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.
Eligibility
Sex
ALL
Min age
8 Weeks
Max age
65 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Phase I, dose escalation — 100 days Safety and toxicity of CD45RA depleted DLI as defined by infusional toxicities and acute GVHD grad III-IV.
Phase II, extension phase — 100 days Acute graft-versus-host disease grade III-IV defined as GVHD occurring within 100 days after HCT
Trial sites (2)
Facility
City
Region
Status
University Children's Hospital University Clinic Tuebingen
Tübingen
Germany
Recruiting
University Hospital Tuebingen, Department of Hematology, Oncology, Immunology and Rheumatology
Tübingen
Germany
Recruiting
More University Hospital Tuebingen trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.