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Efficacy of the Use of Bortezomib for the Treatment of Relapsed Leukemia or Positive MRD

Primary Purpose

Acute Lymphoblastic Leukemia, in Relapse, Chemotherapeutic Toxicity, Minimal Residual Disease

Status

Recruiting

Phase

Phase 4

Locations

Mexico

Study Type

Interventional

Intervention

Bortezomib

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia, in Relapse focused on measuring Acute lymphoblastic leukemia, Bortezomib, Relapse, Minimal Residual Disease, Toxicity

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

Hospital General de México "Dr. Eduardo Liceaga"Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Care Group

Bortezomib Treatment Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Survival Outcome

The event in which patient is discharge from Hospital stay.

Hospital stay

Time in which patients stay in the Hospital before discharge

Leukocytes count

Number of leukocytes found in peripheral blood at the end of each chemotherapy cycle

Platelets count

Number of platelets found in peripheral blood at the end of each chemotherapy cycle

Date of Remission

Time in which the patient completes remission

Secondary Outcome Measures

Full Information

NCT ID

NCT05137860

First Posted

November 16, 2021

Last Updated

January 2, 2022

Sponsor

Hospital General de Mexico

1. Study Identification

Unique Protocol Identification Number

NCT05137860

Brief Title

Efficacy of the Use of Bortezomib for the Treatment of Relapsed Leukemia or Positive MRD

Official Title

Efficacy of the Use of Bortezomib for the Treatment of Relapsed Leukemia or Positive Minimal Residual Disease

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 12, 2021 (Actual)

Primary Completion Date

December 22, 2022 (Anticipated)

Study Completion Date

June 23, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital General de Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Lymphoblastic Leukemia, in Relapse, Chemotherapeutic Toxicity, Minimal Residual Disease

Keywords

Acute lymphoblastic leukemia, Bortezomib, Relapse, Minimal Residual Disease, Toxicity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Clinical Randomized Trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard Care Group

Arm Type

No Intervention

Arm Description

Arm Title

Bortezomib Treatment Group

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Bortezomib

Other Intervention Name(s)

Intervention Group

Intervention Description

Combination of Bortezomib with Standard Chemotherapy scheme for acute lymphoblastic patients in relapse.

Primary Outcome Measure Information:

Title

Survival Outcome

Description

The event in which patient is discharge from Hospital stay.

Time Frame

3 months

Title

Hospital stay

Description

Time in which patients stay in the Hospital before discharge

Time Frame

3 months

Title

Leukocytes count

Description

Number of leukocytes found in peripheral blood at the end of each chemotherapy cycle

Time Frame

3 months

Title

Platelets count

Description

Number of platelets found in peripheral blood at the end of each chemotherapy cycle

Time Frame

3 months

Title

Date of Remission

Description

Time in which the patient completes remission

Time Frame

3 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christian O Ramos Peñafiel, PhD

Phone

+52 55 27892000

Ext

2020

leukemiachop@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Adan G Gallardo Rodriguez, MSc

Phone

+52 55 27892000

Ext

2020

nutriologo.agallardo8@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adolfo Martinez Tovar, PhD

Organizational Affiliation

Hospital General de Mexico

Official's Role

Study Director

Facility Information:

Facility Name

Hospital General de México "Dr. Eduardo Liceaga"

City

Mexico City

ZIP/Postal Code

06720

Country

Mexico

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christian O Ramos Peñafiel, PhD

Phone

+52 55 2789 2000

Ext

2020

leukemiachop@hotmail.com

First Name & Middle Initial & Last Name & Degree

Adan G Gallardo-Rodriguez, MSc

Phone

+52 55 2789 2000

Ext

2020

nutriologo.agallardo8@gmail.com

First Name & Middle Initial & Last Name & Degree

Carlos Martínez Murillo, PhD

First Name & Middle Initial & Last Name & Degree

Humberto Castellanos Sinco, PhD

First Name & Middle Initial & Last Name & Degree

Odín de la Mora Estrada, PhD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

All participants and their information will be managed by intern investigators and will be kept secure for personal data protection according to Mexican laws.

Citations:

PubMed Identifier

8197160

Citation

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.

Results Reference

background

PubMed Identifier

28116786

Citation

Bertaina 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 Reference

result

PubMed Identifier

30957229

Citation

Horton 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.

Results Reference

result

Learn more about this trial

Efficacy of the Use of Bortezomib for the Treatment of Relapsed Leukemia or Positive MRD

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