Recruiting PHASE2 Precursor Cell Lymphoblastic Leukemia-Lymphoma

Tests treatment safety and results for Precursor Cell Lymphoblastic Leukemia-Lymphoma

Official title Efficacy and Safety of Low-dose Chemotherapy Plus Immuno-targeted Drugs in Newly Diagnosed Adult Ph- B-ALL

ClinicalTrials.gov ID: NCT06387121

What this study is testing

What is Vincristine?

Vincristine is an investigational medicine, being studied as a potential treatment for precursor cell lymphoblastic leukemia-lymphoma.

Also referred to as VCR.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
In the treatment of Ph-negative (Ph-) B-cell acute lymphoblastic leukemia (B-ALL) among adult patients, therapeutic outcomes remain suboptimal despite advances in chemotherapy and immunotherapy. A subset of adults with Ph- B-ALL have comorbidities or physiological limitations that preclude the safe administration of intensive regimens.
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Newly diagnosed Ph-negative B-cell acute lymphoblastic leukemia according to World Health Organization (WHO) 2016 criteria
  • CD22 positive tumor cells
  • ≥18 years of age
  • Estimated survival ≥3 months
  • Consent and effective contraception for men and women of childbearing potential

You likely can't join if

  • Burkitt lymphoma/leukemia
  • acute leukemias of ambiguous lineage
  • pregnant women
  • severe uncontrolled active infection
  • previous history of chronic liver disease (e.g. cirrhosis) or venous occlusive liver disease (VOD) or sinus obstruction syndrome (SOS)
  • History of clinically significant ventricular arrhythmia, syncope of unknown origin (not vasovagal) or sinoatrial block or higher degree...
See the full eligibility criteria
Who can join
  • Newly diagnosed Ph-negative B-cell acute lymphoblastic leukemia according to World Health Organization (WHO) 2016 criteria
  • CD22 positive tumor cells
  • ≥18 years of age
  • Estimated survival ≥3 months
  • Consent and effective contraception for men and women of childbearing potential
  • Understanding and signing of informed consent forms and agreement to comply with study requirements.
What rules you out
  • Burkitt lymphoma/leukemia
  • acute leukemias of ambiguous lineage
  • pregnant women
  • severe uncontrolled active infection
  • previous history of chronic liver disease (e.g. cirrhosis) or venous occlusive liver disease (VOD) or sinus obstruction syndrome (SOS)
  • History of clinically significant ventricular arrhythmia, syncope of unknown origin (not vasovagal) or sinoatrial block or higher degree atrioventricular (AV) block Chronic bradycardia state (unless permanent pacemaker...
  • New or chronic hepatitis B or C infection (positive for hepatitis B surface antigen and anti-hepatitis C antibody, respectively) or known HIV seropositivity. HIV testing may need to be performed according to local...
  • Psychiatric disorders likely to prevent the subject from completing treatment or informed consent
  • Other conditions considered unsuitable for the study by the investigator.

The study team makes the final eligibility decision.

Where it's taking place

  • Tianjin, Tianjin Municipality, China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.