T-lymphoblastic LymphomaPhase 2NCT05576532
Venetoclax Plus IM2 Regimen for Relapsed and Refractory T Lymphoblastic Lymphoma/Leukemia
A Phase 2 study testing BCL2 Inhibitor plus IM2 regimen in people with T-lymphoblastic Lymphoma and Relapsed Disease, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 45 years
- Conditions the study is for
- T-lymphoblastic Lymphoma, Relapsed Disease, Refractory Lymphoma
- What is being tested?
- BCL2 Inhibitor plus IM2 regimen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2023to 10 Oct 2025
- Phase
- Phase 2
- 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 14 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai General hospital,Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Xianmin G Song, +862163240090, shongxm@139.com
About this study
Official title: The Efficacy and Safety of Venetoclax Plus IM2 Regimen for Relapsed and Refractory T Lymphoblastic Lymphoma/Leukemia
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;
- Conditions
- T-lymphoblastic Lymphoma, Relapsed Disease, Refractory Lymphoma, Refractory Leukemia, Safety, Efficacy, Self
- Being tested
- BCL2 Inhibitor plus IM2 regimen
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Recurrence, Lymphoma, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCL2 Inhibitor plus IM2 regimenDrug
oral bcl-2 inhibitor plus IM2(Ifosfamide plus Mitoxantrone or Idarubicin plus methotrexate) chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| bcl-2 inhibitor plus IM2 regimen | Experimental | bcl-2 inhibitor plus IM2 regimen Receives: Drug: BCL2 Inhibitor plus IM2 regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate after 2 cycles of chemotherapy
complete response rate plus partial response rate
Measured: 2 months after chemotherapy
Overall response rate after 4 cycles of chemotherapy
complete response rate plus partial response rate
Measured: 4 months after chemotherapy
Grade 3-4 Adverse events incidence
Grade 3-4 Adverse events incidence
Measured: 28 days after chemotherapy
Secondary outcomes (2)
Overall survival
OS for patients enrolled
Measured: 12 months
Progression free survival
PFS for patients enrolled
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start10 Jan 2023
- Primary completion10 Oct 2024 (estimated)
- Study completion10 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-lymphoblastic LymphomaStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianmin Song, MD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Xianmin G Song, Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05576532
- Sponsor's protocol ID
- SHXYXY-2022-VEN-T-LBL
- Status last verified
- Jun 2023
- First submitted
- 9 Oct 2022
- Last updated
- 28 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Venetoclax Plus IM2 Regimen for Relapsed and Refractory T Lymphoblastic Lymphoma/Leukemia
- ClinicalTrials.gov ID
- NCT05576532
- Acronym / sponsor ID
- SHXYXY-2022-VEN-T-LBL
- Conditions
- T-lymphoblastic Lymphoma, Relapsed Disease, Refractory Lymphoma, Refractory Leukemia, Safety, Efficacy, Self
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 10 Oct 2024 (estimated)
- Study completion
- 10 Oct 2025 (estimated)
- First posted
- 12 Oct 2022 (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.
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;
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bcl-2 inhibitor plus IM2 regimen | Experimental | Drug: BCL2 Inhibitor plus IM2 regimenbcl-2 inhibitor plus IM2 regimen |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| BCL2 Inhibitor plus IM2 regimenoral bcl-2 inhibitor plus IM2(Ifosfamide plus Mitoxantrone or Idarubicin plus methotrexate) chemotherapy | Drug | bcl-2 inhibitor plus IM2 regimen |
Primary outcome
Overall response rate after 2 cycles of chemotherapy
Time frame: 2 months after chemotherapy
complete response rate plus partial response rate
Overall response rate after 4 cycles of chemotherapy
Time frame: 4 months after chemotherapy
complete response rate plus partial response rate
Grade 3-4 Adverse events incidence
Time frame: 28 days after chemotherapy
Grade 3-4 Adverse events incidence
2 secondary outcomes
Overall survival
Time frame: 12 months
Progression free survival
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
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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.
Xianmin G Song principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BCL2 Inhibitor plus IM2 regimen in people with T-lymphoblastic Lymphoma and Relapsed Disease, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 1 inclusion and 1 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 28 Jun 2023. 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 China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Xianmin G Song (+862163240090, shongxm@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate after 2 cycles of chemotherapy (time frame: 2 months after chemotherapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jun 2023.