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Leukemia trial pulled before it started: safer transplant prep remains untested

NCT ID NCT02577094

Disease control Sponsor: Nantes University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial was designed to test a milder conditioning regimen using a radioactive antibody (90Y-Epratuzumab) followed by chemotherapy and a stem cell transplant for adults with CD22-positive B-cell acute lymphoblastic leukemia. The goal was to find the safest dose that still controls the disease. However, the study was withdrawn before any patients were enrolled, so no data were collected.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
90Y-Epratuzumab (a radioactive antibody targeting CD22) combined with busulfan, fludarabine, and thymoglobulins
What this could lead to
If it had proceeded, this trial could have pointed toward a safer way to prepare patients for stem cell transplants, potentially reducing side effects while controlling leukemia.
What could go wrong
The trial was withdrawn before enrolling any participants, so no results are available. The approach involves significant risks, including toxicity from radiation and chemotherapy, and it was only in early-phase testing.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Finished

Jan 2017

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 years and older

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 * Acute lymphoblastic Leukemia (ALL) CD22 + B-type in RC1 with high risk * B-Cell Acute Lymphoblastic Leukemia (ALL) CD22+ beyond RC1. * Expression of CD22 ≥ 30% in tumor population evaluated by flow cytometry or immunohistochemistry at diagnosis stage or relapse stage. * HLA-identical donor intra family or not, without major HLA mismatch (9 / 10th accepted) without contra-indication for stem cell mobilization * ECOG (Eastern Cooperative Oncology Group) ≤ 2 * Having or not received previously Epratuzumab * Eligible for an allograft with reduced conditioning regimen * With a signed informed consent * Patient in age of children bearing with adequate contraception * Patient affiliated to or beneficiary of the National Health Service Exclusion Criteria: * T-cell ALL * Known hypersensibility to 90Y-DOTA-hLL2 * Immunization against hLL2 for patients having already received one or several injections of this antibody * Patient eligible for myeloablative conditioning regimen * Other prior malignancies must have had at least a 2-year disease-free interval with the exception of successfully treated carcinoma skin cancer or carcinoma in situ of the cervix. * Patient with progressive psychiatric condition. * HIV positive, hepatitis B-antigen positive, or hepatitis C positive patients who need a treatment * Pregnant or breast-feeding women * Women with childbearing potential without effective contraception * Serious concomitant and uncontrolled infection * Usual contraindications in the allogeneic transplant: * Adult patient protected by the French law

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Conditions

The condition(s) this trial relates to.

B-cell acute lymphoblastic leukemia precursor B-cell acute lymphoblastic leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lymphocyte B CD22 positive acute lymphoblastic leukemia

More trials for these conditions

Other studies related to the condition(s) this trial covers.