Allo HSCT Using RIC and PTCy for Hematological Diseases

This study is looking at a type of stem cell transplant called allogeneic hematopoietic stem cell transplant (allo HSCT) for people with certain blood cancers like acute myeloid leukemia or acute lymphocytic leukemia. It uses a reduced intensity conditioning (RIC) regimen, which means the chemotherapy before transplant is less harsh. You would receive a stem cell infusion, along with medications like fludarabine, cyclophosphamide, and allopurinol. The main goal is to see how well this approach prevents acute and chronic graft-versus-host disease (GVHD), a common complication where the donor cells attack your body. People aged 0 to 75 with good health scores and a suitable related donor can participate. The current recruitment status is unclear.

Study design: This is a Phase II interventional study planning to enroll 56 participants. It uses a specific preparative regimen followed by a stem cell infusion from a related, unrelated, or partially matched family donor.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: The study will evaluate acute and chronic graft-versus-host disease (GVHD) rates for 12 months after the transplant.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Allo HSCT Using RIC and PTCy for Hematological Diseases

Recruiting

PHASE2Up to 75InterventionalTreatment

Masonic Cancer Center, University of Minnesota

~56 participants

Updated 2026-07-06 on ClinicalTrials.gov

What's tested:Peripheral Blood Stem Cell TransplantAllopurinol 300 MGFludarabineCyclophosphamideBone Marrow Cell TransplantTotal Body Irradiation

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Evaluate rates of acute graft-versus-host disease (GVHD)

Measured over 12 months

+1 more outcome measured

Conditions

Acute Myelogenous Leukemia

Acute Lymphocytic Leukemia

Biphenotypic Acute Leukemia

Undifferentiated Leukemia

Prolymphocytic Leukemia

Chronic Myelogenous Leukemia

Plasma Cell Leukemia

Myelodysplastic Syndromes

Leukemia, Myeloid

Myelodysplastic Syndrome With Excess Blasts-1

Burkitt Lymphoma

Relapsed T-Cell Lymphoma

Relapsed Chronic Lymphocytic Leukemia

Small Lymphocytic Lymphoma

Marginal Zone Lymphoma

Follicular Lymphoma

Myeloproliferative Neoplasm

Myelofibrosis

NCT05805605

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesotano site contact published
Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

Mark Juckett · PRINCIPAL_INVESTIGATOR · Masonic Cancer Center, University of Minnesota

Who to contact

Mark Juckett

[email protected]

6126255469

Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime

Eligibility criteria

Inclusion

Age 0 to 75 years of age with Karnofsky score ≥ 70% (≥ 16 years) or Lansky score ≥ 50 (\< 16 years).

5/6 or 6/6 related donor, OR a 7-8/8 HLA-A, B, C, DRB1 allele match, OR a haplotype (at least 5/10) matched related donor. Donors will be requested to provide PBSCs although bone marrow is acceptable according to donor preference.

t(8,21) without cKIT mutation

inv(16) or t(16;16) without cKIT mutation

Normal karyotype with mutated NPM1 and wild type FLT-ITD (unless persistently NPM1 positive by PCR following two cycles of chemotherapy)

Normal karyotype with double mutated CEBPA

Acute prolymphocytic leukemia (APL) in first molecular remission at the end of consolidation

Evidence of high risk cytogenetics, e.g. t(9;22), t(1;19), t(4;11), other MLL rearrangements, IKZF1

30 years of age or older at diagnosis

White blood cell counts of greater than 30,000/mcL (B-ALL) or greater than 100,000/mcL (T-ALL) at diagnosis

CNS leukemia involvement during the course of disease

Slow cytologic response (\>10% lymphoblasts in bone marrow on Day 14 of induction therapy)

Evidence of persistent immonophenotypic or molecular minimal residual disease (MRD) at the end of induction and consolidation therapy.

Exclusion

Pregnant or breast feeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a negative pregnancy test prior to starting therapy.

Untreated active infection

Active central nervous system malignancy

CML in blast crisis

Intermediate or high grade NHL, mantle cell NHL, and Hodgkin disease that is progressive on salvage therapy. Stable disease is acceptable to move forward provided it is non-bulky.

Less than 3 months since prior myeloablative transplant

Evidence of progressive disease by imaging modalities or biopsy - persistent PET activity, though possibly related to lymphoma, is not an exclusion criterion in the absence of CT changes indicating progression.

What this trial measures

Evaluate rates of acute graft-versus-host disease (GVHD)12 months
Number of participants with GVHD grades 2-4 after one year post transplant.
Evaluate rates of chronic graft-versus-host disease (GVHD)12 months
Number of participants with chronic GVHD after one year post transplant.

Trialytics