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Clinical Trial 20131

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT04191187

Phase: Phase II
Principal Investigator: Elmariah, Hany

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Study Title

Reduced-Intensity Fludarabine, Melphalan, and Total Body Irradiation Conditioning for Transplantation of HLA-Haploidentical Related Hematopoietic Cells (Haplo-HCT) For Patients With Hematologic Malignancies


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.


Primary Objective: The primary objective is to estimate probability of the 18 months DFS after a HLA-haploidentical related hematopoietic cells transplant (Haplo-HCT) using a reduced intensity conditioning regimen with fludarabine/melphalan/total body irradiation (TBI) conditioning for patients with advanced age or comorbidities. Secondary Objectives: > Incidence of day 100 grade II-IV and grade III-IV acute graft versus-host-disease (GVHD) * Probability of 6 month and 18 months treatment-related mortality (TRM) * Probability of 18 months relapse incidence * Probability of 18 months overall survival (OS)



Bone Marrow Transplant; Chemotherapy (NOS); Radiotherapy


Alkeran (Melphalan); Cellcept (Mycophenolate Mofetil); FK506 (Tacrolimus); G-CSF (); Melphalan (); Mycophenolate Mofetil (); Rapamune (Sirolimus); Rapamycin (Sirolimus); Sirolimus (); Tacrolimus (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

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 (> 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 > 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 > 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:
  • Progressed within 12 months of achieving a partial or complete remission Patients who had remissions lasting up
  • Patients who had remission lasting > 12 months are eligible after at least two prior therapies
  • Patients with primary, refractory disease. Bulky disease and an estimated tumor doubling time of less than one month require debulking therapy prior to transplant.
  • 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
  • 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

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.