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Also known as Cyclophosphamide, cytophosphane, Endoxan, Neosar, Procytox, Revimmune
Cytoxan · 1 trial · 4 indications
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
| Arm | Type | Description |
|---|---|---|
| Fludarabine, cytoxan, then alemtuzumab | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| Alemtuzumab | DRUG | 3 to 30 mg, IV |
| Fludarabine | DRUG | \[(2R,3R,4S,5R)-5-(6-amino-2-fluoro-purin-9-yl)- 3,4-dihydroxy-oxolan-2-yl\]methoxyphosphonic acid |
| Cytoxan | DRUG | (RS)-N,N-bis(2-chloroethyl)-1,3,2-oxazaphosphinan-2-amine 2-oxide |
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...
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