Diffuse Large B-cell Lymphoma(DLBCL)Phase 1NCT03571828
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 562 in Subjects With r/r Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, or Follicular Lymphoma
A Phase 1 study testing AMG 562 in people with Diffuse Large B-cell Lymphoma(DLBCL) and Mantle Cell Lymphoma (MCL), run by Amgen at 12 sites in 4 countries.
Trial summary
Evaluate the safety and tolerability of AMG 562 in adult subjects with DLBCL, MCL, or FL. Estimate the maximum tolerated dose (MTD) and/or a biologically active dose (e.g., recommended phase 2 dose [RP2D]) Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Diffuse Large B-cell Lymphoma(DLBCL), Mantle Cell Lymphoma (MCL), Follicular Lymphoma (FL)
- What is being tested?
- AMG 562
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 12 sitesin 4 countries
- Study dates
- 29 Oct 2018to 12 Jan 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has provided informed consent prior to initiation of any study-specific activities/procedures
- Age ≥ 18 at the time of informed consent.
- Biopsy proven B-NHL including:
- DLBCL, which also includes DLBCL that represents transformation of indolent NHL (including follicular, marginal zone, and lymphoplasmacytic lymphoma excluding chronic lymphocytic leukemia or Hodgkin Lymphoma) and DLBCL with alterations of MYC and BCL2 and/or BCL6 also described as double-hit and triple-hit lymphomas.
- FL
- MCL Presentations of these histologies with substantial occurrence of malignant cells into the bloodstream (lymphocyte count ≥ 7 x 10^9/L) including all leukemic presentations are excluded.
Show all 28Show fewer
- The following histologies are not eligible:
- Lymphoblastic lymphoma Burkitt lymphoma Any histologies not specifically mentioned must be discussed with the Medical Monitor
- Subjects with transformation of indolent lymphoma must have received therapy after a diagnosis of transformation that is appropriate for aggressive histology.
- Subjects who received prior CD19-targeting treatment are allowed (CAR-T cell therapy is excluded). A biopsy following CD19-targeting treatment is required unless no lesions are accessible or the risk of the biopsy is deemed too high by the investigator For Part 2 (Expansion in patients with DLBCL): only biopsy proven DLBCL (biopsy proven at least at primary diagnosis), including DLBCL that represents transformation of indolent NHL (including follicular, marginal zone, and lymphoplasmacytic lymphoma excluding chronic lymphocytic leukemia or Hodgkin Lymphoma) are eligible. Other histologies are not eligible.
- Presentations of these histologies with substantial occurrence of malignant cells into the bloodstream (lymphocyte count ≥ 7 x 10^9/L) including all leukemic presentations are excluded.
- Subjects with transformation of indolent lymphoma must have received therapy after a diagnosis of transformation that is appropriate for aggressive histology as described in inclusion criterial.
- Subjects who received prior CD19-targeting treatment are allowed (CAR-T cell therapy is excluded) A biopsy following CD19-targeting treatment is required unless no lesions are accessible or the risk of the biopsy is deemed too high by the investigator - For DLBCL: Refractory (no prior CR/CMR) to first or later line of treatment or relapsed (prior CR/CMR) after two or more prior treatments, with at least one treatment consisting of standard multiagent chemotherapy containing an anthracycline AND an approved anti-CD20 agent. Examples of appropriate therapy include but are not limited to R-CHOP (14 or 21), R-CHOEP, and DA-R-EOCH.
- For FL: Refractory (no prior CR/CMR) to first or later line of treatment or relapsed (prior CR/CMR) after three or more prior treatments, with at least one treatment consisting of a standard chemotherapy containing an approved anti-CD20 agent.
- Examples of appropriate therapy include but are not limited to R-CHOP, R-CVP, and BR.
- For MCL: Refractory (no prior CR/CMR) to first or later line of treatment or relapsed (prior CR/CMR) after three or more prior treatments, with at least one treatment consisting of a standard chemotherapy containing an approved anti-CD20 agent. Examples of appropriate therapy include but are not limited to R-CHOP, BR and hyper-CVAD alternating with R-MTX/Ara-C.
- For subjects with refractory B-NHL and who have received radiotherapy, PET positivity should be demonstrated no less than 6 weeks after the last dose of radiotherapy
- Minimum life expectancy of 12 weeks
- Radiographically measurable disease with a clearly demarcated nodal lesion at least 1.5 cm in its largest dimension or a target extranodal lesion at least 1.0 cm in its largest dimension. In the dose exploration phase in case disease is not radiographically measurable PET positivity (ie, Deauville ≥4) instead is acceptable.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Laboratory parameters (completed within 14 days prior to enrollment):
- Hematology:
- Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L
- Platelets ≥ 75 x 10^9/L
- Chemistry:
- Creatinine clearance ≥ 60 mL/min (calculated using Cockcroft Gault equation)
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 3X upper limit of normal (ULN)
- Total bilirubin (TBL) < 2x ULN (unless Gilbert's disease or if liver involvementwith lymphoma)
Who cannot join
- Treatment within 30 days prior to enrollment with another investigational device or drug (interventional clinical study / studies). Other investigational procedures while participating in this study are excluded (observational studies are permitted).
- Prior anti-cancer therapy as specified below:
- At least 6 weeks must have elapsed since any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists, etc) before the first dose of AMG 562.
- Other targeted anti-cancer therapy (chemotherapy, molecular targeted therapy, steroids) within 14 days or 5 half lives (which ever is longer) prior to first dose of AMG 562. Patients requiring continued treatment due to aggressive disease may only be included if there is agreement by both the investigator and the Amgen Medical Monitor.
- Radiation therapy completed within 28 days prior to first dose of AMG 562.
- Autologous HSCT within six weeks prior to start of AMG 562 treatment.
Show all 38Show fewer
- At least 4 weeks must have elapsed since any prior treatment with antibody therapy (exception immune checkpoint inhibitors) before the first dose of AMG 562.
- Prior CD19-directed CAR-T cell therapies
- Prior allogeneic HSCT.
- For Part 2 (Expansion in patients with DLBCL): fluorodeoxyglucose non-avid patients.
- Baseline electrocardiogram (ECG) QTc > 470 msec.
- Autoimmune disorders requiring chronic systemic steroid therapy or any other form of immunosuppressive therapy. Patient may be included if the treatment is discontinued more than 3 months prior to the first dose of AMG 562 at a low likelihood of relapse AND if there is agreement by both the investigator and the Amgen Medical Monitor.
- Unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to CTCAE version 4.0 grade 1, or to levels dictated in the eligibility criteria with the exception of alopecia or toxicities from prior anti-tumor therapy that are considered irreversible (defined as having been present and stable for > 28 days) which may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and the Amgen Medical Monitor.
- Presence of clinically relevant central nervous system (CNS) pathology such as epilepsy, paresis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
- Evidence of CNS involvement by NHL.
- Known infection with human immunodeficiency virus (HIV).
- Exclusion of hepatitis infection based on the following results and/or criteria:
- Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B).
- Negative HBsAg and positive for hepatitis B core antibody: Assay for hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B.
- Positive Hepatitis C virus antibody (HCVAb): Assay for hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C.
- History of malignancy other than B-NHL within the past 3 years with the exception of:
- Malignancy treated with curative intent and with no known active disease present for ≥ 3 years before enrollment and felt to be at low risk for recurrence by the treating physician.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- Adequately treated cervical carcinoma in situ without evidence of disease.
- Adequately treated breast ductal carcinoma in situ without evidence of disease.
- Prostatic intraepithelial neoplasia without evidence of prostate cancer.
- Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.
- Major surgery within 28 days of first dose AMG 562.
- History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of first dose of AMG 562.
- Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management within 7 days of first dose AMG 562. NOTE: Simple UTI and uncomplicated bacterial pharyngitis are permitted after consultation with sponsor and if responding to active treatment.
- Subject has known sensitivity to immunoglobulins or any of the products or components to be administered during dosing.
- Males and females of reproductive potential who are unwilling to practice highly effective method(s) of birth control while on study through 110 days (females) and 170 days (males) after receiving the last dose of study drug. Highly effective methods of birth control include sexual abstinence (males, females); vasectomy; bilateral tubal ligation/occlusion; or a condom with spermicide (males) in combination with hormonal birth control or intrauterine device (IUD) (females).
- Females who are lactating/breastfeeding or who plan to breastfeed while on study through 110 days after receiving the last dose of study drug.
- Females with a positive pregnancy test.
- Females planning to become pregnant while on study through 110 days after receiving the last dose of study drug.
- Males who are unwilling to abstain from sperm donation while on study through 170 days after receiving the last dose of study drug.
- Subjects likely to not be available to complete all protocol- required study visits or procedures including BM aspirates/biopsies, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge.
- History or evidence of any other clinically-relevant concurrent disorder, condition or disease (eg, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia requiring therapy at time of screening) with the exception of those outlined above that, in the opinion of the investigator or Amgen medical monitor, if consulted, would not pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
United States7 sites
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21201
Roswell Park Cancer Institute
Buffalo, New York, 14263
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
City of Hope National Medical Center
Duarte, California, 91010
University of California Los Angeles
Los Angeles, California, 90095
Washington University
St Louis, Missouri, 63110
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
Germany3 sites
Klinikum der Universität München Campus Großhadern
München, 81377
Universitatsklinikum Ulm
Ulm, 89081
Universitätsklinikum Würzburg
Würzburg, 97080
Belgium1 site
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, 3000
About this study
Official title: A Phase 1, First-in-Human, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 562 in Subjects With Relapsed / Refractory Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, or Follicular Lymphoma
Evaluate the safety and tolerability of AMG 562 in adult subjects with DLBCL, MCL, or FL. Estimate the maximum tolerated dose (MTD) and/or a biologically active dose (e.g., recommended phase 2 dose [RP2D])
- Conditions
- Diffuse Large B-cell Lymphoma(DLBCL), Mantle Cell Lymphoma (MCL), Follicular Lymphoma (FL)
- Being tested
- AMG 562
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 562Drug
AMG 562 is a BiTE® antibody construct that targets CD19 and is intended for the treatment of patients with B-cell malignancies.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose Exploration | Experimental | Dose exploration cohorts to estimate the MTD, safety, tolerability, and PK of different doses of AMG 562 in subjects with relapsed/refractory DLBCL, MCL or FL using a Bayesian logistic regression model (BLRM; Neuenschwander et al, 2008). Receives: Drug: AMG 562 |
| Part 2: Dose Expansion | Experimental | dose expansion part to gain further clinical experience, safety and efficacy data for AMG 562 in subjects with relapsed / refractory DLBCL. The dose to be evaluated will be at or below the MTD estimated in the dose exploration cohorts. Receives: Drug: AMG 562 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)
Measured: Day 1 to Day 28
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial participant. TEAEs were any AE that occurred after receiving at least 1 dose of treatment.
Treatment-related TEAEs were those considered related to study treatment by the investigator.
Disease-Related TEAEs were events (serious or non-serious) anticipated to occur in the study population due to the underlying disease.
Any clinically significant changes in vital signs, physical examinations, electrocardiograms (ECG)s and clinical laboratory tests were recorded as TEAEs.
Measured: Up to 2 years
Secondary outcomes (9)
Maximum Observed Concentration (Cmax) of AMG 562
Measured: Day 1
Time of Maximum Concentration (Tmax) of AMG 562
Measured: Day 1
Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Timepoint (AUClast) of AMG 562
Measured: Day 1
Half-life (t1/2) of AMG 562
Measured: Day 22
Objective Response Rate (ORR) Per Lugano Classification
ORR was defined as the percentage of participants with a confirmed complete metabolic response (CMR) or partial metabolic response (PMR) as defined by Lugano Classification.
Per the Lugano Classification, positron emission tomography-computed tomography (PET-CT) were defined on the 5-point scale as scores 1, 2, or 3 (where 1 = no uptake above background; 2 = uptake </= mediastinum; and 3 = uptake > mediastinum but </= liver) and PET-positive scans, as scores of 4 or 5 (where 4 = uptake moderately higher than liver; 5 = uptake markedly higher than liver and/or new lesions).
CMR: score of 1, 2 or 3 in nodal or extranodal sites with or without a residual mass.
PMR: score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size.
Measured: Day 1 up to 2 years
Best Overall Response Per Lugano Classification
Per the Lugano Classification, positron emission tomography-computed tomography (PET-CT) were defined on the 5-point scale as scores 1, 2, or 3 (where 1 = no uptake above background; 2 = uptake </= mediastinum; and 3 = uptake > mediastinum but </= liver) and PET-positive scans, as scores of 4 or 5 (where 4 = uptake moderately higher than liver; 5 = uptake markedly higher than liver and/or new lesions).
CMR: score of 1, 2 or 3 in nodal or extranodal sites with or without a residual mass.
PMR: score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size.
No metabolic response (NMR): score of 4 or 5 with no obvious change in fluorodeoxyglucose (FDG) uptake.
Progressive metabolic disease (PMD): score 4 or 5 in any lesion with an increase in intensity of FDG uptake from baseline (and/or new FDG-avid foci consistent with lymphoma).
Measured: Day 1 up to 2 years
Duration of Response (DOR)
DOR was defined as the time from the date of an initial objective response per Lugano classification to the earlier of progression or death. Participants who had not ended their response at the time of analysis had DOR censored at their last disease assessment date.
Measured: Day 1 up to 2 years
Progression Free Survival (PFS)
PFS was defined as the interval from Day 1 to the earlier of a lymphoma progression or death from any cause; otherwise, PFS was censored at the last radiographic assessment date. If a participant had no post baseline radiographic assessment and a vital status of alive or unknown, PFS was censored at Day 1.
Measured: Day 1 up to 2 years
Overall Survival (OS)
OS was defined as the time from the date of Day 1 until death due to any cause. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was alive.
Measured: Day 1 up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start29 Oct 2018
- Primary completion12 Jan 2022
- Study completion12 Jan 2022
Why it stopped: Amgen decided to discontinue study because of a business decision and not because of safety reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diffuse Large B-cell Lymphoma(DLBCL)Studies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571828
- Sponsor's protocol ID
- 20170533
- Status last verified
- Sep 2023
- First submitted
- 18 Jun 2018
- Last updated
- 22 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-Human, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 562 in Subjects With Relapsed / Refractory Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, or Follicular Lymphoma
- ClinicalTrials.gov ID
- NCT03571828
- Acronym / sponsor ID
- 20170533
- Conditions
- Diffuse Large B-cell Lymphoma(DLBCL), Mantle Cell Lymphoma (MCL), Follicular Lymphoma (FL)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Amgen decided to discontinue study because of a business decision and not because of safety reasons
- Enrolment
- 10 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- 12 Jan 2022 (actual)
- Study completion
- 12 Jan 2022 (actual)
- First posted
- 28 Jun 2018 (actual)
- Results
- Posted 22 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the safety and tolerability of AMG 562 in adult subjects with DLBCL, MCL, or FL. Estimate the maximum tolerated dose (MTD) and/or a biologically active dose (e.g., recommended phase 2 dose [RP2D])
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose Exploration | Experimental | Drug: AMG 562Dose exploration cohorts to estimate the MTD, safety, tolerability, and PK of different doses of AMG 562 in subjects with relapsed/refractory DLBCL, MCL or FL using a Bayesian logistic regression model (BLRM; Neuenschwander et al, 2008). |
| Part 2: Dose Expansion | Experimental | Drug: AMG 562dose expansion part to gain further clinical experience, safety and efficacy data for AMG 562 in subjects with relapsed / refractory DLBCL. The dose to be evaluated will be at or below the MTD estimated in the dose exploration cohorts. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Subject has provided informed consent prior to initiation of any study-specific activities/procedures
- Age ≥ 18 at the time of informed consent.
- Biopsy proven B-NHL including:
- Lymphoblastic lymphoma Burkitt lymphoma Any histologies not specifically mentioned must be discussed with the Medical Monitor
- Subjects with transformation of indolent lymphoma must have received therapy after a diagnosis of transformation that is appropriate for aggressive histology.
Key exclusion criteria (38 listed)
- Treatment within 30 days prior to enrollment with another investigational device or drug (interventional clinical study / studies). Other investigational procedures while participating in this study are excluded (observational studies are permitted).
- Prior anti-cancer therapy as specified below:
- Prior CD19-directed CAR-T cell therapies
- Prior allogeneic HSCT.
- For Part 2 (Expansion in patients with DLBCL): fluorodeoxyglucose non-avid patients.
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 |
|---|---|---|
| AMG 562AMG 562 is a BiTE® antibody construct that targets CD19 and is intended for the treatment of patients with B-cell malignancies. | Drug | Part 1: Dose Exploration, Part 2: Dose Expansion |
Primary outcome
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)
Time frame: Day 1 to Day 28
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Time frame: Up to 2 years
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial participant. TEAEs were any AE that occurred after receiving at least 1 dose of treatment. Treatment-related TEAEs were those considered related to study treatment by the investigator. Disease-Related TEAEs were events (serious or non-serious) anticipated to occur in the study population due to the underlying disease. Any clinically significant changes in vital signs, physical examinations, electrocardiograms (ECG)s and clinical laboratory tests were recorded as TEAEs.
9 secondary outcomes
Maximum Observed Concentration (Cmax) of AMG 562
Time frame: Day 1
Time of Maximum Concentration (Tmax) of AMG 562
Time frame: Day 1
Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Timepoint (AUClast) of AMG 562
Time frame: Day 1
Half-life (t1/2) of AMG 562
Time frame: Day 22
Objective Response Rate (ORR) Per Lugano Classification
Time frame: Day 1 up to 2 years
Best Overall Response Per Lugano Classification
Time frame: Day 1 up to 2 years
Duration of Response (DOR)
Time frame: Day 1 up to 2 years
Progression Free Survival (PFS)
Time frame: Day 1 up to 2 years
Overall Survival (OS)
Time frame: Day 1 up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Related trials for Diffuse Large B-cell Lymphoma(DLBCL)
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
RecruitingPhase 2
Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma
High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements, Recurrent Diffuse Large B-Cell Lymphoma
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Lymphoma, Waldenström Macroglobulinemia (WM)
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.
MD study director
Amgen
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AMG 562 in people with Diffuse Large B-cell Lymphoma(DLBCL) and Mantle Cell Lymphoma (MCL), run by Amgen at 12 sites in 4 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 28 inclusion and 38 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: stopped early, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Germany, Belgium, Canada. 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?
Yes. Results are posted in the registry (first posted 22 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) (time frame: Day 1 to Day 28). The study lists 2 primary outcomes in all. 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 22 Mar 2024.