Allo HSCT Using RIC and PTCy for Hematological Diseases

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Masonic Cancer Center, University of Minnesota
Study ID
NCT05805605
Phase
PHASE2
Status
Recruiting
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Conditions

  • Acute Lymphocytic Leukemia
  • Acute Myelogenous Leukemia
  • Biphenotypic Acute Leukemia
  • Burkitt Lymphoma
  • Chronic Myelogenous Leukemia
  • Follicular Lymphoma
  • Leukemia, Myeloid
  • Marginal Zone Lymphoma
  • Myelodysplastic Syndrome With Excess Blasts-1
  • Myelodysplastic Syndromes
  • Myelofibrosis
  • Myeloproliferative Neoplasm
  • Plasma Cell Leukemia
  • Prolymphocytic Leukemia
  • Relapsed Chronic Lymphocytic Leukemia
  • Relapsed T-Cell Lymphoma
  • Small Lymphocytic Lymphoma
  • Undifferentiated Leukemia

Eligibility Criteria

Sex
ALL
Age
N/A - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Peripheral Blood Stem Cell Transplant — BIOLOGICAL
    On day 0, a target dose of 5 x 106 CD34 cells/kg will be infused.
  • Allopurinol 300 MG — DRUG
    300 mg/day from day -7 to day 0. Allopurinol 150mg/m2/day for pediatric participants.
  • Fludarabine — DRUG
    30 mg/m2 IV over 1 hour. Administered on day -6 to day -2.
  • Cyclophosphamide — DRUG
    Administered as a 2 hour IV infusion on day -6, +3, and +4.
  • Bone Marrow Cell Transplant — BIOLOGICAL
    On day 0, a target dose of 3 x 108 nucleated cells/kg recipient weight will be infused.
  • Total Body Irradiation — RADIATION
    The dose of TBI will be 200 cGy given in a single fraction on day -1.
  • Sirolimus Pill — DRUG
    All participants begin +5 to day +60. Loading dose on day +5 of 5 mg/m2/day orally once (max dose of 8 mg). Maintenance dose 2.5 mg/m2 orally daily to maintain a level of 8-12 ng/ml (max dose of 4 mg).
  • Mycophenolate Mofetil — DRUG
    All patients begin day +5 through day +35. 3 gram/day IV/PO for patients who are ≥ 40 kg divided in 2 doses. In obese patients (\>125% IBW) 15 mg/kg every 12 hours may be considered. Pediatric patients will receive MMF at the dose of 15 mg/kg/dose (maximum of 1 gram per dose) every 8 hours.

Study Details

This is a Phase II study following subjects proceeding with our Institutional non-myeloablative cyclophosphamide/ fludarabine/total body irradiation (TBI) preparative regimen followed by a related, unrelated, or partially matched family donor stem cell infusion using post-transplant cyclophosphamide (PTCy), sirolimus and MMF GVHD prophylaxis.

Key Dates

Start date
May 1, 2023
Status verified
Jun 2025
Primary completion
Oct 22, 2027
Completion
Oct 22, 2028

Study Design

Enrollment
56 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cy/Flu/TBI + Post transplant CY

Primary Outcome Measure

Evaluate rates of acute graft-versus-host disease (GVHD) [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Masonic Cancer Center at University of MinnesotaMinneapolisMinnesota55455
Mark Juckett

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By research site
Masonic Cancer Center at University of Minnesota· Minneapolis, MN

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