Clinical evidence of transformation to a more aggressive subtype of lymphoma
Richter’s transformation confirmed by biopsy
Known histological transformation to an aggressive lymphoma
Active Richter’s transformation
History of Richter’s or prolymphocytic transformation
Known histological transformation to an aggressive lymphoma (ie, Richter transformation). Note: Biopsy documentation of the absence or presence of transformation is not required.
For patients with Richter’s transformation, one prior line of therapy for either CLL or Richter’s transformation (RT) is required
Grade 3B FL or evidence of transformation of FL to a more aggressive lymphoma
Patients with previously treated CLL and biopsy-proven Richter’s transformation with diffuse large B-cell lymphoma (DLBCL) histology according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria (Richter Transformation - RT) and CD19 positive by flow cytometry OR immunohistochemistry.
Richter’s transformation confirmed by biopsy
Clinical evidence of transformation to a more aggressive subtype of lymphoma or Grade 3B FL.
CLL patients with known or suspected transformed disease (i.e. Richter’s transformation)\r\n* Note: biopsy proven absence of transformation is not required
Large cell transformation
Evidence ongoing transformation into aggressive NHL
CLL patients with active transformed disease (Richter’s transformation) are ineligible for enrollment on this study
Known histological transformation from CLL to an aggressive lymphoma (Richter's)
Known histological transformation from iNHL or CLL to an aggressive form of non-Hodgkin lymphoma (ie, Richter transformation) except if the CLL patient is enrolling in the B-cell receptor (BCR) previously treated cohort
Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation)
Patients must not have any history of Richter’s transformation or prolymphocytic leukemia (prolymphocytes in blood > 55%)
Evidence of disease transformation at the time of study entry
Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation)
Presence of more than 55% pro-lymphocytes in peripheral blood; patients with Richter’s transformation are not excluded
Evidence of diffuse large B-cell transformation
Active Richter’s transformation
Cohort B-4: 1) Histologically-confirmed Richter syndrome defined as transformation of CLL or SLL into an aggressive lymphoma 2) Previously treated with at least one line of standard, systemic chemotherapy or not eligible for standard therapy 3) At least 1 measurable site of disease based on the Revised Response Criteria for Malignant Lymphoma
Transformation of CLL to aggressive non-Hodgkin's lymphoma (Richter's transformation)
Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation)
Transformation of CLL to aggressive Non-Hodgkin's lymphoma (Richter's transformation or pro-lymphocytic leukemia)
Grade 1, 2, or 3a FL without pathologic evidence of transformation
Transformation of CLL to aggressive non-Hodgkin lymphoma or central nervous system (CNS) involvement by CLL
Grade 3B FL and/or clinical evidence of transformation to a more aggressive subtype of lymphoma.
Presence of disease transformation from a previously diagnosed low-grade lymphoma
Evidence of diffuse large B-cell transformation.
Follicular lymphoma with histology documented by the participating institution (grades 1, 2 or 3a)\r\n* For subjects with presumptive evidence of transformation based on clinical assessment of factors such as, but not limited to, increasing lactate dehydrogenase (LDH), rapidly worsening disease, or frequent B-symptoms, a pre-treatment biopsy is required to rule out large cell transformation
Subjects with known SCLC transformation
CLL transformation
Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation)
Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation)
Prior radiotherapy is allowed if it was given for low-grade lymphoma before transformation in those with transformed NHL and as long as no chemotherapy was administered in conjunction with radiation
Transformation to a more aggressive subtype of lymphoma or grade 3b FL
Prolymphocytic transformation
Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation)
Patients with B-CLL (not in Richter’s transformation) with measurable disease
Patients with tMF who received 1 systemic single-agent CT (except methotrexate) prior to transformation.
Evidence of aggressive or highly aggressive lymphoma or Richter’s transformation based on WHO/REAL classification criteria(1)
Pathologic evidence of malignant transformation
FL with evidence of large cell transformation
Known transformation to an aggressive B-cell malignancy.
Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation)
Patients with Richter’s transformation are not allowed in the study
Patients with the Hodgkin variant transformation of CLL will be excluded
Known histological transformation from iNHL to diffuse large B-cell lymphoma or Richter’s transformation for CLL
Richter's transformation or CLL transformation to aggressive lymphoma
History of Richter’s or prolymphocytic transformation