Can a bone drug plus immune signal stop blood cancer from returning after transplant?
NCT ID NCT03862833
First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time
Summary
People who receive a haploidentical stem cell transplant for a blood cancer face a high risk that the disease will come back. Researchers are testing whether giving zoledronic acid with low-dose interleukin-2 soon after the transplant can expand a type of donor immune cell called Vγ9Vδ2 T cells that attacks tumor cells. The phase 1 trial enrolls adults up to age 70 and escalates the IL-2 dose to find the highest amount patients can tolerate. The main goal is safety and dose, while secondary measures track immune recovery, survival, and signs of graft-versus-host disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- zoledronic acid combined with low-dose interleukin-2
- What this could lead to
- If it works, this approach could give doctors a way to lower relapse risk after a haploidentical stem cell transplant by activating the donor immune cells that fight blood cancers.
- What could go wrong
- This is a small phase 1 safety study, so the main goal is finding a tolerable dose, not proving the combination prevents relapse. The treatment could cause serious immune reactions, including graft-versus-host disease, and the early findings may not hold in larger trials.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
30 people
The number who actually took part.
- Started
-
May 2019
- Finished
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Aug 2023
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Nantes Uh
Nantes, France
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