Chronic Lymphatic Leukemia Clinical Trial
Official title:
Open Label Multi-center Pilot Phase I/II Non-controlled Clinical Trial to Assess Safety and Efficieecy of the Lenalidomide and Dexamethasone Association in Patients With Chronic Relapse or Treatment Resistant Lymphatic Leukemia Following Treatment Containing Fludarabine.
Despite certain notable progress, treatment of patients with Chronic Lymphatic Leukemia
(CLL) is still disappointing. Although thanks to the use of treatment of (immune)
chemotherapy, mainly based on fludarabine, rituximab and alemtuzumab, the rate of complete
response (CR) has increased from minus 10% observed when clorambucil was the core of the
therapy to a 60-70%, with time all patients relapse and most of them die at the end due to
the disease or to involvements related to the treatment. Progress when understanding the CLL
biology have cleared a series of aspects: 1) there is a significant proportion of CLL cells
actively copying themselves, contrary to the opinion that most of CLL cells are in G0 phase
of the cell cycle; 2) Immune regulatory mechanism basically measured by T cells and NK cells
have an important role in the continuous accumulation of CLL cells in the body; 3) Cells of
the stroma are essential to maintain survival of CLL cells through a series of cytokines or
chemokines. Under the light of this evidence, it is worth studying new treatment modes
directed not only to CLL cells but also to the microenvironment and immune functions.
Lenalidomide is being investigated as treatment for several oncologic indications including
myelodysplastic syndromes, multiple myeloma and non-Hodgkin lymphoma. Within the scope of
CLL, it has been proved that lenalidomide is active in patients with relapsing / treatment
resistant CLL patients. Forty five patients with relapsing CLL, 51% resistant to
fludarabine, where included in a phase II study and were treated orally with 25 mg of
lenalidomide on days 1 to 21 of a cycle of 28 days. The total response rate was of 47% with
up to a 9% of complete responses.
The combination of lenalidomide with dexamethasone is being investigated in multiple myeloma
and has revealed as a highly efficient treatment in relapsing/ treatment resistant patients
as well as in those newly diagnosed. Bearing in mind that both drugs, lenalidomide and
dexamethasone, are clinically active in CLL the investigators have designed a study with
this combination in relapsing or treatment resistant patients following treatments
containing fludarabine which do not meet the requirements for an intensive rescue treatment.
Given initial doses of 10 and 25 mg of lenalidomide daily may be associated with tumor lysis
cases, it is proposed a low initial dose of lenalidomide in the first cycle 2.5mg., with
further increases to prevent the occurrence of tumor lysis syndrome
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01809847 -
Ofatumumab Induction and Maintenance in Elderly Patients With Poor Risk CLL in the Context of Allogeneic Transplantation
|
Phase 2 |