Actively Recruiting
Study Evaluating the Safety and the Efficacy of Human T Lymphoid Progenitor (HTLP) Injection to Accelerate Immune Reconstitution After Umbilical Cord Blood (UCB) Transplantation in Adult Patients With Hematologic Malignancies (HTLP-ONCO)
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-11-20
10
Participants Needed
5
Research Sites
336 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
U
URC-CIC Paris Descartes Necker Cochin
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an open-labelled and non-controlled Phase I/II clinical trial, evaluating the safety and the efficacy of Human T Lymphoid Progenitor (HTLP) injection to accelerate immune reconstitution after umbilical cord blood (UCB) transplantation in adult patients with hematologic malignancies. The dose limiting toxicity of HTLP injection will be evaluated using a model-based design.
CONDITIONS
Official Title
Study Evaluating the Safety and the Efficacy of Human T Lymphoid Progenitor (HTLP) Injection to Accelerate Immune Reconstitution After Umbilical Cord Blood (UCB) Transplantation in Adult Patients With Hematologic Malignancies (HTLP-ONCO)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to less than 66 years eligible for allogeneic stem cell transplantation and fit for the conditioning regimen
- Diagnosed with hematologic malignancies
- No matched related sibling donor or 10/10 matched unrelated donor available
- Have two umbilical cord blood (UCB) units with HLA matches of 4/8 to 8/8 for loci A, B, C, and DRB1
- At least one UCB unit with either at least 3 x 10e7 total nucleated cells per kg or at least 1.5 x 10e5 CD34+ cells per kg before freezing
- No donor specific antibodies with mean fluorescence intensity over 5000
- Affiliated with social security
- Provided written, informed consent
You will not qualify if you...
- Any standard contraindications to allogeneic transplant
- Left ventricular ejection fraction below 50%
- Abnormal lab results: ALT/AST over 10 times upper limit, total bilirubin over 2.5 times upper limit, creatinine clearance below 60 ml/min
- Unable to understand or provide informed consent
- Active infections including HTLV-I, HIV-I, or HIV-II
- Pregnant or breastfeeding women of childbearing potential
- Progressive hematologic malignancies
- Participation in another protocol within one month before inclusion that may affect immune recovery after bone marrow transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Hôpital Saint Louis
Paris, France
Actively Recruiting
2
Service d'Hématologie et thérapie cellulaire / CHU of Bordeaux
Pessac, France, 33604
Actively Recruiting
3
IUCT Oncopole Toulouse
Toulouse, France
Actively Recruiting
4
Institut Gustave Roussy
Villejuif, France
Not Yet Recruiting
5
Hematology department / Necker Children's Hospital
Paris, Île-de-France Region, France, 75015
Actively Recruiting
Research Team
O
Olivier HERMINE, PhD & MD
CONTACT
N
Nelly Briand, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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