Acute Myeloid LeukemiaPhase 1NCT02674763
Open-label Study of IMGN779 in Adult Patients With Relapsed/Refractory CD33-positive Acute Myeloid Leukemia
A Phase 1 study testing IMGN779 in people with Acute Myeloid Leukemia, run by ImmunoGen, Inc. at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- IMGN779
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 7 sitesUnited States
- Study dates
- Mar 2016to Jul 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, 87106
Comprehensive Cancer Center (UAB CCC)
Birmingham, Alabama, 35294
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Roswell Park Cancer Institute
Buffalo, New York, 14263
Baylor Scott & White University Medical Center
Dallas, Texas, 75246
The University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030
Knight Cancer Institute - OSHU
Portland, Oregon, 97239
About this study
Official title: A Phase 1, Multi-center, Open-label Study of IMGN779 Administered Intravenously in Adult Patients With Relapsed/Refractory CD33-positive Acute Myeloid Leukemia
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.
Read the 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.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- IMGN779
- Keywords
- Acute Myeloid Leukemia, AML, IMGN779, ImmunoGen, Phase 1, Relapsed, Refractory, CD33, Dose Escalation, Dose Expansion
- Medical subject headings
- Leukemia, Myeloid, Acute, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMGN779Drug
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Schedule A | Experimental | IMGN779 administered on days 1 and 15 of a 28-day cycle Receives: Drug: IMGN779 |
| Dose Escalation Schedule B | Experimental | IMGN779 administered on days 1, 8, 15 and 22 of a 28-day cycle Receives: Drug: IMGN779 |
| Dose Escalation Schedule C | Experimental | IMGN779 administered on days 1 and 8 of a 21-day cycle Receives: Drug: IMGN779 |
| Dose Expansion Cohort | Experimental | Patients with Relapsed AML; IMGN779 administered at dose and schedule selected as the putative RP2D. Receives: Drug: IMGN779 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of IMGN779
Measured: 28 days
Secondary outcomes (6)
Treatment emergent adverse events
Measured: Up to 12 months
Objective Response Rate (ORR) (complete response [CR= CR+CRp+CRi]+partial remission [PR])
Measured: Up to 12 months
PK parameters: maximum plasma concentration (Cmax) of IMGN779
Measured: up to 12 months
PK parameters: area under the time-concentration curve (AUC) of IMGN779
Measured: Up to 12 months
PK parameters: terminal half-life (t½) of IMGN779
Measured: Up to 12 months
Immunogenicity: Presence of Antibody-Drug Antibody (ADA)
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionJun 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmunoGen, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick Zweidler-McKay, MD, Study director, ImmunoGen, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02674763
- Sponsor's protocol ID
- IMGN779 0601
- Status last verified
- Sep 2019
- First submitted
- 1 Feb 2016
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multi-center, Open-label Study of IMGN779 Administered Intravenously in Adult Patients With Relapsed/Refractory CD33-positive Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT02674763
- Acronym / sponsor ID
- IMGN779 0601
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute Myeloid Leukemia, AML, IMGN779, ImmunoGen, Phase 1, Relapsed, Refractory, CD33
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- ImmunoGen, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2016 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 4 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Schedule A | Experimental | Drug: IMGN779IMGN779 administered on days 1 and 15 of a 28-day cycle |
| Dose Escalation Schedule B | Experimental | Drug: IMGN779IMGN779 administered on days 1, 8, 15 and 22 of a 28-day cycle |
| Dose Escalation Schedule C | Experimental | Drug: IMGN779IMGN779 administered on days 1 and 8 of a 21-day cycle |
| Dose Expansion Cohort | Experimental | Drug: IMGN779Patients with Relapsed AML; IMGN779 administered at dose and schedule selected as the putative RP2D. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMGN779 | Drug | Dose Escalation Schedule A, Dose Escalation Schedule B, Dose Escalation Schedule C, Dose Expansion Cohort |
Primary outcome
Maximum Tolerated Dose (MTD) of IMGN779
Time frame: 28 days
6 secondary outcomes
Treatment emergent adverse events
Time frame: Up to 12 months
Objective Response Rate (ORR) (complete response [CR= CR+CRp+CRi]+partial remission [PR])
Time frame: Up to 12 months
PK parameters: maximum plasma concentration (Cmax) of IMGN779
Time frame: up to 12 months
PK parameters: area under the time-concentration curve (AUC) of IMGN779
Time frame: Up to 12 months
PK parameters: terminal half-life (t½) of IMGN779
Time frame: Up to 12 months
Immunogenicity: Presence of Antibody-Drug Antibody (ADA)
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Zweidler-McKay, MD study director
ImmunoGen, Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IMGN779 in people with Acute Myeloid Leukemia, run by ImmunoGen, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of IMGN779 (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2019.