R-CHOP and Alemtuzumab in Patients With Chronic Lymphocytic Leukemia

Sponsor
CABYC
Study ID
NCT00504491
Phase
PHASE2
Status
Withdrawn

Conditions

  • Chronic Lymphocytic Leukaemia
  • Patients Relapsed With Purines Therapy
  • Patients Resistant to a Purine Analogous

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

Since there is no standard rescue therapy for refractory CLL or relapsed to the purine analogous, our target is to carry out a rescue therapy combining several chemotherapy agents (CHOP) adding the synergistic effect of Rituximab in order to act against tumour-like CLL forms, with assessable size lymph nodes. Afterwards, based in other studies, we shall study the role of Alemtuzumab as drug for consolidation or improvement of responses obtained with the initial therapy (CHOP-R), acting by "cleaning" from peripheral blood and bone marrow the CLL lymphocytes that may have had remain as residual after chemotherapy induction therapy. More precisely, the addition of Alemtuzumab as maintenance treatment would increase the complete responses with negative residual disease number and may prolong the duration of the response. For this, it is necessary to have not only an adequate and rigorous clinical follow-up but also biological, i.e. being able to analyze minimal residual disease by molecular biology techniques. This is the reason of writing this phase II clinical trial protocol.

Key Dates

Start date
Jul 31, 2007
Status verified
Dec 2011
Primary completion
Jan 31, 2012
Completion
Jun 30, 2012

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Four Rituximab - CHOP courses will be given The courses will be given every 21 days Drug Dose Day Rituximab (Mabthera) 500mg/m2 1(\*) (\*\*) Cyclophosphamide 750mg/m2 1 Adriamycin 50mg/m2 1 Vincristine 1,4 mg/m2 1 Prednisone 60mg/m2 1 to 5 (\*\*) 1st course, 375 mg/m2 (\*) If lymphocyte count is \> 30 X 10 9/l, dose will be split up in two, which will be given in days 0 and 1

Primary Outcome Measure

Response rate obtained after R-CHOP regimen followed by consolidation therapy with Alemtuzumab, as second line therapy. Haematological and non haematological toxicity will be graded in accordance with the WHO system [ Time Frame: 57 months ]

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