Open-label Study of IMGN779 in Adult Patients With Relaps... | NCT02674763

Studies
Open-label Study of IMGN779 in Adult Patients With Relapsed/Refractory CD33-positive Acute Myeloid Leukemia

NCT02674763

Sponsor

ImmunoGen, Inc.

Status

Completed

Last Update Posted

Sep 4, 2019Actual

Enrollment

62Actual

Phase

Phase 1

Conditions

Acute Myeloid Leukemia

Interventions

IMGN779

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

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016Actual

Primary Completion Date

Jun 2019Actual

Completion Date

Jul 2019Actual

First Submitted Date

Feb 1, 2016

First Submission Date that Met QC Criteria

Feb 2, 2016

First Posted Date

Feb 4, 2016Estimated

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

Sep 3, 2019

Last Update Posted Date

Sep 4, 2019Actual

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

This is an open label, multicenter Phase 1 study to determine the MTD, dosing schedule and RP2D of IMGN779 when administered as mono-therapy to adult AML patients with CD33 -positive disease.

Detailed Description

In the Dose Escalation Phase, patients will be assigned to one of three schedules. The MTD for all schedules will be determined from the assessment of Dose Limiting Toxicities (DLTs). The Dose Expansion Phase will consist of one cohort based on patients response to prior therapy according to the MTD selected.

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

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dose Escalation Schedule A	Experimental	IMGN779 administered on days 1 and 15 of a 28-day cycle	Drug: IMGN779
Dose Escalation Schedule B	Experimental	IMGN779 administered on days 1, 8, 15 and 22 of a 28-day cycle	Drug: IMGN779
Dose Escalation Schedule C	Experimental	IMGN779 administered on days 1 and 8 of a 21-day cycle	Drug: IMGN779
Dose Expansion Cohort	Experimental	Patients with Relapsed AML; IMGN779 administered at dose and schedule selected as the putative RP2D.	Drug: IMGN779

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IMGN779	Drug		Dose Escalation Schedule A Dose Escalation Schedule B Dose Escalation Schedule C Dose Expansion Cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum Tolerated Dose (MTD) of IMGN779		28 days

Secondary Outcomes

Measure	Description	Time Frame
Treatment emergent adverse events		Up to 12 months
Objective Response Rate (ORR) (complete response [CR= CR+CRp+CRi]+partial remission [PR])		Up to 12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Dose Escalation: Patients with relapsed or refractory AML
Dose Expansion: Patients with relapsed AML or patients who refuse, or are not suitable candidates for induction therapy

Exclusion Criteria:

Dose Escalation: Acute Promyelocytic Leukemia
Any concurrent anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, biologic or any investigational agents (with the exception of hydroxyurea or leukapheresis for control of hyperleukocytosis) within 14 days or five half-lives of drugs, whichever is shorter, prior to Cycle 1 Day 1
AML patients with known, active leptomeningeal/central nervous system (CNS) involvement
Prior treatment with IMGN779
Women who are pregnant or breast feeding

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patrick Zweidler-McKay, MD	ImmunoGen, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Comprehensive Cancer Center (UAB CCC)		Birmingham	Alabama	35294	United States
Dana-Farber Cancer Institute

Condition Browse Module

MeSH Terms

ID	Term
D015470	Leukemia, Myeloid, Acute
D012008	Recurrence

Ancestor Terms

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

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