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Home » Find Clinical Trials » Dose-escalation Study of Oral Administration of S 55746 in Patients With Chronic Lymphocytic Leukaemia and B-Cell Non-Hodgkin Lymphoma

Dose-escalation Study of Oral Administration of S 55746 in Patients With Chronic Lymphocytic Leukaemia and B-Cell Non-Hodgkin Lymphoma

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Servier Protocol Code: CL1-55746-001 Sponsor: Institut de Recherches Internationales Servier Clinicaltrials.gov Identifier: NCT02920697 EudraCT Number: 2013-003779-36

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How to participate in this study
If you think you are eligible for this study (see
eligibility criteria
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.)
Name: Institut de Recherches Internationales Servier, Département des études cliniques
Phone number: +33 1 55 72 60 00
The study has 18 locations

Study description

This study is needed to test the study drug, S055746, in patients with B-Cell Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukaemia (CLL).

NHL is a cancer that starts in the lymphatic system. This system is part of the body’s defense system that fights against infections. CLL is a cancer that starts in the white blood cells (called lymphocytes). In these 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.

The main goals of this study were:

  • To test the safety of S055746.
  • To find the maximum tolerated dose of S055746. The MTD is the highest dose of the drug that can be taken without too much risk.
Official title: Phase I Dose-escalation Study of Oral Administration of the Selective Bcl2 Inhibitor S 55746 in Patients With Refractory or Relapsed Chronic Lymphocytic Leukaemia and B-Cell Non-Hodgkin Lymphoma
Results
English (USA)
Conditions
Chronic Lymphocytic Leukaemia (CLL) B-Cell Non-Hodgkin Lymphoma (NHL) Multiple Myeloma (MM)
Interventions / Treatments
  • S 55746
Other study id numbers
  • CL1-55746-001

Eligibility Criteria

Eligible age for the study

18 years and older (Adult, Older Adult)

Sex

Male/Female

Accepts Healthy Volunteers

No

To take part in the study, participants had to:

  • Be aged 18 years or older.
  • Have been diagnosed with NHL or CLL that:
    • Came back after standard treatment (called relapsed).

or

    • Did not respond to the standard treatment (called refractory).

Participants could not take part in the study if they:

  • Had previously received a drug that blocks BCL-2.
  • Had received anticancer medicines within 3 weeks before starting the study.
  • Had undergone treatment with radiation within 8 weeks or major surgery within 3 weeks before the starting the study.

How is the study designed?

Allocation
Non-randomized
Interventional study model
Single Group
Participant Group / Arm
Experimental: B-cell Non-Hodgkin Lymphoma (NHL) and Multiple Myeloma (MM)

All participants took the same study drug, S55746, available as oral 100 mg tablets. Participants took the study drug during time periods called “cycles”. Participants took oral tablets of S55746 once daily during 21-days cycles. There was no interruption of treatment between cycles.

The treatment was maintained as long as the cancer did not progress and the participants did not have too severe side effects.

Intervention / Treatment
Drug: S 55746
Participant Group / Arm
Experimental: Chronic Lymphocytic Leukaemia (CLL)

All participants took the same study drug, S55746, available as oral 100 mg tablets. Participants took the study drug during time periods called “cycles”. Participants took oral tablets of S55746 once daily during 21-days cycles. There was no interruption of treatment between cycles.

The treatment was maintained as long as the cancer did not progress and the participants did not have to severe side effects.

Intervention / Treatment
Drug: S 55746

Keywords

Additional Relevant MeSH Terms Glioma
Leukemia, B-Cell Lymphoma, B-Cell Multiple Myeloma