Phase 2
Completed N=30
FCM-R (Fludarabine, Cyclophosphamide, Mitoxantrone, Rituximab) in Previously Untreated Patients With Chronic Lymphocytic Leukemia (CLL) < 70 Years
Source: ClinicalTrials.gov NCT00254410 ↗Enrolled (actual)
30
Serious AEs
16.7%
Results posted
Dec 2018
Primary outcomePrimary: Clinical Response Rate at 3 Months — 29 Participants
Summary
The goal of this clinical research study is to learn if using a combination of fludarabine, cyclophosphamide, and mitoxantrone plus rituximab, with the growth factor pegylated filgrastim, will improve the response to treatment, and increase the time this response lasts, for patients with previously untreated CLL. The safety of this combination will also be studied.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Response Rate at 3 Months |
29 | — |
| PRIMARY Clinical Response Rate at 6 Months |
28 | — |
| SECONDARY Molecular Response Rate at 3 Months |
17 | — |
| SECONDARY Molecular Response Rate at 6 Months |
10 | — |
Eligibility Criteria
Inclusion Criteria
- Untreated CLL, CLL/ prolymphocytic leukemia (PLL), or small lymphocytic lymphoma (SLL) with indication for therapy (Indications for therapy include at least one of the following: i) one or more disease-related symptoms [fever, night sweats, weight loss, pronounced fatigue]; ii) advanced stage disease (Rai stage >/= 3 or Binet stage C); iii) autoimmune anemia and/or thrombocytopenia that is unresponsive to other therapies; iv) massive or progressive hepatomegaly and/or splenomegaly and/or lymphadenopathy; iv) recurrent infections; v) rapid lymphocyte doubling time of /= 1 year postmenopausal or surgically sterilized) need a negative serum or urine pregnancy test within 14 days of study enrollment.
Exclusion Criteria
- Active hepatitis B (at least one of the following markers positive: HBsAg, HBeAg, Immunoglobulin M (IgM) hepatitis B core antibody (anti-HBc), Hepatitis B (HBV) DNA).
- Concurrent chemotherapy or immunotherapy.
- Pregnant patients.
- History of HIV
- Symptomatic central nervous system (CNS) disease
- Symptomatic heart disease (NYHA class >/= 3) or left ventricle (LV) ejection fraction < 40% (by multiple gated acquisition scan (MUGA) or echocardiogram)
Data sourced from ClinicalTrials.gov (NCT00254410). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.