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Tests treatment safety and results for Hematologic Malignancy
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)
ClinicalTrials.gov ID: NCT04707300
What this study is testing
What is Human T Lymphoid Progenitor (HTLP) injection?
Human T Lymphoid Progenitor (HTLP) injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hematologic malignancy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 66
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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
See the full eligibility criteria
- 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...
- Absence of Donor Specific Antibodies (DSA) with a MFI \> 5000
- Patient affiliated to social security
- Written, informed consent of the patient
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
- Pessac, France
- Toulouse, France
- Villejuif, France
- Paris, Île-de-France Region, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 66 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France; Pessac, France; Toulouse, France; Villejuif, France; Paris, Île-de-France Region, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.