Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Peripheral Blood Stem Cell Transplant

    Biological/Vaccine

    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/Vaccine

    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.

Treatment groups

56 Participants
are divided into 1 treatment group
Group A: Cy/Flu/TBI + Post transplant CYExperimental treatment 8 interventions

Trial outcomes

Primary outcomes

1

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

Number of participants with GVHD grades 2-4 after one year post transplant.

Time frame
12 months
2

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

Number of participants with chronic GVHD after one year post transplant.

Time frame
12 months

Secondary outcomes

1

Observe rates of relapse (RR)

Number of participants that experienced relapse within 100 days of treatment.

Time frame
100 days
2

Overall Survival (OS)

Observe overall participant survival at Day 100 and at 1 and 3 years

Time frame
72 months
3

Observe transplant related mortality (TRM)

Number of participants with transplant related mortality within 12 months of treatment.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Masonic Cancer Center, University of Minnesota

Lead sponsor

Source ClinicalTrials.gov
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