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

Who is this study for? Adult patients with Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
Status: Active_not_recruiting
Location: See location...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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:

• 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

Locations
United States
Florida
H. Lee Moffitt Cancer Center & Research Institute
Tampa
Time Frame
Start Date: 2019-12-06
Completion Date: 2025-02
Participants
Target number of participants: 37
Treatments
Experimental: Conditioning Regimen + Transplant
All participants will receive a conditioning regimen of Fludarabine, Melphalan and Total Body Irradiation prior to transplantation of HLA-Haploidentical Related Hematopoietic Cells (Haplo-HCT)
Sponsors
Leads: H. Lee Moffitt Cancer Center and Research Institute

This content was sourced from clinicaltrials.gov