Clinical trial · Interventional
A Phase II Trial of Alemtuzumab and Rituximab in Patients With Previously Untreated CLL
A Phase II Trial of Alemtuzumab (Campath-1H) and Rituximab (Rituxan) in Patients With Previously Untreated CLL
NCT00858117CI-TRIAL-00048164completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Monoclonal antibodies, such as alemtuzumab and 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 alemtuzumab together with rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying the side effects of giving alemtuzumab together with rituximab and to see how well it works in treating patients with previously untreated B-cell 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 |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alemtuzumab | Biological | Alemtuzumab | ALIAS |
| Rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Alemtuzumab and Rituximab
- description
- Administration of Alemtuzumab combined with Rituximab to test the feasibility of combining these two monoclonal antibodies as a first line therapy in patients with B-cell chronic lymphocytic leukemia.
- interventionNames
- Biological: Alemtuzumab
- Biological: Rituximab
Primary outcomes (2)
- measure
- Number of Patients Treated With Alemtuzumab and Rituximab Combination With a Response (CR or PR) Assessed by NCI-WG 1996 Criteria With Lymph-adenopathy and Organomegaly Measured During Physical Examination
- timeFrame
- At week 9, and post-18 weeks then every 3 months for a year and up every 6 months for up to 2 years
- description
- Response rate (complete remission(CR) + partial remission(PR)) will be, assessed by NCI-WG 1996 criteria with lymphadenopathy and organomegaly measured during physical examination. CR=Absence of lymphadenopathy and constitutional symptoms, Normal CBC (leukocytes ≥ 1500/μl, Platelets \>100,000/μl, Hemoglobin \> 11.0 gm/dl), peripheral blood lymphocytes ≤ 4,000/μl.The marrow sample must be at least normocellular with \< 30% of nucleated cells being lymphocytes. PR=absence of constitutional symptoms, ≥ 50% decrease in peripheral blood lymphocyte count from the pretreatment baseline value, ≥ 50% reduction in lymphadenopathy, ≥ 50% reduction in size of liver and/or spleen and one of the following: polymorphonuclear leukocytes ≥ 1,500/μl or 50% improvement over baseline platelets \> 100,000/μl or 50% improvement over baseline or hemoglobin \> 11.0 gm/dl or 50% improvement over baseline without transfusions
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of B-cell chronic lymphocytic leukemia (CLL)\*, as defined by the following criteria:
* Peripheral blood absolute lymphocyte count \> 5,000/mm³
* Small- to moderate-size lymphocytes with \< 55% prolymphocytes, atypical lymphocytes, or lymphoblasts
* Phenotypically characterized B-CLL expressing CD20 and CD52, as defined by the following:
* Predominant population of cells share B-cell antigens with CD-5 in the absence of other pan-T-cell markers (e.g., CD-3, CD-2)
* B-cell expresses either lambda or kappa light chains
* Surface immunoglobulin with low-cell surface density expression NOTE: \*Presence of splenomegaly, hepatomegaly, or lymphadenopathy are not required for the diagnosis of CLL
* Requires therapy, as indicated by ≥ 1 of the following criteria:
* Unintentional weight loss \> 10% within the past 6 months
* Extreme fatigue (i.e., ECOG performance status 2)
* Fevers \> 100.5°F for 2 weeks without evidence of infection
* Night sweats without evidence of infection
* Evidence of progressive marrow failure as manifested by the development of or worsening of anemia (hemoglobin \< 10 g/dL) and/or thrombocytopenia (platelet count \< 100,000/mm³)
* Massive (i.e., \> 6 cm below left costal margin) or progressive splenomegaly
* Massive nodes/clusters (\> 5 cm), progressive symptomatic adenopathy, or adenopathy resulting in end-organ damage
* Progressive lymphocytosis with an increase of \> 50% over 2 months or an anticipated doubling time \< 6 months
* Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease is not sufficient for eligibility
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* ANC ≥ 1,000/mm³\*
* Platelet count ≥ 50,000/mm³\*
* Hemoglobin ≥ 10 g/dL\*
* Serum creatinine ≤ 2.0 mg/dL OR creatinine clearance \> 40 mL/min
* Bilirubin \< 2 mg/dL
* AST and ALT ≤ 2 times normal (unless secondary to tumor infiltration/lymphadenopathy)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after completion of study treatment
* No active autoimmune anemia or thrombocytopenia
* No active infection requiring oral or intravenous antibiotics
* No second malignancy, other than basal cell carcinoma of the skin or in situ carcinoma of the cervix, unless curatively treated ≥ 2 years ago NOTE: \*If cytopenias are due to degree of bone marrow involvement, patient may be eligible at the discretion of the principal investigator.
PRIOR CONCURRENT THERAPY:
* Prior corticosteroid therapy allowed
* No prior cytotoxic therapy (other than corticosteroids)References
Publications (0)
Data not yet available
No reference posted for this study.