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Venetoclax Plus IM2 Regimen for Relapsed and Refractory T Lymphoblastic Lymphoma/Leukemia

Primary Purpose

T-lymphoblastic Lymphoma, Relapsed Disease, Refractory Lymphoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
BCL2 Inhibitor plus IM2 regimen
Sponsored by
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for T-lymphoblastic Lymphoma

Eligibility Criteria

14 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

Fourteen to 45 Years Old, Male and female; Expected survival > 12 weeks; ECOG score 0-2; Confirmed diagnosis of T lymphoblastic lymphoma: a. Patients who do not get a PR with ≥2 induction chemotherapy or a CR with ≥ 4 induction chemotherapy b. Relapsed patients c. For any Patients who failed ASCT/allo-SCT d.The disease can be assessed (BM or CT scan) Confirmed diagnosis of acute T lymphoblastic leukemia (disease involved in BM, and no signs of lymph nodes or mass involvement): Patients who do not get a CR with ≥2 prior induction therapy such as Hyper-A and B regimens. b. relapsed after CR with chemotherapy c. For any Patients failed ASCT/allo-SCT Liver, kidney, and cardiopulmonary functions meet the following requirements: a. Ccr≥60mL/min(Cockcroft Gault) b. Left ventricular ejection fraction >50%; c.Baseline oxygen saturation>92%; d. Total bilirubin ≤ 1.5×ULN; e. ALT and AST≤ 3×ULN; Able to understand and sign the Informed Consent

Exclusion Criteria:

Malignant tumors other than T cell malignancies within 5 years prior to screening, in addition, to adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection, and ductal carcinoma in situ after radical resection; Uncontrolled infection including bacterial or virus or fungal disease; patients with positive HBsAg or HBcAb and positive peripheral blood HBV DNA titer detection; HCV antibody positive and peripheral blood HCV RNA positive; HIV antibody positive; syphilis positive; Any instability of systemic disease, including but not limited to unstable angina, cerebrovascular accident, transient cerebral ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York heart association (NYHA) classification ≥ III), need drug therapy of severe arrhythmia, liver, kidney, or metabolic disease; Any uncontrolled disease may affect entry Current or history of CNS involvement by malignancy.Known history or presence of clinically relevant central nervous system (CNS) pathology.Patients with a known history or prior diagnosis of other immunologic or inflammatory disease affecting the CNS (such as epilepsy) Pregnant or lactating woman, and a female subject who plans to have a pregnancy within 1 year after cell transfusion, or male subject whose partner plans to have a pregnancy within 1 year after cell transfusion; Active or uncontrollable infection requiring systemic therapy Known be allergic to Venetoclax or Ifosfamide or Mitoxantrone or Idarubicin or methotrexate The investigators consider other conditions unsuitable for enrollment. Early relapse(time from the end of IM2 regimen to relapse within 6 months ) post- or refractory to IM2 chemotherapy Patients who may not be able to sign the Informed Consent due to disease,or who do not understand or unwillingness or inability to comply with research requirements

Sites / Locations

  • Shanghai General hospital,Shanghai Jiao Tong University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

bcl-2 inhibitor plus IM2 regimen

Arm Description

bcl-2 inhibitor plus IM2 regimen

Outcomes

Primary Outcome Measures

Overall response rate after 2 cycles of chemotherapy
complete response rate plus partial response rate
Overall response rate after 4 cycles of chemotherapy
complete response rate plus partial response rate
Grade 3-4 Adverse events incidence
Grade 3-4 Adverse events incidence

Secondary Outcome Measures

Overall survival
OS for patients enrolled
Progression free survival
PFS for patients enrolled

Full Information

First Posted
October 9, 2022
Last Updated
June 27, 2023
Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05576532
Brief Title
Venetoclax Plus IM2 Regimen for Relapsed and Refractory T Lymphoblastic Lymphoma/Leukemia
Official Title
The Efficacy and Safety of Venetoclax Plus IM2 Regimen for Relapsed and Refractory T Lymphoblastic Lymphoma/Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2023 (Actual)
Primary Completion Date
October 10, 2024 (Anticipated)
Study Completion Date
October 10, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
To evaluate the safety and efficacy of Venetoclax plus IM2 regimen for relapsed and refractory T lymphoblastic lymphoma/leukemia. Dosage of Venetoclax:100mg/d-400mg/d(dose adjustment when concomitant used with CYP3A inhibitor) for 1-28 days (at least 7 days); IM2 regimen: Ifosfamide 1-1.5g/m2/d for 5 days; Mitoxantrone 6-8g/m2/d for 3 days( or Liposome mitoxantrone 20mg/m2 d1 or Idarubicin 6-8mg/m2/d for 3 days) ;methotrexate 1-1.5g/m2/d for 1 day;

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
T-lymphoblastic Lymphoma, Relapsed Disease, Refractory Lymphoma, Refractory Leukemia, Safety, Efficacy, Self

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
bcl-2 inhibitor plus IM2 regimen
Arm Type
Experimental
Arm Description
bcl-2 inhibitor plus IM2 regimen
Intervention Type
Drug
Intervention Name(s)
BCL2 Inhibitor plus IM2 regimen
Intervention Description
oral bcl-2 inhibitor plus IM2(Ifosfamide plus Mitoxantrone or Idarubicin plus methotrexate) chemotherapy
Primary Outcome Measure Information:
Title
Overall response rate after 2 cycles of chemotherapy
Description
complete response rate plus partial response rate
Time Frame
2 months after chemotherapy
Title
Overall response rate after 4 cycles of chemotherapy
Description
complete response rate plus partial response rate
Time Frame
4 months after chemotherapy
Title
Grade 3-4 Adverse events incidence
Description
Grade 3-4 Adverse events incidence
Time Frame
28 days after chemotherapy
Secondary Outcome Measure Information:
Title
Overall survival
Description
OS for patients enrolled
Time Frame
12 months
Title
Progression free survival
Description
PFS for patients enrolled
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Fourteen to 45 Years Old, Male and female; Expected survival > 12 weeks; ECOG score 0-2; Confirmed diagnosis of T lymphoblastic lymphoma: a. Patients who do not get a PR with ≥2 induction chemotherapy or a CR with ≥ 4 induction chemotherapy b. Relapsed patients c. For any Patients who failed ASCT/allo-SCT d.The disease can be assessed (BM or CT scan) Confirmed diagnosis of acute T lymphoblastic leukemia (disease involved in BM, and no signs of lymph nodes or mass involvement): Patients who do not get a CR with ≥2 prior induction therapy such as Hyper-A and B regimens. b. relapsed after CR with chemotherapy c. For any Patients failed ASCT/allo-SCT Liver, kidney, and cardiopulmonary functions meet the following requirements: a. Ccr≥60mL/min(Cockcroft Gault) b. Left ventricular ejection fraction >50%; c.Baseline oxygen saturation>92%; d. Total bilirubin ≤ 1.5×ULN; e. ALT and AST≤ 3×ULN; Able to understand and sign the Informed Consent Exclusion Criteria: Malignant tumors other than T cell malignancies within 5 years prior to screening, in addition, to adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection, and ductal carcinoma in situ after radical resection; Uncontrolled infection including bacterial or virus or fungal disease; patients with positive HBsAg or HBcAb and positive peripheral blood HBV DNA titer detection; HCV antibody positive and peripheral blood HCV RNA positive; HIV antibody positive; syphilis positive; Any instability of systemic disease, including but not limited to unstable angina, cerebrovascular accident, transient cerebral ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York heart association (NYHA) classification ≥ III), need drug therapy of severe arrhythmia, liver, kidney, or metabolic disease; Any uncontrolled disease may affect entry Current or history of CNS involvement by malignancy.Known history or presence of clinically relevant central nervous system (CNS) pathology.Patients with a known history or prior diagnosis of other immunologic or inflammatory disease affecting the CNS (such as epilepsy) Pregnant or lactating woman, and a female subject who plans to have a pregnancy within 1 year after cell transfusion, or male subject whose partner plans to have a pregnancy within 1 year after cell transfusion; Active or uncontrollable infection requiring systemic therapy Known be allergic to Venetoclax or Ifosfamide or Mitoxantrone or Idarubicin or methotrexate The investigators consider other conditions unsuitable for enrollment. Early relapse(time from the end of IM2 regimen to relapse within 6 months ) post- or refractory to IM2 chemotherapy Patients who may not be able to sign the Informed Consent due to disease,or who do not understand or unwillingness or inability to comply with research requirements
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xianmin G Song
Phone
+862163240090
Email
shongxm@139.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xianmin G Song
Organizational Affiliation
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai General hospital,Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xianmin G Song
Phone
+862163240090
Email
shongxm@139.com

12. IPD Sharing Statement

Learn more about this trial

Venetoclax Plus IM2 Regimen for Relapsed and Refractory T Lymphoblastic Lymphoma/Leukemia

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