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

Sponsor

Seagen Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00528333

Collaborator

(none)

211

Enrollment

Locations

Arms

Duration (Months)

10.6

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia	Drug: Lintuzumab (SGN-33) Drug: Low dose cytarabine Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

211 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2007

Actual Primary Completion Date :

Aug 1, 2010

Actual Study Completion Date :

Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Lintuzumab plus low dose cytarabine	Drug: Lintuzumab (SGN-33) 600 mg IV on days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent 28-day cycle up to a maximum of 12 cycles. Other Names: SGN-33 Drug: Low dose cytarabine 20 mg SC twice a day on days 1-10 of each 28 day cycle up to a maximum of 12 cycles. Other Names: Ara-C, Cytosar
Active Comparator: 2 Placebo plus low dose cytarabine	Drug: Low dose cytarabine 20 mg SC twice a day on days 1-10 of each 28 day cycle up to a maximum of 12 cycles. Other Names: Ara-C, Cytosar Drug: Placebo IV administration on days 1, 8, 15, and 22 of cycle 1 and days 1 and 15 of each subsequent 28-day cycle up to a maximum of 12 cycles

Arm

Intervention/Treatment

Experimental: 1

Lintuzumab plus low dose cytarabine

Drug: Lintuzumab (SGN-33)

600 mg IV on days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent 28-day cycle up to a maximum of 12 cycles.

Other Names:

SGN-33

Drug: Low dose cytarabine

20 mg SC twice a day on days 1-10 of each 28 day cycle up to a maximum of 12 cycles.

Other Names:

Ara-C, Cytosar

Active Comparator: 2

Placebo plus low dose cytarabine

Drug: Low dose cytarabine

20 mg SC twice a day on days 1-10 of each 28 day cycle up to a maximum of 12 cycles.

Other Names:

Ara-C, Cytosar

Drug: Placebo

IV administration on days 1, 8, 15, and 22 of cycle 1 and days 1 and 15 of each subsequent 28-day cycle up to a maximum of 12 cycles

Outcome Measures

Primary Outcome Measures

Overall survival [12 months]

Secondary Outcome Measures

Complete blood counts (CBC), Transfusion Requirements, Infections or Fevers of Unknown Origin Requiring Hospitalization or IV Antibiotics [13 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southern Cancer Center	Mobile	Alabama	United States	36608
2	Tower Cancer Research Foundation	Beverly Hills	California	United States	90210
3	Glendale Memorial Hospital	Glendale	California	United States	91204
4	Kenmar Research Institute	Los Angeles	California	United States	90057
5	University of California Los Angeles	Los Angeles	California	United States	90095-1678
6	Bay Area Cancer Research Group	Pleasant Hill	California	United States	94523
7	University of Colorado Cancer Center	Aurora	Colorado	United States	80045
8	Lakeland Regional Cancer Center	Lakeland	Florida	United States	33805
9	H. Lee Moffitt Cancer Center & Research Institute	Tampa	Florida	United States	33612
10	Rush University Medical Center	Chicago	Illinois	United States	60612
11	Joliet Oncology-Hematology Associates	Joliet	Illinois	United States	60435
12	Michigan State University, Breslin Cancer Center	Lansing	Michigan	United States	48910
13	Billings Clinic Cancer Research	Billings	Montana	United States	59101
14	Northshore University Hospital, Monter Cancer Center	Lake Success	New York	United States	11042
15	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
16	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
17	Western Pennsylvania Cancer Institute	Pittsburgh	Pennsylvania	United States	15224
18	Cancer Centers of the Carolinas	Greenville	South Carolina	United States	29601
19	University of Texas, MD Anderson Cancer Center	Houston	Texas	United States	77030
20	Gunderson Clinic	La Crosse	Wisconsin	United States	54601