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A Study of CAL-101 and Rituximab in Elderly Patients With Untreated CLL or SLL (101-08)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01203930
First received: September 15, 2010
Last updated: December 4, 2012
Last verified: December 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the safety and clinical activity of CAL-101 in combination with rituximab in patients with CLL or SLL


Condition Intervention Phase
Chronic Lymphocytic Leukemia (CLL)
Small Lymphocytic Lymphoma (SLL)
 Drug: CAL-101
Drug: Rituximab
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Drug Information available for: Rituximab
U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Evaluate the overall response rate [ Time Frame: every 2-3 months ] [ Designated as safety issue: No ]
    Clinical activity will be evaluated using standard response definitions


Secondary Outcome Measures:
  • Assess the duration of response and progression-free survival [ Time Frame: every 2-3 months ] [ Designated as safety issue: No ]
    Clinical activity will be evaluated using standard response definitions

  • Determine plasma exposures of CAL-101 [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    Periodic serial plasma samples will be collected for analysis of CAL-101 concentration

  • Investigate the pharmacodynamic effects of CAL-101 Treatment [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    Periodic serial plasma samples will be collected for analysis of exploratory pharmacodynamic measures

  • Evaluate the safety of CAL-101 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Safety will be evaluated by assessing extent of exposure to CAL-101, adverse events, clinical laboratory data, vital signs


Enrollment: 64
Study Start Date: October 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: single
Cal-101 and rituximab
 Drug: CAL-101
CAL-101 150 mg BID for 12 months or until disease progression or unacceptable toxicity
Drug: Rituximab
Rituximab 375 mg/m2 weekly x 8 weeks
Other Name: Rituxan

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 splenomegaly
    • Massive nodes (i.e., > 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy
    • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01203930

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
The Universtity of Texas MD Anderson Cancer Center
Houston, Texas, United States
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Ronald Dubowy, MD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01203930     History of Changes
Other Study ID Numbers: 101-08
Study First Received: September 15, 2010
Last Updated: December 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
CLL
SLL
CAL-101
 PI3K
Rituximab
Rituxan

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 16, 2013