Reduced Intensity Flu/Mel/TBI Conditioning for HAPLO HCT Patients With Hematologic Malignancies

  • STATUS
    Recruiting
  • End date
    Dec 11, 2024
  • participants needed
    34
  • sponsor
    H. Lee Moffitt Cancer Center and Research Institute
Updated on 11 March 2021
cancer
remission
chronic myeloid leukemia
myeloid leukemia
lymphoid leukemia
total body irradiation
fludarabine
hematologic malignancy
anemia
chronic lymphocytic leukemia
tyrosine
hla-a
lymphoma
myelofibrosis
hodgkin's disease
myeloproliferative disorder
waldenstrom's macroglobulinemia
melphalan
myeloablative conditioning
leukemia
lymphocytic leukemia
transplant conditioning
autologous transplant
autologous transplantation
kinase inhibitor
burkitt's lymphoma
consolidation chemotherapies
blast cells
chemotherapy regimen
autograft
prolymphocytic leukemia
follicular lymphoma
cancer chemotherapy
b-cell lymphoma
mantle cell lymphoma
t-cell lymphoma
pancytopenia
myeloproliferative neoplasm
b-cell small lymphocytic lymphoma

Summary

This is a single arm, phase II trial of HLA-haploidentical related hematopoietic cells transplant (Haplo-HCT) using reduced intensity conditioning (fludarabine and melphalan and total body irradiation). Peripheral blood is the donor graft source. This study is designed to estimate disease-free survival (DFS) at 18 months post-transplant.

Details
Condition Bone marrow disorder, childhood ALL, Hodgkin's Disease, Lymphoma, Preleukemia, Waldenstrom's Macroglobulinemia, Acute myeloid leukemia, Mantle cell lymphoma, Lymphoma, Acute biphenotypic leukemia, Burkitt's Lymphoma, B-Cell Lymphoma, MYELOPROLIFERATIVE DISORDER, MYELODYSPLASTIC SYNDROME, Chronic myeloid leukemia, Prolymphocytic Leukemia, Non-Hodgkin's Lymphoma, Lymphoma, B-Cell, Myelodysplastic Syndromes (MDS), Acute Myelogenous Leukemia (AML), Recurrent Chronic Lymphocytic Leukemia, Relapsed Chronic Lymphocytic Leukemia, Relapsed Follicular Lymphoma, Myeloproliferative Neoplasms, Relapsed Small Lymphocytic Lymphoma, Lymphocytic Leukemia, Acute, Undifferentiated Leukemia, Waldenstrom Macroglobulinemia, Relapsed Large Cell Lymphoma, Relapsed T-Cell Lymphoma, Relapsed Marginal B-cell Lymphoma, Relapsed T-Cell Lymphoma, Relapsed Marginal B-cell Lymphoma, Relapsed T-Cell Lymphoma, Relapsed Marginal B-cell Lymphoma, Relapsed T-Cell Lymphoma, Relapsed Marginal B-cell Lymphoma, Relapsed T-Cell Lymphoma, Relapsed Marginal B-cell Lymphoma, Relapsed T-Cell Lymphoma, Relapsed Marginal B-cell Lymphoma, Relapsed T-Cell Lymphoma, Relapsed Marginal B-cell Lymphoma, acute lymphoblastic leukemia, leukemia, acute lymphoblastic, myelodysplastic syndromes, myeloproliferative neoplasm, myeloproliferative disorders, burkitt lymphoma, chronic lymphocytic leukemia, relapsed, myelodysplastic syndrome (mds), hodgkin, hodgkin's lymphomas, hodgkin lymphomas, hodgkins lymphoma, hodgkin's lymphoma, biphenotypic acute leukemia, acute lymphoid leukaemia, acute lymphocytic leukemia, acute lymphoblastic leukemia (all), acute myelogenous leukemia, anll, acute myeloblastic leukemia, chronic myelogenous leukemia, Relapsed T-Cell Lymphoma, Relapsed Marginal B-cell Lymphoma, Relapsed T-Cell Lymphoma, Relapsed Marginal B-cell Lymphoma, Relapsed T-Cell Lymphoma, Relapsed Marginal B-cell Lymphoma, Relapsed T-Cell Lymphoma, Relapsed Marginal B-cell Lymphoma
Treatment melphalan, Fludarabine, Total body irradiation
Clinical Study IdentifierNCT04191187
SponsorH. Lee Moffitt Cancer Center and Research Institute
Last Modified on11 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 55 years or HCT Co-Morbidity score (HCT-CI) >/=3
Lack of a suitable 8/8 HLA-matched sibling donor
Adequate performance status is defined as Karnofsky score 70%
Patients and selected donor must be HLA typed at high resolution using DNA based typing at the following HLA-loci: HLA-A, -B, -C and DRB1. Donors must be HLA-haploidentical relatives including, but not limited to, children, siblings, or parents, defined as having a shared HLA haplotype between donor and patient at HLA-A, -B, -C, and -DRB1
Acute Myeloid Leukemia (AML): Must be in remission with morphology (<5% blasts)
Acute Lymphoblastic Leukemia (ALL)/lymphoma second or greater complete remission (CR) first CR unable to tolerate consolidation chemotherapy due to chemotherapy-related toxicities, first CR high-risk ALL
Biphenotypic/Undifferentiated/Prolymphocytic Leukemias in first or subsequent CR
Myelodysplastic syndrome: any subtype including refractory anemia (RA) if severe pancytopenia or complex cytogenetics. Blasts must be less than 5%. If 5% of more requires chemotherapy for cytoreduction to </=5% prior to transplantation
Chronic Myelogenous leukemia in accelerated phase: patient must have failed at least two different Tyrosine Kinase Inhibitor (TKI)s, been intolerant to all TKIs, or have T315l mutation
Myeloproliferative neoplasms/myelofibrosis: Blasts must be less than 5%. If 5% or more requires chemotherapy for cytoreduction to </=5% prior to transplantation
Relapsed large-cell lymphoma, mantle-cell lymphoma or Hodgkin lymphoma that is chemotherapy sensitive and has failed or ineligible for an autologous transplant
Burkitt's lymphoma in second CR or subsequent CR
Relapsed T-cell lymphoma that is chemotherapy sensitive in CR/Partial Response (PR) that has failed or ineligible for an autologous transplant
Natural killer cell malignancies
Relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma, follicular lymphoma with any of the following
Lymphoplasmacytic lymphoma is eligible after initial therapy if chemotherapy sensitive
Progressed within 12 months of achieving a partial or complete remission Patients who had remissions lasting up
Adequate organ function as defined per protocol
Patients who had remission lasting > 12 months are eligible after at least two prior therapies
Sexually active females of child bearing potential and males with partners of child bearing potential must agree to use adequate birth control during study treatment
Patients with primary, refractory disease. Bulky disease and an estimated tumor doubling time of less than one month require debulking therapy prior to transplant

Exclusion Criteria

Pregnant or breastfeeding
Untreated active infection
Active HIV infection
Prior allogenic transplant at any time prior or less than 6 months since prior autologous transplant (if applicable)
Active central nervous system malignancy
Favorable risk AML defined as per protocol
Active central nervous system malignancy
Favorable risk AML defined as having one of the following
t(8,21) without cKIT mutation or evidence of immunophenotypic, cytogenetic or molecular minimal residual disease (MRD)
inv(16) or t(16;16) without cKIT mutation or evidence of MRD
Normal karyotype with mutated NPM1 but FLT3-ITD wild type without evidence of MRD
Normal karyatype with double mutated CEBPA without evidence of MRD
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