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A Genetic Risk-Stratified, Randomized Phase II Study of Four Fludarabine/Antibody Combinations for Patients With Symptomatic, Previously Untreated Chronic Lymphocytic Leukemia

Phase 2
18 Years
Open (Enrolling)
B-cell Chronic Lymphocytic Leukemia, Stage I Chronic Lymphocytic Leukemia, Stage II Chronic Lymphocytic Leukemia, Stage III Chronic Lymphocytic Leukemia, Stage IV Chronic Lymphocytic Leukemia

Thank you

Trial Information

A Genetic Risk-Stratified, Randomized Phase II Study of Four Fludarabine/Antibody Combinations for Patients With Symptomatic, Previously Untreated Chronic Lymphocytic Leukemia


I. To determine the two-year progression-free survival (PFS) after remission induction (RI)
with four different chemo-immunotherapy combinations for patients with untreated,
symptomatic, lower-risk and high-risk chronic lymphocytic leukemia (CLL) to decide which of
the four arms, if any, to take forward into a randomized phase III trial.


I. To determine the induction response to fludarabine phosphate and rituximab (FR) and
fludarabine phosphate, cyclophosphamide, and rituximab (FCR) in each of these arms, along
with the consolidation response to lenalidomide in patients with CLL.

II. To determine the toxicity from these four chemoimmunotherapy combinations and that of
consolidation therapy with lenalidomide.

III. To determine the induction response and toxicity of FCR in patients with del (11q22.3)
along with consolidation response, 2-year PFS and toxicity of lenalidomide in this specific
genetic group.

IV. To determine the effect of pretreatment biologic characteristics on clinical outcomes,
such as attaining a complete response to induction therapy and progression-free survival.

V. To collect relapse samples to determine the frequency of clonal evolution among patients
with IgVH mutated and unmutated disease and to study mechanisms of resistance to

VI. To determine if flow cytometry-negative status immediately post-therapy and at 24 months
after study entry is an effective surrogate marker for prolonged progression-free survival
and overall survival.

OUTLINE: This is a multicenter study. Patients are stratified according to risk group
(intermediate vs high). Patients are randomized to 1 of 3 treatment arms or assigned to arm
IV if found to be del (11q22.3) positive.

ARM I (remission-induction [RI] therapy with fludarabine and rituximab): Patients receive
rituximab IV on days 1, 3, and 5 of course 1 and on day 1 of all subsequent courses.
Patients also receive fludarabine phosphate IV over 30 minutes or orally on days 1-5.

Treatment repeats every 28 days for up to 6 courses in the absence of disease progression.

ARM II (RI therapy with fludarabine and rituximab followed by remission-consolidation [RC]
therapy with lenalidomide): Patients undergo RI therapy as in arm I. Patients with a
complete or partial response or stable disease proceed to RC therapy beginning approximately
4 months after completion of RI, comprising oral lenalidomide once daily on days 1-21.

Treatment repeats every 28 days for 3-6 courses in the absence of disease progression.

ARM III (RI therapy with fludarabine phosphate, rituximab, and cyclophosphamide): Patients
receive rituximab IV on days 1 and 3 of course 1 and on day 1 of all subsequent courses.
Patients also receive fludarabine phosphate IV over 30 minutes or orally followed by
cyclophosphamide IV over 30 minutes on days 1-3.

Treatment repeats every 28 days for up to 6 courses in the absence of disease progression.

ARM IV [del(11q22.3)-positive] (RI therapy with fludarabine, rituximab, and cyclophosphamide
followed by RC therapy with lenalidomide): Patients undergo the first course of RI therapy
as in arm I or II, followed by rituximab IV on day 1 of all subsequent courses, and
fludarabine IV over 30 minutes and cyclophosphamide IV over 30 minutes on days 1-3.

Treatment repeats every 28 days for up to 6 courses in the absence of disease progression.
Beginning approximately 4 months after completion of RI therapy, patients receive RC therapy
comprising oral lenalidomide as in arm II. Patients undergo bone marrow aspirate and blood
sample collection at baseline; 3 months after completion of RI therapy; 2 months after
completion of lenalidomide consolidation therapy (arm II and IV only); 2 years after study
enrollment; and then at the time of relapse.

Samples are assessed for interphase cytogenetic abnormalities; clonal evolution; IgV_H gene
mutational status; CD38, CD49d, and ZAP-70 expression; p53 dysfunction, gene expression
profile, and epigenetic changes in methylation. Samples are also assessed for flow cytometry
negativity status. Studies include fluorescence in situ hybridization, chromosomal
translocation, flow cytometry, and cytogenetics.

After completion of study therapy, patients are followed every 3 months for 1 year and then
every 6 months for up to 15 years.

Inclusion Criteria:

- Diagnosis of B-cell chronic lymphocytic leukemia (CLL) meeting the following

- Absolute lymphocytosis > 5,000/μL

- Lymphocytes must appear mature with < 55% prolymphocytes

- Bone marrow aspirate smear must show > 30% of all nucleated cells as being
lymphoid OR bone marrow core biopsy must show lymphoid infiltrates compatible
with marrow involvement by CLL

- Overall cellularity must be normocellular or hypercellular

- Lymphocyte phenotype must reveal predominant B-cell monoclonal population
sharing a B-cell marker (i.e., CD19, CD20, or CD23) with the CD5 antigen, in the
absence of other pan-T-cell markers

- B-cells must be monoclonal with regard to expression of either kappa or
lambda light chains and have surface immunoglobulin expression of low

- Patients with bright surface immunoglobulin levels must have CD23

- Must have symptomatic, active disease and meet 1 of the following risk criteria
according to the modified three-stage Rai staging system:

- Intermediate-risk disease (i.e., Rai stage I or II) with evidence of active
disease as demonstrated by at least one of the following criteria:

- Massive or progressive splenomegaly, hepatomegaly, and/or lymphadenopathy

- Presence of weight loss > 10% within the past 6 months

- Grade 2 or 3 fatigue

- Fevers > 100.5° F or night sweats for > 2 weeks without evidence of

- Progressive lymphocytosis with an increase of > 50% over a 2-monthperiod or
an anticipated doubling time of < 6 months

- High-risk disease (i.e., Rai stage III or IV)

- Concurrent participation on CALGB-20702 (Leukemia Correlative Studies) required

- Performance status 0-2

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use two effective methods of contraception for ≥ 4 weeks prior
to, during, and for ≥ 4 weeks after completion of lenalidomide therapy (for patients
randomized to arm II or IV)

- Creatinine ≤ 1.5 times upper limit of normal

- No medical condition requiring chronic use of oral corticosteroids

- Patients with HIV infection may be eligible provided they meet the following

- CD4-positive cell count > 350/mm³

- HIV viral load< 10,000 copies HIV RNA/mL (if not on anti-HIV therapy) OR < 50
copies HIV RNA/mL (if on anti-HIV therapy)

- No evidence of hepatitis B or C infection

- No evidence of resistant strains of HIV

- No history of AIDS-defining condition

- No prior therapy for CLL, including corticosteroids for autoimmune complications that
have developed since the initial diagnosis of CLL

- No concurrent zidovudine or stavudine

- No concurrent hormones or other chemotherapy, except steroids for hypersensitivity
reactions or new adrenal failure or hormones for non-disease-related conditions
(e.g., insulin for diabetes)

- No concurrent chronic oral steroids

- No concurrent palliative radiotherapy

- No concurrent epoetin alfa or darbepoetin alfa during remission consolidation therapy
(for patients randomized to arm II or IV)

- Concurrent participation on CALGB-9665 allowed

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PFS rate

Outcome Description:

Rates within arm will be estimated with their exact 90% confidence intervals. The chi-square test will be used to test whether the 2-year PFS of Arm B is significantly better than that of Arm A, and, secondarily, the log-rank test will be used to test for arm differences in time-to-progression.

Outcome Time Frame:

Interval between randomization and progression or death, whichever comes first, assessed up to 2 years

Safety Issue:


Principal Investigator

John Byrd

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B


United States: Food and Drug Administration

Study ID:




Start Date:

January 2008

Completion Date:

Related Keywords:

  • B-cell Chronic Lymphocytic Leukemia
  • Stage I Chronic Lymphocytic Leukemia
  • Stage II Chronic Lymphocytic Leukemia
  • Stage III Chronic Lymphocytic Leukemia
  • Stage IV Chronic Lymphocytic Leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid



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