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Phase 2 N=33 Treatment

Rituximab, Alemtuzumab, and GM-CSF As First-Line Therapy in Treating Patients With Early-Stage Chronic Lymphocytic Leukemia

Leukemia

Enrolled (actual)
33
Serious AEs
3.0%
Results posted
May 2012
Primary outcome: Primary: Number of Confirmed Responses (Complete or Partial Response Noted as the Objective Status for a Duration of at Least 2 Months) at 6 Months — 31 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Alemtuzumab (Biological); Rituximab (Biological); Sargramostim (Biological)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Mayo Clinic
Primary completion
Feb 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Confirmed Responses (Complete or Partial Response Noted as the Objective Status for a Duration of at Least 2 Months) at 6 Months
31
SECONDARY
Progression Free Survival
13.0
SECONDARY
Duration of Response
14.9
SECONDARY
Time to Next Treatment
33.5
SECONDARY
Overall Survival
NA

Summary

RATIONALE: 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 find cancer cells and help kill them or carry cancer-killing substances to them. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving monoclonal antibody therapy together with GM-CSF may be an effective treatment for early-stage chronic lymphocytic leukemia. PURPOSE: This phase II trial is studying the side effects of giving rituximab and alemtuzumab together with GM-CSF and to see how well it works in treating patients with early-stage chronic lymphocytic leukemia.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of chronic lymphocytic leukemia (CLL) meeting the following criteria:
  • Minimum threshold peripheral blood lymphocyte count 5 x 10^9/L
  • Monoclonality (light chain exclusion) of B lymphocytes detected by immunophenotyping (CD19-positive), demonstrating ≥ 3 of the following characteristics:
  • CD5-positive
  • CD23-positive
  • Dim surface light chain expression
  • Dim surface CD20 expression
  • Negative for IGH/CCND1 translocation AND/OR immunostaining is negative for cyclin D1 expression by fluorescent in-situ hybridization (FISH) analysis
  • Rai stage 0, I, or II disease that does not meet standard NCI-Working Group criteria for treatment of CLL
  • Poor prognosis as defined by ≥ 1 of the following factors:
  • Unmutated IgVH mutation status AND CD38 expression (i.e., ≥ 30% cells positive on flow cytometry)
  • Unmutated IgVH mutation status AND ZAP-70 expression (i.e., ≥ 20% cells positive on flow cytometry)
  • VH3-21 gene segment use irrespective of mutation status AND CD38 expression (≥ 30% cells positive on flow cytometry)
  • VH3-21 gene segment use irrespective of mutation status AND ZAP-70 expression (≥ 20% cells positive on flow cytometry)
  • 11q-negative*
  • 17p-negative* NOTE: *Determination of IgVH mutation status is not required in patients whose eligibility is based on 17p13- or 11q22- deletions

PATIENT CHARACTERISTICS:

  • ECOG performance status 0- 2
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Total bilirubin ≤ 3.0 times ULN OR direct bilirubin ≤ 1.5 ULN
  • AST ≤ 3.0 times ULN (unless due to hemolysis or CLL)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must practice effective contraception
  • Willing to provide mandatory blood samples (for patients at the Mayo Clinic in Rochester only) for research studies as required by the protocol
  • No comorbid conditions, including any of the following:
  • New York Heart Association Class III or IV heart disease
  • Myocardial infarction within the past month
  • Uncontrolled infection
  • HIV infection or AIDS
  • Serological evidence of active hepatitis B infection (i.e., serum antigen or e-antigen positivity) or positive hepatitis C serology
  • No other active primary malignancy requiring treatment or limiting survival to ≤ 2 years
  • No active autoimmune hemolytic anemia, immune thrombocytopenia, or pure red blood cell aplasia

PRIOR CONCURRENT THERAPY:

  • More than 4 weeks since prior major surgery
  • No prior chemotherapy or monoclonal antibody treatment for CLL
  • No concurrent corticosteroids
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00562328). 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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