Clinical trial · Interventional
Phase 2 Fludarabine, Cytoxan and FCCAM <Alemtuzumab> in Untreated B-Cell Chronic Lymphocytic Leukemia
A Multi-Center Phase 2 Efficacy and Pharmacokinetic Study Evaluating Fludarabine, Cyclophosphamide, and Subcutaneous Campath (FCCam, Alemtuzumab) for Previously Untreated B-Cell Chronic Lymphocytic Leukemia
NCT00230282CI-TRIAL-00015783completedPhase 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)
The primary objective of this study was to evaluate the safety and efficacy of the combination of fludarabine and cyclophosphamide in previously untreated CLL patients. Participants will receive fludarabine and cyclophosphamide on days 1, 2, and 3 of six 28-day cycles.
Conditions
Conditions (4)
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 Leukemia | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| Chronic Leukemia | Chronic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Chronic Lymphocytic Leukemia (CLL) | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alemtuzumab | Drug | Alemtuzumab | ALIAS |
| Cytoxan | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fludarabine, cytoxan, then alemtuzumab
- description
- Fludarabine and cyclophosphamide days 1 to 3 for six 28-day cycles. Minimal residual disease positive responders continued on-treatment to receive alemtuzumab 30 mg weekly. MRD negative responders were observed.
- interventionNames
- Drug: Alemtuzumab
- Drug: Fludarabine
- Drug: Cytoxan
Primary outcomes (1)
- measure
- Number of Subjects Maintaining Partial Response (PR) or Complete Response (CR)
- timeFrame
- 24 weeks
- description
- Response criteria as per the NCI-WG Revised Guidelines for B-CLL Complete remission: No lymphadenopathy by physical exam No hepatomegaly or splenomegaly Absence of constitutional symptoms Polymorphonuclear leukocytes \> 1,500/uL, Platelets \> 100,000/uL, Hemoglobin \> 11.0 g/dL Bone marrow aspirate and biopsy normocellular with \< 30% lymphocytes Absent lymphoid nodules Partial remission: * 50% decrease in peripheral blood lymphocyte count from the pretreatment baseline value * 50% reduction in lymphadenopathy and/or ≥ 50% reduction in the size of the liver and/or spleen AND one or more of the following Polymorphonuclear leukocytes \> 1,500/uL or 50% improvement over baseline Platelets \> 100,000/uL or 50% improvement over baseline Hemoglobin \> 11.0 g/dL or 50% improvement over baseline
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* ≥ age 18
* Karnofsky performance status 60% or above
* Confirmed immunohistological diagnosis of Chronic Lymphocytic Leukemia (CLL)
* Rai Stage I to IV as follows:
* Advanced stage disease (Rai Stage III or IV, or modified Rai High Risk)
* OR
* Patients with Rai Stage I - II or (Modified Rai Intermediate-Risk) disease must have an indication for therapy based on 1996 NCI revised criteria for active disease as follows:
* Any one of the following disease-related symptoms:
1. Weight loss ≥ 10% body weight within the previous 6 months
2. Extreme fatigue
3. Fever greater than 100.5° F for ≥ 2 weeks without evidence of infection
4. Night sweats without evidence of infection
* Evidence of progressive marrow failure based on the development of worsening of anemia or thrombocytopenia
* Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroid therapy
* Massive (\> 6 cm below the left costal margin) or progressive splenomegaly
* Bulky (\>10 cm in cluster) or progressive lymphadenopathy
* Progressive lymphocytosis \> 50% increase over 2 months, or anticipated doubling time \< 6 months
* Patients with immunoglobulin VH gene in unmutated nucleotide sequence configuration, as defined by ≥ 98% homology with the nearest germline counterpart
* Serum creatinine ≤ 2x the upper limit of normal
* Total serum bilirubin ≤ 2x the upper limit of normal.
* AST ≤ 2x the upper limit of normal.
* ALT ≤ 2x the upper limit of normal.
* Signed written informed consent
Exclusion Criteria:
* Prior pharmacological treatment for CLL
* Past history of anaphylaxis following exposure to monoclonal antibodies
* Active secondary malignancy or a history of malignant disease (other than CLL or non-melanoma skin cancer) within the preceding 5 years
* Any medical condition requiring systemic corticosteroids
* Active systemic infection
* Major systemic or other illness (including Coombs positivity and active hemolysis) that would, in the opinion of the investigator, interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of study results
* HIV positive by serologic testing
* Pregnant or nursing female
* Unwilling/unable to practice an acceptable form of contraception.References
Publications (0)
Data not yet available
No reference posted for this study.