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An Open-labelled, International, Multicenter, Dose Escalating, Phase I/II Study of SPC2996,an LNA Antisense Molecule Against Bcl-2, in Patients With Relapsed or Refractory Chronic Lymphocytic Leukaemia


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Chronic Lymphocytic Leukemia

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Trial Information

An Open-labelled, International, Multicenter, Dose Escalating, Phase I/II Study of SPC2996,an LNA Antisense Molecule Against Bcl-2, in Patients With Relapsed or Refractory Chronic Lymphocytic Leukaemia


Chronic Lymphocytic Leukaemia (CLL) is the most common leukaemia in adults in the US and
most of Western Europe. Many patients suffering from CLL have tumour cells expressing high
amounts of Bcl-2 protein. Since over expression of Bcl-2 inhibits apoptosis, it is possible
that this gene participates in the pathogenesis of CLL. By lowering the Bcl-2 protein in
these tumour cells the cells may go into apoptosis due to changed balance in pro- and anti
apoptotic proteins and thereby it might be possible to induce a tumour response.

The study is an open-labelled, international, multicenter, dose escalating phase I/II study
where patients receive 6, 3, 2 or 1 dose(s) of SPC2996, a LNA antisense molecule against
Bcl-2, over a period of up to 2 weeks, and are followed for 6 months.


Inclusion Criteria:



- patients with relapsed or refractory Chronic Lymphocytic Leukaemia requiring therapy

- screening blood sample must show circulating lymphocyte count of more then 5 x 109/L
and circulating lymphocytes expressing the phenotype CD5+CD20+CD23+.

- The PCR Bcl-2 m-RNA level must be positive

- the patients must be 18 years or older and have given informed consent.

Exclusion Criteria:

- previous treatment with rituximab, alemtuzumab or autologous stem cell
transplantation within 6 months prior to Visit 1 or allogeneic stem cell
transplantation at any time

- patients that received anti-cancer therapy, glucocorticoids or radiotherapy within 4
weeks prior to Visit 1 and patients with known or suspected transformation of CLL

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change in Bcl-2 m-RNA levels

Outcome Time Frame:

from Day 0 to Day 13

Principal Investigator

Betrand Coiffier, Prof. MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Hospitalier Lyon Sud, Lyon, France

Authority:

United States: Food and Drug Administration

Study ID:

SPC2996-101

NCT ID:

NCT00285103

Start Date:

June 2005

Completion Date:

December 2007

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Antisense, mRNA antagonist, Bcl-2, CLL
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location
Holden Comprehensive Cancer Center, Univ. of Iowa Iowa City, Iowa  52242