The Treatment of Newly Diagnosed CD19+Mixed Phenotype Acute Leukemia in Adults

March 10, 2025 updated by: Ruijin Hospital
Evaluation the efficacy and safety of the combination of injectable bevacizumab, low-intensity chemotherapy, and venula in the treatment of newly diagnosed CD19+mixed phenotype acute leukemia in adults

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Shanghai Zhaxin integrated hospital of traditional Chinese and Western Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients fully understand this study, voluntarily participate and sign an informed consent form (ICF);
  2. Age: 18-75 years old (including boundary values of 18 and 75);
  3. Clinically diagnosed adult Mixed Phenotype Acute Leukemia (WHO 2016 criteria) patients with CD19 positivity

Exclusion Criteria:

The subject's previous history of anti-tumor treatment meets one of the following conditions:

  1. Individuals who have previously received bevacizumab
  2. Individuals who have received CAR-T therapy or other gene modified cell therapies prior to screening;
  3. Within 5 half lives of the first use of the investigational drug, having received anti-tumor treatment including surgery, chemotherapy, targeted therapy, or participating in other clinical trials and receiving clinical trial medication;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Drug: Bevacizumab
Evaluation of the efficacy and safety of the combination of injectable bevacizumab, low-intensity chemotherapy, and venula in the treatment of newly diagnosed CD19+mixed phenotype acute leukemia in adults

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Negative conversion rate of evaluable residual lesions (MRD)
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

March 10, 2025

First Submitted That Met QC Criteria

March 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 10, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPC-DED-AML-KXX

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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