Clinical trial · Interventional
Fludarabine, Rituximab, and Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia
A Phase II Study of Fludarabine + Rituximab Induction Followed by Alemtuzumab (Campath-1H, NSC #715969, IND #10864) Administered Subcutaneously as Consolidation in Untreated Patients With B-Cell Chronic Lymphocytic Leukemia
- 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)
This phase II trial is studying how well giving fludarabine together with rituximab followed by alemtuzumab works in treating patients with chronic lymphocytic leukemia. 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 can find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving fludarabine together with rituximab followed by alemtuzumab may kill more cancer cells.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-cell Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| Stage I Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | CURATED_BROADER | 0.78 |
| Stage II Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | CURATED_BROADER | 0.78 |
| Stage III Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | CURATED_BROADER | 0.78 |
| Stage IV Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alemtuzumab | Biological | Alemtuzumab | ALIAS |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (alemtuzumab, rituximab, fludarabine phosphate)
- description
- Patients receive induction therapy comprising rituximab IV over 4 hours on days 1, 3, and 5 of course 1 and day 1 of all subsequent courses and fludarabine IV over 30 minutes on days 1-5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression. Approximately 4 months after completion of induction therapy, patients achieving a partial response, nodular partial response, or stable disease receive consolidation therapy comprising alemtuzumab subcutaneously on days 1-3. Treatment repeats weekly for up to 6 courses in the absence of disease progression.
- interventionNames
- Biological: alemtuzumab
- Biological: rituximab
- Drug: fludarabine phosphate
Primary outcomes (1)
- measure
- Number of Participants With a Complete Response After Treatment With Fludarabine & Rituximab Followed by Alemtuzumab
- timeFrame
- Duration of treatment (up to 13.5 months)
- description
- A complete response, as defined by the National Cancer Institute Working Group (NCIWG): \- CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate \& biopsy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Specific Diagnosis of B-Cell CLL * An absolute lymphocytosis of \> 5,000/μL * Morphologically, the lymphocytes must appear mature with \< 55% prolymphocytes * Bone marrow examination must include at least a unilateral aspirate and biopsy; the aspirate smear must show \> 30% of all nucleated cells to be lymphoid or the bone marrow core biopsy must show lymphoid infiltrates compatible with marrow involvement by CLL; the overall cellularity must be normocellular or hypercellular * Local institution lymphocyte phenotype must reveal a predominant B-cell monoclonal population sharing a B-cell marker (CD19, CD20, CD23) with the CD5 antigen, in the absence of other pan-T-cell markers; additionally, the B-cells must be monoclonal with regard to expression of either κ or λ and have surface immunoglobulin expression of low density; patients with bright surface immunoglobulin levels must have CD23 co-expression * Patients must be in the intermediate- or high-risk categories of the modified three-stage Rai staging system (i.e., stages I, II, III, or IV) * Patients in the intermediate-risk group must have evidence of active disease as demonstrated by at least one of the following criteria: * Massive or progressive splenomegaly, hepatomegaly and/or lymphadenopathy; * Presence of weight loss \> 10% over the preceding 6 month period; * Grade 2 or 3 fatigue; * Fevers \> 100.5°F or night sweats for greater than 2 weeks without evidence of infection; * Progressive lymphocytosis with an increase of \> 50% over a 2 month period or an anticipated doubling time of less than 6 months * No prior therapy for CLL including corticosteroids for autoimmune complications that have developed since the initial diagnosis of CLL * No medical condition requiring chronic use of oral corticosteroids * Performance Status 0 - 2 * Due to alterations in host immunity, patients with HIV may not be enrolled * Due to the unknown teratogenic potential of alemtuzumab, pregnant or nursing women may not be enrolled; women and men of reproductive potential should agree to use an effective means of birth control * Creatinine =\< 1.5 x upper limit of institutional normal value * Coomb's Testing NEGATIVE
References
Publications (1)
- DERIVEDJones JA, Ruppert AS, Zhao W, Lin TS, Rai K, Peterson B, Larson RA, Marcucci G, Heerema NA, Byrd JC. Patients with chronic lymphocytic leukemia with high-risk genomic features have inferior outcome on successive Cancer and Leukemia Group B trials with alemtuzumab consolidation: subgroup analysis from CALGB 19901 and CALGB 10101. Leuk Lymphoma. 2013 Dec;54(12):2654-9. doi: 10.3109/10428194.2013.788179. Epub 2013 May 9. PMID 23547837