Phase 2
N=68
Pentostatin, Cyclophosphamide, and Rituximab With or Without Bevacizumab in Treating Patients With B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Leukemia · Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00816595 ↗Enrolled (actual)
68
Serious AEs
24.2%
Results posted
May 2014
Primary outcome: Primary: Complete and Overall Response Rate — 50.0; 33.3; 93.8; 96.7 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- bevacizumab (Biological); pegfilgrastim (Biological); rituximab (Biological); cyclophosphamide (Drug); pentostatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete and Overall Response Rate |
50.0; 33.3; 93.8; 96.7 | — |
| SECONDARY Overall Survival |
NA; NA | — |
| SECONDARY Progression-free Survival |
NA; 34.1 | — |
Summary
RATIONALE: 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 or by stopping them from dividing. Monoclonal antibodies, such as rituximab and bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether giving pentostatin and cyclophosphamide together with rituximab is more effective with or without bevacizumab in treating patients with B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma.
PURPOSE: This randomized phase II trial is studying the side effects of giving pentostatin and cyclophosphamide together with rituximab with or without bevacizumab and to see how well it works in treating patients with B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following:
- Biopsy proven small lymphocytic lymphoma (SLL)
- Chronic lymphocytic leukemia (CLL)* as evidenced by the following criteria:
- Peripheral blood lymphocyte count > 5, 000/mm³ consisting of small to moderate size lymphocytes
- Immunophenotyping consistent with CLL, defined by the following:
- The predominant population of lymphocytes share both B-cell antigens (CD19, CD20, or CD23) as well as CD-5 in the absence of other pan-T-cell markers (CD-3 or CD-2)
- Dim surface immunoglobulin expression
- Exclusively kappa and lambda light chains
- Negative FISH analysis for t(11;14)(IgH/CCND1) on peripheral blood or tissue biopsy samples NOTE: *Splenomegaly, hepatomegaly, or lymphadenopathy are not required for the diagnosis of CLL
- Has ≥ 1 of the following indications** for chemotherapy:
- Evidence of progressive marrow failure as manifested by the development of or worsening anemia (hemoglobin ≤ 11 g/dL) and/or thrombocytopenia (platelet count ≤ 100,000/mm³)
- Symptomatic or progressive lymphadenopathy, splenomegaly or hepatomegaly
- Has ≥ 1 of the following disease-related symptoms:
- Weight loss > 10% within the past 6 months
- Extreme fatigue attributed to CLL
- Fevers > 100.5^oF for 2 weeks without evidence of infection
- Night sweats without evidence of infection
- Progressive lymphocytosis (not due to the effects of corticosteroids) with an increase of > 50% over a 2-month period or an anticipated doubling time of 150 mm Hg or diastolic BP > 100 mm Hg
- Hypertension allowed provided it is controlled with a stable anti-hypertensive regimen
- History of hypertensive crises or hypertensive encephalopathy
- Deep venous thromboses or pulmonary embolism within the past 12 months
- No evidence of bleeding diathesis or coagulopathy
- No uncontrolled or active hemolytic anemia requiring immunosuppressive therapy or other pharmacologic treatment
- No active or recent history (within the past 30 days) of hemoptysis (≥ ½ teaspoon of bright red blood per episode)
- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- No active peptic ulcer disease
- No serious non-healing wound, ulcer, or bone fracture
- No significant traumatic injury within the past 28 days
- No uncontrolled infection
- No active HIV infection
- No other active primary malignancy (except nonmelanoma skin cancer or carcinoma in situ of the cervix) requiring treatment or limiting survival to ≤ 2 years
- No psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude study participation
PRIOR CONCURRENT THERAPY:
- Prior corticosteroids allowed
- More than 4 weeks since prior radiotherapy
- More than 28 days since prior and no concurrent major surgical procedure or open biopsy
- More than 7 days since prior minor surgical procedure, fine needle aspiration, or core biopsy (other than bone marrow biopsy)
- No concurrent therapeutic doses of coumadin-derivative anticoagulants (e.g., warfarin)
- Doses of ≤ 2 mg daily allowed for prophylaxis of thrombosis
- Prophylactic doses of low molecular weight heparin allowed
- No other concurrent investigational agents for treatment of CLL or SLL
- No other concurrent specific anticancer treatment except hormonal therapy
Data sourced from ClinicalTrials.gov (NCT00816595). 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.