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Blinatumomab Followed by High-dose Chemotherapy for Ph-negative Acute Lymphoblastic Leukemia (ALL)

NCT04554485 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2024-04-04

No results posted yet for this study

Summary

This is a phase II interventional trial to evaluate the efficacy of blinatumomab followed by high-dose chemotherapy in the first-line treatment for Ph-negative acute lymphoblastic leukemia (ALL) in adults. The aim is to increase the number of complete molecular responses after first two cycles of therapy. Early molecular response is considered to be the most powerful prognostic factor in ALL. Thus, a higher proportion of early molecular responses should translate into improved survival and fewer indications for allogeneic stem cell transplants

Conditions

  • Lymphoblastic Leukemia, Acute, Adult
  • Ph Negative ALL
  • Newly Diagnosed

Interventions

DRUG

Blinatumomab

Single cycle of blinatumomab followed by high-dose chemotherapy in the induction therapy for Ph-negative acute lymphoblastic leukemia in adults

Sponsors & Collaborators

  • CZECRIN - Czech Clinical Research Infrastructure Network

    collaborator UNKNOWN

  • Institute of Hematology and Blood Transfusion, Czech Republic

    lead OTHER

Principal Investigators

  • Cyril Salek, MD · Institute of Hematology and Blood Transfusion, Czech Republic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-09
Primary Completion
2024-02-29
Completion
2024-02-29

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04554485 on ClinicalTrials.gov