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Antibody-Guided chemotherapy aims to give relapsed leukemia patients a second shot

NCT ID NCT01219816

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Adults with B-cell acute lymphoblastic leukemia that has come back or stopped responding to treatment have few options. This phase 2 trial tests whether adding epratuzumab, an antibody that attaches to the CD22 protein found on most of these leukemia cells, to standard chemotherapy can improve the chance of a complete response. Researchers will give participants either an intensive chemotherapy regimen called HyperCVAD or a gentler combination of vincristine and dexamethasone, depending on their age and fitness, along with epratuzumab. The main goal is to see how many patients achieve a complete remission, which could make them eligible for a stem cell transplant.

What this could mean

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

Active substance
epratuzumab, an antibody that targets the CD22 protein on leukemia cells, added to chemotherapy
What this could lead to
If it works, this combination could help more adults with relapsed or refractory B-ALL reach a second remission and become eligible for a potentially curative stem cell transplant.
What could go wrong
This is a phase 2 trial in a small group of very sick patients, so it may not improve remission rates or survival. Adding epratuzumab to intensive chemotherapy could also cause serious side effects, including infections and low blood counts.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

57 people

The number who actually took part.

Start date

Nov 2010

Finished

Nov 2016

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 years * B-ALL (OMs) with \>= 20 % of blasts in bone marrow * CD22+ expression \>= 30% of the blast population * Refractory B-ALL defined by treatment failure after 2 successive courses of induction therapy or relapse \< 6 months after first CR * First relapse of B-ALL * Second relapse or beyond * Performance status 0-2 * Creatinine clearance \>= 50 ml/min (Cockroft formula) * Serum bilirubine \<= 30 µmom/l * Written informed consent Exclusion Criteria: * T-ALL * Meningeal involvement * CD22 expression on tumor cells or \< 30% * HIV positive * Active Hepatitis B or C * Left ventricular ejection fraction \< 50% in patients \<60 years * Contra-indication to Epratuzumab * 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 5 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

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Conditions

The condition(s) this trial relates to.

precursor B-cell acute lymphoblastic leukemia

As listed by the trial registrant

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

B-ALL CD22+ expression Refractory B-ALL

Contacts and locations

Locations

  • Angers University Hospital

    Angers, 49933, France

  • CHU de Poitiers

    Poitiers, 86021, France

  • Edouard Herriot Hospital

    Lyon, 69437, France

  • HEnri Mondor Hospital

    Créteil, 94010, France

  • Haut-Leveque Hospital

    Pessac, 33604, France

  • Institut Paoli Calmette

    Marseille, 13373, France

  • Nantes University Hospital

    Nantes, 44000, France

  • Purpan Hospital

    Toulouse, 37509, France

  • Saint Louis Hospital

    Paris, 75010, France

  • St Antoine

    Paris, 75015, France

  • University Hospital

    Caen, 14000, France

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