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Not yet recruiting NCT06225050

M-2018-334 in Hematological Malignancies

No phase Interventional Hematological Malignancies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CliniMACS Prodigy® LP-TCRα/β-19-45RA (Trial Version).
Who it may be relevant to
Registry conditions: Hematological Malignancies. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Single-center Pilot Study Using TCRα/β and CD45RA Depleted Stem Cell Grafts From Haploidentical Donors for Hematopoietic Cell Transplantation in Adults(HAPLO2022)

Overview

This is a single-center, open-label, single-arm, pilot clinical study using TCRα/β and CD45RA depleted stem cell grafts from haploidentical donors for hematopoietic cell transplantation in 12 to 18 adult patients.

Interventions

  • Device CliniMACS Prodigy® LP-TCRα/β-19-45RA (Trial Version)
    PBSC grafts from haploidentical donors depleted of TCRaβ+ cells and CD45RA+ cells using CliniMACS Prodigy® will be infused into patients intravenously (IV)

Primary outcome measures

  • Incidence of severe acute GVHD (aGVHD) till Day 100 [Time frame: 100 days after haploidentical hematopoietic cell transplantation]
Secondary outcome measures (12)
  • Performance of the CliniMACS Prodigy® LP-TCRα/β-19-45RA(Trial Version) [Time frame: Until Last Patient Last Visit(24 Months)]
  • Incidence of acute GVHD (aGVHD) till six months post-transplantation [Time frame: 6 Months]
  • Neutrophil Engraftment [Time frame: Day 7]
  • Platelet Engraftment [Time frame: Day 0]
  • Chronic GVHD [Time frame: 1 Year]
  • Non-relapse mortality (NRM) [Time frame: Until Last patient last Visit(24 Months)]
  • Infusion toxicity [Time frame: 15 minutes, 30 minutes, 2 hours, and 4 hours post infusion]
  • Graft failure [Time frame: 30 Days]
  • Overall survival (OS) [Time frame: Day 100 and through study completion, an average of 1 year post transplantation]
  • Disease-free survival (DFS) [Time frame: Day 100 and through study completion, an average of 1 year post transplantation]
  • GVHD/relapse-free survival (GRFS) [Time frame: GRFS will be assessed at Month 12 post transplantation]
  • Immunosuppression-free survival (ISFS) [Time frame: Assessed at 1 year with a starting point at Day 45 post-transplantation]

Eligibility criteria

Inclusion criteria

  • Patients, between 18 years to 75 years of age, with high-risk hematological malignancy requiring an allogeneic hematopoietic stem cell transplantation (AlloHCT), but do not have an HLA-matched donor available

Exclusion criteria

  • <3 months after preceding autologous transplantation or prior AlloHCT
  • History of neurological impairment (active seizures, severe peripheral neuropathy, signs of leukoencephalopathy, active CNS infection)
  • Active fungal infections with radiological and clinical progression
  • Liver function abnormalities with bilirubin >2 mg/dL and elevation of transaminases higher than 400 U/L
  • Chronic active viral hepatitis
  • Cardiac dysfunction: adult patients ejection fraction <50% on echocardiography
  • Patients with uncontrolled, >grade II hypertension (per Common Toxicity Criteria, CTC)
  • Creatinine clearance <60 mL/min/1.73m2
  • Respiratory failure necessitating supplemental oxygen
  • HIV infection
  • Positive anti-donor HLA antibody
  • Treatment with checkpoint inhibitors in the period between 3 months prior to and 3 months after transplantation
  • Female patients who are pregnant or breast feeding, or adults of reproductive potential not willing to use an effective method of birth control during study treatment and for at least 12 months thereafter. Note: Women of childbearing potential must have a negative serum pregnancy test at study entry
  • Concurrent severe or uncontrolled medical disease (e.g., uncontrolled diabetes, myocardial infarction within 6 months prior to the study) which by assessment of the treating physician could compromise participation in the study
  • Patients with a history of psychiatric illness or a condition which could interfere with their ability to understand the requirements of the study (this includes alcoholism/drug addiction).
  • Patients unwilling or unable to comply with the protocol or unable to give informed consent
  • Treatment with any investigational product within 4 weeks prior to study treatment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06225050 · M-2018-334

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗