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Phase 2 N=60 Treatment

FCR Plus Sargramostim (GM-CSF) as Frontline Therapy for Symptomatic Chronic Lymphocytic Leukemia

Chronic Lymphocytic Leukemia

Bottom Line

View on ClinicalTrials.gov: NCT00381004 ↗
Enrolled (actual)
60
Serious AEs
20.0%
Results posted
Aug 2015
Primary outcome: Primary: Participant Overall Response Rate (ORR) at 6 Months Includes Complete Remissions, Partial Remission, or Nodule Partial Remissions. — 100 Percentage of Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Cyclophosphamide (Drug); Fludarabine (Drug); Sargramostim (Drug); Rituximab (Drug)
Age
Pediatric, Adult, Older Adult
Sex
All
Sponsor
M.D. Anderson Cancer Center
Primary completion
Dec 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Participant Overall Response Rate (ORR) at 6 Months Includes Complete Remissions, Partial Remission, or Nodule Partial Remissions.		 100 —
PRIMARY
Number of Participants With Overall Response Includes Complete Remissions, Partial Remission, or Nodule Partial Remissions.		 45; 6; 9 —
SECONDARY
Number of Participants Progression-free		 60 —

Summary

The goal of this clinical research study is to learn if using a combination of fludarabine, cyclophosphamide, and rituximab, with sargramostim (GM-CSF) can help to control previously untreated chronic lymphocytic leukemia (CLL). The safety of this combination will also be studied. This study will evaluate antibody-dependent cellular cytotoxicity (ADCC) and its relationship to response.

Eligibility Criteria

Inclusion Criteria

  • Untreated CLL, CLL/PLL, or SLL (small lymphocytic lymphoma) with indication for therapy. Indications for therapy include at least one of the following: (1) one or more disease-related symptoms [fever, night sweats, weight loss > 10% in prior 6 months, pronounced fatigue]; (2) advanced stage disease (Rai stage >/= 3 or Binet stage C); (3) autoimmune anemia and/or thrombocytopenia that is unresponsive to other therapies; (4) massive or progressive hepatomegaly and/or splenomegaly and/or lymphadenopathy; (5) recurrent infections; (6) rapid lymphocyte doubling time of /= 1 year after menses cease and/or surgically sterilized) need a negative serum or urine pregnancy test within 2 days of study enrollment..

Exclusion Criteria

  • Active hepatitis B (at least one of the following markers positive: HBsAg, hepatitis B e antigen (HBeAg), immunoglobulin M (IgM) anti-HBc, hepatitis B virus (HBV) DNA).
  • Concurrent chemotherapy or immunotherapy.
  • Pregnant patients.
  • History of HIV
  • Symptomatic central nervous system (CNS) disease
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00381004). 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.

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