Clinical trial · Interventional

Study Evaluating Gemtuzumab Ozogamicin in Acute Myeloid Leukemia

A Dose Ranging Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (GO) Given in Combination With Cytarabine in Relapsed or Refractory Patients and Alder De Novo Patients With Acute Myeloid Leukemia.

NCT00037596CI-TRIAL-00009443completedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

The primary objectives are a) to establish the maximum tolerated dose of gemtuzumab ozogamicin in combination with cytarabine and b) to assess the safety of gemtuzumab ozogamicin when given concurrently with cytarabine.

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 (2)

Intervention	Type	Mapped drug	Match
cytarabine.	Drug	Cytarabine	ALIAS
Gemtuzumab Ozogamicin	Drug	Gemtuzumab Ozogamicin	ALIAS

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* Morphologic diagnosis of AML from bone marrow aspirate and biopsy
* Flow cytometry, performed at the study site, must demonstrate that the patient has AML that is CD33+, based on local laboratory criteria
* Age 18 years or older for relapsed or refractory patients for Phase I of this study

Exclusion Criteria:

* Patients with de novo AML of the M3 subtype
* AML following an antecedent hematologic disorder (myelodysplasia or myeloproliferation) of \> 2 months duration
* AML secondary to exposure to chemotherapy or radiation

References

Publications (1)

DERIVEDHibma J, Knight B. Population Pharmacokinetic Modeling of Gemtuzumab Ozogamicin in Adult Patients with Acute Myeloid Leukemia. Clin Pharmacokinet. 2019 Mar;58(3):335-347. doi: 10.1007/s40262-018-0699-5. PMID 30062662