UCB Transplant for Hematological Diseases Using a Non Myeloablative Prep

  • STATUS
    Recruiting
  • End date
    Dec 8, 2029
  • participants needed
    162
  • sponsor
    Masonic Cancer Center, University of Minnesota
Updated on 8 October 2020
cancer
remission
sirolimus
chronic myeloid leukemia
myeloid leukemia
lymphoid leukemia
total body irradiation
fludarabine
hematologic malignancy
blast crisis
anemia
cyclophosphamide
chronic lymphocytic leukemia
tyrosine
lymphoma
myelofibrosis
multiple myeloma
hodgkin's disease
acute leukemia
myeloproliferative disorder
flow cytometry
ejection fraction
waldenstrom's macroglobulinemia
heart failure
leukemia
bone marrow procedure
hematologic disorder
lymphocytic leukemia
gilbert's syndrome
cytopenia
adult t-cell leukemia/lymphoma
cebpa
b-cell acute lymphoblastic leukemia
autologous transplant
autologous transplantation
consolidation therapy
burkitt's lymphoma
consolidation chemotherapies
hemolysis
blood transfusion
pulse oximetry
autograft
prolymphocytic leukemia
follicular lymphoma
b-cell lymphoma
mantle cell lymphoma
plasma cell leukemia
pancytopenia
marginal zone lymphoma
hematologic disease
myeloproliferative neoplasm
nodal mass
raeb i
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 with modifications based on factors including diagnosis, disease status, and prior treatment. Single or double unit selected according to current University of Minnesota umbilical cord blood graft selection algorithm.

Details
Treatment cyclophosphamide, Fludarabine, Sirolimus, TBI, MMF, ATG, Umbilical cord blood cell infusion
Clinical Study IdentifierNCT02722668
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: MALT Lymphoma or Myeloproliferative Neoplasms/Myelofibrosis or Leukemia (Pediatric) or MRD Positive Leukemia or Relapsed Chronic Lymphocytic Leukemia ...?
Age, Performance Status, and Graft Criteria
<70 years of age with no matched 5/6 or 6/6 sibling donor - patients 70 and 75 years of age may be eligible if they have a Co-Morbidity score 2 (<http://www.qxmd.com/calculate-online/hematology/hct-ci>)
Karnofsky score 70% ( 16 years) or Lansky score 50 (< 16 years)
UCB graft selected according to current University of Minnesota umbilical cord blood graft selection algorithm
Eligible Diseases All diseases listed below are advanced hematologic malignancies not curable by conventional chemotherapy. Responses to conventional treatment range from zero to 30% but are typically short lived
Acute Leukemias: Must be in remission by morphology (<5% blasts). Note cytogenetic relapse or persistent disease without morphologic relapse is acceptable. 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
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
Biphenotypic/Undifferentiated/Prolymphocytic Leukemias in first or subsequent CR
Chronic myelogenous leukemia in chronic or accelerated phase, or CML blast crisis in morphological remission (<5% blasts): Chronic phase patients must have failed at least two tyrosine kinase inhibitors, been intolerant to all available TKIs, or have T315I mutation
Myelodysplastic syndrome: 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. If 5% blasts, patient requires chemotherapy for cytoreduction to <5% blasts prior to transplantation
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
Leukemia or MDS in aplasia. These patients may be taken to transplant if after induction therapy they remain with aplastic bone marrow and no morphological or flow-cytometry evidence of disease 28 days post-therapy. These high risk patients will be analyzed separately
Burkitt's lymphoma in CR2 or subsequent CR
Relapsed T-Cell Lymphoma that is chemotherapy sensitive in CR/PR that has failed or ineligible for an autologous transplant
Natural killer cell malignancies
Large-cell lymphoma, Hodgkin lymphoma and multiple myeloma with chemotherapy sensitive disease who are ineligible for an autologous transplant
Relapsed Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma, follicular lymphoma which have progressed within 12 months 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 should be considered for debulking chemotherapy before transplant. Patients with refractory disease are eligible, unless bulky disease and an estimated tumor doubling time of less than one month
Lymphoplasmacytic lymphoma, mantle-cell lymphoma, prolymphocytic leukemia are eligible after initial therapy if chemotherapy sensitive
Relapsed Multiple Myeloma that is chemotherapy sensitive and has failed or ineligible for an autologous transplant
Plasma Cell Leukemia after initial therapy if achieved at least in partial remission; or relapsed and achieved subsequent remission (CR/PR)
Acquired Bone marrow failure syndromes, except for Fanconi anemia
Myeloproliferative Neoplasms/Myelofibrosis
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
Additional Criteria for Bulky Disease (lymphomas)
If stable disease is best response, the largest residual nodal mass must < 5 cm (approximately)
If response to previous therapy, the largest residual mass must represent a 50% reduction and be < 7.5 cm (approximately)
Organ Function Criteria
Adequate organ function is defined as
Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction > 40%. For children that are not able to cooperate with MUGA and echocardiography, such should be clearly stated in the physician's note
Pulmonary: DLCO, FEV1, FVC 40% predicted, and absence of O2 requirements. For children that are not able to cooperate with PFTs, a pulse oximetry with exercise should be attempted. If neither test can be obtained it should be clearly stated in the physician's note
Liver: Transaminases 5 x upper limit of normal (ULN) and total bilirubin 2.5 mg/dL except for patients with Gilbert's syndrome or hemolysis
Renal: Creatinine 2.0 mg/dl (adults) and creatinine clearance 40 mL/min (pediatrics). Adults with a creatinine > 1.2 mg/dl or a history of renal dysfunction must have estimated creatinine clearance 40 ml/min/1.73m^2. Adequate performance status is defined as Karnofsky score 70% ( 16 years of age) or Lansky score 50 (pediatrics)
Sexually active females of childbearing potential and males with partners of child-bearing potential 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 negative pregnancy test prior to starting therapy
Untreated active infection
Active HIV infection or known HIV positive serology
Less than 3 months since prior myeloablative transplant
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
CML in blast crisis
Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressing on salvage therapy
Active central nervous system malignancy
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cancer
remission
sirolimus
chronic myeloid leukemia
myeloid leukemia
lymphoid leukemia
total body irradiation
fludarabine
hematologic malignancy
blast crisis
anemia
cyclophosphamide
chronic lymphocytic leukemia
tyrosine
lymphoma
myelofibrosis
multiple myeloma
hodgkin's disease
acute leukemia
myeloproliferative disorder
flow cytometry
ejection fraction
waldenstrom's macroglobulinemia
heart failure
leukemia
bone marrow procedure
hematologic disorder
lymphocytic leukemia
gilbert's syndrome
cytopenia
adult t-cell leukemia/lymphoma
cebpa
b-cell acute lymphoblastic leukemia
autologous transplant
autologous transplantation
consolidation therapy
burkitt's lymphoma
consolidation chemotherapies
hemolysis
blood transfusion
pulse oximetry
autograft
prolymphocytic leukemia
follicular lymphoma
b-cell lymphoma
mantle cell lymphoma
plasma cell leukemia
pancytopenia
marginal zone lymphoma
hematologic disease
myeloproliferative neoplasm
nodal mass
raeb i
myelodysplastic syndrome with excess blasts-2

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