Fact CheckerSign in

NCT04191187CompletedPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 11 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
34 (actual)
First submitted
6 Dec 2019
Start date
6 Dec 2019
Primary completion date
11 Feb 2024
Lead sponsor
H. Lee Moffitt Cancer Center and Research Institute
NCT number
NCT04191187

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 34
  • From 6 Dec 2019 to the primary completion date, 11 Feb 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior allogenic transplant at any time prior or less than 6 months since prior autologous transplant (if applicable)

Other illness

  • Untreated active infection
  • Active HIV infection
  • Active central nervous system malignancy
  • Active central nervous system malignancy
  • t(8,21) without cKIT mutation or evidence of immunophenotypic, cytogenetic or molecular minimal residual disease (MRD)

Other

  • Pregnant or breastfeeding
  • Favorable risk AML defined as per protocol
  • Favorable risk AML defined as having one of the following:
  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
H Lee Moffitt Cancer Center & Research Institute
Coordinator of this site? Confirm its status
TampaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.