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A Phase 2 Single Arm Study to Investigate the Safety and Clinical Activity of CAL-101 in Combination With Rituximab in Elderly Patients With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Phase 2
65 Years
Open (Enrolling)
Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)

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Trial Information

A Phase 2 Single Arm Study to Investigate the Safety and Clinical Activity of CAL-101 in Combination With Rituximab in Elderly Patients With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

This Phase 2 study will be the first time that CAL-101 is administered to previously
untreated patients with hematologic malignancies. CAL-101 has demonstrated clinical activity
as a single agent in relapsed or refractory CLL and SLL with acceptable toxicity, which
supports its evaluation in previously untreated patients. The study population is limited to
patients over 65 years of age because younger patients are generally appropriate for
standard immunochemotherapy regimens that are highly active. Since the mechanism of action
of CAL-101 is distinct from rituximab, it is hypothesized that the combination will be more
active than either agent alone. This study will establish initial safety and clinical
activity of CAL-101 in combination with rituximab in patients with CLL or SLL.

Inclusion Criteria:

- Histologically or cytologically confirmed CLL or SLL.

- Age ≥ 65

- CLL - Binet Stage C or Rai stage III or IV or has active disease defined by meeting
at least one of the following criteria:

- Evidence of progressive marrow failure as manifested by the development of, or
worsening of, anemia and/or thrombocytopenia

- Massive (i.e., >6 cm below the left costal margin) or progressive or symptomatic

- Massive nodes (i.e., > 10 cm in longest diameter) or progressive or symptomatic

- Progressive lymphocytosis with an increase of more than 50% over a 2-month
period or lymphocyte doubling time of less than 6 months

- Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroids
or other standard therapy

- At least one of the following disease-related symptoms:

- Unintentional weight loss ≥10% within the previous 6 months

- Significant fatigue

- Fevers >100.4F for ≥2 weeks without other evidence of infection

- Night sweats for ≥1 month without evidence of infection

- SLL - has active disease as defined above for CLL, except the lymphocytosis criterion
does not apply

- World Health Organization (WHO) Performance Status of ≤2

- For men of child-bearing potential, willing to use adequate methods of contraception
for the entire duration of the study

- Able to provide written informed consent

Exclusion Criteria:

- Prior therapy for CLL or SLL, except corticosteroids for symptom relief

- Treatment with a short course of corticosteroids for symptom relief within 1-week
prior to Visit 1

- Known active central nervous system involvement of the malignancy

- Ongoing active, serious infection requiring systemic therapy. Patients may be
receiving prophylactic antibiotics and antiviral therapy at the discretion of the
treating physician.

Serum creatinine ≥2.0 mg/dL

- Serum bilirubin ≥2 mg/dL (unless due to Gilbert's syndrome) or serum transaminases
(i.e., aspartate aminotransferase [AST], alanine aminotransferase [ALT]) ≥2 x upper
limit of normal

- Positive test for human immunodeficiency virus (HIV) antibodies

- Active hepatitis B or C (confirmed by ribonucleic acid [RNA] test). Patients with
serologic evidence of prior exposure are eligible.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate the overall response rate

Outcome Description:

Clinical activity will be evaluated using standard response definitions

Outcome Time Frame:

every 2-3 months

Safety Issue:


Principal Investigator

Ronald Dubowy, MD

Investigator Role:

Study Director

Investigator Affiliation:

Gilead Sciences


United States: Food and Drug Administration

Study ID:




Start Date:

October 2010

Completion Date:

March 2013

Related Keywords:

  • Chronic Lymphocytic Leukemia (CLL)
  • Small Lymphocytic Lymphoma (SLL)
  • CLL
  • SLL
  • CAL-101
  • PI3K
  • Rituximab
  • Rituxan
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma



Memorial Sloan Kettering Cancer Center New York, New York  10021
Sarah Cannon Research Institute Nashville, Tennessee  37203
The Universtity of Texas MD Anderson Cancer Center Houston, Texas