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RecruitingPhase 2NCT03314974

Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders

Myeloablative Allogeneic Hematopoietic Cell Transplantation Using a Related or Unrelated Donor for the Treatment of Hematological Diseases

Sponsor

Masonic Cancer Center, University of Minnesota

Enrollment

300 participants

Start Date

Mar 30, 2018

Study Type

INTERVENTIONAL

Conditions

Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaChronic Lymphocytic LeukemiaAcute LeukemiaLymphomaFollicular LymphomaSmall Lymphocytic LymphomaMyelofibrosisChronic Myelogenous LeukemiaPlasma Cell LeukemiaLymphoplasmacytic LymphomaMyelodysplasiaMyeloproliferative NeoplasmsRefractory AnemiaHigh Risk AnemiaMarginal Zone B-Cell Lymphoma

Summary

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

Max Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating an intensive type of bone marrow transplant (using high-dose chemotherapy to wipe out the immune system before the transplant) from a matched donor for patients with blood cancers or serious blood disorders who are not responding to standard treatments. **You may be eligible if...** - You are 60 years old or younger - You are physically functional enough to handle intensive treatment (Karnofsky score 70% or higher) - Your kidneys, liver, heart, and lungs are working well enough - You have a blood cancer or serious blood disorder that needs a transplant - You are willing to give written consent **You may NOT be eligible if...** - You are over 60 years old - Your organ function is too poor for intensive treatment - You have certain infections that make transplant unsafe - You are unable to give consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALHSCT with TBI Regimen

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

BIOLOGICALHSCT with Non-TBI Regimen

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

Locations(1)

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, United States

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NCT03314974

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