Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID06754267

Venetoclax Combined With Olverembatinib and Predinisone in Treating Ph-positive Precursor B Cell Acute Lymphoblastic Leukemia A Phase II, Single-Arm, Multicenter Study

Led by First Affiliated Hospital of Zhejiang University · Updated on 2024-12-31

36

Participants Needed

1

Research Sites

160 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Precursor B cell acute lymphoblastic leukemia (B-ALL) is a fast-growing type of leukemia with a high chance of relapse and poor long-term survival in adults. Philadelphia chromosome positive (Ph+) ALL, caused by a specific chromosome translocation, is a common abnormality in this disease and accounts for about 30% of adult ALL cases. This research is a phase II, open-label study aiming to explore the safety and effectiveness of combining Venetoclax with Olverembatinib and Predinisone to improve survival outcomes for adults with newly diagnosed Ph+ B-ALL. Participants will receive a treatment regimen combining three drugs: Venetoclax, a BCL-2 inhibitor; Olverembatinib, a tyrosine kinase inhibitor; and Predinisone, a glucocorticoid. The study plans to enroll 36 participants to undergo this combination therapy in cycles lasting 28 days each, with the primary goal of assessing complete molecular response after three cycles. Throughout the study, participants will be closely monitored for treatment response and safety. Researchers will evaluate the molecular response at the end of the third treatment cycle to determine the level of disease control. The study includes assessments of participants' health status and side effects, with informed consent and ongoing follow-up to ensure safety and gather detailed information about the treatment effects.

CONDITIONS

Official Title

Venetoclax Combined With Olverembatinib and Predinisone in Treating Ph+ B-ALL

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with new precursor B-cell acute lymphoblastic leukemia positive for Philadelphia chromosome
  • Age 18 years or older
  • ECOG performance status score between 0 and 2
  • Expected survival time of at least 3 months
  • No organ dysfunction limiting use of study treatment
  • Able to understand the study and provide informed consent
  • Men and women of childbearing age must agree to use effective contraception during treatment and for 12 months after last dose
Not Eligible

You will not qualify if you...

  • Accelerated phase or blast crisis of chronic myeloid leukemia
  • Involvement of central nervous system or extramedullary lesions
  • Previous systemic anti-leukemia treatment except allowed pretreatment
  • History of myocardial infarction within 12 months or heart disease such as unstable angina, heart failure, uncontrolled hypertension, arrhythmia, or LVEF below 50%
  • Severe lung, liver, or kidney disease limiting trial participation
  • Other malignancies within last 5 years except localized thyroid or in situ skin cancer
  • Elevated liver enzymes, bilirubin, or creatinine above specified limits
  • Known HIV infection
  • Conditions preventing use of study drugs
  • Unable to understand or follow study protocol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310003

Actively Recruiting

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Research Team

J

Jie Jin, M.D.

C

Chenying Li, Ph.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Frequently Asked Questions

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Published Research Related To This Trial

Detection of MRD may predict the outcome of patients with Philadelphia chromosome-positive ALL treated with tyrosine kinase inhibitors plus chemotherapy.

Farhad Ravandi, Jeffrey L Jorgensen, Deborah A Thomas...

https://pubmed.ncbi.nlm.nih.gov/23836561

Nilotinib combined with multiagent chemotherapy for newly diagnosed Philadelphia-positive acute lymphoblastic leukemia.

Dae-Young Kim, Young-Don Joo, Sung-Nam Lim...

https://pubmed.ncbi.nlm.nih.gov/26065651

Prognostic factors for progression in patients with Philadelphia chromosome-positive acute lymphoblastic leukemia in complete molecular response within 3 months of therapy with tyrosine kinase inhibitors.

Koji Sasaki, Hagop M Kantarjian, Nicholas J Short...

https://pubmed.ncbi.nlm.nih.gov/33793964

A new chemotherapy-free regimen of olverembatinib in combination with venetoclax and dexamethasone for newly diagnosed Ph+ acute lymphoblastic leukemia: Preliminary outcomes of a prospective study.

Hailong Tang, Weijing Jia, Shuangshuang Jia...

https://pubmed.ncbi.nlm.nih.gov/38482543

Long-term follow-up of a phase 2 study of chemotherapy plus dasatinib for the initial treatment of patients with Philadelphia chromosome-positive acute lymphoblastic leukemia.

Farhad Ravandi, Susan M O'Brien, Jorge E Cortes...

https://pubmed.ncbi.nlm.nih.gov/26308885

Final report of a phase II study of imatinib mesylate with hyper-CVAD for the front-line treatment of adult patients with Philadelphia chromosome-positive acute lymphoblastic leukemia.

Naval Daver, Deborah Thomas, Farhad Ravandi...

https://pubmed.ncbi.nlm.nih.gov/25682595

UKALLXII/ECOG2993: addition of imatinib to a standard treatment regimen enhances long-term outcomes in Philadelphia positive acute lymphoblastic leukemia.

Adele K Fielding, Jacob M Rowe, Georgina Buck...

https://pubmed.ncbi.nlm.nih.gov/24277073