Clinical trial · Interventional
A Study of Lintuzumab (SGN-33) in Combination With Low Dose Cytarabine in Patients 60+ Years With AML
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
NCT00528333CI-TRIAL-00016541completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lintuzumab (SGN-33) | Drug | — | UNRESOLVED |
| Low dose cytarabine | Drug | Cytarabine | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Lintuzumab plus low dose cytarabine
- interventionNames
- Drug: Lintuzumab (SGN-33)
- Drug: Low dose cytarabine
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Placebo plus low dose cytarabine
- interventionNames
- Drug: Low dose cytarabine
- Drug: Placebo
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
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).
References
Publications (1)
- RESULTSekeres MA, Lancet JE, Wood BL, Grove LE, Sandalic L, Sievers EL, Jurcic JG. Randomized phase IIb study of low-dose cytarabine and lintuzumab versus low-dose cytarabine and placebo in older adults with untreated acute myeloid leukemia. Haematologica. 2013 Jan;98(1):119-28. doi: 10.3324/haematol.2012.066613. Epub 2012 Jul 16. PMID 22801961