Combination Chemotherapy With or Without Rituximab in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia

NCT00337246 | Completed Phase 2

• 6 other identifiers: CTRU-NCRI-UKCLL01-FCM/FCM-RCDR0000485181EU-20626ROCHE-NCRI-UKCLL01-FCM/FCM-RISRCTN77546448EUDRACT-2004-003982-34
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 16

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as fludarabine, cyclophosphamide, and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving combination chemotherapy together with rituximab may kill more cancer cells. It is not yet known whether giving combination chemotherapy together with rituximab is more effective than combination chemotherapy alone in treating chronic lymphocytic leukemia. PURPOSE: This randomized phase II trial is studying how well giving combination chemotherapy with or without rituximab works in treating patients with previously treated chronic lymphocytic leukemia.

Conditions

Leukemia

Keywords

refractory chronic lymphocytic leukemia; stage I chronic lymphocytic leukemia; stage II chronic lymphocytic leukemia; stage III chronic lymphocytic leukemia; stage IV chronic lymphocytic leukemia

Outcome Measures

Primary Outcomes (1)

• Overall response rate as measured by NCI Response Criteria

Secondary Outcomes (4)

• Proportion of patients with undetectable minimal residual disease

• Progression-free survival at 2 years

• Overall survival at 2 years

• Toxicity

Interventions

rituximab BIOLOGICAL

cyclophosphamide DRUG

fludarabine phosphate DRUG

mitoxantrone hydrochloride DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of chronic lymphocytic leukemia requiring therapy * Previously treated with ≥ 1 chemotherapeutic regimen PATIENT CHARACTERISTICS: * WHO performance status 0-2 * Life expectancy ≥ 12 weeks * Creatinine clearance ≥ 30 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile female patients must use effective contraception for 4 weeks before, during, and for 6 months after completion of study treatment * Fertile male patients must use effective contraception during and for 6 months after completion of study treatment * No history of anaphylaxis after exposure to rat or mouse-derived complementary-determining region (CDR)-grafted humanized monoclonal antibodies * No toxicity attributable to purine analogues (e.g., autoimmune hemolytic anemia, neurological toxicity, or allergy) * No active infection * No other severe (particularly cardiac or pulmonary) diseases or mental disorders that would preclude study participation PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior fludarabine (or other purine analogues) combined with cyclophosphamide and mitoxantrone hydrochloride * No prior rituximab, either alone or in combination with chemotherapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cancer Research UK: lead

Study Sites (16)

Birmingham Heartlands Hospital

Birmingham, England, B9 5SS, United Kingdom

Location

Blackpool Victoria Hospital

Blackpool, England, FY3 8NR, United Kingdom

Location

Kent and Canterbury Hospital

Canterbury, England, CT2 7NR, United Kingdom

Location

St Helier Hospital

Carshalton, England, SM5 1AA, United Kingdom

Location

Darent Valley Hospital

Dartford Kent, England, DA2 8DA, United Kingdom

Location

Medway Maritime Hospital

Gillingham Kent, England, ME7 5NY, United Kingdom

Location

Leeds General Infirmary at Leeds Teaching Hospital NHS Trust

Leeds, England, LS1 3EX, United Kingdom

Location

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

Royal Liverpool and Broadgreen Hospitals NHS Trust

Liverpool, England, L7 8XP, United Kingdom

Location

Maidstone Hospital

Maidstone, England, ME16 9QQ, United Kingdom

Location

Christie Hospital NHS Trust

Manchester, England, M20 4BX, United Kingdom

Location

Royal Cornwall Hospital

Truro, Cornwall, England, TR1 3LJ, United Kingdom

Location

Kent and Sussex Hospital

Tunbridge Wells, Kent, England, TN4 8AT, United Kingdom

Location

Wishaw General Hospital

Wishaw, England, ML2 0DP, United Kingdom

Location

Monklands General Hospital

Airdrie, Scotland, ML6 0JF, United Kingdom

Location

University Hospital of Wales

Cardiff, Wales, CF14 4XW, United Kingdom

Location

Related Publications (1)

• Hillmen P, Cohen DR, Cocks K, Pettitt A, Sayala HA, Rawstron AC, Kennedy DB, Fegan C, Milligan DW, Radford J, Mercieca J, Dearden C, Ezekwisili R, Smith AF, Brown J, Booth GA, Varghese AM, Pocock C; NCRI CLL Sub-Group. A randomized phase II trial of fludarabine, cyclophosphamide and mitoxantrone (FCM) with or without rituximab in previously treated chronic lymphocytic leukaemia. Br J Haematol. 2011 Mar;152(5):570-8. doi: 10.1111/j.1365-2141.2010.08317.x. Epub 2011 Jan 14.

  PMID: 21231927 RESULT

MeSH Terms

Conditions

Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Rituximab; Cyclophosphamide; fludarabine phosphate; Mitoxantrone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; 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; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Quinones; Polycyclic Compounds

Study Officials

• Peter Hillmen, MD

  Leeds General Infirmary

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 13, 2006
• First Posted: June 15, 2006
• Study Start: July 1, 2005
• Study Completion: March 1, 2011
• Last Updated: August 2, 2013

Record last verified: 2007-05

Locations

GB (16)