18 and older, any sex, with Chronic Lymphocytic Leukemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Response Rate (ORR) as Assessed by the Investigator Using the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 CriteriaPrimary· 2-3 months after last dose of the study treatment (up to approximately 9 months)
ORR was defined as percentage of participants achieving Complete Response (CR), incomplete CR (CRi) or Partial Response (PR). CR: lymphocytes below 4 x 10\^9/L, absence of lymphadenopathy, hepatomegaly and splenomegaly, absence of disease or constitutional symptoms, neutrophils \> 1.5 x 10\^9/L, platelets \> 100 x 10\^9/L, hemoglobin \> 110 g/L, bone marrow at least normocellular for age. CRi: CR with persistent cytopenia, i.e. anemia, thrombocytopenia and/or neutropenia. PR: reduction ≥ 50% of the lymphocyte count AND reduction ≥ 50% of the lymphadenopathy OR reduction ≥ 50% of the size of th
Group
Value
95% CI
Obinutuzumab + Bendamustine
78.6
66.8 – 87.1
Best Response Rate as Assessed by the Investigator Using the IWCLL 2008 CriteriaSecondary· During study treatment and until 6 months after end of study treatment at approximately 12 months
Best overall response was defined as percentage of participants achieving a best response of CR, CRi and PR. CR: lymphocytes below 4 x 10\^9/L, absence of lymphadenopathy, hepatomegaly and splenomegaly, absence of disease or constitutional symptoms, neutrophils \> 1.5 x 10\^9/L, platelets \> 100 x 10\^9/L, hemoglobin \> 110 g/L, bone marrow at least normocellular for age. CRi: CR with persistent cytopenia, i.e. anemia, thrombocytopenia and/or neutropenia. PR: reduction ≥ 50% of the lymphocyte count AND reduction ≥ 50% of the lymphadenopathy OR reduction ≥ 50% of the size of the liver if enlarg
CR
Group
Value
95% CI
Obinutuzumab + Bendamustine
46.3
CRi
Group
Value
95% CI
Obinutuzumab + Bendamustine
1.9
PR
Group
Value
95% CI
Obinutuzumab + Bendamustine
42.6
Progression Free Survival (PFS)Secondary· From start of treatment up to disease progression or relapse or death, whichever occurred first (up to approximately 4.5 years)
PFS is defined as the time from the start of treatment to disease progression (DP), relapse or death from any cause, whichever occurs first, as assessed by the investigator. DP: at least one of the following characteristics: increase ≥ 50% in lymphocytes up to at least 5 x 10\^9/L, appearance of new palpable lymph nodes, increase ≥ 50% of the longest diameter of any previous area of clinically significant lymphadenopathy, increase ≥ 50% of the size of the liver and/or spleen, transformation to a more aggressive histology, after treatment progression of any cytopenia: decrease of hemoglobin lev
Group
Value
95% CI
Obinutuzumab + Bendamustine
24.14
20.81 – 27.47
Overall Survival (OS)Secondary· From start of treatment up to death of any cause (up to approximately 4.5 years)
OS was defined as the time from the start of study treatment to death from any cause.
Group
Value
95% CI
Obinutuzumab + Bendamustine
NA
NA – NA
Event Free Survival (EFS)Secondary· From start of treatment up to disease progression or relapse or death or start of a new anti-leukemic therapy, whichever occurred first (up to approximately 4.5 years)
EFS was defined as the time from the start of treatment to DP/relapse, death from any cause or start of a new anti-leukemia therapy. DP: at least one of the following characteristics: increase ≥ 50% in lymphocytes up to at least 5 x 10\^9/L, appearance of new palpable lymph nodes, increase ≥ 50% of the longest diameter of any previous area of clinically significant lymphadenopathy, increase ≥ 50% of the size of the liver and/or spleen, transformation to a more aggressive histology, after treatment, progression of any cytopenia: decrease of hemoglobin levels of more than 20 g/L or to below 100
Group
Value
95% CI
Obinutuzumab + Bendamustine
24.14
19.96 – 28.32
Disease Free Survival (DFS)Secondary· From occurrence of complete response up to disease progression or death, whichever occurred first (up to approximately 4.5 years)
DFS was defined for all participants who achieved complete response (CRi or CR). DFS lasted from the date on which CRi or CR was recorded until the date on which the first DP or death from any cause occurred. DP: at least one of the following characteristics: increase ≥ 50% in lymphocytes up to at least 5 x 10\^9/L, appearance of new palpable lymph nodes, increase ≥ 50% of the longest diameter of any previous area of clinically significant lymphadenopathy, increase ≥ 50% of the size of the liver and/or spleen, transformation to a more aggressive histology, after treatment, progression of any c
Group
Value
95% CI
Obinutuzumab + Bendamustine
23.02
21.38 – 24.66
Duration of Response (DR)Secondary· From occurrence of CR or PR up to disease progression or death, whichever occurred first (up to approximately 4.5 years)
DR was defined for participants with CRi, CR or PR. DR spanned from the date on which response was recorded until the date on which DP or death from any cause occurred. DP: at least one of the following characteristics: increase ≥ 50% in lymphocytes up to at least 5 x 10\^9/L, appearance of new palpable lymph nodes, increase ≥ 50% of the longest diameter of any previous area of clinically significant lymphadenopathy, increase ≥ 50% of the size of the liver and/or spleen, transformation to a more aggressive histology, after treatment, progression of any cytopenia: decrease of hemoglobin levels
Group
Value
95% CI
Obinutuzumab + Bendamustine
21.41
17.60 – 25.22
Time to Re-treatment/New Anti-leukemia TherapySecondary· Up to 4.5 years
Time to re-treatment/new leukemia therapy was defined as the time between the start of treatment and the date of the first administration of re-treatment or new leukemia therapy.
Group
Value
95% CI
Obinutuzumab + Bendamustine
NA
NA – NA
Percentage of Participants With Minimal Residual Disease (MRD) NegativitySecondary· At approximately 9 months
MRD negativity was defined as the presence of less than 1 cell of CLL per 10,000 leukocytes (= category 0, \<0.01%) assessed in bone marrow (BM) and peripheral blood (PB) by flow cytometry after the end of the treatment at the final response assessment.
MRD in BM: Cat 0
Group
Value
95% CI
Obinutuzumab + Bendamustine
36.4
MRD in PB: Cat 0
Group
Value
95% CI
Obinutuzumab + Bendamustine
53.4
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)Secondary· Up to approximately 4.5 years
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. An SAE was any AE that was any of the following: fatal, life-threatening,
AEs
Group
Value
95% CI
Obinutuzumab + Bendamustine
94.4
SAEs
Group
Value
95% CI
Obinutuzumab + Bendamustine
51.4
Percentage of Participants With AEs of Special Interest (AESIs)Secondary· Up to approximately 4.5 years
AESIs included any of the following: SAEs associated with the infusion of obinutuzumab: obinutuzumab serious infusion-related reactions, which were defined as AEs occurring during or within 24 hours following the administration of an infusion of obinutuzumab and considered related to obinutuzumab; serious infection; serious neutropenia; any tumor lysis syndrome (TLS); second malignancies.
Group
Value
95% CI
Obinutuzumab + Bendamustine
45.8
Percentage of Participants With Infusion-related Reactions (IRRs)Secondary· Up to end of treatment at 6 months
IRRs were defined as AEs occurring during or within 24 hours following the administration of an infusion and considered related to drug treatment.
Group
Value
95% CI
Obinutuzumab + Bendamustine
20.8
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to approximately 4.5 years.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This phase II trial was designed to evaluate the efficacy of obinutuzumab and bendamustine treatment in participants with refractory or relapsed chronic lymphocytic leukemia (CLL). Participants receive up to six 28-day cycles of treatment. Treatment consists of intravenous (IV) administration of obinutuzumab and bendamustine. Treatment time is expected to last 6 months, and participant follow-up will last 2 years.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
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· Phase 2
· completed
NCT04849715 — A Study of Parsaclisib, a PI3Kδ Inhibitor, in Combination With Bendamustine and Rituximab in Patients With Newly Diagnos
· Phase 3
· withdrawn
NCT03755804 — Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17
· Phase 2
· active not recruiting
NCT02927769 — A Study of Nivolumab Plus Brentuximab Vedotin in Patients Between 5 and 30 Years Old, With Hodgkin's Lymphoma (cHL), Rel
· Phase 2
· completed
NCT01716806 — A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL)
· Phase 2
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
Last refreshed: 7 February 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02071225.