Umbilical Cord Blood Transplantation Using a Myeloablative Preparative Regimen for Hematological Diseases

  • STATUS
    Recruiting
  • End date
    Oct 26, 2023
  • participants needed
    200
  • sponsor
    Masonic Cancer Center, University of Minnesota
Updated on 26 January 2021
remission
chronic myeloid leukemia
myeloid leukemia
lymphoid leukemia
total body irradiation
fludarabine
blast crisis
anemia
mycophenolate mofetil
imatinib
cyclophosphamide
chronic lymphocytic leukemia
lymphoma
myelofibrosis
multiple myeloma
cyclosporine
acute leukemia
myelodysplasia
umbilical cord blood transplantation
lymphoblastic lymphoma
hypodiploidy
waldenstrom's macroglobulinemia
leukemia
bone marrow procedure
hematologic disorder
lymphocytic leukemia
minimal residual disease
myeloproliferative syndromes
residual tumor
burkitt's lymphoma
blast cells
chemotherapy regimen
preparative regimen
prolymphocytic leukemia
follicular lymphoma
raeb
cancer chemotherapy
b-cell lymphoma
mantle cell lymphoma
plasma cell leukemia
pancytopenia
hematologic disease
nodal mass
b-cell small lymphocytic lymphoma

Summary

This is a treatment guideline for an unrelated umbilical cord blood transplant (UCBT) using a myeloablative preparative regimen for the treatment of hematological diseases, including, but not limited to acute leukemias. The myeloablative preparative regimen will consist of cyclophosphamide (CY), fludarabine (FLU) and fractionated total body irradiation (TBI).

Description

This is a study to collect routine clinical data from UCBT using unrelated single or double UCB units as an alternative, non-HLA-matched stem cell source for patients with hematological diseases.

  • data collection from transplant preparative therapy consisting of treatments with chemotherapeutic regimens and total body irradiation.
  • data collection from umbilical cord blood selection and infusion.
  • data collection from standard supportive disease and transplant related care.

Pre- and post-transplant medication, UCB selection and infusion, supportive care, and follow-up will be according to the current University of Minnesota BMT guidelines.

An average of 18 patients are expected to be treated on this protocol per year.

Details
Condition childhood ALL, Follicular Lymphoma, Diffuse Large B-Cell Lymphoma, Multiple Myeloma, Lymphoma, Preleukemia, leukemia, MALT Lymphoma, 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, MYELODYSPLASTIC SYNDROME, Chronic myeloid leukemia, Prolymphocytic Leukemia, Lymphocytic Leukemia, Chronic, Non-Hodgkin's Lymphoma, Lymphoma, B-Cell, Myelodysplastic Syndromes (MDS), Acute Myelogenous Leukemia (AML), Leukemia (Pediatric), Lymphocytic Leukemia, Acute, Myelofibrosis, Lymphoproliferative disorders, Marginal Zone Lymphoma, Waldenstrom Macroglobulinemia, leukemia, acute lymphoblastic, lymphoblastic lymphoma, myelodysplasia, myelodysplastic syndromes, non-hodgkin's lymphoma (nhl), burkitt lymphoma, leukemia chronic lymphocytic, chronic lymphocytic leukemia (cll), small lymphocytic lymphoma, diffuse large cell lymphoma, diffuse large b cell lymphoma, b-cell small lymphocytic lymphoma, multiple myeloma (mm), myelodysplastic syndrome (mds), acute lymphoid leukaemia, acute lymphocytic leukemia, acute lymphoblastic leukemia (all), acute myelogenous leukemia, anll, acute myeloblastic leukemia, chronic myelogenous leukemia
Treatment cyclophosphamide, Fludarabine, Total body irradiation, Umbilical Cord Blood, Mycophenylate mofetil, Cyclosporine A
Clinical Study IdentifierNCT01962636
SponsorMasonic Cancer Center, University of Minnesota
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age less than or equal to 55 yrs?
Gender: Male or Female
Do you have any of these conditions: MALT Lymphoma or Leukemia (Pediatric) or Follicular Lymphoma or Waldenstrom Macroglobulinemia or Preleukemia or Lymphoma, B-Cell or Marginal Zone Lymp...?
Do you have any of these conditions: Lymphocytic Leukemia, Acute or myelodysplasia or Myelodysplastic Syndromes (MDS) or leukemia, acute lymphoblastic or burkitt lymphoma or Lymphoma or M...?
Eligible Disease Status
Acute Myeloid Leukemia (AML): high risk CR1 (as evidenced by preceding MDS, high risk cytogenetics, 2 cycles to obtain CR, erythroblastic or megakaryocytic leukemia; 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): high risk CR1 as defined by cytogenetics (such as 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
Advanced Myelofibrosis
Myelodysplasia (MDS) IPSS INT-2 or High Risk (i.e. RAEB, RAEBt) or Refractory Anemia with severe pancytopenia or high risk cytogenetics: 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 de-bulking chemotherapy before transplant
Lymphoplasmacytic Lymphoma, Mantle-Cell Lymphoma, Prolymphocytic Leukemia 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
Availability of suitable UCB unit(s)
to 55 years
Voluntary written consent (adult or parental/guardian)

Exclusion Criteria

previous irradiation that precludes the safe administration of TBI - Radiation Oncology will evaluate all patients who have had previous radiation therapy
chemotherapy refractory large cell and high grade NHL (ie progressive disease after > 2 salvage regimens)
if 18 years old, prior myeloablative transplant within the last 6 months. If >18 years old prior myeloablative allotransplant or autologous transplant
extensive prior therapy including > 12 months alkylator therapy or > 6 months alkylator therapy with extensive radiation
pregnant or breastfeeding
HIV positive
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