Advanced myelodysplastic syndrome (MDS; BM blasts >5%) or acute myeloid leukemia
- Psychiatric illness/social situations that, in the judgement of the enrolling Investigator, would limit compliance with study requirements
- Other illness or a medical issue that, in the judgement of the enrolling Investigator, would exclude the patient from participating in this study
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
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, 55455
Meera Srikanthan, MD, srika038@umn.edu
About this study
A phase II trial of a reduced intensity conditioned (RIC) allogeneic hematopoietic cell transplant (HCT) with post-transplant cyclophosphamide (PTCy) for idiopathic severe aplastic anemia (SAA), paroxysmal nocturnal hemoglobinuria (PNH), acquired pure red cell aplasia (aPRCA), or acquired amegakaryocytic thrombocytopenia (aAT) utilizing population pharmacokinetic (popPK)-guided individual dosing of pre-transplant conditioning and differential dosing of low dose total body irradiation based on age, presence of myelodysplasia and/or clonal hematopoiesis.
- Conditions
- Severe Aplastic Anemia, Acquired Amegakaryocytic Thrombocytopenia, Acquired Pure Red Cell Aplasia, Paroxysmal Nocturnal Hemoglobinuria
- Being tested
- Rituximab, Rabbit ATG, Cyclophosphamide, Fludarabine, Total Body Irradiation
- Keywords
- HCT, RIC, SAA, PTCy, aAT, aPRCA
- Medical subject headings
- Anemia, Aplastic, Acquired amegakaryocytic thrombocytopenia, Hemoglobinuria, Paroxysmal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
For patients with EBV IgG seropositivity or EBV PCR positivity on pre-transplant evaluations, Rituximab 375 mg/m2 is given IV once on day -14 (+/-2 day) in the outpatient setting. Pre-medicate 30 minutes prior to rituximab with methylprednisolone (1 mg/kg) IV, acetaminophen 15 mg/kg (maximum 650mg) IV or PO and diphenhydramine 1 mg/kg (maximum 50mg) IV or PO.
Rabbit ATGDrug
Also called Thymoglobulin
Rabbit ATG will be administered at doses and days indicated above, infused through a 0.22 micrometer filter over 4-6 hours. Pre-medicate 30 minutes prior to ATG infusion with methylprednisolone 1 mg/kg IV, (max dose = 125 mg), acetaminophen 15 mg/kg dose (max dose = 650 mg) enterally and diphenhydramine 1 mg/kg/dose (max dose = 50 mg) enterally or IV.
CyclophosphamideDrug
Cyclophosphamide 14.5 mg/kg is be given as a 2-hour infusion on day -6. If the patient is obese (actual body weight (ABW) >/= 125% of the ideal body weight (IBW)), cyclophosphamide should be dosed using the adjusted body weight (AdjBW): 0.5(ABW-IBW) + IBW. Uroprotection with MESNA (14.5 mg/kg/day) in IV continuous infusion will be provided per institutional guidelines. Hyperhydration is not required for 14.5 mg/kg cyclophosphamide doses.
Cyclophosphamide will be administered at 50 mg/kg using ABW over 2 hours on days +3 and +4. If the patient is obese (ABW >/= 125% of the ideal body weight (IBW)), cyclophosphamide should be dosed using the adjusted body weight (AdjBW): 0.5(ABW-IBW) + IBW. Uroprotection with MESNA (50 mg/kg/day) in IV continuous infusion as well as hyperhydration will be provided per institutional guidelines.
FludarabineDrug
For all patients, fludarabine dosing will be model-based using Bayesian methodology IV every 24 hours on days -6 to -3 with a cumulative area under the curve (cAUC) of 20 mg*hr/L.
Total Body IrradiationRadiation
Also called TBI
For patients age >/= 25 years, with myelodysplasia, or clonal hematopoiesis, total body irradiation will be 4 Gy, provided in two fractions on day -1. For all other patients, total body irradiation will be 2 Gy provided in a single fraction on day -1.
Each dose of 2 Gy will be given at a dose rate between 1 and 1.9 Gy/minute prescribed to the midplane of the patient at the level of the umbilicus.
Cell InfusionBiological
On day 0 the cells will be infused per cell source specific institutional guidelines.
Post-Transplant G-CSFDrug
Also called Filgrastim
Beginning on day +5, patients will receive G-CSF SQ or IV 5 micrograms/kg once daily until post-nadir ANC > 1500/μL for 3 consecutive days or >3000/μL for 1 day.
TacrolimusDrug
Tacrolimus will begin on day +5 at an initial dose of 0.03 mg/kg/day IV via continuous infusion. Goal trough levels will be 10-15 ug/mL until day +14 posttransplant, then decreased to a goal of 5-10 ng/mL thereafter. In the absence of GvHD, tacrolimus will discontinue at day +180 without a taper.
Also called MMF
Mycophenolate mofetil (MMF) therapy will begin on day +5. For pediatric service patients dosing of MMF will be 15 mg/kg/dose (max = 1000 mg) three times daily. For adult service patients dosing of MMF will be 15 mg/kg/dose (max = 1500 mg) twice daily. The same dosage is used orally or intravenously. Consider dose modification and/or pharmacokinetic measurements if renal and/or hepatic impairment (GFR<25 mL/minute corrected). Stop MMF at Day +35 or 7 days after engraftment achieved (ANC>500 x 106 neutrophils/L x 3 days) if later than day +35. If sufficient acute GvHD is observed to require systemic therapy, MMF should be continued for 7 days after initiation of systemic therapy. Afterward, use of MMF is at the discretion of the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: No clonal hematopoiesis | Experimental | Participants 25 years of age and younger with no clonal hematopoiesis. Active study treatment includes the conditioning regimen followed by the stem cell infusion and GvHD prophylaxis through day +180. Supportive care and follow up activities continue through two years post HCT. Receives: Drug: Rituximab; Drug: Rabbit ATG; Drug: Cyclophosphamide; Drug: Fludarabine; Radiation: Total Body Irradiation; Biological: Cell Infusion; Drug: Post-Transplant G-CSF; Drug: Tacrolimus; Drug: Mycophenolate Mofetil |
| Arm B: Clonal hematopoiesis | Experimental | Participants 25-75 years old and/or with clonal hematopoiesis. Active study treatment includes the conditioning regimen followed by the stem cell infusion and GvHD prophylaxis through day +180. Supportive care and follow up activities continue through two years post HCT. Receives: Drug: Rituximab; Drug: Rabbit ATG; Drug: Cyclophosphamide; Drug: Fludarabine; Radiation: Total Body Irradiation; Biological: Cell Infusion; Drug: Post-Transplant G-CSF; Drug: Tacrolimus; Drug: Mycophenolate Mofetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of grade 3-4 acute GvHD
Incidence of grade 3-4 acute graft-versus host disease (GvHD) at 1 year post HCT.
Measured: 1 year post HCT
Incidence of chronic GvHD-free, failure-free survival (GFFS)
Incidence of chronic GvHD-free, failure-free survival (GFFS) 1 year post HCT
Measured: 1 year post HCT
Incidence of chronic GvHD-free survival
Incidence of chronic GvHD-free survival at 1 year post HCT
Measured: 1 year post HCT
Secondary outcomes (7)
Incidence of failure-free survival (GFFS)
Incidence of chronic GvHD-free, failure-free survival (GFFS) 2 years post HC
Measured: 2 years post HCT
Incidence of neutrophil recovery
Incidence of neutrophil recovery at day 42 post HCT
Measured: Day 42 post HCT
Incidence of platelet recovery
Incidence of platelet recovery at 6 months post HCT
Measured: 6 months post HCT
Incidence of grade 3-4 acute GvHD
Incidence of grade 3-4 acute GvHD at 100 days post HCT
Measured: 100 days post HCT
Incidence of any chronic GvHD
Incidence of any chronic GvHD at 1 year post HCT
Measured: 1 year post HCT
Overall survival
Overall survival at 1 and 2 years
Measured: 1 and 2 years post HCT
Incidence of chronic GvHD-free survival
Incidence of chronic GvHD-free survival at 2 years post HCT
Measured: 2 years post HCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start5 Jun 2024
- Primary completion1 May 2035 (estimated)
- Study completion1 May 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Aplastic AnemiaStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412497
- Sponsor's protocol ID
- 2023LS101
- Status last verified
- Jun 2026
- First submitted
- 9 May 2024
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MT2023-20: Hematopoietic Cell Transplant With Reduced Intensity Conditioning and Post-transplant Cyclophosphamide for Severe Aplastic Anemia and Other Forms of Acquired Bone Marrow Failure.
- ClinicalTrials.gov ID
- NCT06412497
- Acronym / sponsor ID
- 2023LS101
- Conditions
- Severe Aplastic Anemia, Acquired Amegakaryocytic Thrombocytopenia, Acquired Pure Red Cell Aplasia, Paroxysmal Nocturnal Hemoglobinuria
- Keywords
- HCT, RIC, SAA, PTCy, aAT, aPRCA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- 1 May 2035 (estimated)
- Study completion
- 1 May 2036 (estimated)
- First posted
- 14 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase II trial of a reduced intensity conditioned (RIC) allogeneic hematopoietic cell transplant (HCT) with post-transplant cyclophosphamide (PTCy) for idiopathic severe aplastic anemia (SAA), paroxysmal nocturnal hemoglobinuria (PNH), acquired pure red cell aplasia (aPRCA), or acquired amegakaryocytic thrombocytopenia (aAT) utilizing population pharmacokinetic (popPK)-guided individual dosing of pre-transplant conditioning and differential dosing of low dose total body irradiation based on age, presence of myelodysplasia and/or clonal hematopoiesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: No clonal hematopoiesis | Experimental | Drug: Rituximab, Drug: Rabbit ATG, Drug: Cyclophosphamide, Drug: Fludarabine, Radiation: Total Body Irradiation, Biological: Cell Infusion, Drug: Post-Transplant G-CSF, Drug: Tacrolimus, Drug: Mycophenolate MofetilParticipants 25 years of age and younger with no clonal hematopoiesis. Active study treatment includes the conditioning regimen followed by the stem cell infusion and GvHD prophylaxis through day +180. Supportive care and follow up activities continue through two years post HCT. |
| Arm B: Clonal hematopoiesis | Experimental | Drug: Rituximab, Drug: Rabbit ATG, Drug: Cyclophosphamide, Drug: Fludarabine, Radiation: Total Body Irradiation, Biological: Cell Infusion, Drug: Post-Transplant G-CSF, Drug: Tacrolimus, Drug: Mycophenolate MofetilParticipants 25-75 years old and/or with clonal hematopoiesis. Active study treatment includes the conditioning regimen followed by the stem cell infusion and GvHD prophylaxis through day +180. Supportive care and follow up activities continue through two years post HCT. |
Who may qualify
- Ages
- 0 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Idiopathic Severe Aplastic Anemia (SAA), characterized by one of the following:
- Paroxysmal Nocturnal Hemoglobinuria (PNH), including AA-PNH overlap syndrome, acquired pure red cell aplasia (aPRCA), or acquired amegakaryocytic thrombocytopenia (aAT), characterized by one of the following:
- Adequate organ function within 30 days of conditioning regimen
Key exclusion criteria (9 listed)
- Pregnant, breastfeeding or intending to become pregnant during the study. Persons of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days of the start of treatment
- Uncontrolled infection
- Evidence of moderate or severe portal fibrosis or cirrhosis on biopsy
- Known allergy to any of the study components
- Prior radiation therapy deemed excessive by radiation therapist for proposed low dose TBI exposure on this protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RituximabFor patients with EBV IgG seropositivity or EBV PCR positivity on pre-transplant evaluations, Rituximab 375 mg/m2 is given IV once on day -14 (+/-2 day) in the outpatient setting. Pre-medicate 30 minutes prior to rituximab with methylprednisolone (1 mg/kg) IV, acetaminophen 15 mg/kg (maximum 650mg) IV or PO and diphenhydramine 1 mg/kg (maximum 50mg) IV or PO. | Drug | Arm A: No clonal hematopoiesis, Arm B: Clonal hematopoiesis |
| Rabbit ATGAlso: ThymoglobulinRabbit ATG will be administered at doses and days indicated above, infused through a 0.22 micrometer filter over 4-6 hours. Pre-medicate 30 minutes prior to ATG infusion with methylprednisolone 1 mg/kg IV, (max dose = 125 mg), acetaminophen 15 mg/kg dose (max dose = 650 mg) enterally and diphenhydramine 1 mg/kg/dose (max dose = 50 mg) enterally or IV. | Drug | Arm A: No clonal hematopoiesis, Arm B: Clonal hematopoiesis |
| CyclophosphamideCyclophosphamide 14.5 mg/kg is be given as a 2-hour infusion on day -6. If the patient is obese (actual body weight (ABW) >/= 125% of the ideal body weight (IBW)), cyclophosphamide should be dosed using the adjusted body weight (AdjBW): 0.5(ABW-IBW) + IBW. Uroprotection with MESNA (14.5 mg/kg/day) in IV continuous infusion will be provided per institutional guidelines. Hyperhydration is not required for 14.5 mg/kg cyclophosphamide doses. Cyclophosphamide will be administered at 50 mg/kg using ABW over 2 hours on days +3 and +4. If the patient is obese (ABW >/= 125% of the ideal body weight (IBW)), cyclophosphamide should be dosed using the adjusted body weight (AdjBW): 0.5(ABW-IBW) + IBW. Uroprotection with MESNA (50 mg/kg/day) in IV continuous infusion as well as hyperhydration will be provided per institutional guidelines. | Drug | Arm A: No clonal hematopoiesis, Arm B: Clonal hematopoiesis |
| FludarabineFor all patients, fludarabine dosing will be model-based using Bayesian methodology IV every 24 hours on days -6 to -3 with a cumulative area under the curve (cAUC) of 20 mg*hr/L. | Drug | Arm A: No clonal hematopoiesis, Arm B: Clonal hematopoiesis |
| Total Body IrradiationAlso: TBIFor patients age >/= 25 years, with myelodysplasia, or clonal hematopoiesis, total body irradiation will be 4 Gy, provided in two fractions on day -1. For all other patients, total body irradiation will be 2 Gy provided in a single fraction on day -1. Each dose of 2 Gy will be given at a dose rate between 1 and 1.9 Gy/minute prescribed to the midplane of the patient at the level of the umbilicus. | Radiation | Arm A: No clonal hematopoiesis, Arm B: Clonal hematopoiesis |
| Cell InfusionOn day 0 the cells will be infused per cell source specific institutional guidelines. | Biological | Arm A: No clonal hematopoiesis, Arm B: Clonal hematopoiesis |
| Post-Transplant G-CSFAlso: FilgrastimBeginning on day +5, patients will receive G-CSF SQ or IV 5 micrograms/kg once daily until post-nadir ANC > 1500/μL for 3 consecutive days or >3000/μL for 1 day. | Drug | Arm A: No clonal hematopoiesis, Arm B: Clonal hematopoiesis |
| TacrolimusTacrolimus will begin on day +5 at an initial dose of 0.03 mg/kg/day IV via continuous infusion. Goal trough levels will be 10-15 ug/mL until day +14 posttransplant, then decreased to a goal of 5-10 ng/mL thereafter. In the absence of GvHD, tacrolimus will discontinue at day +180 without a taper. | Drug | Arm A: No clonal hematopoiesis, Arm B: Clonal hematopoiesis |
| Mycophenolate MofetilAlso: MMFMycophenolate mofetil (MMF) therapy will begin on day +5. For pediatric service patients dosing of MMF will be 15 mg/kg/dose (max = 1000 mg) three times daily. For adult service patients dosing of MMF will be 15 mg/kg/dose (max = 1500 mg) twice daily. The same dosage is used orally or intravenously. Consider dose modification and/or pharmacokinetic measurements if renal and/or hepatic impairment (GFR<25 mL/minute corrected). Stop MMF at Day +35 or 7 days after engraftment achieved (ANC>500 x 106 neutrophils/L x 3 days) if later than day +35. If sufficient acute GvHD is observed to require systemic therapy, MMF should be continued for 7 days after initiation of systemic therapy. Afterward, use of MMF is at the discretion of the treating physician. | Drug | Arm A: No clonal hematopoiesis, Arm B: Clonal hematopoiesis |
Primary outcome
Incidence of grade 3-4 acute GvHD
Time frame: 1 year post HCT
Incidence of grade 3-4 acute graft-versus host disease (GvHD) at 1 year post HCT.
Incidence of chronic GvHD-free, failure-free survival (GFFS)
Time frame: 1 year post HCT
Incidence of chronic GvHD-free, failure-free survival (GFFS) 1 year post HCT
Incidence of chronic GvHD-free survival
Time frame: 1 year post HCT
Incidence of chronic GvHD-free survival at 1 year post HCT
7 secondary outcomes
Incidence of failure-free survival (GFFS)
Time frame: 2 years post HCT
Incidence of neutrophil recovery
Time frame: Day 42 post HCT
Incidence of platelet recovery
Time frame: 6 months post HCT
Incidence of grade 3-4 acute GvHD
Time frame: 100 days post HCT
Incidence of any chronic GvHD
Time frame: 1 year post HCT
Overall survival
Time frame: 1 and 2 years post HCT
Incidence of chronic GvHD-free survival
Time frame: 2 years post HCT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituximab, Rabbit ATG and Cyclophosphamide in people with Severe Aplastic Anemia and Acquired Amegakaryocytic Thrombocytopenia, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meera Srikanthan, MD ((612) 626-2961, srika038@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of grade 3-4 acute GvHD (time frame: 1 year post HCT). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.