Lymphoma, Non-HodgkinPhase 1NCT01534715
IMGN529 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia
A Phase 1 study testing IMGN529 in people with Lymphoma, Non-Hodgkin and Chronic Lymphocytic Leukemia, run by ImmunoGen, Inc. at 7 sites in 2 countries.
Trial summary
The purpose of this study is to test the safety and tolerability of IMGN529 in patients with relapsed or refractory non-Hodgkin's lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin, Chronic Lymphocytic Leukemia
- What is being tested?
- IMGN529
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Jan 2012to Jul 2016
- 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
- Relapsed or refractory NHL including tumor types: Follicular lymphoma (FL), marginal zone lymphoma (MZL)/mucosa-associated lymphoid tissue (MALT), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL).
- Adequate organ function
- ECOG ≤ 2
- Recovered or stabilized from prior treatments.
Who cannot join
- Allogeneic stem cell transplantation
- Pregnant or lactating females
- Known central nervous system, meningeal or epidural disease including brain metastases
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Ohio State University
Columbus, Ohio, 43210
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
CTRC at UTHSCSA
San Antonio, Texas, 78229
Switzerland1 site
Oncology Institute of Southern Switzerland
Bellinzona, CH-5800
About this study
Official title: A Phase I, Multi-center, Open-label Study of IMGN529 Administered Intravenously in Adult Patients With Relapsed or Refractory Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia
The purpose of this study is to test the safety and tolerability of IMGN529 in patients with relapsed or refractory non-Hodgkin's lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL).
- Being tested
- IMGN529
- Medical subject headings
- Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMGN529Drug
| Study group | Role | What they receive |
|---|---|---|
| IMGN529 | Experimental | Dose escalation study, dosing done every 3 weeks. Receives: Drug: IMGN529 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of dose limiting toxicities
Measured: During study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-HodgkinStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmunoGen, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01534715
- Sponsor's protocol ID
- IMGN0301
- Status last verified
- Aug 2016
- First submitted
- 14 Feb 2012
- Last updated
- 29 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multi-center, Open-label Study of IMGN529 Administered Intravenously in Adult Patients With Relapsed or Refractory Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT01534715
- Acronym / sponsor ID
- IMGN0301
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- ImmunoGen, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 17 Feb 2012 (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.
The purpose of this study is to test the safety and tolerability of IMGN529 in patients with relapsed or refractory non-Hodgkin's lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMGN529 | Experimental | Drug: IMGN529Dose escalation study, dosing done every 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Relapsed or refractory NHL including tumor types: Follicular lymphoma (FL), marginal zone lymphoma (MZL)/mucosa-associated lymphoid tissue (MALT), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL).
- Adequate organ function
- ECOG ≤ 2
- Recovered or stabilized from prior treatments.
Key exclusion criteria (3 listed)
- Allogeneic stem cell transplantation
- Pregnant or lactating females
- Known central nervous system, meningeal or epidural disease including brain metastases
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 |
|---|---|---|
| IMGN529 | Drug | IMGN529 |
Primary outcome
Occurrence of dose limiting toxicities
Time frame: During study
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 29 Dec 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IMGN529 in people with Lymphoma, Non-Hodgkin and Chronic Lymphocytic Leukemia, run by ImmunoGen, Inc. at 7 sites in 2 countries.
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 4 inclusion and 3 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 29 Dec 2017. 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, Switzerland. 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?
Occurrence of dose limiting toxicities (time frame: During study). 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 29 Dec 2017.