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Trial Title:
CD45RA Depleted DLI After TCRα/β Depleted Haploidentical HCT
NCT ID:
NCT05943067
Condition:
Hematologic Malignancy
Conditions: Official terms:
Hematologic Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
CD45RA depleted donor lymphocyte infusion (DLI)
Description:
CD45RA depleted donor lymphocyte infusion (DLI) after TCRα/β depleted haploidentical HCT
Arm group label:
Single-arm
Summary:
The purpose of this clinical trial is to examine safety and toxicity of CD45RA depleted
donor lymphocyte infusion (DLI) after transplantation of TCRα/β/CD19 depleted peripheral
blood stem cells.
Detailed description:
Patients will undergo routine reduced intensity conditioning regimen and intravenous
infusion of T-cell receptor alpha/beta (TCRα/β)/CD19 depleted peripheral blood stem cells
(not content of clinical trial).
If no graft-versus-host disease (GVHD) occurs, patients receive the trial-related memory
T cell donor lymphocyte infusion (DLI) on Day 30 after transplantation.
In a dose finding part (phase I) escalating doses will be applied in cohorts of three
(three plus three design) patients with a maximum of 18 patients for three dose levels
(dose level 1-3). A fourth lower dose level (dose level 0) is started, if >=2 out of 6
patients with dose level 1 develop aGVHD III/IV. The maximum tolerated dose (MTD) will be
used for the confirmatory part (phase II) of the study.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Adult and pediatric patients with hematological malignancies in complete remission (CR),
partial remission (PR) or with stable disease
- Acute myeloid leukemia (AML):
- Patients with high-risk AML in first complete remission (CR1)
- Patients with relapsed or primary therapy-refractory AML
- Acute lymphoid leukemia (ALL):
- Patients with high-risk ALL in CR1
- Patients with relapsed or primary refractory ALL
- Hodgkin's disease: Patients with relapsed or primary refractory Hodgkin's disease
- Non-Hodgkin's lymphoma: Patients with relapsed or primary refractory Non- Hodgkin's
lymphoma
- Myelodysplastic Syndrome (MDS)/ Myeloproliferative Syndrome (MPS):
°Patients with refractory MDS/MPS
- Multiple myeloma (MM): Patients with relapsed or refractory multiple myeloma
Exclusion Criteria:
- Age >65 years or <8 weeks
- Patients with progressive disease prior hematopoietic cell transplantation (HCT)
- <3 months after preceding HCT
- Treatment with T-cell or Interleukin-2 (IL-2) targeted medication (e.g. alemtuzumab,
basiliximab) within 60 days prior to study product infusion
- Treatment with prednisolone at >2 mg/kg/day (or equivalent dosing of alternative
glucocorticosteroids) at time of study product infusion.
- Known allergy/hypersensitivity to any component of the study product
- Treatment with another investigational drug within one month before inclusion
- History of neurological impairment (active seizures, severe peripheral neuropathy,
signs of leukoencephalopathy, active Central Nervous System (CNS) infection) Note:
For patients with heavy pretreatment with irradiation or intrathecal chemotherapy
pre-transplant CNS MRI and neurological consultation are mandatory.
- 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
- Ejection fraction <40% or Shortening fraction <20% on echocardiography. Patients
with > grade II hypertension by Common Toxicity Criteria (CTC)
- Creatinine clearance below threshold defined for stem cell transplantation according
to local clinical standard
- Respiratory failure necessitating supplemental oxygen
- HIV infection
- 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,
congestive heart failure, myocardial infarction within 6 months prior to the study,
unstable and uncontrolled hypertension, chronic renal disease, or active
uncontrolled infection) 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
Gender:
All
Minimum age:
8 Weeks
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospital Tuebingen, Department of Hematology, Oncology, Immunology and Rheumatology
Address:
City:
Tuebingen,
Zip:
72076
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Wolfgang Bethge, MD, PhD
Phone:
+49 (0) 7071 29-83176
Email:
wolfgang.bethge@med.uni-tuebingen.de
Contact backup:
Last name:
Christoph Faul, MD, PhD
Phone:
+49 (0) 7071 29-84087
Email:
christoph.faul@med.uni-tuebingen.de
Facility:
Name:
University Children's Hospital University Clinic Tuebingen
Address:
City:
Tuebingen
Zip:
72076
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Peter Lang, MD, PhD
Phone:
+49 7071 29-81386
Email:
peter.lang@med.uni-tuebingen.de
Contact backup:
Last name:
Michaela Döring, MD, PhD
Phone:
+49 7071 29-81386
Email:
michaela.doering@med.uni-tuebingen.de
Start date:
April 27, 2023
Completion date:
December 2028
Lead sponsor:
Agency:
University Hospital Tuebingen
Agency class:
Other
Source:
University Hospital Tuebingen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05943067
