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Phase 2 N=82 Treatment

Ofatumumab, Pentostatin, and Cyclophosphamide in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Chronic Lymphocytic Leukemia · Stage 0 Chronic Lymphocytic Leukemia · Stage I Chronic Lymphocytic Leukemia · Stage I Small Lymphocytic Lymphoma · Stage II Chronic Lymphocytic Leukemia

Enrolled (actual)
82
Serious AEs
19.5%
Results posted
Sep 2018
Primary outcome: Primary: Arm A: Percentage of Complete Responses — 46 percentage of participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Cyclophosphamide (Drug); Laboratory Biomarker Analysis (Other); Ofatumumab (Biological); Pentostatin (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Mayo Clinic
Primary completion
May 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Arm A: Percentage of Complete Responses
46
PRIMARY
Arm B: Treatment-free Survival at 18 Months
87.5; 94.1
SECONDARY
Overall Response Rate
96; 97
SECONDARY
Depth of Response After Ofatumumab Consolidation
25
SECONDARY
Treatment-free Survival
56.6; NA

Summary

This phase II trial studies how well giving ofatumumab together with pentostatin and cyclophosphamide works in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. Monoclonal antibodies, such as ofatumumab, can block the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as pentostatin and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ofatumumab together with pentostatin and cyclophosphamide may be a better way to block cancer growth.

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of CLL according to the National Cancer Institute (NCI) criteria or SLL according to the World Health Organization (WHO) criteria, including previous documentation of:
  • Biopsy-proven SLL
  • Diagnosis of CLL according to NCI working group criteria as evidenced by all of the following:
  • Peripheral blood lymphocyte count of > 5,000/mm^3 consisting of small to moderate size lymphocytes, with 10% within the previous 6 months
  • Extreme fatigue attributed to CLL
  • Fevers > 100.5 degree Fahrenheit for 2 weeks without evidence of infection
  • Drenching night sweats without evidence of infection
  • Progressive lymphocytosis due to CLL with an increase of > 50% over a two-month period or an anticipated doubling time of less than six months
  • Prior chemotherapy or monoclonal antibody based therapy for treatment of CLL will be considered prior therapy; nutraceutical treatments with no established benefit in CLL (such as epigallocatechin gallate [EGCG], found in green tea or other herbal treatments) will not be considered "prior treatment"
  • Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease are not sufficient for protocol therapy
  • Serum creatinine = 1.5 x UNL, a direct bilirubin should be performed and must be < 1.5 mg/dL for Gilbert's to be diagnosed
  • Aspartate aminotransferase (AST) =< 3.0 x UNL and alanine aminotransferase (ALT) =< 3.0 x UNL (unless due to hemolysis or CLL)
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0, 1, or 2
  • Willingness to provide blood samples as required
  • Able to adhere to the study visit schedule and other protocol requirements

Exclusion Criteria

  • Any of the following comorbid conditions:
  • New York Heart Association Class III or IV heart disease
  • Recent myocardial infarction (< 1 month)
  • Uncontrolled infection
  • Infection with the human immunodeficiency virus (HIV/acquired immunodeficiency syndrome [AIDS])
  • Infection with known chronic, active Hepatitis C
  • Positive serology for hepatitis B (HB) defined as a positive test for HB surface antigen (HBsAg); in addition, if negative for HBsAg but HB core antibody (HBcAb) positive (regardless of HBsAb status), a HB deoxyribonucleic acid (DNA) test will be performed and if positive the subject will be excluded
  • Pregnant women
  • Nursing women
  • Men or women of childbearing potential who are unwilling to employ adequate contraception
  • Other active primary malignancy requiring treatment or limiting survival to =< 2 years
  • Any radiation therapy =< 4 weeks prior to registration
  • Any major surgery =< 4 weeks prior to registration
  • Current use of corticosteroids; EXCEPTION: low doses of steroids (< 10 mg of prednisone or equivalent dose of other steroid) used for treatment of non-hematologic medical conditions; Note: previous use of corticosteroids is allowed
  • Active hemolytic anemia requiring immunosuppressive therapy or other pharmacologic treatment; patients who have a positive Coombs test but no evidence of hemolysis are NOT excluded from participation
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01024010). 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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