Health TrialsbyHealthPanel

MT2025-35 Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning Treosulfan and Fludarabine, With Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases

ConditionsAMLMDSAcute LeukemiaAcute Myeloid LeukemiaMyelodysplastic Syndromes
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age2-75
SponsorMasonic Cancer Center, University of Minnesota

About this trial

This is a Phase II study following subjects proceeding with Treosulfan (36g/m2) preparative regimen followed by a related, unrelated, or partially matched family donor stem cell infusion, with post-transplant cyclophosphamide (PTCy) at 40mg/kg, tacrolimus and MMF for GVHD prophylaxis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients 2-75 years of age

≤7 5 years of age: Karnofsky score ≥ 70% (≥ 16 years) or Lansky play score ≥ 50 (< 16 years) with appropriate organ criteria as below (in other inclusion criteria)

5/6 or 6/6 related donor, OR a 5-8/8 HLA-A, B, C, DRB1 allele match unrelated donor, OR a haplotype (at least 5/10) related donor

adequate liver (no decompensated liver failure, Child Pugh A, AST/ALT <5X ULN) and renal function (creatinine <2.0)

Disqualifiers

Pregnant or breastfeeding

Evidence of untreated/uncontrolled HIV infection

Untreated active serious infection

Active CNS malignancy

Trial design

Design model

Single group

Treatments tested in this trial

  • Treosulfan

    Drug

    12 g/m2 administered intravenously over 2 hours on days -4, -3, and -2.

  • Fludarabine

    Drug

    Fludarabine will be administered intravenously over 1 hour, every 24 hours on days -6 to -2. The daily dose of fludarabine will be determined by model-based dosing utilizing Bayesian methodology .

  • Total Body Irradiation

    Radiation

    TBI 200 cGy will be administered as a single treatment on day -1 per current institutional guidelines.

  • Tacrolimus

    Drug

    Tacrolimus may be initiated on day +5 either PO or IV gtt , with a goal trough level of 5-10mg/mL and avoiding higher levels for the first two weeks post-transplant, as recent evidence demonstrated increased adverse events for levels over 10 mg/mL.

  • Mycophenolate Mofetil

    Drug

    All patients begin mycophenolate mofetil (MMF) day +5 through day +35 if no acute GVHD or 7 days after engraftment, whichever is later.

  • Cyclophosphamid

    Drug

    Cyclophosphamide 40 mg/kg will be given as an IV infusion over 1-2 hours (depending on volume) on Days +3 post-transplant (between 60 and 72 hours after stem cell infusion) and on Day +4 post-transplant (approximately 24 hours after Day +3 cyclophosphamide).

  • Stem Cell Infusion

    Biological/Vaccine

    Given on day 0.

Treatment groups

132 Participants
are divided into 1 treatment group
Group A: Treo/Flu with PTCyExperimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Overall Survival

Evaluate rates of overall survival at 100 days after transplant.

Time frame
Day 100

Secondary outcomes

1

Transplant Related Mortality

● Estimate transplant related mortality (TRM) at 100 days and 1 year with this conditioning and GVHD prophylaxis combination

Time frame
Day 100 and 1 year
2

Overall Survival

Estimate overall survival at 1 and 2 years

Time frame
1 and 2 years

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
Apply now