Clinical trial · Interventional
Rituximab and Alemtuzumab in Treating Older Patients With Progressive Chronic Lymphocytic Leukemia
A Phase II Randomized Trial Comparing Standard and Low Dose Rituximab: Initial Treatment of Progressive Chronic Lymphocytic Leukemia in Elderly Patients Using Alemtuzumab and Rituximab
NCT01013961CI-TRIAL-00067640terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
RATIONALE: Monoclonal antibodies, such as rituximab and alemtuzumab, 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 rituximab together with alemtuzumab may kill more cancer cells. PURPOSE: This randomized phase II trial is studying two different doses of rituximab to compare how well they work when given together with alemtuzumab in treating older patients with progressive chronic lymphocytic leukemia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alemtuzumab | Biological | Alemtuzumab | ALIAS |
| rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A (standard dose)
- description
- Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m\^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles. Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week.
- interventionNames
- Biological: alemtuzumab
- Biological: rituximab
- type
- EXPERIMENTAL
- label
- Arm B (low dose)
- description
- Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m\^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles. Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria:
* Diagnosis of chronic lymphocytic leukemia (CLL) meeting the following criteria:
* Minimum threshold peripheral lymphocyte count of 5 x 10\^9/L (CLL variant) OR palpable adenopathy \> 1 cm or palpable splenomegaly 9small lymphocytic lymphoma \[SLL\] variant)
* Immunophenotypic demonstrations of a population of B-lymphocytes (as defined by CD19+) that are monoclonal (by light-chain exclusion) AND have ≥ 3 of the following characteristics:
* CD5+
* CD23+
* Dim surface light chain expression
* Dim surface CD20 expression
* FISH analysis is negative for immunoglobulin heavy chain/cyclin D1 gene (IGH/CCND1) and/or immunostaining is negative for cyclin D1 expression (to exclude mantle cell lymphoma)
* Progressive, symptomatic CLL, defined by at least one of the following:
* Weight loss \> 10% within the past 6 months attributable to progressive CLL (grade 2 or higher)
* Extreme fatigue attributable to progressive CLL (grade 3 or higher)
* Fevers \> 100.5° F for 2 weeks without evidence of infection (grade 1 or higher)
* Night sweats without evidence of infection (drenching)
* Evidence of progressive bone marrow failure with hemoglobin \< 11 g/dL or platelet count \< 100 x 10\^9/L
* Rapidly progressive lymphadenopathy for which the largest node is ≤ 5 cm in any dimension
* Largest lymph nodes involved in the neck, axilla, and groin need to be measured and followed for response
Exclusion Criteria:
* Prior treatment for CLL
* Massive splenomegaly \> 6 cm below left costal margin, at rest, on clinical examination
* Lymphadenopathy \> 5 cm in any diameter
* New York Heart Association class III or IV heart disease
* Recent myocardial infarction (within the past month)
* Uncontrolled infection
* Infection with the human immunodeficiency virus (HIV/AIDS)
* Serological evidence of active hepatitis B infection (HBsAg or HBeAg positive)
* Positive hepatitis C serology
* Evidence of active autoimmune hemolytic anemia, immune thrombocytopenia, or pure red blood cell aplasia
* Other active primary malignancy requiring treatment or that limits survival to ≤ 2 years, except for in situ carcinoma of the cervix or breast or non-metastatic basal cell or squamous cell carcinoma of the skin
* Major surgery within 4 weeks prior to pre-registration
* Concomitant use of continuous systemic corticosteroids
* Prior corticosteroids are allowed but not at time of pre-registration to the studyReferences
Publications (0)
Data not yet available
No reference posted for this study.