Other Clinical Trial - Feasibility Study to Evaluate Outpatient

Feasibility Study to Evaluate Outpatient Blinatumomab in Subjects With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL)

B-precursor Acute Lymphoblastic Leukemia Clinical Trial

Official title:
A Phase 4, Multi-center Open-label Feasibility Study to Evaluate Outpatient Blinatumomab Administration in Adult Subjects With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL) in Complete Hematologic Remission

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

B-precursor Acute Lymphoblastic Leukemia
Leukemia
Leukemia, Lymphoid
Neoplasm, Residual
Precursor Cell Lymphoblastic Leukemia-Lymphoma

See also
	Status	Clinical Trial	Phase
	Recruiting	`NCT04601584` - GNR-084 Safety and Pharmacological Characteristics in Refractory or Relapse B-cell Precursor ALL	Phase 1/Phase 2
	Completed	`NCT03123887` - Evaluate the Hematological Remission Rates and Survival Among Chinese Adult Patients With B-precursor ALL	N/A

See also

Status

Clinical Trial

Phase

Recruiting

NCT04601584 - GNR-084 Safety and Pharmacological Characteristics in Refractory or Relapse B-cell Precursor ALL

Phase 1/Phase 2

Completed

NCT03123887 - Evaluate the Hematological Remission Rates and Survival Among Chinese Adult Patients With B-precursor ALL

N/A

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT04506086
Study type	Interventional
Source	Amgen
Contact	Amgen Call Center
Phone	866-572-6436
Email	medinfo@amgen.com
Status	Recruiting
Phase	Phase 4
Start date	August 26, 2021
Completion date	December 28, 2025

Feasibility Study to Evaluate Outpatient Blinatumomab in Subjects With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms