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

  • End date
    Dec 4, 2024
  • participants needed
  • sponsor
    H. Lee Moffitt Cancer Center and Research Institute
Updated on 4 November 2020
chronic myeloid leukemia
myeloid leukemia
lymphoid leukemia
total body irradiation
hematologic malignancy
chronic lymphocytic leukemia
hodgkin's disease
myeloproliferative disorder
waldenstrom's macroglobulinemia
myeloablative conditioning
lymphocytic leukemia
transplant conditioning
autologous transplant
autologous transplantation
kinase inhibitor
burkitt's lymphoma
consolidation chemotherapies
prolymphocytic leukemia
follicular lymphoma
b-cell lymphoma
mantle cell lymphoma
myeloproliferative neoplasm


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.

Treatment melphalan, Fludarabine, Total body irradiation
Clinical Study IdentifierNCT04191187
SponsorH. Lee Moffitt Cancer Center and Research Institute
Last Modified on4 November 2020

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Relapsed Marginal B-cell Lymphoma or Relapsed Chronic Lymphocytic Leukemia or Undifferentiated Leukemia or Relapsed Follicular Lymphoma or Waldenstrom...?
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 which have progressed within 12 months of achieving a partial or complete remission. Patients who had remissions lasting up to 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 is eligible after initial therapy if chemotherapy sensitive
Adequate organ function as defined per protocol
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

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
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