NCT06876701

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for early_phase_1

Timeline
8mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Apr 2025Apr 2027

First Submitted

Initial submission to the registry

March 10, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 14, 2025

Completed
18 days until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

March 14, 2025

Status Verified

March 1, 2025

Enrollment Period

2 years

First QC Date

March 10, 2025

Last Update Submit

March 10, 2025

Conditions

Acute Leukemia

Outcome Measures

Primary Outcomes (1)

  • Negative conversion rate of evaluable residual lesions (MRD)

    1 year

Study Arms (1)

Experimental group

EXPERIMENTAL
Drug: Bevacizumab

Interventions

BevacizumabDRUG

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

Experimental group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • The subject's previous history of anti-tumor treatment meets one of the following conditions:
  • Individuals who have previously received bevacizumab
  • Individuals who have received CAR-T therapy or other gene modified cell therapies prior to screening;
  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Zhaxin integrated hospital of traditional Chinese and Western Medicine

Shanghai, China

Location

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Central Study Contacts

Wang Chun

CONTACT

13386259777Zbruce.zhang@hotmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2025

First Posted

March 14, 2025

Study Start

April 1, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

March 14, 2025

Record last verified: 2025-03

Locations

CN(1)