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Clinical Trial 20131

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

Phase: Phase II
Principal Investigator: Elmariah, Hany

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

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

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.

Objective

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)

Treatments

Therapies

Bone Marrow Transplant; Chemotherapy (NOS); Radiotherapy

Medications

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

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