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Study of a New Intravenous Drug, Called S65487, in Patients With Acute Myeloid Leukemia, Non Hodgkin Lymphoma, Multiple Myeloma or Chronic Lymphocytic Leukemia
Servier Protocol Code:
CL1-65487-002
Sponsor:
Institut de Recherches Internationales Servier
Clinicaltrials.gov Identifier:
NCT03755154
EudraCT Number:
2018-004170-97
Find a recruiting site
How to participate in this study
If you think you are eligible for this study (see
below), you can identify the location closest to you and contact them directly. If you can’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
eligibility criteria
Researchers look for people who fit a certain decription, called eligibility criteria. These include inclusion criteria and exclusion criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Name:
Institut de Recherches Internationales Servier, Département des études cliniques
Phone number:
+33 1 55 72 60 00
The study has 11 locations
Study description
This study was done to see if a new cancer drug called S65487 is safe and could be beneficial for treating the following types of blood cancers:
- Acute Myeloid Leukemia (AML): a cancer of the blood and bone marrow (the spongy tissue inside bones where blood cells are made).
- Non-Hodgkin Lymphoma (NHL): a cancer that starts in the lymphatic system. This system is a part of the body’s defence system that fights against infections.
- Multiple Myeloma (MM): a cancer that affects a type of white blood cells called plasma cells.
- Chronic Lymphocytic Leukemia (CLL): a cancer that starts from white blood cells (called lymphocytes).
In these types of blood cancers, cancer cells have higher amounts of certain proteins. One of these proteins is BCL-2 (B-cell lymphoma-2). This protein protects cancer cells from death, allowing them to survive and multiply.
S65487 is a drug that blocks BCL-2 proteins. By blocking BCL-2 proteins, this drug could cause cancer cells to die.
The main objectives of the study were:
- To look at the safety of S65487.
- To find the highest dose of S65487 that participants could take without too much risk (highest tolerated dose). This highest tolerated dose helps to find the recommended dose (the one that is both safe and effective for patients).
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
Français (France)
English (USA)
Español (España)Conditions
Relapsed or Refractory Acute Myeloid Leukemia
Relapsed or Refractory Non-Hodgkin Lymphoma
Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Chronic Lymphocytic Leukemia
Interventions / Treatments
The treatment(s) given to the participants in the study.
- S65487- initial scheme
- S65487 - alternative scheme
Other study id numbers
Other identification numbers the study may be known by.
- CL1-65487-002
Eligibility Criteria
Researchers look for people who fit a certain decription, called eligibility criteria. These include inclusion criteria and exclusion criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligible age for the study
18 years and older
(Adult, Older Adult)
Sex
Male/FemaleAccepts Healthy Volunteers
NoTo take part, participants had to:
- Be at least 18 years old.
- Have one of the following cancers that returned after improvement (relapsed) or did not respond to any treatment (refractory):
- Acute Myeloid Leukemia (AML)
- Non-Hodgkin Lymphoma (NHL)
- Multiple Myeloma (MM)
- Chronic Lymphocytic Leukemia (CLL)
- Have adequate organ function.
Participants could not take part in the study if they:
- Had received treatment with a similar drug (a Bcl-2 inhibitor) that did not work.
- Had any major surgery or treatment with radiation within the 3 weeks before starting the study.
How is the study designed?
Allocation
How participants are assigned to different groups. Allocation can be random (randomized) or predetermined (non-randomized). Randomized means that participants are assigned at random to their participant group / arm.
Interventional study model
How treatments are given and tested in a study.
Parallel
A parallel study design compares two or more groups at the same time, with each group receiving a different treatment. Researchers then compare the results to determine which treatment is more effective.
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Intervention / Treatment
The treatment(s) given to the participants in the study.
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Experimental:
S65487 - initial scheme
S65487 was given once every week in cycles of 21 days.
Intervention / Treatment
The treatment(s) given to the participants in the study.
Drug:
S65487
The participants received S65487 through infusion (injection given slowly) into a vein.
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Experimental:
S65487 - alternative scheme
S65487 was given on Days 1, 3, 5, 8 and 15 in each 21-day cycle.
Intervention / Treatment
The treatment(s) given to the participants in the study.
Drug:
S65487
The participants received S65487 through infusion (injection given slowly) into a vein.
Keywords
Provided by Servier
Leukemia
Lymphoma
Myeloma
Dose-escalation
Additional Relevant MeSH Terms Glioma
Recurrence
Leukemia, Myeloid, Acute
Lymphoma, Non-Hodgkin
Multiple Myeloma
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia
Lymphoma
Neoplasms, Plasma Cell