EUCTR2019-004883-23-FR
Active, not recruiting
Phase 1
A phase I/II 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-adult
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- APHP
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults (\=18 and \<55 years old) at the time of inclusion
- •High risk AML in CR1 (with t(6;9\), t(v; 11q23\), t(9;22\), Inv(3\), t(3;3\), abnormalities of 3q, monosomy 5, 7, 17, complex caryotype, monosomal caryotype, FLT3\-ITD (Ratio \=O.5\) without NPM1 mutations)
- •AML with any adverse genetic abnormality, secondary or therapy related AML excluding good risk genetic abnormalities, or any poor risk feature
- •MRD\+ patients after first line chemotherapy
- •Relapsed AML in CR2
- •Absence of a matched – related sibling donor (MSD) or a matched unrelated donor (MUD) 10/10
- •SORROR score \= 3
- •Presence of two UCB units with the following criteria\*: HLA\- matched 6/8, 7/8 or 8/8 for HLA\- A, \-B, and DRB1 locus, no mismatch at HLA\- C locus
- •Presence of at least one UCB unit with the following criteria\*: \= 3 x 107 TNC/kg and \= 1\.5 105 CD34\+/kg pre\- freezing AND HLA\- matched 6/8, 7/8 or 8/8 for HLA\- A, \-B, and DRB1 locus, no mismatch at HLA\- C locus
- •\* For the UCB taken into HTLP culture, the UCB with fewer CD34\+ cells number will be chosen, as expansion during HTLP culture has been proven to ensure the appropriate number of CD7\+ needed for each dose.
Exclusion Criteria
- •Active disease at the time of transplantation
- •Previous allogeneic stem cell transplantation
- •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)
- •?Lung: DLCO \< 50%
- •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
Outcomes
Primary Outcomes
Not specified
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