Phase I/II Study of Mitoxantrone, Etoposide and Gemtuzuma... | NCT00660036

Studies
Phase I/II Study of Mitoxantrone, Etoposide and Gemtuzumab Ozogamicin for Acute Myeloid Leukemia

NCT00660036

Sponsor

University of Pittsburgh

Status

Terminated

Last Update Posted

Jan 15, 2016Estimated

Enrollment

5Actual

Phase

Phase 1

Conditions

Acute Myeloid Leukemia

Interventions

Gemtuzumab ozogamicin
Mitoxantrone
Etoposide

Countries

United States

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

Jan 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

due to new safety information

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Apr 2011Actual

Completion Date

Apr 2011Actual

First Submitted Date

Apr 11, 2008

First Submission Date that Met QC Criteria

Apr 11, 2008

First Posted Date

Apr 17, 2008Estimated

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

Jan 14, 2016

Last Update Posted Date

Jan 15, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to investigate the combination of gemtuzumab ozogamicin, mitoxantrone and etoposide as second line therapy in patients with acute myeloid leukemia.

Detailed Description

The combination of mitoxantrone and etoposide is an active regimen in refractory/relapsed AML patients. In order to improve the efficacy of mitoxantrone and etoposide as second line therapy in patients with AML we proposed to conduct a phase I/II clinical trial combining gemtuzumab ozogamicin with mitoxantrone and etoposide. The phase I portion of the trial will determine the maximum tolerated dose of gemtuzumab ozogamicin combined with mitoxantrone and etoposide and the phase II portion of the trial will determine the efficacy and safety of the combined regimen in patients with AML.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gemtuzumab ozogamicin/Mitoxantrone/Etoposide	Experimental		Drug: Gemtuzumab ozogamicin Drug: Mitoxantrone Drug: Etoposide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gemtuzumab ozogamicin	Drug	On Day 6 of an inpatient hospital stay: Based on the study design patients will be treated with one of three doses (3 mg/m^2, 6 mg/m^2 or 9 mg/m^2), administered intravenously in 100 ml of 0.9% sodium chloride over 2 hours.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the toxicity and response rate of the combination therapy of mitoxantrone, etoposide and gemtuzumab ozogamicin as second line therapy in patients with acute myeloid leukemia (AML).		Bone marrow biopsy and aspiration 14 days after gemtuzumab ozogamicin administration, to evaluate response to the study drug regimen.

Secondary Outcomes

Measure	Description	Time Frame
To assess the overall survival in patients with AML treated with the combination of mitoxantrone, etoposide and gemtuzumab ozogamicin.		Indefinite; subjects are followed for survival.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Able to understand and have the ability to provide written consent
Between 18 and 70 years of age
Patients with CD33 positive (determined as CD33 expression in ≥ 20% of leukemic blasts) de novo AML that did not respond to first line induction therapy
ECOG Performance Status of 0-2
Patients must have the following laboratory values within 48 hours prior to beginning protocol treatment: Serum creatinine ≤ 1.5 mg/ml and calculated creatinine clearance ≥ 50mL/min (using the Cockcroft-Gault equation); AST ≤ 59 IU/L; ALT ≤ 72 IU/L; Total bilirubin ≤ 1.3 mg/ml; Note: Hematologic abnormalities will not be used as a criteria for entry or exclusion.
Patients must have left ventricular ejection fraction (LVEF) ≥50%
Females of child-bearing potential must have a negative pregnancy test during screening and all subjects must agree to use an effective method of contraception.

Exclusion Criteria:

Patients with acute promyelocytic leukemia
Prior use of mitoxantrone or etoposide or gemtuzumab ozogamicin
Antecedent hematologic disorder preceding initial presentation of AML or therapy related AML
History of thromboembolic event within the past 12 months
Hepatitis B or C or HIV positive serology
Symptomatic central nervous system (CNS) involvement
History of congestive heart failure
Myocardial infarction in the past 6 months
Uncontrolled, life-threatening infection that is not responding to antimicrobial therapy
History of psychiatric disorder which may compromise compliance with the protocol or which does not allow for appropriate informed consent
Patient may not be receiving any other anti neoplastic investigational agents
INR> 1.5 or patient is receiving systemic anticoagulation (e.g warfarin)
Patient undergone autologous or allogeneic stem cell transplantation
Other active malignancies except for non-melanoma skin cancer or cervical intraepithelial neoplasia
Women who are pregnant or breastfeeding.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D015470	Leukemia, Myeloid, Acute
D012008	Recurrence

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

ID	Term
D000080084	Calicheamicins
D000617	Aminoglycosides
D006027	Glycosides
D002241	Carbohydrates