Completed

Phase 2
Age: 60Years +
All Genders
ID00528333

A Phase IIB, Randomized, Double-Blinded, Placebo-Controlled Study of Low Dose Cytarabine and Lintuzumab Compared to Low Dose Cytarabine and Placebo in Patients 60 Years of Age and Older With Previously Untreated AML

Led by Seagen Inc. · Updated on 2015-01-07

211

Participants Needed

20

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to assess whether there is a survival benefit with lintuzumab given in combination with low dose cytarabine versus low dose cytarabine and placebo in patients with AML.

CONDITIONS

Brief Title

A Study of Lintuzumab (SGN-33) in Combination With Low Dose Cytarabine in Patients 60+ Years With AML

Who Can Participate

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Untreated AML that occurred de novo, after prior exposure to chemotherapy for a separate malignancy, or evolved from an antecedent hematologic disorder.
  • After being informed of the potential benefits and risks of available treatment options, patients must have declined intensive chemotherapy for AML.
  • At least 20% blasts in blood or marrow.
  • Must have a minimum of 50% leukemic blasts that express CD33.
  • ECOG performance status score of 0 to 2.
  • WBC less than 30,000/µL
Not Eligible

You will not qualify if you...

  • No known diagnosis of acute promyelocytic leukemia or chronic myeloid leukemia.
  • No other active systemic malignancies treated with chemotherapy within the last 12 months.
  • Must not have received previous chemotherapy (except hydroxyurea) for AML.
  • Must not have significantly abnormal kidney or liver disease.
  • Must not have known human immunodeficiency virus (HIV).

Trial Site Locations

Total: 20 locations

1

Southern Cancer Center

Mobile, Alabama, United States, 36608

Status Unknown

2

Tower Cancer Research Foundation

Beverly Hills, California, United States, 90210

Status Unknown

3

Glendale Memorial Hospital

Glendale, California, United States, 91204

Status Unknown

4

Kenmar Research Institute

Los Angeles, California, United States, 90057

Status Unknown

5

University of California Los Angeles

Los Angeles, California, United States, 90095-1678

Status Unknown

6

Bay Area Cancer Research Group

Pleasant Hill, California, United States, 94523

Status Unknown

7

University of Colorado Cancer Center

Aurora, Colorado, United States, 80045

Status Unknown

8

Lakeland Regional Cancer Center

Lakeland, Florida, United States, 33805

Status Unknown

9

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, United States, 33612

Status Unknown

10

Rush University Medical Center

Chicago, Illinois, United States, 60612

Status Unknown

11

Joliet Oncology-Hematology Associates

Joliet, Illinois, United States, 60435

Status Unknown

12

Michigan State University, Breslin Cancer Center

Lansing, Michigan, United States, 48910

Status Unknown

13

Billings Clinic Cancer Research

Billings, Montana, United States, 59101

Status Unknown

14

Northshore University Hospital, Monter Cancer Center

Lake Success, New York, United States, 11042

Status Unknown

15

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Status Unknown

16

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

Status Unknown

17

Western Pennsylvania Cancer Institute

Pittsburgh, Pennsylvania, United States, 15224

Status Unknown

18

Cancer Centers of the Carolinas

Greenville, South Carolina, United States, 29601

Status Unknown

19

University of Texas, MD Anderson Cancer Center

Houston, Texas, United States, 77030

Status Unknown

20

Gunderson Clinic

La Crosse, Wisconsin, United States, 54601

Status Unknown

Loading map...

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

A Study Evaluating Escalating Doses of 211^At-Labeled Anti-C...

Acute Lymphoblastic Leukemia

Actively Recruiting

1 location

Phase I Study of 225Ac-DOTA-Anti-CD38 Daratumumab with Fluda...

Acute Lymphoblastic Leukemia

Actively Recruiting

1 location

A Clinical Study to Evaluate the Safety and Efficacy of CLL1...

Acute Myeloid Leukemia

Actively Recruiting

1 location

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Randomized phase IIb study of low-dose cytarabine and lintuzumab versus low-dose cytarabine and placebo in older adults with untreated acute myeloid leukemia.

Mikkael A Sekeres, Jeffrey E Lancet, Brent L Wood...

https://pubmed.ncbi.nlm.nih.gov/22801961