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A Phase 1 Study of XmAb®5574 to Evaluate the Safety, Tolerability, and Pharmacokinetics in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

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Trial Information

A Phase 1 Study of XmAb®5574 to Evaluate the Safety, Tolerability, and Pharmacokinetics in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia


Inclusion Criteria:



- relapsed or refractory CLL/SLL

- at least 18 years of age

- able to receive outpatient treatment and follow-up at the treating institution

- completed all CLL therapies > 4 weeks prior to first study dose

Exclusion Criteria:

- previously treated with an anti-CD19 antibody therapy

- undergone prior allogeneic stem cell transplantation within 6 months or having active
graft versus host disease

- active Richter's syndrome

- designated Class III or IV by the New York Heart Association (NYHA) criteria

- history of myocardial infarction or stroke within the last 6 months

- active viral, bacterial, or systemic fungal infection requiring treatment

- HIV or Hepatitis C positive

- Hepatitis B infection

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the dose limiting toxicities

Outcome Time Frame:

28 days

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

XmAb5574-01

NCT ID:

NCT01161511

Start Date:

September 2010

Completion Date:

January 2013

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
  • CLL
  • SLL
  • CD19
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma

Name

Location

Medical College of GeorgiaAugusta, Georgia  30912
The Ohio State UniversityColumbus, Ohio  43210
Sarah Cannon Research InstituteNashville, Tennessee  37203