Health Trials

Allo HSCT Using RIC and PTCy for Hematological Diseases

ConditionsAcute Myelogenous LeukemiaAcute Lymphocytic LeukemiaBiphenotypic Acute LeukemiaUndifferentiated LeukemiaProlymphocytic LeukemiaChronic Myelogenous LeukemiaPlasma Cell LeukemiaMyelodysplastic SyndromesLeukemia, MyeloidMyelodysplastic Syndrome With Excess Blasts-1Burkitt LymphomaRelapsed T-Cell LymphomaRelapsed Chronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaMarginal Zone LymphomaFollicular LymphomaMyeloproliferative NeoplasmMyelofibrosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeUp to 75
SponsorMasonic Cancer Center, University of Minnesota

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Peripheral Blood Stem Cell Transplant
  • Allopurinol 300 MG
  • Fludarabine
  • Cyclophosphamide
  • Bone Marrow Cell Transplant
  • Total Body Irradiation
  • Sirolimus Pill
  • Mycophenolate Mofetil

Treatment groups

56 Participants
are divided into 1 treatment group

Sponsors and collaborators

Masonic Cancer Center, University of Minnesota

Lead sponsor

Source ClinicalTrials.gov