Can a bone drug plus immune signal stop blood cancer from returning after transplant?

NCT ID NCT03862833

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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

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

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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