Trials / Unknown
UnknownNCT05137860
Efficacy of the Use of Bortezomib for the Treatment of Relapsed Leukemia or Positive MRD
Efficacy of the Use of Bortezomib for the Treatment of Relapsed Leukemia or Positive Minimal Residual Disease
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 56 (estimated)
- Sponsor
- Hospital General de Mexico · Other Government
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
Summary
Various drugs have been added to different treatment regimens in order to improve the response rate in patients with Acute Lymphoblastic Leukemia, however, it has been shown that adding Bortezomib to the relapsing regimen improves the proportion of second complete remissions without increasing chemotherapy toxicity. Therefore, proteasome inhibitors can drastically modify the prognosis of patients, since their synergy with drugs such as steroids has positioned them as an attractive strategy.
Detailed description
Mortality associated with leukemia has decreased due to the use of various chemotherapy combinations, the addition of new agents, or the chemical modification of existing drugs. Despite advances in treatment, the prognosis in the adult population continues to be unfavorable. About 25% of the patients will be refractory to the first treatment regimen and the rest will have a disease-free survival below 40%. The chemotherapy intensity reduction strategy based on risk stratification according to Minimal Residual Disease (MRD) is a strategy used by various pediatric centers in order to detect patients at high risk of relapse.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bortezomib | Combination of Bortezomib with Standard Chemotherapy scheme for acute lymphoblastic patients in relapse. |
Timeline
- Start date
- 2021-12-12
- Primary completion
- 2022-12-22
- Completion
- 2023-06-23
- First posted
- 2021-11-30
- Last updated
- 2022-01-18
Locations
1 site across 1 country: Mexico
Source: ClinicalTrials.gov record NCT05137860. Inclusion in this directory is not an endorsement.