Tolerance and Efficacy of Subcutanous Low Doses Rituximab for CLL Consolidation Treatment

NCT01521689 | Unknown Phase 2

• 1 other identifier: LLCR lowdoz / IPC 2009-004
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic Lymphocytic Leukemia (CLL) is still an incurable disease. However recent advances have established correlation between the quality of the response (in particular achievement of negativity of minimal residual disease (MRD) and progression free and overall survival. That is why MRD negative complete remission (CR) is the current goal in CLL treatment. The association of Rituximab fludarabine cyclophosphamide leads to the best response rate with 52 to 72% CR in "medically" fit untreated CLL patients. MRD results in this setting are still preliminary and around 50%. However many other situations (unfit, elderly, relapse, haematological toxicity leading to early interruption of treatment…) are associated with much lower response rate that would be improved by consolidation treatment. Monoclonal antibodies are the treatment of choice for consolidation because of sparing marrow and targeting CLL cells. Alemtuzumab has been used for this purpose and results confirm improvement of CR and MRD negative responses but alemtuzumab induced immunodeficiency lead to unacceptable infectious complications. Rituximab monotherapy induces low response rate at standard dose regimen. This is at least partially due to shaving of CD20, mechanism by which CD20 is lost from the leukemic cells but these cells are not cleared. Using low doses of rituximab reduced shaving and allowed CLL cells clearance by the mononuclear phagocytic system. Such low doses of rituximab can be administered subcutaneously. The investigators then propose subcutaneous low dose rituximab in consolidation to CLL patients responding after induction but having not achieved MRD negative CR.

Conditions

Chronic Lymphocytic Leukemia

Keywords

MRD negative CR

Outcome Measures

Primary Outcomes (1)

• Residual disease

  \- minimal residual disease (MRD) negative complete response (CR) rate after consolidation using subcutaneous low dose of rituximab, from randomisation up to 3 month after the end of treatment

  up to 3 month after the end of treatment

Secondary Outcomes (6)

• overall survival

  From date of inclusion until date of death, assessed up to 10 years

• Adverse events

  up to 3 months

• -Quality of life

  up to 3 months after the end of treatment

• Immune functions

  up to 3 months after the end of treatment

• - Progression free survival

  up to time of progression assessed up to 10 years

Study Arms (1)

Rituximab

EXPERIMENTAL

Consolidation treatment with sub cutaneaous low doses of Rituximab

Drug: Rituximab

Interventions

Rituximab DRUG

Low doses of sub cutaneaous rituximab

Rituximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CLL (Matutes 4 or 5) in CR after induction treatment with negative MRD or PR
• age\>18
• performance status\<=2
• signed informed consent

You may not qualify if:

• cytopenia
• other malignant affection
• HIV or HBV positive
• steroids treatment
• richter syndrome
• pregnant or breastfeeding women

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Study Sites (1)

Institut Paoli Calmettes

Marseille, 13009, France

Location

Related Links

• Web site of the sponsor

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Thérèse AURRAN, MD

  Institut Paoli-Calmettes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2011
• First Posted: January 31, 2012
• Study Start: December 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 20, 2015

Record last verified: 2015-03

Locations

FR (1)