NCT02988466 · REGISTRY CONDITION SEARCH

Reduced Intensity (RIC) Conditioning And Transplantation of HLA-Haplo-HCT

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: 2025-05-28

This is a single institution phase II study of a reduced intensity conditioning (RIC) followed by a haploidentical hematopoietic cell transplant (haplo-HCT) in persons with diagnosis of hematologic malignancy. Conditioning will consists of fludarabine, cyclophosphamide, melphalan and total body irradiation (TBI) preparative regimen with a melphalan dose reduction for patients ≥55 years old and those with HCT Comorbidity Index (CI) \>3. This study uses a two-stage phase II design with accrual goal of 84 patients, using 28 patients separately for arms A, C and D

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 (DFS)

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outcome · POSTED

Incidence of Grade II-IV and Grade III-IV Acute Graft Versus-host-disease (GVHD)

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outcome · POSTED

Treatment Related Mortality (TRM)

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outcome · POSTED

Relapse Incidence

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outcome · POSTED

Incidence of Serious Fungal and Viral Infection

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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: * Karnofsky performance status of ≥70% or Lansky play score ≥ 70% * A related haploidentical bone marrow donor with up to 2 or 3 HLA locus-mismatches * The donor and recipient must be HLA identical for at least one haplotype (using high resolution DNA based typing) at the following genetic loci: HLA-A, HLA-B, HLA-C, and HLA-DRB1. * Adequate liver and renal function * Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction ≥ 40% * Diffusion capacity corrected (DLCOcorr) \> 40% predicted, and absence of O2 requirements * \> 6 months after prior autologous transplant (if applicable) * Agrees to use contraception during study treatment * Voluntary written consent (adult or parent/guardian with presentation of the minor information sheet, if appropriate) * Patients who are HIV+ must have undetectable viral load. All HIV+ patients must be evaluated by Infectious Disease (ID) and a HIV management plan establish prior to transplantation Exclusion Criteria: * \< 70 years with an available 5-6/6 HLA-A, B, DRB1 matched sibling donor * Pregnancy or breastfeeding * Current active and uncontrolled serious infection * Acute leukemia in morphologic relapse/persistent disease defined as \> 5% blasts in normocellular bone marrow OR any % blasts if blasts have unique morphologic markers (e.g. Auer rods). * CML in blast crisis * Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressive on salvage therapy. * stable non-bulky disease is acceptable. * Active central nervous system malignancy Criteria For Donor Selection: * Donors must be HLA-haploidentical relatives of the patient, defined as having a shared HLA haplotype between donor and patient at HLA-A, -B, -C, and -DRB1. * Eligible donors (14-70 years old) include biological children, siblings or half siblings, or parents, able and willing to undergo bone marrow harvesting. * For donors \<18 years, the maximum recipient weight (actual body weight) should not exceed 1.25 times the donor weight (actual body weight)1 In addition, bone marrow product volume should be limited to 20 ml/kg donor weight for donors \<18 years.
healthy Volunteers: false
maximum Age: 75 Years
sex: ALL
std Ages: CHILD
ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients \<55 years old with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2
intervention Names
Biological: Haplo HCT <55 years old
Drug: GVHD Prophylaxis
label
Arm A: Haplo-HCT <55 years old
type
EXPERIMENTAL
description
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients ≥55 years old or younger with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3.
intervention Names
Biological: Haplo HCT ≥55 years old
Drug: GVHD Prophylaxis
label
CLOSED Arm B: Haplo-HCT ≥55 years old
type
EXPERIMENTAL
description
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 aged ≥55 and \< 65 years old.
intervention Names
Drug: GVHD Prophylaxis
Biological: Haplo HCT ≥55 and < 65 years old
label
Arm C: Haplo-HCT HCT-CI ≤2 aged ≥55 and < 65yo
type
EXPERIMENTAL
description
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients patients ≥65 and ≤75 years old OR any age group with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3.
intervention Names
Drug: GVHD Prophylaxis
Biological: Haplo HCT ≥65 and ≤75 years old
label
Arm D: Haplo-HCT aged ≥65 and ≤75yo OR any age HCT-CI ≥3
type
EXPERIMENTAL

interventions

arm Group Labels
Arm A: Haplo-HCT <55 years old
description
* Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel) * Total body irradiation (TBI) * Non-T-cell depleted donor bone marrow stem cell infusion Day 0
name
Haplo HCT <55 years old
other Names
HLA-haploidentical related hematopoietic cells transplant
type
BIOLOGICAL
arm Group Labels
CLOSED Arm B: Haplo-HCT ≥55 years old
description
* Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel): Dose reduction by 30% * Total body irradiation (TBI) * Non-T-cell depleted donor bone marrow stem cell infusion
name
Haplo HCT ≥55 years old
other Names
HLA-haploidentical related hematopoietic cells transplant
type
BIOLOGICAL
arm Group Labels
Arm A: Haplo-HCT <55 years old
Arm C: Haplo-HCT HCT-CI ≤2 aged ≥55 and < 65yo
Arm D: Haplo-HCT aged ≥65 and ≤75yo OR any age HCT-CI ≥3
CLOSED Arm B: Haplo-HCT ≥55 years old
description
* Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF)
name
GVHD Prophylaxis
type
DRUG
arm Group Labels
Arm C: Haplo-HCT HCT-CI ≤2 aged ≥55 and < 65yo
description
* Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel) * Total body irradiation (TBI) * non-T-cell depleted donor bone marrow stem cells
name
Haplo HCT ≥55 and < 65 years old
other Names
HLA-haploidentical related hematopoietic cells transplant
type
BIOLOGICAL
arm Group Labels
Arm D: Haplo-HCT aged ≥65 and ≤75yo OR any age HCT-CI ≥3
description
* Fludarabine (Flu) * Cyclophosphamide (Cy) * Total body irradiation (TBI)
name
Haplo HCT ≥65 and ≤75 years old
other Names
HLA-haploidentical related hematopoietic cells transplant
type
BIOLOGICAL

Study design

allocation

NON_RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 78
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Percentage of participants that were disease-free survival (DFS) at 1 year post-transplant
measure
Disease-free Survival (DFS)
time Frame
1 year

secondary Outcomes

description
Percentage of participants with incidence of grade II-IV and grade III-IV acute graft versus-host-disease (GVHD).
measure
Incidence of Grade II-IV and Grade III-IV Acute Graft Versus-host-disease (GVHD)
time Frame
day 100
description
Percentage of participants experiencing treatment related mortality (TRM).
measure
Treatment Related Mortality (TRM)
time Frame
6 month, 1 and 2 year
description
Percentage of participants experiencing a relapse incidence at 1 and 2 years.
measure
Relapse Incidence
time Frame
1 and 2 year
description
Percentage of participants experiencing incidence of serious fungal and viral infection post-HCT
measure
Incidence of Serious Fungal and Viral Infection
time Frame
at day 100 and 1 year

Full study description

brief Summary: This is a single institution phase II study of a reduced intensity conditioning (RIC) followed by a haploidentical hematopoietic cell transplant (haplo-HCT) in persons with diagnosis of hematologic malignancy. Conditioning will consists of fludarabine, cyclophosphamide, melphalan and total body irradiation (TBI) preparative regimen with a melphalan dose reduction for patients ≥55 years old and those with HCT Comorbidity Index (CI) \>3. This study uses a two-stage phase II design with accrual goal of 84 patients, using 28 patients separately for arms A, C and D

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice