Relapsed or Refractory Acute Myeloid LeukemiaPhase 1NCT03755154
Study of a New Intravenous Drug, Called S65487, in Patients With Acute Myeloid Leukemia, Non Hodgkin Lymphoma, Multiple Myeloma or Chronic Lymphocytic Leukemia
A Phase 1 study testing S65487- initial scheme and S65487 - alternative scheme in people with Relapsed or Refractory Acute Myeloid Leukemia and Relapsed or Refractory Non-Hodgkin Lymphoma, run by Institut de Recherches Internationales Servier at 11 sites in 4 countries.
Trial summary
The purpose of this first in human study is to assess safety, tolerability, Pharmacokinetic (PK) and preliminary clinical activity and to estimate the Maximum Tolerated Doses (MTD(s))/ Recommended Phase 2 Doses (RP2D(s)) of S65487 as single agent administered intravenously (i.v.) in adult patients with refractory or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Acute Myeloid Leukemia, Relapsed or Refractory Non-Hodgkin Lymphoma, Relapsed or Refractory Multiple Myeloma
- What is being tested?
- S65487- initial scheme and S65487 - alternative scheme
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 11 sitesin 4 countries
- Study dates
- 17 Jul 2019to 6 Nov 2023
- 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
- Patients with cytologically confirmed and documented de novo, secondary or therapy-related AML, excluding acute promyelocytic leukaemia with relapsed or refractory disease without established alternative therapy. Or patients with measurable confirmed Multiple Myeloma (IMWG) with relapsed or refractory disease who have previously received at least three lines of treatment and without established alternative therapy. Or patients with histologically and measurable confirmed Non Hodgkin Lymphoma defined as Diffuse Large B cell Lymphoma (DLBCL), Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL), High-Grade B cell Lymphoma with relapsed or refractory disease who have received at least two lines of therapy (including rituximab) and without established alternative therapy. Or patients with Chronic Lymphocytic Leukemia (CLL) who have relapsed or are refractory (except treatment failure), as defined per iwCLL, from venetoclax treatment and without established alternative therapy.
- ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2.
- For NHL, MM patients and CLL patients: haematological function (independent of any growth factor support) based on the last assessment performed before inclusion, defined as: absolute neutrophil count (ANC) ≥ 1 x 109/L, haemoglobin ≥ 8 g/dL, platelet count ≥ 50 x 109/L for NHL and MM patients, platelet count ≥ 30 x 109/L for CLL patients.
- For AML patients: circulating Blood White Cell count (WBC count) < 25 x 109/L (with or without use of hydroxycarbamide/leukapheresis) based on the last assessment performed before inclusion.
- Adequate renal function based on the last assessment performed before inclusion, assessed as Glomerular Filtration Rate (GFR) using Modification of Diet in Renal Disease (MDRD) Formula.
- Adequate hepatic function based on the last assessment performed before inclusion.
Who cannot join
- Pregnancy, breastfeeding or possibility of becoming pregnant during the study.
- Participation in another interventional study at the same time or another interventional study requiring investigational treatment intake within 3 weeks or at least 5 half-lives (whichever is longer) prior to the first S65487 administration.
- Participant already enrolled in the study (informed consent signed) and has received at least one dose of S65487.
- Patients who have not recovered from toxicity of previous anticancer therapy, including grade ≥ 2 non-hematologic toxicity, prior to the first IMP administration (including peripheral neurotoxicity). Certain toxicities will not be considered in this category (e.g. alopecia).
- Patients refractory to a previous treatment with a Bcl-2 inhibitor.
- For AML patients : Allogenic stem cell transplant within 3 months before the first IMP administration and/or patients who still receive immunosuppressive treatment within 3 months before the first IMP administration and/or patients with active Graft-versus-host disease within 3 months before the first IMP administration and/or patient who receive donor lymphocyte infusion (DLI) within 3 months before the first IMP administration.
- For NHL, MM and CLL patients : Prior allogenic stem cell transplant before the first IMP administration and/or Autologous stem cell transplant within 3 months before the first IMP administration.
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
Spain4 sites
Clinica Universidad de Navarra
Madrid, 28027
Clínica Universidad Navarra- Servicio de Hematología
Pamplona, 31008
Hospital Clínico Universitario de Salamanca- Servicio de Hematología (4a planta)
Salamanca, 37007
Hospital Universitario La Fe - Servicio de Hematología - Torre F - Planta 7
Valencia, 46026
France3 sites
Centre Hospitalier Universitaire Régionale de Lille Hôpital Huriez
Lille, 59037
CHU Nantes Hôtel Dieu
Nantes, 44093
CHU de Nice - Hôpital l'Archet 1 Hématologie clinique
Nice, 06200
United Kingdom3 sites
King's College Hospital NHS Foundation Trust
London, SE5 9RS
The Christie NHS foundation Trust
Manchester, M20 4BX
Freeman Hospital
Newcastle, NE7 7DN
Australia1 site
The Alfred Hospital Malignant Haematology & Stem Cell Transplantation Services
Melbourne, Victoria, 3004
About this study
Official title: Phase I, Open Label, Non-randomised, Non-comparative, Multi-center Study, Evaluating S65487, a Bcl-2 Inhibitor Intravenously Administered, in Patients With Relapsed or Refractory Acute Myeloid Leukemia, Non Hodgkin Lymphoma, Multiple Myeloma or Chronic Lymphocytic Leukemia
The purpose of this first in human study is to assess safety, tolerability, Pharmacokinetic (PK) and preliminary clinical activity and to estimate the Maximum Tolerated Doses (MTD(s))/ Recommended Phase 2 Doses (RP2D(s)) of S65487 as single agent administered intravenously (i.v.) in adult patients with refractory or relapsed Acute Myeloid Leukemia (AML), Non-Hodgkin Lymphoma (NHL), Multiple Myeloma (MM) or Chronic Lymphocytic Leukemia (CLL).
Read the detailed description
This study is designed in two parts: one part for dose escalation, one part for dose expansion.The dose escalation part will be followed by expansion part at the MTD(s)/RP2D(s)
This study will utilize an adaptative Bayesian Logistic Regression model to guide dose escalation and estimate the MTD(s) based on the Dose Limiting Toxicity (DLT) relationship(s) for S65487 in the indications.
- Conditions
- Relapsed or Refractory Acute Myeloid Leukemia, Relapsed or Refractory Non-Hodgkin Lymphoma, Relapsed or Refractory Multiple Myeloma, Relapsed or Refractory Chronic Lymphocytic Leukemia
- Being tested
- S65487- initial scheme, S65487 - alternative scheme
- Keywords
- Leukemia, Lymphoma, Myeloma, Dose-escalation
- Medical subject headings
- Recurrence, Leukemia, Myeloid, Acute, Lymphoma, Non-Hodgkin, Multiple Myeloma, Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Lymphoma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S65487- initial schemeDrug
S65487 is administered as single agent via i.v. infusion once a week on a 3-week cycle.
S65487 - alternative schemeDrug
S65487 is administered in 3 to 5 i.v. infusions the first week of each cycle then once a week on the rest of the 3-week cycle.
| Study group | Role | What they receive |
|---|---|---|
| S65487 - initial scheme | Experimental | Not described Receives: Drug: S65487- initial scheme |
| S65487 - alternative scheme | Experimental | Not described Receives: Drug: S65487 - alternative scheme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose Limiting Toxicity (DLT)
Safety criterion
Measured: until the end of the first cycle (each cycle is 21days)
Incidence and severity of Adverse Events
Safety and tolerability criteria
Measured: through study completion an average of 6 months
Incidence and severity of Serious Adverse Events
Safety and tolerability criteria
Measured: through study completion an average of 6 months
Number of participants with dose reductions
Measured: through study completion an average of 6 months
Number of participants with dose interruptions
Measured: through study completion an average of 6 months
Dose intensity
Measured: through study completion an average of 6 months
Secondary outcomes (6)
The pharmacokinetic (PK) profile of S65487: Area Under the Curve (AUC)
Measured: Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 3 (alternative schedule only), Cyle 1 Day 5 (alternative schedule only), Cycle 1 Day 8, Cycle 1 Day 9, Day 1 of next cycles (one cycle is 21 days)
PK profile of S65487: Volume of distribution at steady-state (Vss)
Measured: Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 3 (alternative schedule only), Cyle 1 Day 5 (alternative schedule only), Cycle 1 Day 8, Cycle 1 Day 9, Day 1 of next cycles (one cycle is 21 days)
PK profile of S65487: total CLearance (CL)
Measured: Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 3 (alternative schedule only), Cyle 1 Day 5 (alternative schedule only), Cycle 1 Day 8, Cycle 1 Day 9, Day 1 of next cycles (one cycle is 21 days)
PK profile of S65487: terminal half-life (t½z)
Measured: Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 3 (alternative schedule only), Cyle 1 Day 5 (alternative schedule only), Cycle 1 Day 8, Cycle 1 Day 9, Day 1 of next cycles (one cycle is 21 days)
Best Overall Response (BOR)
Best Response observed during the treatment period
Measured: Through study completion, an average of 6 months
Overall Response Rate (ORR)
Proportion of patients in whom a complete response (CR) or a partial response (PR)
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start17 Jul 2019
- Primary completion6 Nov 2023
- Study completion6 Nov 2023
Why it stopped: The study was prematurely terminated on 14th March 2023 for strategic considerations due to the limited efficacy seen with this treatment in monotherapy. This decision was not based on any safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Internationales Servier
- Sponsor type
- University, hospital or other
- Collaborators
- ADIR, a Servier Group company
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03755154
- Sponsor's protocol ID
- CL1-65487-002
- Other IDs
- 2018-004170-97, 2018
- Status last verified
- Oct 2024
- First submitted
- 13 Nov 2018
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Open Label, Non-randomised, Non-comparative, Multi-center Study, Evaluating S65487, a Bcl-2 Inhibitor Intravenously Administered, in Patients With Relapsed or Refractory Acute Myeloid Leukemia, Non Hodgkin Lymphoma, Multiple Myeloma or Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT03755154
- Acronym / sponsor ID
- CL1-65487-002
- Conditions
- Relapsed or Refractory Acute Myeloid Leukemia, Relapsed or Refractory Non-Hodgkin Lymphoma, Relapsed or Refractory Multiple Myeloma, Relapsed or Refractory Chronic Lymphocytic Leukemia
- Keywords
- Leukemia, Lymphoma, Myeloma, Dose-escalation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was prematurely terminated on 14th March 2023 for strategic considerations due to the limited efficacy seen with this treatment in monotherapy. This decision was not based on any safety concerns.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institut de Recherches Internationales ServierUniversity, hospital or other
- Collaborators
- ADIR, a Servier Group company
- Study start
- 17 Jul 2019 (actual)
- Primary completion
- 6 Nov 2023 (actual)
- Study completion
- 6 Nov 2023 (actual)
- First posted
- 27 Nov 2018 (actual)
- 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 first in human study is to assess safety, tolerability, Pharmacokinetic (PK) and preliminary clinical activity and to estimate the Maximum Tolerated Doses (MTD(s))/ Recommended Phase 2 Doses (RP2D(s)) of S65487 as single agent administered intravenously (i.v.) in adult patients with refractory or relapsed Acute Myeloid Leukemia (AML), Non-Hodgkin Lymphoma (NHL), Multiple Myeloma (MM) or Chronic Lymphocytic Leukemia (CLL).
Detailed description
This study is designed in two parts: one part for dose escalation, one part for dose expansion.The dose escalation part will be followed by expansion part at the MTD(s)/RP2D(s)
This study will utilize an adaptative Bayesian Logistic Regression model to guide dose escalation and estimate the MTD(s) based on the Dose Limiting Toxicity (DLT) relationship(s) for S65487 in the indications.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S65487 - initial scheme | Experimental | Drug: S65487- initial scheme |
| S65487 - alternative scheme | Experimental | Drug: S65487 - alternative scheme |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with cytologically confirmed and documented de novo, secondary or therapy-related AML, excluding acute promyelocytic leukaemia with relapsed or refractory disease without established alternative therapy. Or patients with measurable confirmed Multiple Myeloma (IMWG) with relapsed or refractory disease who have previously received at least three lines of treatment and without established alternative therapy. Or patients with histologically and measurable confirmed Non Hodgkin Lymphoma defined as Diffuse Large B cell Lymphoma (DLBCL), Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL), High-Grade B cell Lymphoma with relapsed or refractory disease who have received at least two lines of therapy (including rituximab) and without established alternative therapy. Or patients with Chronic Lymphocytic Leukemia (CLL) who have relapsed or are refractory (except treatment failure), as defined per iwCLL, from venetoclax treatment and without established alternative therapy.
- ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2.
- For NHL, MM patients and CLL patients: haematological function (independent of any growth factor support) based on the last assessment performed before inclusion, defined as: absolute neutrophil count (ANC) ≥ 1 x 109/L, haemoglobin ≥ 8 g/dL, platelet count ≥ 50 x 109/L for NHL and MM patients, platelet count ≥ 30 x 109/L for CLL patients.
- For AML patients: circulating Blood White Cell count (WBC count) < 25 x 109/L (with or without use of hydroxycarbamide/leukapheresis) based on the last assessment performed before inclusion.
- Adequate renal function based on the last assessment performed before inclusion, assessed as Glomerular Filtration Rate (GFR) using Modification of Diet in Renal Disease (MDRD) Formula.
Key exclusion criteria (7 listed)
- Pregnancy, breastfeeding or possibility of becoming pregnant during the study.
- Participation in another interventional study at the same time or another interventional study requiring investigational treatment intake within 3 weeks or at least 5 half-lives (whichever is longer) prior to the first S65487 administration.
- Participant already enrolled in the study (informed consent signed) and has received at least one dose of S65487.
- Patients who have not recovered from toxicity of previous anticancer therapy, including grade ≥ 2 non-hematologic toxicity, prior to the first IMP administration (including peripheral neurotoxicity). Certain toxicities will not be considered in this category (e.g. alopecia).
- Patients refractory to a previous treatment with a Bcl-2 inhibitor.
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 |
|---|---|---|
| S65487- initial schemeS65487 is administered as single agent via i.v. infusion once a week on a 3-week cycle. | Drug | S65487 - initial scheme |
| S65487 - alternative schemeS65487 is administered in 3 to 5 i.v. infusions the first week of each cycle then once a week on the rest of the 3-week cycle. | Drug | S65487 - alternative scheme |
Primary outcome
Incidence of Dose Limiting Toxicity (DLT)
Time frame: until the end of the first cycle (each cycle is 21days)
Safety criterion
Incidence and severity of Adverse Events
Time frame: through study completion an average of 6 months
Safety and tolerability criteria
Incidence and severity of Serious Adverse Events
Time frame: through study completion an average of 6 months
Safety and tolerability criteria
Number of participants with dose reductions
Time frame: through study completion an average of 6 months
Number of participants with dose interruptions
Time frame: through study completion an average of 6 months
Dose intensity
Time frame: through study completion an average of 6 months
6 secondary outcomes
The pharmacokinetic (PK) profile of S65487: Area Under the Curve (AUC)
Time frame: Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 3 (alternative schedule only), Cyle 1 Day 5 (alternative schedule only), Cycle 1 Day 8, Cycle 1 Day 9, Day 1 of next cycles (one cycle is 21 days)
PK profile of S65487: Volume of distribution at steady-state (Vss)
Time frame: Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 3 (alternative schedule only), Cyle 1 Day 5 (alternative schedule only), Cycle 1 Day 8, Cycle 1 Day 9, Day 1 of next cycles (one cycle is 21 days)
PK profile of S65487: total CLearance (CL)
Time frame: Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 3 (alternative schedule only), Cyle 1 Day 5 (alternative schedule only), Cycle 1 Day 8, Cycle 1 Day 9, Day 1 of next cycles (one cycle is 21 days)
PK profile of S65487: terminal half-life (t½z)
Time frame: Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 3 (alternative schedule only), Cyle 1 Day 5 (alternative schedule only), Cycle 1 Day 8, Cycle 1 Day 9, Day 1 of next cycles (one cycle is 21 days)
Best Overall Response (BOR)
Time frame: Through study completion, an average of 6 months
Overall Response Rate (ORR)
Time frame: Through study completion, an average of 6 months
Results and safety
The study was stopped early (reason given: The study was prematurely terminated on 14th March 2023 for strategic considerations due to the limited efficacy seen with this treatment in monotherapy. This decision was not based on any safety concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Find Results on Servier Clinical Trial Data websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
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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.
11 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 S65487- initial scheme and S65487 - alternative scheme in people with Relapsed or Refractory Acute Myeloid Leukemia and Relapsed or Refractory Non-Hodgkin Lymphoma, run by Institut de Recherches Internationales Servier at 11 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 6 inclusion and 7 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 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Spain, France, United Kingdom, Australia. 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 was stopped early (reason given: The study was prematurely terminated on 14th March 2023 for strategic considerations due to the limited efficacy seen with this treatment in monotherapy. This decision was not based on any safety concerns.). Results are not available in the source record.
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?
Incidence of Dose Limiting Toxicity (DLT) (time frame: until the end of the first cycle (each cycle is 21days)). The study lists 6 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 16 Oct 2024.