ISRCTN16544962
Completed
Phase 2
A randomised, phase IIB trial in previously untreated patients with chronic lymphocytic leukaemia (CLL) to compare fludarabine, cyclophosphamide and rituximab (FCR) with FC, mitoxantrone and low dose rituximab (FCM-miniR)
eeds Teaching Hospitals NHS Trust (UK)0 sites206 target enrollmentSeptember 25, 2008
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Chronic lymphocytic leukaemia (CLL)
- Sponsor
- eeds Teaching Hospitals NHS Trust (UK)
- Enrollment
- 206
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28628003 results 2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28336937 results
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Both males and females, at least 18 years old
- •2\. B\-CLL with a characteristic immunophenotype
- •3\. Binet's Stages B, C or Progressive Stage A
- •4\. Requiring therapy by the International Workshop on CLL (IWCLL) criteria in that they must have at least one of the following: Evidence of progressive marrow failure as manifested by the development of, or worsening of, anaemia and/or thrombocytopenia
- •5\. Massive (i.e. 6 cm below the left costal margin) or progressive or symptomatic splenomegaly
- •6\. Massive nodes (i.e. 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy
- •7\. Progressive lymphocytosis with an increase of more than 50% over a 2\-month period or lymphocyte doubling time (LDT) of less than 6 months as long as the lymphocyte count is over 30 x 10^9/L
- •8\. A minimum of any one of the following disease\-related symptoms must be present:
- •8\.1\. Unintentional weight loss more than or equal to 10% within the previous 6 months
- •8\.2\. Significant fatigue (i.e. Eastern Cooperative Oncology Group PS 2 or worse; cannot work or unable to perform usual activities)
Exclusion Criteria
- •1\. Prior therapy for CLL
- •2\. Active infection
- •3\. Past history of anaphylaxis following exposure to rat or mouse derived CDR\-grafted humanised monoclonal antibodies
- •4\. Pregnancy, lactation or women of child\-bearing potential unwilling to use medically approved contraception whilst receiving treatment
- •5\. Men whose partners are capable of having children but who are not willing to use appropriate medically approved contraception during the study, unless they are surgically sterile
- •6\. Central nervous system (CNS) involvement with CLL
- •7\. Mantle cell lymphoma
- •8\. Other severe, concurrent diseases or mental disorders
- •9\. Known HIV positive
- •10\. Patient has active or prior hepatitis B or C
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 2
Study of the effectiveness of the addition of Capecitabine to a standard regimen containing Adriamycin®, Cyclophosphamide and Docetaxel as neoadjuvant treatment in large or locally advanced breast cancersarge or locally advanced breast cancerCancerMalignant neoplasm of breastISRCTN00407556nited Lincolnshire Hospitals NHS Trust (UK)130
Completed
Not Applicable
Evaluating the feasibility, acceptability and potential effectiveness of complex nursing intervention focused on quality of life assessment on advanced cancer patients with palliative care needsISRCTN41201864niversity of Genoa (Università di Genova)46
Completed
Phase 2
stekinumab in adolescents with recent-onset type 1 diabetesType 1 diabetes mellitusNutritional, Metabolic, EndocrineISRCTN14274380Cardiff University88
Completed
Phase 2
A two-arm phase II randomised trial of intermittent chemotherapy plus continuous cetuximab and of intermittent chemotherapy plus intermittent cetuximab in first line treatment of patients with K-ras-normal (wild-type) metastatic colorectal cancerMetastatic colorectal cancerCancerColorectal cancerISRCTN38375681Medical Research Council (MRC) (UK)130
Completed
Not Applicable
Evaluation of a computer aid for assessing stomach symptomsISRCTN12595588niversity of Durham (UK)530