CHAIROS Study A Study of MabThera/Rituxan (Rituximab) Maintenance Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Naive to Chemotherapy

NCT02013817 | Completed Phase 2 Results

• 1 other identifier: ML18434
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 8

Brief Summary

This study will evaluate the efficacy and safety of intense combination treatment including MabThera/Rituxan (rituximab), followed by MabThera/Rituxan maintenance therapy in patients with B-cell CLL who are naive to chemotherapy. The anticipated time on study treatment is 2.5 years.

Conditions

Lymphocytic Leukemia, Chronic

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With a Best Clinical Response of Clinical Remission (CR)

  Best clinical response was determined according to the National Cancer Institute (NCI) Clinical and Clinical plus (+) Radiological evaluations by central response assessment. Assessment of response was performed according to the NCI revised guidelines for the diagnosis and treatment of chronic lymphocytic lymphoma (CLL) with additional computerized tomography (CT) scan evaluation of lymphadenopathy. Per NCI guidelines, CR requires all of the following criteria at least 2 months after the last treatment: no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/constitutional symptoms; neutrophils greater than (\>)1500 per microliter (/µL), platelets (PL) \>100,000/µL, hemoglobin (Hb) \>11.0 grams per deciliter (g/dL), lymphocytes (LC) (less than) \<4000/µL, bone marrow (BM) sample must be normocellular for age, \<30% LC.

  Weeks 1, 5, 9, 12, 13, 17, 21 and 24

Secondary Outcomes (5)

• Percentage of Participants With the Best Clinical Response by Visit (Clinical Assessment)

  Weeks 12 and 24 and at Final Staging (Week 4 after last maintenance dose)

• Percentage of Participants With the Best Clinical Response by Visit (Clinical + Radiological Assessment)

  Weeks 12 and 24 and at Final Staging (Week 4 after last maintenance dose)

• Time to Next Treatment - Percentage of Participants With an Event

  Weeks 1, 5, 9, 12, 13, 17, 21 and 24 and every 8 weeks for 64 Weeks and every 6 months

• Time to Next Treatment - Time to Event

  Weeks 1, 5, 9, 12, 13, 17, 21 and 24 and every 8 weeks for 64 Weeks and every 6 months

• Percentage of Participants With Adverse Events (AEs)

  Day 1 of Cycles 1, 2, 3, 4, 5, and 6 to 28 days after the last trial medication.

Study Arms (1)

MabThera/Rituxan

EXPERIMENTAL

Drug: rituximab [MabThera/Rituxan]; Drug: fludarabine; Drug: cyclophosphamide

Interventions

rituximab [MabThera/Rituxan] DRUG

Every 4 weeks for 6 cycles of induction, followed by maintenance therapy every 3 months x 8

MabThera/Rituxan

fludarabine DRUG

Every 4 weeks, 6 cycles

MabThera/Rituxan

cyclophosphamide DRUG

Every 4 weeks, 3 cycles

MabThera/Rituxan

Eligibility Criteria

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

You may qualify if:

• Adult patients, \>/= 18 years of age
• B-cell CLL
• No previous chemotherapy, radiotherapy, or immunotherapy

You may not qualify if:

• Reduced organ function, or bone marrow dysfunction not due to CLL
• Patients with a history of other malignancies within 2 years prior to study entry, except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer
• Patients with a history of severe cardiac disease.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (8)

Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie

Innsbruck, 6020, Austria

Location

LKH Hochsteiermark; Abt. für Innere Medizin

Leoben, 8700, Austria

Location

Kh Der Barmherzigen Schwestern; Interne I X

Linz, 4010, Austria

Location

A.Ö. Krankenhaus Der Elisabethinen Linz; I. Interne Abt.

Linz, 4020, Austria

Location

Kepler Universitätskliniken GmbH - Med Campus III; I. Medizinische Abteilung

Linz, 4020, Austria

Location

Landeskrankenhaus Rankweil; Interne E

Rankweil, 6830, Austria

Location

Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

Salzburg, 5020, Austria

Location

Klinikum Kreuzschwestern Wels; Iii. Interne Abt.

Wels, 4600, Austria

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Rituximab; fludarabine; Cyclophosphamide

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; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 17, 2013
• Study Start: October 11, 2005
• Primary Completion: September 24, 2012
• Study Completion: September 24, 2012
• Last Updated: August 18, 2017
• Results First Posted: September 10, 2014

Record last verified: 2017-07

Locations

AU (8)