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Phase II Trial of Ofatumumab for Older Patients and Patients Who Refuse Fludarabine-Based Regimens With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Phase 2
18 Years
Open (Enrolling)
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

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Trial Information

Phase II Trial of Ofatumumab for Older Patients and Patients Who Refuse Fludarabine-Based Regimens With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Inclusion Criteria:

1. CD20+ B-cell chronic lymphocytic leukemia (B-CLL) or small lymphocytic lymphoma
according to NCI criteria (see Appendix B).

2. Previously untreated CLL or small lymphocytic lymphoma (SLL).

3. Patients must require treatment according to NCI-Working Group guidelines (see
Appendix C).

4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of ≤2 (see Appendix

5. Laboratory values as follows ≤7 days of initiation of treatment:

- Creatinine <3.0 mg/dL

- Aspartate amino transferase (AST) or alanine amino transferase (ALT) and
alkaline phosphatase (ALP) must be <3 x upper limit of normal (ULN)

- Total bilirubin <1.5 x the institutional ULN

6. Patients must be hepatitis B sAg negative. Note: Patients who are HepB sAg negative
but are HepB cAb positive (regardless of HepB sAb status) will NOT be allowed.

7. Women of childbearing potential must have a negative serum pregnancy test performed
≤7 days prior to start of treatment. Women of childbearing potential or men with
partners of childbearing potential must use effective birth control measures during
treatment. If a woman becomes pregnant or suspects she is pregnant while
participating in this study, she must agree to inform her treating physician

8. Patients ≤ 65 years of age, or patients 18-64 years of age who have declined
fludarabine-based regimens, are eligible.

9. Patient must be accessible for treatment and follow-up.

10. Patients must be able to understand the nature of this study, give written informed
consent prior to study entry, and comply with study requirements.

Exclusion Criteria:

1. Previous therapy for CLL/SLL. (Patients who have received steroids or IVIG for
autoimmune complications of CLL are eligible).

2. Current active hepatic or biliary disease (with the exception of patients with
Gilbert's syndrome, asymptomatic gallstones, liver metastases, or stable chronic
liver disease, per assessment by the treating physician).

3. Active bacterial or viral infection, or infection requiring intravenous antibiotic
treatment at the time of accrual.

4. Central nervous system lymphoma/CLL.

5. Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (i.e., Richters

6. History of other malignancy within 2 years of study entry which could affect
compliance with the protocol or interpretation of results. Patients with a history
of curatively treated basal or squamous cell carcinoma of the skin or in situ
carcinoma of the cervix, low grade, early-stage, localized prostate cancer treated
surgically with curative intent, ductal carcinoma in situ (DCIS) of the breast
treated with curative intent, are generally eligible. These cases should be
discussed with the study chair or study co-chair prior to enrollment.

7. Patients who are HepB sAg positive and/or HepB cAb positive.

8. Concurrent severe, intercurrent illness including, but not limited to, ongoing or
active infection, or psychiatric illness/social situations that would limit
compliance with study requirements.

9. Any condition that would prevent patient comprehension of the nature of, and risk
associated with, the study.

10. A serious underlying medical condition that would impair the ability of the patient
to receive protocol treatment.

11. A major surgical procedure, open biopsy, or significant traumatic injury ≤28 days of
beginning treatment, or anticipation of the need for major surgery during the course
of the study.

12. Treatment with any known non-marketed drug substance or experimental therapy within 5
terminal half lives or 4 weeks prior to visit 1, whichever is longer. Patients may
not receive any other investigational or anti-cancer treatments while participating
in this study.

Type of Study:


Study Design:

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

Outcome Measure:

Progression-free survival (PFS)

Outcome Description:

To assess the overall response rate of patients with previously untreated CLL or SLL receiving ofatumumab.

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator

Ian Flinn, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Sarah Cannon Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

July 2010

Completion Date:

July 2014

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
  • Ofatumumab
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma



Florida Cancer Specialists Fort Myers, Florida  33901
Northeast Georgia Medical Center Gainesville, Georgia  30501
South Carolina Oncology Associates Columbia, South Carolina  29201
The Ohio State University Columbus, Ohio  43210
Hematology-Oncology Associates of Northern NJ Morristown, New Jersey  07962
Portsmouth Regional Hospital Portsmouth, New Hampshire  03802
St. Louis Cancer Care Chesterfield, Missouri  63017
Tennessee Oncology Nashville, Tennessee  37203
Oncology Hematology Care Cincinnati, Ohio  45242
Providence Medical Group Terre Haute, Indiana  47802
Chattanooga Oncology Hematology Associates Chattanooga, Tennessee  37404
Woodlands Medical Specialists Pensacola, Florida  32503