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Reduced Intensity Allogeneic HCT for Advanced Blood Cancers

This study is for adults aged 18 to 75 with advanced blood cancers like leukemia or myelodysplastic syndromes. It's testing a new approach to allogeneic hematopoietic cell transplantation (HCT), also known as a bone marrow transplant. You would receive a reduced intensity conditioning (RIC) treatment using Fludarabine and Melphalan, which is often easier to tolerate. Then, you'd receive donor cells that have been specially prepared using the CliniMACS CD34 Reagent System to include purified regulatory T-cells (Treg) along with other stem cells. The goal is to see if this special cell preparation helps reduce graft-versus-host disease (GVHD) while still preventing the cancer from returning. Researchers will measure how many people are free from both GVHD and cancer relapse after 12 months, and overall survival after 2 years. The study is currently recruiting 66 participants.

Study design
This interventional study plans to enroll 66 participants. It is testing different combinations of conventional T-cells and regulatory T-cells.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will follow participants for at least 2 years to measure overall survival and the incidence of acute GVHD.

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

NCT05088356

Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft

Active, Not Recruiting
PHASE1Ages 18–75InterventionalTreatment
Stanford University
~66 participants
Updated 2026-05-12 on ClinicalTrials.gov
What's tested:Purified regulatory T-cells (Treg) plus CD34+ HSPCFludarabineMelphalanCliniMACS CD34 Reagent SystemTacrolimusCyclophosphamide

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine the GVHD-free relapse-free survival (GRFS) post-HCT ( Arm-A)
Measured over 12 months
+4 more outcomes measured

Conditions

Allogeneic Hematopoietic Cell Transplantation (HCT)
Advanced Hematologic Malignancies
Acute Leukemia
Chronic Myelogenous Leukemia
Myelodysplastic Syndromes
Myeloproliferative Disorders

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Where it's being run

1 sites across 1 states
California1

Study leadership

  • Everett Meyer, MD,PhD · PRINCIPAL_INVESTIGATOR · Stanford Universiy

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Acute myeloid, lymphoid, or mixed phenotype leukemia in complete remission (CR) or CR with incomplete hematologic recovery (CRi) or beyond first complete remission (CR1) without the presence of minimal residual disease
Acute myeloid, leukemia, or mixed phenotype leukemia that is either:
Not in morphologic CR with bone marrow infiltration by leukemic blasts of ≤10%, or
In morphologic CR with evidence of minimal residual disease positivity by either multiparametric flow cytometric analysis or by a nucleic acid-based technique
Primary refractory acute myeloid, lymphoid, or mixed phenotype leukemia
Chronic myelogenous leukemia (accelerated, blast or second chronic phase)
Myelodysplastic syndromes
Myeloproliferative syndromes b. Match to the patient as follows:
Availability of a 8/8 or 7/8 HLA-matched donor (related or unrelated) defined by Class I (HLA-A, -B, -C) serologic typing (or higher resolution) and Class II (HLA-DRB1) molecular typing.
If the donor is a 7/8 HLA-match, the mismatch must be a permissive allelic mismatch as assessed by an independent HLA and transplantation expert. 2. For Arm A1 and Arm A3:
Availability of a 8/8 HLA-matched donor (related or unrelated) defined by Class I (HLA-A, -B, -C) serologic typing (or higher resolution) and Class II (HLA-DRB1) molecular typing. 3. For Arm B (CLOSED):
Availability of a 8/8 HLA matched donor (related or unrelated) defined by Class I (HLA-A, B, C) serologic typing (or higher resolution) and Class II (HLA DRB1) molecular typing.
Must be a related or unrelated, 8/8 or 7/8-HLA match to recipient at HLAA, -B, -C, and -DRB1. If 7/8 HLA-matched, must be with permissive allelic HLA mismatch as assessed by an independent HLA and transplantation expert.
Must be a related or unrelated, 8/8 HLA match to recipient at HLA A, B, C, and DRB1
Must be a haploidentical donor who is ≥ 4/8 but \< 7/8 match at HLA-A, -B,
C, and -DRB1, with at most one mismatch per locus.
Must be a related or unrelated 7/8 HLA matched to recipient at HLA A, B, C, DRB1 or -DQB1
The donor is a first-degree or second-degree blood relative of the recipient, or
Documented urgent medical need (DUMN), meaning no comparable human cell product is available and the recipient is likely to suffer death or serious morbidity without the human cell product, as attested by the Investigator or sub-investigator

Exclusion

A positive crossmatch of any titer; or
The presence of anti-donor HLA antibody to any HLA locus n. Any uncontrolled autoimmune disease requiring active immunosuppressive treatment o. Concurrent malignancies or active disease within 1 year, except nonmelanomatous skin cancers that have been curatively resected

What this trial measures

  • Determine the GVHD-free relapse-free survival (GRFS) post-HCT ( Arm-A)12 months

    Clinical effect will be assessed as graft vs host disease (GVHD)-free relapse free survival (GRFS), GVHD-free is defined as no GVHD symptoms, and relapse free survival is defined as survival at 12 months without relapse. The outcome will be measured in Arm A only.

  • Determine the overall survival (OS) post-HCT ( Arm-B)2 years

    Overall survival is measured as number of participants alive. Alive at the time of last observation will be censored.

  • Incidence of Grade III-IV acute GVHDAt baseline, day +30, 60, 90, 180, year 1 and year 2

    Acute GVHD will be staged and graded per Mount Sinai Acute GvHD International Consortium (MAGIC) Standardization criteria.

  • The incidence and timing of primary graft failure2 years from the Day 0 (day of CD34+ peripheral blood stem cell infusion

    Primary graft failure is defined as being alive with donor CD3 chimerism \<5% at day +30 after transplant without recovery of neutrophils (i.e. without achieving an absolute neutrophil count \[ANC\] ≥ 500/mm3 for 3 consecutive days) at Day+28

  • Donor CD3 chimerism at Day+60 post-HCT2 years from the Day 0 (day of CD34+ peripheral blood stem cell infusion)

    Defined as a percentage on donor CD3 cells chimerism at day +60 after transplantation.