Allo HSCT Using RIC for Hematological Diseases

  • STATUS
    Recruiting
  • End date
    Mar 8, 2023
  • participants needed
    124
  • sponsor
    Masonic Cancer Center, University of Minnesota
Updated on 8 October 2020
cancer
remission
chronic myeloid leukemia
stem cell transplantation
graft versus host disease
myeloid leukemia
lymphoid leukemia
total body irradiation
fludarabine
hematologic malignancy
tacrolimus
blast crisis
anemia
mycophenolate mofetil
cyclophosphamide
chronic lymphocytic leukemia
hla-a
lymphoma
multiple myeloma
myelodysplasia
lymphoblastic lymphoma
ejection fraction
waldenstrom's macroglobulinemia
residual disease
leukemia
renal impairment
bone marrow procedure
hematologic disorder
lymphocytic leukemia
glomerular filtration rate
minimal residual disease
cytopenia
thrombocytopenia
myeloproliferative syndromes
residual tumor
burkitt's lymphoma
oximetry
blood transfusion
pulse oximetry
graft-versus-host disease
prolymphocytic leukemia
follicular lymphoma
raeb
mantle cell lymphoma
mold
plasma cell leukemia
allopurinol
hematologic disease
nodal mass
myelodysplastic syndrome with excess blasts-2

Summary

This is a phase II trial using a non-myeloablative cyclophosphamide/ fludarabine/total body irradiation (TBI) preparative regimen followed by a related or unrelated donor stem cell infusion. The primary objective is to evaluate rates of acute graft-versus-host disease (GVHD) grades II-IV and chronic GVHD with an updated GVHD prophylaxis of tacrolimus and mycophenolate mofetil (MMF) with a non-myeloablative preparative regimen in persons with hematologic malignancies.

Details
Treatment cyclophosphamide, Fludarabine, Tacrolimus, TBI, MMF, Allopurinol, ATG, Peripheral Blood Stem Cells, Related or Unrelated Bone Marrow Cells
Clinical Study IdentifierNCT02661035
SponsorMasonic Cancer Center, University of Minnesota
Last Modified on8 October 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age less than or equal to 75 yrs?
Gender: Male or Female
Do you have any of these conditions: Leukemia (Pediatric) or Follicular Lymphoma or Waldenstrom Macroglobulinemia or Preleukemia or Lymphoma, B-Cell or Multiple Myeloma or Non-Hodgkin's L...?
Age, Performance Status, and Graft Criteria
Age 0 to 70 years of age with Karnofsky score 70% ( 16 years) or Lansky score 50 (< 16 years) - refer to appendix III
Patients 70 and 75 years of age may be eligible if they have a HCT-CI Co-Morbidity score 2 - refer to appendix II
Must be 3 months after prior myeloablative transplant, if applicable
6 or 6/6 related donor match or a 7-8/8 HLA-A,B,C,DRB1 allele matched unrelated donor marrow and/or PBSC donor match per current institutional guidelines Related donors will be evaluated and collected per MT2012-14C; Unrelated donors will be identified and collected per usual procedures
Eligible Diseases
Acute Myeloid Leukemia (AML): high risk CR1 (as evidenced by preceding MDS, high risk cytogenetics, 2 cycles to obtain CR, erythroblastic or megakaryocytic leukemia, FLT-3 ITD +; CR2+. All patients must be in CR as defined by hematological recovery, AND <5% blasts by light microscopy within the bone marrow with a cellularity of 15%
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 Lymphocytic Leukemia (ALL): factor that define high risk CR1 include but are not limited to cytogenetics demonstrating t(9;22), t (1:19), t(4;11), other MLL rearrangements, hypodiploidy, or IKZF1 abnormalities), DNA index < 0.81, > 1 cycle to obtain CR or presence minimal residual disease (MRD). Patients in CR2+ are eligible. All patients must be in CR as defined by hematological recovery, AND <5% blasts by light microscopy within the bone marrow with a cellularity of 15%
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 achieved 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 imatinib mesylate
Plasma Cell Leukemia after initial therapy, who achieved at least a partial remission
Myelodysplasia (MDS) requiring transplant as defined as: IPSS INT-2 or High Risk; R-IPSS High or Very High; WHO classification: RAEB-1, RAEB-2; Severe Cytopenias: ANC < 0.8, Anemia or thrombocytopenia requiring transfusion; Poor or very poor risk cytogenetics based on IPSS or R-IPSS definitions; therapy-related MDS. Blasts must be < 5% by 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 de-bulking chemotherapy before transplant
Lymphoplasmacytic Lymphoma, Mantle-Cell Lymphoma, Prolymphocytic Leukemia, NK cell malignancies are eligible after initial therapy in CR1+ or PR1+
Large Cell NHL > CR2/> PR2: Patients in CR2/PR2 with initial short remission (<6 months) are eligible
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
Myeloproliferative Syndromes
Organ Function Criteria Adequate organ function is defined as
Liver: AST and ALT < 5 x upper limit of normal and bilirubin < 3 x upper limit of normal
Renal: Creatinine 2.0 mg/dl (adults) and estimated glomerular filtration rate (GFR) 40 mL/min (pediatrics). Adults with a creatinine > 1.2 mg/dl or a history of renal dysfunction must have estimated glomerular filtration rate (GFR) > 40 mL/min
Albumin > 2.5 g/dL
Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction > 35%
Pulmonary: DLCOcorr 40% predicted, and absence of O2 requirements. For children that are not able to cooperate with PFTs, a pulse oximetry with or without exercise should be attempted. If neither test can be obtained it should be clearly stated in the physician's note
If recent mold infection (e.g. aspergillus) must have minimum of 30 days of therapy and responsive disease and be cleared by Infectious Disease
Females of child bearing potential and sexually active males must agree to use adequate birth control during study treatment
Voluntary written consent (adult or parent/guardian with presentation of the minor information sheet, if appropriate)

Exclusion Criteria

Pregnant or breast feeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy
Untreated active infection
Active CNS disease
Active HIV infection or known HIV positive serology
Congenital bone marrow failure syndrome
Previous irradiation that precludes the safe administration of an additional dose of 200 cGy of TBI
CML in refractory blast crisis
Intermediate or high grade NHL, mantle cell NHL, and Hodgkin disease that is progressive on salvage therapy. Stable disease is acceptable to move forward provided it is non-bulky
Multiple myeloma progressive on salvage chemotherapy
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cancer
remission
chronic myeloid leukemia
stem cell transplantation
graft versus host disease
myeloid leukemia
lymphoid leukemia
total body irradiation
fludarabine
hematologic malignancy
tacrolimus
blast crisis
anemia
mycophenolate mofetil
cyclophosphamide
chronic lymphocytic leukemia
hla-a
lymphoma
multiple myeloma
myelodysplasia
lymphoblastic lymphoma
ejection fraction
waldenstrom's macroglobulinemia
residual disease
leukemia
renal impairment
bone marrow procedure
hematologic disorder
lymphocytic leukemia
glomerular filtration rate
minimal residual disease
cytopenia
thrombocytopenia
myeloproliferative syndromes
residual tumor
burkitt's lymphoma
oximetry
blood transfusion
pulse oximetry
graft-versus-host disease
prolymphocytic leukemia
follicular lymphoma
raeb
mantle cell lymphoma
mold
plasma cell leukemia
allopurinol
hematologic disease
nodal mass
myelodysplastic syndrome with excess blasts-2

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