Status:
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)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
URC-CIC Paris Descartes Necker Cochin
Conditions:
Hematologic Malignancy
Eligibility:
All Genders
18-66 years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Detailed Description
Allogeneic bone marrow transplantation (AlloSCT) is the treatment of choice for high- risk acute myeloid leukemias in complete first remission after induction therapy and other high-risk hematological...
Eligibility Criteria
Inclusion
- Adult patients (≥ 18 years old and \<66 years old) at the time of inclusion and eligible for an allogeneic stem cells transplantation and fit to receive the specified conditioning regimen
- Patients with hematologic malignancies
- Absence of a matched - related sibling donor (MSD) or a matched unrelated donor (MUD) 10/10
- Presence of two UCB units with the following criteria\*: HLA- matched 4/8, 5/8, 6/8, 7/8 or 8/8 for HLA- A, -B, -C and DRB1 loci
- AND
- • Presence of at least one UCB unit with the following criteria\*: ≥ 3 x 10e7 TNC/kg or ≥ 1.5 10e5 CD34+/kg pre- freezing
- \* For the UCB taken into HTLP culture, the CD34+ content does not need to meet the above cellularity criteria, as expansion during HTLP culture has been proven to ensure the appropriate number of CD7+ needed for each dose.
- The non- cultured UCB will be chosen to have a higher CD34+ cell content in order to enable long- term hematopoietic engraftment
- Absence of Donor Specific Antibodies (DSA) with a MFI \> 5000
- Patient affiliated to social security
- Written, informed consent of the patient
Exclusion
- Any of the standard contraindications to allogeneic transplant
- Left ventricular ejection fraction \<50%
- Abnormal biochemistry results (ALT/AST\>10xULN, total bilirubin\>2.5xULN, creatinin clearance \<60ml/min)
- Inability to understand and provide informed consent
- Concomitant infectious disease: HTLV-I, HIV-I or HIV-II
- Pregnancy or breastfeeding for women of childbearing potential
- Patients with progressive hematologic malignancies
- Previous participation within one month before inclusion in another protocol in which drugs may influence immune reconstitution of bone marrow transplantation
Key Trial Info
Start Date :
February 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04707300
Start Date
February 16 2022
End Date
August 1 2028
Last Update
November 20 2025
Active Locations (5)
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1
Hôpital Saint Louis
Paris, France
2
Service d'Hématologie et thérapie cellulaire / CHU of Bordeaux
Pessac, France, 33604
3
IUCT Oncopole Toulouse
Toulouse, France
4
Institut Gustave Roussy
Villejuif, France