NCT04191187 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2025-12-11

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Disease Free Survival

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outcome · POSTED

Percentage of Participants With Graft vs Host Disease (GVHD) Free Survival

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outcome · POSTED

Percentage of Participants Overall Survival (OS)

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outcome · POSTED

Percentage of Participants With Treatment Related Mortality (TRM) at 6 Months

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outcome · POSTED

Percentage of Participants With Treatment Related Mortality (TRM) at 18 Months

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outcome · POSTED

Percentage of Participants With Relapse Free Survival (RFS)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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 (\<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 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 * Active central nervous system malignancy * Favorable risk AML defined as having one of the following: * 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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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)
intervention Names
Drug: Fludarabine
Drug: Melphalan
Radiation: Total Body Irradiation
label
Conditioning Regimen + Transplant
type
EXPERIMENTAL

interventions

arm Group Labels
Conditioning Regimen + Transplant
description
Fludarabine 30mg/m\^2/day will be administered over 30-60 minutes intravenous infusion on Days -6 through -2 for a total dose of 150 mg/m\^2
name
Fludarabine
other Names
Fludara
type
DRUG
arm Group Labels
Conditioning Regimen + Transplant
description
Melphalan 70 mg/m\^2 over 45 minutes will be administered Day -6. Melphalan dose will be calculated based on Actual Body Weight.
name
Melphalan
other Names
Alkeran
type
DRUG
arm Group Labels
Conditioning Regimen + Transplant
description
Total Body Irradiation (TBI) will be delivered at a dose of 200 centigray units (cGy)
name
Total Body Irradiation
type
RADIATION

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 34
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Disease Free Survival (DFS) is defined as the time from the date of Peripheral Blood Stem Cell Transplant (PBSCT) to first documentation of relapse or death due to any cause, whichever comes first.
measure
Disease Free Survival
time Frame
Up to 18 months post-transplant

secondary Outcomes

description
GVHD-free survival is defined as the time from the date of PBSCT to date of events which include grade III-IV acute GVHD and systemic therapy-requiring chronic GVHD.
measure
Percentage of Participants With Graft vs Host Disease (GVHD) Free Survival
time Frame
At 180 days post-transplant
description
OS is defined as the time from the date of PBSCT to the date of death due to any cause.
measure
Percentage of Participants Overall Survival (OS)
time Frame
Up to 18 months
description
TRM is defined as death not directly due to disease
measure
Percentage of Participants With Treatment Related Mortality (TRM) at 6 Months
time Frame
at 6 months post-transplant
description
TRM is defined as death not directly due to disease
measure
Percentage of Participants With Treatment Related Mortality (TRM) at 18 Months
time Frame
at 18 months post-transplant
description
RFS is defined as the time from the date of PBSCT to relapse or death.
measure
Percentage of Participants With Relapse Free Survival (RFS)
time Frame
Up to 18 months post-transplant

Full study description

brief 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.

Source references

Source notices and limitations

Discovery and provenance

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ctgov-registry-1336d216cbd1bbff780dac70
edge id
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requested nct id
NCT04191187
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https://clinicaltrials.gov/api/v2/studies?query.cond=Acute+Undifferentiated+Leukemia&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
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true
id
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nct id
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occurrences
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NCT04191187
end
11
exact text
NCT04191187
start
0
offset unit
unicode_code_points
query cond
Acute Undifferentiated Leukemia
query disease state id
ds-acute-undifferentiated-leukemia
source file
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source file sha256
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source json pointer
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source kind
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source string sha256
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source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Acute+Undifferentiated+Leukemia&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice