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Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed Acute Myeloid Leukemia (AML)

Primary Purpose

Acute Myeloid Leukemia

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

5-Azacitidine

Gemtuzumab ozogamicin

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring AML

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of Relapsed AML
Eastern Cooperative Oncology Group (ECOG) performance status 0-2, and life expectancy > 3 months
≥ 18 years old
Previously untreated for current AML relapse
Adequate organ function
Written informed consent

Exclusion Criteria:

Pregnant or breast-feeding women
Growth factors that support platelet or white cell number or function must not have been administered within the past 7 days
Currently receiving another investigational drug
Currently receiving other anti-cancer agents
Uncontrolled infection
HIV positive
Received previous therapy with either Mylotarg or 5-azacitidine

Sites / Locations

UCSD Moores Cancer Center
Stanford University
Northside Hospital/BMTGA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Phase 1 Dose Level 1

Phase 1 Dose Level 2

Phase I Dose Level 3

Phase 2 Dose Level 1

Arm Description

5-Azacitidine, Gemtuzumab ozogamicin 75 mg/m^2 5-Aza 2 days then GO at 3 mg/m^2

5-Azacitidine, Gemtuzumab ozogamicin 75mg/m^2 5-Aza for 4 days then GO at 6 mg/m^2

5-Azacitidine, Gemtuzumab ozogamicin 75 mg/m^2 5-Aza for 6 days then GO at 6 mg/m^2

Outcomes

Primary Outcome Measures

Number of Participants With Dose Limiting Toxicities

MTD was the maximum number of 5-azacitadine doses (75mg/m2) at which fewer than 1/3 of patients experienced a DLT during cycle 1 of therapy based on CTCAE Version 3.0. In the phase I portion, we assessed 3 dose levels of azacitidine starting on day 1, with 6, 4, and 4 patients in cohort 1, 2, and 3, respectively. We identified no dose-limiting toxicities and identified the phase 2 dose as 75 mg/m2 of 5-azacitadine for 6 days.

Secondary Outcome Measures

Number of Participants With Response to the Combination Treatment of Mylotarg With 5-azacitidine

Full Information

NCT ID

NCT00766116

First Posted

October 2, 2008

Last Updated

January 31, 2019

Sponsor

University of California, San Diego

Collaborators

Celgene Corporation, Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00766116

Brief Title

Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed Acute Myeloid Leukemia (AML)

Official Title

A Phase I/II Trial of the Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed AML

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

July 2005 (Actual)

Primary Completion Date

September 26, 2014 (Actual)

Study Completion Date

September 26, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, San Diego

Collaborators

Celgene Corporation, Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study will test an experimental combination of the drugs Mylotarg and 5-azacitidine in the hopes of finding a treatment that may be effective against Acute Myeloid Leukemia that has come back after treatment.

Detailed Description

In the Phase I portion of the study patients with a diagnosis of AML who have relapsed disease will be treated with an assigned number of doses of 5 azacitidine followed by Mylotarg administered two times over two weeks In the Phase II portion of the study patients will be treated with the dose of 5azacitidine determined to be safe in the Phase I portion of the study followed by Mylotarg. A sample of blood or bone marrow will be obtained prior to initiation of treatment and another sample obtained after treatment with 5-azacitidine but before Mylotarg and the samples will be tested in the laboratory to determine response to treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myeloid Leukemia

Keywords

AML

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Phase 1 Dose Level 1

Arm Type

Experimental

Arm Description

5-Azacitidine, Gemtuzumab ozogamicin 75 mg/m^2 5-Aza 2 days then GO at 3 mg/m^2

Arm Title

Phase 1 Dose Level 2

Arm Type

Experimental

Arm Description

5-Azacitidine, Gemtuzumab ozogamicin 75mg/m^2 5-Aza for 4 days then GO at 6 mg/m^2

Arm Title

Phase I Dose Level 3

Arm Type

Experimental

Arm Description

5-Azacitidine, Gemtuzumab ozogamicin 75 mg/m^2 5-Aza for 6 days then GO at 6 mg/m^2

Arm Title

Phase 2 Dose Level 1

Arm Type

Experimental

Arm Description

5-Azacitidine, Gemtuzumab ozogamicin 75 mg/m^2 5-Aza for 6 days then GO at 6 mg/m^2

Intervention Type

Drug

Intervention Name(s)

5-Azacitidine

Other Intervention Name(s)

Vidaz

Intervention Description

Given in cohorts of 3 starting with 2 doses of 5-azacitidine. The doses of 5-azacitidine will be escalated to 4 and then 6 doses if the dose escalation rules permit.

Intervention Type

Drug

Intervention Name(s)

Gemtuzumab ozogamicin

Other Intervention Name(s)

Mylotarg

Intervention Description

Mylotarg given 2 times over 2 weeks

Primary Outcome Measure Information:

Title

Number of Participants With Dose Limiting Toxicities

Description

Time Frame

up to 28 days

Secondary Outcome Measure Information:

Title

Number of Participants With Response to the Combination Treatment of Mylotarg With 5-azacitidine

Time Frame

Hematologic and Cytogeneic Response to treatment will be assessed when evaluated at the time the ANC has reached 1000/mm3 for three consecutive days, assessed up to 4 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of Relapsed AML Eastern Cooperative Oncology Group (ECOG) performance status 0-2, and life expectancy > 3 months ≥ 18 years old Previously untreated for current AML relapse Adequate organ function Written informed consent Exclusion Criteria: Pregnant or breast-feeding women Growth factors that support platelet or white cell number or function must not have been administered within the past 7 days Currently receiving another investigational drug Currently receiving other anti-cancer agents Uncontrolled infection HIV positive Received previous therapy with either Mylotarg or 5-azacitidine

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Edward D Ball, MD

Organizational Affiliation

UCSD

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCSD Moores Cancer Center

City

La Jolla

State/Province

California

ZIP/Postal Code

92093

Country

United States

Facility Name

Stanford University

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

Northside Hospital/BMTGA

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed Acute Myeloid Leukemia (AML)

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