Clinical trial · Interventional
M-2018-334 in Hematological Malignancies
A Single-center Pilot Study Using TCRα/β and CD45RA Depleted Stem Cell Grafts From Haploidentical Donors for Hematopoietic Cell Transplantation in Adults(HAPLO2022)
NCT06225050CI-TRIAL-00098306HAPLO2022recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 12, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260912-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CliniMACS Prodigy® LP-TCRα/β-19-45RA (Trial Version) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HSC Recipient
- description
- PBSC grafts from haploidentical donors depleted of TCRaβ+ cells and CD45RA+ cells using CliniMACS Prodigy® will be infused into patients intravenously (IV)
- interventionNames
- Device: CliniMACS Prodigy® LP-TCRα/β-19-45RA (Trial Version)
Primary outcomes (1)
- measure
- Incidence of severe acute GVHD (aGVHD) till Day 100
- timeFrame
- 100 days after haploidentical hematopoietic cell transplantation
- description
- Participants will be evaluated for the occurrence of aGVHD, grades III-IV in the first 100 days after transplantation and the time to occurrence of aGVHD, grades III-IV will be recorded. Severity of acute GVHD will be graded according to the CONSENSUS CRITERIA FOR GRADING OF ACUTE GVHD which has four Grades from Grade I to Grade IV. The higher the Score, the Worse the outcome.
Secondary outcomes (14)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.