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Tests treatment safety and results for Acute Lymphobkastic Leukemia
Official title Efficacy of Low-dose Venetoclax With Itraconazole + TACL for R/R ALL Patients
ClinicalTrials.gov ID: NCT07039877
What this study is testing
What is Venetoclax low dose with itraconazole?
Venetoclax low dose with itraconazole is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for acute lymphobkastic leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Relapsed/refractory acute lymphoblastic leukemia remains a challenge in the context of limited access to immunotherapy in developing countries. With such poor 5-year overall survival rates of 10%, the investigators need strategies that surpass the complete response rate achieved in this setting, which does not exceed 60% effectiveness with different regimens, and to eventually transfer patients to hematopoietic stem cell transplantation.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 45
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Monterrey, Nuevo León, Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Monterrey, Nuevo León, Mexico. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.