Study Evaluating the Safety and Efficacy of Gemtuzumab Oz... | NCT00037583

Studies
Study Evaluating the Safety and Efficacy of Gemtuzumab Ozogamicin in Patients With Acute Myeloid Leukemia

NCT00037583

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Status

Completed

Last Update Posted

Aug 21, 2009Estimated

Enrollment

69Actual

Phase

Phase 2

Conditions

Acute Myeloid Leukemia

Interventions

Gemtuzumab Ozogamicin

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Not provided

Primary Completion Date

Sep 2003Actual

Completion Date

Sep 2003Actual

First Submitted Date

May 17, 2002

First Submission Date that Met QC Criteria

May 17, 2002

First Posted Date

May 20, 2002Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 20, 2009

Last Update Posted Date

Aug 21, 2009Estimated

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

69Actual

Name	Type	Description	Arm Group Labels	Other Names
Gemtuzumab Ozogamicin	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All adult patients with relapsed or refractory AML, as well as younger de novo AML patients are eligible for the study
Relapsed, refractory, and de novo AML patients are allowed in Phase I of this study
Phase II will only allow enrollment of younger de novo AML

Exclusion Criteria:

AML following an antecedent hematologic disorder (myelodysplasia or myeloproliferation) of greater than 2 months duration
De novo patients with M3 AML
AML secondary to exposure to chemotherapy or radiation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

59 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30062662	Derived	Hibma 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.

ID	Term
D015470	Leukemia, Myeloid, Acute
D007938	Leukemia

ID	Term
D007951	Leukemia, Myeloid
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases

ID	Term
D000080084	Calicheamicins
D000617	Aminoglycosides
D006027	Glycosides
D002241	Carbohydrates