A Study of Obinutuzumab + Bendamustine (BG) in Participants With Previously Untreated Chronic Lymphocytic Leukemia (CLL)
Status: | Active, not recruiting |
---|---|
Conditions: | Blood Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/21/2018 |
Start Date: | March 31, 2015 |
End Date: | February 22, 2019 |
A Phase II, Open-Label Study of Obinutuzumab Plus Bendamustine (BG) in Patients With Previously Untreated Chronic Lymphocytic Leukemia
This is a Phase 2, open-label, multicenter study to evaluate the safety and efficacy of BG
induction therapy in participants with previously untreated CLL. The anticipated time on
study treatment is 24 weeks.
induction therapy in participants with previously untreated CLL. The anticipated time on
study treatment is 24 weeks.
Inclusion Criteria:
- Participants must satisfy one of the criteria for treatment initiation, as outlined in
the iwCLL NCI-WG guidelines. The criteria include: (a) Evidence of progressive marrow
failure as manifested by the development of, or worsening of, anemia and/or
thrombocytopenia, (b) Massive (i.e., greater than or equal to [>=] 6 centimeters [cm]
below the left costal margin) or progressive or symptomatic splenomegaly, (c) Massive
nodes (i.e., >= 10 cm in longest diameter) or progressive or symptomatic
lymphadenopathy, (d) Progressive lymphocytosis with an increase of greater than (>) 50
percent (%) over a 2-month period or lymphocyte doubling time (LDT) of less than (<) 6
months, (e) Autoimmune anemia and/or thrombocytopenia that is poorly responsive to
corticosteroids or other standard therapy, (f) Constitutional symptoms, defined as any
one or more of the following disease-related symptoms or signs: unintentional weight
loss of >=10% within the previous 6 months, significant fatigue (i.e., Eastern
Cooperative Oncology Group Performance Status [ECOG PS] of 2 or worse or the inability
to work or perform usual activities), fevers higher than 100.5 degrees Fahrenheit
(°F)/38.0 degrees Celsius (°C) for >= 2 weeks without other evidence of infection, or
night sweats for >1 month without evidence of infection
- Absolute neutrophil count (ANC) >=1.5 × 10^9 per liter (/L) and platelets >=75 ×
10^9/L unless cytopenia is caused by the underlying disease, i.e., no evidence of
additional bone marrow dysfunction (e.g., myelodysplastic syndrome, hypoplastic bone
marrow)
- Life expectancy >6 months
- ECOG PS of 0, 1, or 2
- Willing to use acceptable contraceptive measures as defined by the protocol during and
at least for 6 months (male participants) or 12 months (female participants) after the
last dose of study drug
Exclusion Criteria:
- Pregnant or lactating, or intending to become pregnant during the study: Women who are
not postmenopausal (>=12 months of non-therapy-induced amenorrhea) or surgically
sterile must have a negative serum pregnancy test result within 14 days prior to
initiation of study drug
- Participants who have received previous CLL therapy, including investigational
therapies
- Transformation of CLL to aggressive non-Hodgkin's lymphoma (Richter's transformation)
- Inadequate renal function
- Inadequate liver function: National Cancer Institute Common Terminology Criteria for
Adverse Events (NCI CTCAE) Grade 3 liver function tests (aspartate aminotransferase
[AST] or alanine aminotransferase [ALT] >5× upper limit of normal [ULN] for >2 weeks;
bilirubin >3× ULN) unless due to underlying disease
- History of other malignancy, which could affect compliance with the protocol or
interpretation of results
- Participants with active bacterial, viral, or fungal infection requiring systemic
treatment
- Participants with known infection with human immunodeficiency virus (HIV) or human
T-cell leukemia virus 1 (HTLV-1)
- Positive hepatitis serology: (a) Participants with positive serology for hepatitis B,
defined as positivity for hepatitis B surface antigen (HBsAg), or participants who are
HBsAg negative but are hepatitis B core antibody (anti-HBc) positive, (b) Participants
positive for anti-HBc, but with negative hepatitis B Virus (HBV) deoxyribonucleic acid
(DNA), will be considered for inclusion by the Medical Monitor on a case-by-case basis
in order to ensure feasibility of monthly DNA testing and availability of appropriate
care in case of hepatitis B reactivation, (c) Participants with positive serology for
hepatitis C (HCV) unless HCV (by ribonucleic acid [RNA]) is confirmed negative
- History of severe allergic or anaphylactic reactions to monoclonal antibodies
- Evidence of significant, uncontrolled concomitant diseases that could affect
compliance with the protocol or interpretation of results, including significant
cardiovascular disease (such as New York Heart Association Class III or IV cardiac
disease, myocardial infarction within the previous 6 months, unstable arrhythmias, or
unstable angina) or pulmonary disease (including obstructive pulmonary disease and
history of symptomatic bronchospasm)
- Vaccination with a live vaccine a minimum of 30 days prior to study treatment
- Use of investigational agents of any kind within 30 days before study treatment
We found this trial at
31
sites
340 Kennestone Hospital Boulevard
Marietta, Georgia 30060
Marietta, Georgia 30060
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11143 Parkview Plaza Dr # 100
Fort Wayne, Indiana 46845
Fort Wayne, Indiana 46845
(260) 484-8830
Fort Wayne Medical Oncology and Hematology Fort Wayne Medical Oncology and Hematology provides state-of-the-art cancer...
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1871 SE Tiffany Ave # 100
Port Saint Lucie, Florida 34952
Port Saint Lucie, Florida 34952
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Center for Cancer & Blood Disorders Widely recognized for its compassionate, expert care, the Center...
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1 Hospital Drive
Columbia, Missouri 65212
Columbia, Missouri 65212
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
Fairfax, Virginia 22031
(703) 280-5390
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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1448 Common Street
New Braunfels, Texas 78130
New Braunfels, Texas 78130
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5050 Northeast Hoyt Street
Portland, Oregon 97227
Portland, Oregon 97227
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