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lintuzumab

Phase 2

Acute Myeloid Leukemia | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Jan 7, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment293

FDA Designations

No designations recorded

Clinical trial landscape

lintuzumab · 3 trials · 5 indications

Phase 2 1Phase 1 2
NCT00528333A Study of Lintuzumab (SGN-33) in Combination With Low Dose Cytarabine in Patients 60+ Years With AMLAcute Myeloid Leukemia
COMPLETED211 Analytics
PHASE2COMPLETED
A Study of Lintuzumab (SGN-33) in Combination With Low Dose Cytarabine in Patients 60+ Years With AML
Acute Myeloid LeukemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall survival
12 months
The incidence of adverse events and lab abnormalities
1 month after last dose
The incidence of adverse events and lab abnormalities.
13 months
Pharmacokinetic (PK) profile and immunogenicity (Human Anti-Human Antibody; HAHA).
13 months
Antitumor activity.
13 months

Secondary Endpoints

Complete blood counts (CBC), Transfusion Requirements, Infections or Fevers of Unknown Origin Requiring Hospitalization or IV Antibiotics
13 months
Antitumor activity
Every other 21-day cycle
Pharmacokinetic (PK) profile and immunogenicity (Human Anti-Human Antibody; HAHA)
1 month after last dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALLintuzumab plus low dose cytarabine
2ACTIVE_COMPARATORPlacebo plus low dose cytarabine

Interventions

NameTypeDescription
Lintuzumab (SGN-33)DRUG600 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.
Low dose cytarabineDRUG20 mg SC twice a day on days 1-10 of each 28 day cycle up to a maximum of 12 cycles.
PlaceboDRUGIV 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
lintuzumabDRUG4 or 8 mg/kg IV (in the vein) on Days 1, 8 and 15 for the first 21-day cycle; 4 or 8 mg/kg IV (in the vein) on Days 1 and 8 for the second through the eighth 21-day cycle
lenalidomideDRUG10 or 15 mg per day, taken orally on Days 1-14 of each 21-day cycle
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Eligibility Criteria

Age Range60 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites20

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 inten...

Countries:United States
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Frequently asked questions about lintuzumab

What is lintuzumab used for?

Lintuzumab is an investigational drug being studied for the treatment of Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML). It is in Phase 2 clinical development for these oncology indications. Lintuzumab is not approved by the FDA and remains under investigation.

Who makes lintuzumab?

Lintuzumab is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 2 clinical development for the treatment of Myelodysplastic Syndrome and Acute Myeloid Leukemia.

What phase is lintuzumab in?

Lintuzumab is in Phase 2 clinical development. It has completed two Phase 1 trials and one Phase 2 trial. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is lintuzumab in?

Lintuzumab has been studied in three completed clinical trials. NCT00283114 was a Phase 1 safety study in patients with Acute Myeloid Leukemia and Myelodysplastic Syndrome. NCT00502112 was a Phase 1 study combining lintuzumab with lenalidomide in MDS patients. NCT00528333 was a Phase 2 study combining lintuzumab with low dose cytarabine in AML patients aged 60 and older.

Is lintuzumab the same as SGN-33?

Yes, lintuzumab is also known as SGN-33. In clinical trial NCT00528333, the drug is referred to as lintuzumab (SGN-33). This alternative name may appear in older literature or trial records.