Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders

  • STATUS
    Recruiting
  • End date
    Nov 10, 2025
  • participants needed
    40
  • sponsor
    Masonic Cancer Center, University of Minnesota
Updated on 1 June 2021
cancer
remission
chronic myeloid leukemia
stem cell transplantation
graft versus host disease
myeloid leukemia
lymphoid leukemia
total body irradiation
fludarabine
tacrolimus
blast crisis
anemia
mycophenolate mofetil
cyclophosphamide
chronic lymphocytic leukemia
tyrosine
lymphoma
myelofibrosis
busulfan
multiple myeloma
acute leukemia
myeloproliferative disorder
myelodysplasia
flow cytometry
lymphoblastic lymphoma
ejection fraction
waldenstrom's macroglobulinemia
residual disease
HIV Infection
cell transplantation
leukemia
bone marrow procedure
lymphocytic leukemia
minimal residual disease
adult t-cell leukemia/lymphoma
cebpa
b-cell acute lymphoblastic leukemia
residual tumor
autologous transplant
consolidation therapy
burkitt's lymphoma
consolidation chemotherapies
blast cells
blood transfusion
chemotherapy regimen
renal dysfunction
preparative regimen
graft-versus-host disease
autograft
prolymphocytic leukemia
follicular lymphoma
raeb
cancer chemotherapy
myelomonocytic leukemia
b-cell lymphoma
mantle cell lymphoma
lymphoblasts
plasma cell leukemia
pancytopenia
blood cell count
polycythemia vera
juvenile myelomonocytic leukemia
essential thrombocythemia
thrombocytosis
nodal mass
t(1;19)
b-cell small lymphocytic 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).

Details
Condition childhood ALL, Follicular Lymphoma, Multiple Myeloma, Juvenile Myelomonocytic Leukemia, Lymphoma, Preleukemia, leukemia, MALT Lymphoma, Anemia, Waldenstrom's Macroglobulinemia, Acute myeloid leukemia, Mantle cell lymphoma, Plasma cell leukemia, Myelosclerosis with myeloid metaplasia, Lymphoproliferative Disorder, Lymphoma, Chronic Lymphocytic Leukemia, Burkitt's Lymphoma, B-Cell Lymphoma, MYELOPROLIFERATIVE DISORDER, MYELODYSPLASTIC SYNDROME, Refractory Anemia, Chronic myeloid leukemia, Prolymphocytic Leukemia, Lymphocytic Leukemia, Chronic, Non-Hodgkin's Lymphoma, Lymphoma, B-Cell, Myelodysplastic Syndromes (MDS), Acute Myelogenous Leukemia (AML), Acute Leukemia, Acquired Bone Marrow Failure Syndromes, Myeloproliferative Neoplasms, Natural Killer Cell Malignancies, MRD Positive Leukemia, Leukemia (Pediatric), Lymphocytic Leukemia, Acute, Anemia; Non-Hodgkin’s Lymphoma, High Risk Anemia, Diffuse Large Cell Non Hodgkins Lymphoma, High Grade Non-Hodgkin's Lymphoma, Adult, Biphenotypic/Undifferentiated/Prolymphocytic Leukemias, High Grade Non-Hodgkin's Lymphoma, Adult, Biphenotypic/Undifferentiated/Prolymphocytic Leukemias, High Grade Non-Hodgkin's Lymphoma, Adult, Biphenotypic/Undifferentiated/Prolymphocytic Leukemias, Myelofibrosis, Lymphoproliferative disorders, Marginal Zone Lymphoma, Waldenstrom Macroglobulinemia, High Grade Non-Hodgkin's Lymphoma, Adult, Biphenotypic/Undifferentiated/Prolymphocytic Leukemias, acute lymphoblastic leukemia, leukemia, acute lymphoblastic, lymphoblastic lymphoma, myelodysplasia, myelodysplastic syndromes, myeloproliferative neoplasm, myeloproliferative disorders, refractory anaemia, anemia refractory, burkitt lymphoma, leukemia chronic lymphocytic, chronic lymphocytic leukemia (cll), small lymphocytic lymphoma, lymphomas, b-cell small lymphocytic lymphoma, multiple myeloma (mm), myelodysplastic syndrome (mds), acute leukemias, acute lymphoid leukaemia, acute lymphocytic leukemia, acute lymphoblastic leukemia (all), acute myelogenous leukemia, anll, acute myeloblastic leukemia, chronic myelogenous leukemia, High Grade Non-Hodgkin's Lymphoma, Adult, Biphenotypic/Undifferentiated/Prolymphocytic Leukemias, High Grade Non-Hodgkin's Lymphoma, Adult, Biphenotypic/Undifferentiated/Prolymphocytic Leukemias, High Grade Non-Hodgkin's Lymphoma, Adult, Biphenotypic/Undifferentiated/Prolymphocytic Leukemias, High Grade Non-Hodgkin's Lymphoma, Adult, Biphenotypic/Undifferentiated/Prolymphocytic Leukemias, High Grade Non-Hodgkin's Lymphoma, Adult, Biphenotypic/Undifferentiated/Prolymphocytic Leukemias
Treatment HSCT with TBI Regimen, HSCT with Non-TBI Regimen
Clinical Study IdentifierNCT03314974
SponsorMasonic Cancer Center, University of Minnesota
Last Modified on1 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age: 60 years of age
Performance Status: Karnofsky 80%, Lansky play score 70
Consent: Voluntary written consent (adult or legally authorized representative; or parental/guardian)
Adequate Organ Function
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
Hepatic: Bilirubin, AST, alkaline phosphatase <4 times the upper limit of institutional normal
Pulmonary: Diffusion capacity of oxygen, corrected for hemoglobin, > 50% of predicted. For pediatric patients not able to undergo PFTs or diffusion testing: O2 sat of >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
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
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
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 <21 years, however, are eligible with (M2 marrow) with < 25% blasts in marrow after having failed one or more cycles of chemotherapy
Acute lymphoblastic leukemia (ALL)/lymphoma: second or greater CR; CR1 unable to tolerate consolidation chemotherapy due to chemotherapy-related toxicities; CR1 high-risk ALL
High risk ALL is defined as having one of the following
Evidence of high risk cytogenetics, e.g. t(9;22), t(1;19), t(4;11), other MLL rearrangements, IKZF1
years of age or older at diagnosis
White blood cell counts of greater than 30,000/mcL (B-ALL) or greater than 100,000/mcL (T-ALL) at diagnosis
CNS leukemia involvement during the course of disease
Slow cytologic response (>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 <21 years are also considered high risk CR1 if they had M2 or M3 marrow at day 42 from the initiation of induction or M3 marrow at the end of induction. They are eligible once they achieve a complete remission
Chronic Myelogenous Leukemia excluding refractory blast crisis: To be eligible in first chronic phase (CP1) patient must have failed or be intolerant to one or more tyrosine kinase inhibitors
Plasma Cell Leukemia after initial therapy, in patients who have achieved at least a partial remission
Myeloproliferative Neoplasms/Myelofibrosis, either primary as a result of polycythemia vera or essential thrombocythemia, with disease risk of intermediate or high-risk according to DIPSS criteria. Blasts must be <10% by bone marrow aspirate morphology
Myelodysplasia (MDS) IPSS INT-2 or High Risk (i.e. RAEB, RAEBt) or Refractory Anemia with severe pancytopenia, transfusion dependence, or high risk cytogenetics or molecular features. Blasts must be < 10% by a representative bone marrow aspirate morphology
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Marginal Zone B-Cell Lymphoma or Follicular Lymphoma are eligible if there was disease progression/relapse within 12 of achieving a partial or complete remission. Patients who had remissions lasting > 12 months, are eligible after at least two prior therapies. Patients with bulky disease (nodal mass greater than 5 cm) should be considered for debulking chemotherapy before transplant
Lymphoplasmacytic Lymphoma, Mantle-Cell Lymphoma, Prolymphocytic Leukemia are eligible after initial therapy in CR1+ or PR1+
Diffuse large Cell NHL > CR/> PR: Patients in CR/PR with initial short remission (<6 months) are eligible, or those who have failed/or are not eligible for autologous transplant
Lymphoblastic Lymphoma, Burkitt's Lymphoma, and other high-grade NHL after initial therapy if stage III/IV in CR1/PR1 or after progression if stage I/II < 1 year
Multiple Myeloma beyond PR2: Patients with chromosome 13 abnormalities, first response lasting less than 6 months, or -2 microglobulin > 3 mg/L, may be considered for this protocol after initial therapy
Juvenile myelomonocytic leukemia
Biphenotypic/Undifferentiated/Prolymphocytic Leukemias in first or subsequent CR
MRD positive leukemia (AML, ALL or accelerated/blast phase CML). Selected patients in morphologic CR, but with positive immunophenotypic (flow cytometry) or molecular evidence of MRD may be eligible if recent chemotherapy has not resulted in MRD negative status
Natural Killer Cell Malignancies
Acquired Bone Marrow Failure Syndromes except for Fanconi Anemia or Dyskeratosis Congenita
Other Leukemia Subtypes: A major effort in the field of hematology is to identify patients who are of high risk for treatment failure so that patients can be appropriately stratified to either more (or less) intensive therapy. This effort is continually ongoing and retrospective studies identify new disease features or characteristics that are associated with treatment outcomes. Therefore, if new features are identified after the writing of this protocol, patients can be enrolled with the approval of two members of the study committee

Exclusion Criteria

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
Active central nervous system malignancy
if 18 years old, prior myeloablative transplant within the last 6 months. If >18 years old prior myeloablative allotransplant or autologous transplant
Active HIV infection or known HIV positive serology
active uncontrolled infection
Pregnant or breastfeeding. 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
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