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Rescue Treatment With Rituximab-CHOP Therapy and Alemtuzumab (R-CHOP-A) in Refractory or Recidivant Patients With Chronic Lymphocytic Leukemia After Purine-analogous Treatment

Phase 2
18 Years
70 Years
Not Enrolling
Chronic Lymphocytic Leukaemia, Patients Resistant to a Purine Analogous, Patients Relapsed With Purines Therapy

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Trial Information

Rescue Treatment With Rituximab-CHOP Therapy and Alemtuzumab (R-CHOP-A) in Refractory or Recidivant Patients With Chronic Lymphocytic Leukemia After Purine-analogous Treatment


The objectives of this clinical trial are the following:

- Main objective of the study: Overall response rate obtained after R-CHOP regime
followed by Alemtuzumab consolidation as second line therapy

- Secondary objectives

- Determine the molecular complete response rate after R-CHOP regimen

- Determine the efficacy of Alemtuzumab in response improvement after R-CHOP
regimen: conversion of PR to CR and of MRD+ to MRD-.

- Applicability (toxicity profile) of Alemtuzumab consolidation therapy.

- As additional objectives will be considered:

1. Prognostic value of several biological variables (ZAP-70 and cytogenetics)
having influence on the response

2. Response duration

3. Progression free survival

4. Overall survival

Inclusion Criteria:

1. Patient's written informed consent before initiation of any specific procedure
related with the study.

2. Age ≥ 18 years and ≤ 70 years

3. (ECOG) ≤ 2

4. Patients suffering from chronic lymphocyte leukaemia according to the established
diagnostic criteria (Addendum A).

5. Active CLL defined by the presence of one or more of the following criteria:

- Related symptoms: weight loss >10% in the 6 previous months, or fever >38ºC for
2 weeks with no evidence of infections, or extreme fatigue, or night sweats with
no evidence of infection.

- 5.2.Enlarged lymph nodes or giant node clusters (>10 cm in diameter) or
progressive growth lymph nodes.

- 5.3.Giant splenomegaly (> 6 cm under ribs border) or progressive splenomegaly.

- 5.4.Progressive lymphocytosis (>50% increase in a period of 2 months) or
lymphocyte duplication time (expected) < 6 months

- 5.5.Proof of progressive bone marrow failure evidenced by development or
worsening of anaemia and/or thrombopenia.

6. Patients previously treated in first line with purine analogous and showing:

- Treatment failure (stable disease or progression)

- Relapse within three years of therapy.

7. Agreement to use a high efficacy contraception method throughout all study period.

Exclusion Criteria:

1. Age > 70 years

2. Patients having received more than one therapy line

3. Patients that had not received previously purine analogous therapy.

4. CLL patients in transformation to more aggressive cytologic or pathologic forms
(Pro-lymphocytic leukaemia large cell lymphoma, Hodgkin's lymphoma)

5. Hypersensitivity shown as anaphylactic reaction to any of the DRUGS used in the

6. Patients with severe heart, lung, neurological, psychiatric or metabolic diseases not
due to CLL

7. Patients under systemic and continued steroid therapy.

8. Impairment of renal function (Creatinine > 2 times the upper limit of normal)
non-attributable to CLL.

9. Patients suffering anaemia or thrombocytopenia of autoimmune origin as well as those
with a positive Coombs test

10. Impairment of liver function (Bilirubin, ASAT/ALAT or Gamma-GT > 2 times upper limit
of normal) non attributable to CLL

11. Patients with active severe infectious disease

12. Patients suffering another malignancy (with the exception of focalized skin

13. Patients with positive serum tests for HBsAg or CHV

14. Patients with history of HIV or other severe immune depression conditions.

15. Pregnant or breast feeding women

16. Patients unable to attend the controls under outpatient regimen

17. Patients previously treated with alemtuzumab

Type of Study:


Study Design:

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

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

Outcome Time Frame:

57 months

Principal Investigator

Francesc Bosch, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital Clinic de Barcelona


Spain: Spanish Agency of Medicines

Study ID:




Start Date:

July 2007

Completion Date:

June 2012

Related Keywords:

  • Chronic Lymphocytic Leukaemia
  • Patients Resistant to a Purine Analogous
  • Patients Relapsed With Purines Therapy
  • Rituximab-CHOP
  • Alemtuzumab
  • Chronic lymphocytic leukaemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid