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Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders

ConditionsAcute LeukemiaAcute Myeloid LeukemiaAcute Lymphoblastic LeukemiaLymphomaChronic Myelogenous LeukemiaPlasma Cell LeukemiaMyeloproliferative NeoplasmsMyelofibrosisMyelodysplasiaRefractory AnemiaHigh Risk AnemiaChronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaMarginal Zone B-Cell LymphomaFollicular LymphomaLymphoplasmacytic LymphomaMantle-Cell LymphomaProlymphocytic LeukemiaDiffuse Large Cell Non Hodgkins LymphomaLymphoblastic LymphomaBurkitt LymphomaHigh Grade Non-Hodgkin's Lymphoma, AdultMultiple MyelomaJuvenile Myelomonocytic LeukemiaBiphenotypic/Undifferentiated/Prolymphocytic LeukemiasMRD Positive LeukemiaNatural Killer Cell MalignanciesAcquired Bone Marrow Failure Syndromes
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeUp to 60
SponsorMasonic Cancer Center, University of Minnesota

About this trial

This is a Phase II study of allogeneic hematopoietic stem cell transplant (HCT) using a myeloablative preparative regimen (of either total body irradiation (TBI); or, fludarabine/busulfan for patients unable to receive further radiation). followed by a post-transplant graft-versus-host disease (GVHD) prophylaxis regimen of post-transplant cyclophosphamide (PTCy), tacrolimus (Tac), and mycophenolate mofetil (MMF).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: ≤ 60 years of age

Performance Status: Karnofsky ≥ 70%, Lansky play score ≥ 70

Consent: Voluntary written consent (adult or legally authorized representative; or parental/guardian)

Renal: Creatinine <2x upper limit of normal. Patients above this limit must have creatinine clearance ≥ 40 ml/min/1.73m2 as determined by an age-appropriate method, such as cystatin C GFR.

Disqualifiers

Chemotherapy refractory large cell and high grade NHL (i.e., progressive disease after > 2 salvage regimens)

CML in blast crisis

Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressing on salvage therapy.

Evidence of progressive disease by imaging modalities or biopsy - persistent PET activity, though possibly related to lymphoma, is not an exclusion criterion in the absence of CT changes indicating progression.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HSCT with TBI Regimen

    Biological/Vaccine

    Day -5 to -2: Total Body Irradiation Day 0: Hematopoietic Stem Cell Transplantation Day +3 to +4: Cyclophosphamide Day +5: Tacrolimus from day +5 until taper day +100 (day +60 for peds if no acute or chronic GVHD present) Day +5: Mycophenolate mofetil through day +35 or 7 days after engraftment, whichever day is later, if no acute GVHD

  • HSCT with Non-TBI Regimen

    Biological/Vaccine

    Day -5 to Day -2: Busulfan and Fludaribine Day 0: Hematopoietic Stem Cell Transplantation Day +3 to +4: Cyclophosphamide Day +5: Tacrolimus from day +5 until taper day +100 (day +60 for peds if no acute or chronic GVHD present) Day +5: Mycophenolate mofetil through day +35 or 7 days after engraftment, whichever day is later, if no acute GVHD

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: TBI RegimenExperimental treatment 1 intervention
Group B: Non-TBI RegimenExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Chronic GVHD - 1 year

Incidence of chronic GVHD

Time frame
1 year

Secondary outcomes

1

Grade II-IV acute GVHD

Cumulative incidence grade II-IV acute GVHD

Time frame
Day +100
2

Chronic GVHD - 2 years

Incidence of chronic GVHD

Time frame
2 years
3

Relapse

Cumulative incidence of relapse

Time frame
2 years
4

Overall survival

Cumulative incidence of overall survival

Time frame
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
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