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Clinical Trial 20131

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

Phase: Phase II
Prinicipal Investigator:

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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)




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 HLAhaploidentical 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 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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