Status:
COMPLETED
Zoledronic Acid in Combination With Interleukin-2 to Expand Vγ9Vδ2 T Cells After T-replete Haplo-identical Allotransplant
Lead Sponsor:
Nantes University Hospital
Conditions:
Hematopoietic Stem Cell Transplantation
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
Patients receiving haplo-SCT are at high-risk of relapse. Vγ9Vδ2 T cells exhibit is a well-known population able to exert cytotoxicity toward a large range of tumor in vitro or in vivo. Activating and...
Detailed Description
Zoledronic acid will be administered as a single dose according to marketing and regulatory authorization at the dose of 4 mg over 15 min intravenously at day+15 post-transplant. Zoledronic acid infus...
Eligibility Criteria
Inclusion
- Age: 18-70 years old
- Patients with a hematological disease eligible for a haplo-SCT using the Baltimore regimen as conditioning regimen (Luznik, BBMT, 2008) (See 5.1.2)
- Patients with no HLA matched sibling or unrelated donors
- ECOG \<=2
- Signed informed consent
- Patient affiliated to or beneficiary of the National Health Service
- Patients previously transplanted are eligible to the study
Exclusion
- Patients with a HLA matched sibling or unrelated donor
- Active uncontrolled infections
- HIV positive, active Hepatitis B or C
- Childbearing or child-breastfeading women
- Women or men without effective contraceptive barrier if needed
- Left ventricular ejection fraction \< 50% with no previous severe cardiopathy
- Respiratory insufficiency defined as DLCO \<40% of the corrected value
- Creatinine clearance \<50 ml/min
- Serum bilirubin \>2.5 or transaminases \>5 fold of normal value except if due to the hematological disease
- Previous or concurrent second malignancy except for adequately treated basal cell carcinoma of the skin, curatively treated in situ carcinoma of the cervix, curatively treated solid cancer, with no evidence of disease for at least 2 years
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Participation at the same time in another study in which investigational drugs are used
- Absence of written informed consent
- Contra-indication to Zoledronic acid: known hypersensitivity to Zoledronic acid or other bisphosphonate or Zoledronic acid formulation (excipients)
- Recent or programmed dental care
- Contra-indication to IL-2: known hypersensitivity to IL-2 or IL-2 formulation (excipients)
- No previous ou current use of zoledronic acid
Key Trial Info
Start Date :
May 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03862833
Start Date
May 7 2019
End Date
August 29 2023
Last Update
October 6 2023
Active Locations (1)
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1
Nantes Uh
Nantes, France