Show 13 earlier versions
2023-03-11
minor
Study Status v13
Re-verified, no change to tracked fields
2022-09-28
minor
Study Status, Study Description, Study Design, Outcome Measures, Eligibility v12
Enrollment targetestimated 50→confirmed 54
Eligibility criteria-4 characters
Inclusion criteria:
Must have a confirmed diagnosis of Chronic LymphomcyticLymphocytic Leukemia or Small Lymphocytic Lymphoma as per IW-CLL 2008 c [...]
Relapsed after or refractory to at least one prior Chronic LymphomcyticLymphocytic Leukemia-directed therapy
Age greater than or equal to 18 y [...] ning, unless significant bone marrow involvement of Chronic LymphomcyticLymphocytic Leukemia confirmed on biopsy:
Absolute Neutrophil Count (AN [...] r limit of normal (ULN) unless due to biopsy proven Chronic LymphomcyticLymphocytic Leukemia kidney infiltration
Women of child-bearing potenti [...]
Secondary endpointsdetails revised at 7 of 7 entries
Study description-3 characters
[...] mab individually for the treatment of patients with Chronic LymphomcyticLymphocytic Leukemia, your type of cancer.
However, the FDA has not app [...] attach to a protein called CD20 on the outside of a Chronic LymphomcyticLymphocytic Leukemia cell.
By attaching to the cell, the antibody can cause the Chronic LymphomcyticLymphocytic Leukemia cell to die.
In this research study, the investiga [...]
2022-01-03
minor
Study Status v11
Re-verified, no change to tracked fields
2020-11-30
minor
Study Status v10
Primary completion dateestimated 2020-07→confirmed 2020-03
2020-01-14
minor
Study Status v9
Primary completion date2019-12→2020-07
Completion date2021-08→2023-07
2019-11-12
notable
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v8
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 4 of 4 sites
2019-02-06
minor
Study Status, Contacts/Locations v7
Primary completion date2018-12→2019-12
2018-10-17
minor
Study Status, Contacts/Locations v6
Study sitescontacts updated at 1 of 4 sites
2017-12-18
minor
Study Status, Study Design, Contacts/Locations v5
Enrollment target40→50
Study sites2→4
2017-07-05
minor
Study Status v4
Re-verified, no change to tracked fields
2016-06-29
minor
Study Status, Study Design, Contacts/Locations, IPDSharing v3
Study sitesdetails revised at 1 of 2 sites
2015-12-11
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start date2015-09→2015-12
Study sitesdetails revised at 2 of 2 sites
2015-09-01
minor
Study Status, Study Description, Eligibility v1
Eligibility criteria+337 characters
Inclusion criteria:
Must have a confirmed diagnosis of CLLChronic Lymphomcytic Leukemia or SLLSmall Lymphocytic Lymphoma as per IW-CLL 2008 criteria and require therapy based on me [...] nfection
Relapsed after or refractory to at least one prior CLLChronic Lymphomcytic Leukemia-directed therapy
Age greater than or equal to 18 years
ECOG PSPerformance Status <2
Heme criteria at screening, unless significant bone marrow involvement of CLLChronic Lymphomcytic Leukemia confirmed on biopsy:
Absolute Neutrophil Count (ANC) ≥500 cells/mm3 (0.5 x 10^9/L).
Growth factor allowed to ach [...] d ALT ≤ 4.0 x upper limi [...]
Study description+78 characters
[...] binutuzumab individually for the treatment of patients with CLLChronic Lymphomcytic Leukemia, your type of cancer.
However, the FDA has not approved the [...] eved to attach to a protein called CD20 on the outside of a CLLChronic Lymphomcytic Leukemia cell.
By attaching to the cell, the antibody can cause the CLLChronic Lymphomcytic Leukemia cell to die.
In this research study, the investigators are [...]