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NCT03314974
Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders
Conditions: Acute Leukemia, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Lymphoma, Chronic Myelogenous Leukemia, Plasma Cell Leukemia, Myeloproliferative Neoplasms, Myelofibrosis, Myelodysplasia, Refractory Anemia, High Risk Anemia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Marginal Zone B-Cell Lymphoma, Follicular Lymphoma, Lymphoplasmacytic Lymphoma, Mantle-Cell Lymphoma, Prolymphocytic Leukemia, Diffuse Large Cell Non Hodgkins Lymphoma, Lymphoblastic Lymphoma, Burkitt Lymphoma, High Grade Non-Hodgkin's Lymphoma, Adult, Multiple Myeloma, Juvenile Myelomonocytic Leukemia, Biphenotypic/Undifferentiated/Prolymphocytic Leukemias, MRD Positive Leukemia, Natural Killer Cell Malignancies, Acquired Bone Marrow Failure Syndromes
Sex: All
Ages: N/A – 60 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 300
Sponsor: Masonic Cancer Center, University of Minnesota
Location: Masonic Cancer Center at University of Minnesota Minneapolis Minnesota
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 Criteria
-Inclusion Criteria:
* 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)
* Adequate Organ Function:
* Renal: Creatinine \95% on room air
* Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction \> 45%. For children not able to cooperate with MUGA or echocardiography, such should be clearly stated in the physician's documentation
* HIV Status: HIV infection with undetectable viral load. All HIV+ patients must be evaluated by Infectious Disease (ID) and a HIV management plan establish prior to transplantation
Other Inclusion Criteria:
* Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment.
* Donor Availability: Patients considered for transplantation must have a sufficient graft as based on current criteria of the University of Minnesota Blood and Marrow Transplantation Program
* Eligible Diseases and Status: Patients are eligible unless their treatment is to be guided by a higher priority protocol.
* Acute Leukemias: Must be in remission by morphology (≤5% blasts). Also a small percentage of blasts that is equivocal between marrow regeneration vs. early relapse are acceptable provided there are no associated cytogenetic markers consistent with relapse.
* Acute Myeloid Leukemia (AML) and related precursor neoplasms: 2nd or greater complete remission (CR); first complete remission (CR1) in patients \> 60 years old; CR1 in ≤ 60 years old that is NOT considered as favorable-risk.
* Favorable risk AML is defined as having one of the following:
* t(8,21) without cKIT mutation
* inv(16) or t(16;16) without cKIT mutation
* Normal karyotype with mutated NPM1 and wild type FLT-ITD
* Normal karyotype with double mutated CEBPA
* Acute prolymphocytic leukemia (APL) in first molecular remission at the end of consolidation
* Very high risk pediatric patients with AML: Patients \10% lymphoblasts in bone marrow on Day 14 of induction therapy)
* Evidence of persistent immonophenotypic or molecular minimal residual disease (MRD) at the end of induction and consolidation therapy
* Very high risk pediatric patients with ALL: patients \ CR/\> PR: Patients in CR/PR with initial short remission (\
Source: ClinicalTrials.gov (NCT03314974). StuddyBuddy aggregates publicly available trial information.