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Promising combo aims to beat relapsed leukemia

NCT ID NCT07039877

Disease control Sponsor: Hospital Universitario Dr. Jose E. Gonzalez Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This phase 2 trial tests whether adding a low dose of venetoclax (a targeted drug) with itraconazole to standard chemotherapy can improve remission rates in people with relapsed or refractory acute lymphoblastic leukemia. The study enrolls 12 adults whose leukemia has returned or not responded to prior treatment. The goal is to achieve complete remission and prepare patients 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
venetoclax (low dose) with itraconazole, plus TACL chemotherapy (asparaginase, dexamethasone, bortezomib, vincristine, mitoxantrone)
What this could lead to
If successful, this could offer a more effective treatment option for patients with relapsed/refractory acute lymphoblastic leukemia, potentially leading to remission and enabling stem cell transplant.
What could go wrong
This is a small, early-phase trial with only 12 participants, so results may not apply broadly. The combination may cause significant side effects, and the overall survival benefit is uncertain.

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

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Apr 2026

An estimate. End dates often move.

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

16 to 45 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: * B-cell or T-cell acute lymphoblastic leukemia. * Philadelphia chromosome negative * Relapsed disease after any line of treatment, defined as detection of disease activity at any time after remission * Refractory disease after first-line treatment, defined as: more than 5% blasts after completion of induction/consolidation by flow cytometry * Not having included venetoclax in any prior regimen. * No prior organ damage, defined as the absence of any serious, life-threatening disease prior to the start of treatment. * Performance status defined by the ECOG scale between 0 and 2. Exclusion Criteria: * Isolated CNS relapse. * Performance status defined by ECOG scale between 3 and 4. * CTCAE-classified sensory or motor neuropathy of grade 3 or higher. * History of hypersensitivity or intolerance to the drugs included in the regimen. * Prior organ damage, defined as the presence of any serious, life-threatening illness prior to the start of treatment.

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia

As listed by the trial registrant

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

Acute lymphobkastic leukemia Acute lymphoblastic leukaemia recurrent Philadelphia chromosome negative ALL

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Universitario Dr. Jose E. Gonzalez

    RECRUITING

    Monterrey, Nuevo León, 64360, Mexico

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