Acute Lymphoblastic Leukemia, in RelapsePhase 4NCT05137860
Efficacy of the Use of Bortezomib for the Treatment of Relapsed Leukemia or Positive MRD
A Phase 4 study testing Bortezomib in people with Acute Lymphoblastic Leukemia, in Relapse and Chemotherapeutic Toxicity, run by Hospital General de Mexico at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, in Relapse, Chemotherapeutic Toxicity, Minimal Residual Disease
- What is being tested?
- Bortezomib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteMexico
- Study dates
- 12 Dec 2021to 23 Jun 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with a confirmatory diagnosis of Acute Lymphoblastic Leukemia relapsed to bone marrow described with more than 5% blasts in bone marrow at any stage of treatment or positivity of minimal residual disease at any stage of treatment.
- Patients who have signed their informed consent from the institution for hospitalization, and accepted the performance of the bone marrow study, and the administration of chemotherapy.
Who cannot join
- Patients with a diagnosis of phenotypic leukemia or bilinear leukemia
- Patients treated only with palliative regimen or transfusion support
- Patients without the administration of prophylaxis to the central nervous system by intrathecal chemotherapy
- Patients with lymphoblastic leukemia with a positive Philadelphia chromosome
- Patients with severe comorbidities may put treatment therapy at risk.
- Patient with a history of cardiac toxicity or arrhythmias associated with treatment
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hospital General de México "Dr. Eduardo Liceaga"
Mexico City, 06720
Christian O Ramos Peñafiel, PhD, +52 55 2789 2000 ext. 2020, leukemiachop@hotmail.com
Adan G Gallardo-Rodriguez, MSc, +52 55 2789 2000 ext. 2020, nutriologo.agallardo8@gmail.com
About this study
Official title: Efficacy of the Use of Bortezomib for the Treatment of Relapsed Leukemia or Positive Minimal Residual Disease
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.
Read the 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
- Acute Lymphoblastic Leukemia, in Relapse, Chemotherapeutic Toxicity, Minimal Residual Disease
- Being tested
- Bortezomib
- Keywords
- Acute lymphoblastic leukemia, Bortezomib, Relapse, Minimal Residual Disease, Toxicity
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Neoplasm, Residual, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BortezomibDrug
Also called Intervention Group
Combination of Bortezomib with Standard Chemotherapy scheme for acute lymphoblastic patients in relapse.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care Group | No intervention | Each patient will receive their standard chemotherapy treatment for patients with relapsed Acute Lymphoblastic Leukemia based on the HyperCVAD scheme for a period of 12 weeks. Each chemotherapy cycle will be monitored by the health team corresponding to the Hematology service and the principal investigator. |
| Bortezomib Treatment Group | Experimental | Each patient will receive their standard chemotherapy treatment for patients with relapsed Acute Lymphoblastic Leukemia based on the HyperCVAD scheme in combination with Bortezomib for a period of 12 weeks. Each chemotherapy cycle will be monitored by the health team corresponding to the Hematology service and the principal investigator. Receives: Drug: Bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival Outcome
The event in which patient is discharge from Hospital stay.
Measured: 3 months
Hospital stay
Time in which patients stay in the Hospital before discharge
Measured: 3 months
Leukocytes count
Number of leukocytes found in peripheral blood at the end of each chemotherapy cycle
Measured: 3 months
Platelets count
Number of platelets found in peripheral blood at the end of each chemotherapy cycle
Measured: 3 months
Date of Remission
Time in which the patient completes remission
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start12 Dec 2021
- Primary completion22 Dec 2022 (estimated)
- Study completion23 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic Leukemia, in RelapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical Randomized Trial
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General de Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Christian Omar Ramos-Peñafiel, MD, PhD, Hospital General de Mexico
- Investigators
- Adolfo Martinez Tovar, PhD, Study director, Hospital General de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137860
- Sponsor's protocol ID
- HGMDI/21/204/03/67
- Status last verified
- Jan 2022
- First submitted
- 16 Nov 2021
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All participants and their information will be managed by intern investigators and will be kept secure for personal data protection according to Mexican laws.
Publications
Burton JD, Bamford RN, Peters C, Grant AJ, Kurys G, Goldman CK, Brennan J, Roessler E, Waldmann TA. A lymphokine, provisionally designated interleukin T and produced by a human adult T-cell leukemia line, stimulates T-cell proliferation and the induction of lymphokine-activated killer cells. Proc Natl Acad Sci U S A. 1994 May 24;91(11):4935-9. doi: 10.1073/pnas.91.11.4935.
PubMed 8197160Bertaina A, Vinti L, Strocchio L, Gaspari S, Caruso R, Algeri M, Coletti V, Gurnari C, Romano M, Cefalo MG, Girardi K, Trevisan V, Bertaina V, Merli P, Locatelli F. The combination of bortezomib with chemotherapy to treat relapsed/refractory acute lymphoblastic leukaemia of childhood. Br J Haematol. 2017 Feb;176(4):629-636. doi: 10.1111/bjh.14505. Epub 2017 Jan 24.
PubMed 28116786Horton TM, Whitlock JA, Lu X, O'Brien MM, Borowitz MJ, Devidas M, Raetz EA, Brown PA, Carroll WL, Hunger SP. Bortezomib reinduction chemotherapy in high-risk ALL in first relapse: a report from the Children's Oncology Group. Br J Haematol. 2019 Jul;186(2):274-285. doi: 10.1111/bjh.15919. Epub 2019 Apr 7.
PubMed 30957229
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Use of Bortezomib for the Treatment of Relapsed Leukemia or Positive Minimal Residual Disease
- ClinicalTrials.gov ID
- NCT05137860
- Acronym / sponsor ID
- HGMDI/21/204/03/67
- Conditions
- Acute Lymphoblastic Leukemia, in Relapse, Chemotherapeutic Toxicity, Minimal Residual Disease
- Keywords
- Acute lymphoblastic leukemia, Bortezomib, Relapse, Minimal Residual Disease, Toxicity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Hospital General de MexicoOther government
- Study start
- 12 Dec 2021 (actual)
- Primary completion
- 22 Dec 2022 (estimated)
- Study completion
- 23 Jun 2023 (estimated)
- First posted
- 30 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Clinical Randomized Trial
| Arm | Type | Receives |
|---|---|---|
| Standard Care Group | No intervention | –Each patient will receive their standard chemotherapy treatment for patients with relapsed Acute Lymphoblastic Leukemia based on the HyperCVAD scheme for a period of 12 weeks. Each chemotherapy cycle will be monitored by the health team corresponding to the Hematology service and the principal investigator. |
| Bortezomib Treatment Group | Experimental | Drug: BortezomibEach patient will receive their standard chemotherapy treatment for patients with relapsed Acute Lymphoblastic Leukemia based on the HyperCVAD scheme in combination with Bortezomib for a period of 12 weeks. Each chemotherapy cycle will be monitored by the health team corresponding to the Hematology service and the principal investigator. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with a confirmatory diagnosis of Acute Lymphoblastic Leukemia relapsed to bone marrow described with more than 5% blasts in bone marrow at any stage of treatment or positivity of minimal residual disease at any stage of treatment.
- Patients who have signed their informed consent from the institution for hospitalization, and accepted the performance of the bone marrow study, and the administration of chemotherapy.
Key exclusion criteria (6 listed)
- Patients with a diagnosis of phenotypic leukemia or bilinear leukemia
- Patients treated only with palliative regimen or transfusion support
- Patients without the administration of prophylaxis to the central nervous system by intrathecal chemotherapy
- Patients with lymphoblastic leukemia with a positive Philadelphia chromosome
- Patients with severe comorbidities may put treatment therapy at risk.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BortezomibAlso: Intervention GroupCombination of Bortezomib with Standard Chemotherapy scheme for acute lymphoblastic patients in relapse. | Drug | Bortezomib Treatment Group |
Primary outcome
Survival Outcome
Time frame: 3 months
The event in which patient is discharge from Hospital stay.
Hospital stay
Time frame: 3 months
Time in which patients stay in the Hospital before discharge
Leukocytes count
Time frame: 3 months
Number of leukocytes found in peripheral blood at the end of each chemotherapy cycle
Platelets count
Time frame: 3 months
Number of platelets found in peripheral blood at the end of each chemotherapy cycle
Date of Remission
Time frame: 3 month
Time in which the patient completes remission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
- Background: PubMed 8197160Burton JD, Bamford RN, Peters C, Grant AJ, Kurys G, Goldman CK, Brennan J, Roessler E, Waldmann TA. A lymphokine, provisionally designated interleukin T and produced by a human adult T-cell leukemia line, stimulates T-cell proliferation and the induction of lymphokine-activated killer cells. Proc Natl Acad Sci U S A. 1994 May 24;91(11):4935-9. doi: 10.1073/pnas.91.11.4935.
- Results publication: PubMed 28116786Bertaina A, Vinti L, Strocchio L, Gaspari S, Caruso R, Algeri M, Coletti V, Gurnari C, Romano M, Cefalo MG, Girardi K, Trevisan V, Bertaina V, Merli P, Locatelli F. The combination of bortezomib with chemotherapy to treat relapsed/refractory acute lymphoblastic leukaemia of childhood. Br J Haematol. 2017 Feb;176(4):629-636. doi: 10.1111/bjh.14505. Epub 2017 Jan 24.
- Results publication: PubMed 30957229Horton TM, Whitlock JA, Lu X, O'Brien MM, Borowitz MJ, Devidas M, Raetz EA, Brown PA, Carroll WL, Hunger SP. Bortezomib reinduction chemotherapy in high-risk ALL in first relapse: a report from the Children's Oncology Group. Br J Haematol. 2019 Jul;186(2):274-285. doi: 10.1111/bjh.15919. Epub 2019 Apr 7.
- Individual participant dataSharing planned: No. All participants and their information will be managed by intern investigators and will be kept secure for personal data protection according to Mexican laws.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adolfo Martinez Tovar, PhD study director
Hospital General de Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bortezomib in people with Acute Lymphoblastic Leukemia, in Relapse and Chemotherapeutic Toxicity, run by Hospital General de Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian O Ramos Peñafiel, PhD (+52 55 27892000 ext. 2020, leukemiachop@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival Outcome (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05137860, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.