[c09aa8]: / clusters / 9knumclustersv2 / clust_993.txt

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For patients with CD+ ALCL, failed or are ineligible or intolerant to brentuximab vedotin
Refractory to prior brentuximab vedotin (i.e. progression while on treatment)
Refractory to prior therapy with brentuximab vedotin (evidence of progression within days of the last dose)
Prior brentuximab vedotin is allowed in the dose-finding portion of the study (dose-finding cohort); in the expansion cohort, patients cannot be refractory to BV (defined as developing progressive disease while on treatment or progressed within months of finished last dose of brentuximab vedotin)
Failed >= prior systemic therapies\r\n* NOTE: For systemic anaplastic large cell lymphoma (ALCL) prior systemic therapy must also include progression on brentuximab vedotin
Prior brentuximab vedotin is allowed provided that patients were not refractory (defined as developing progressive disease while on treatment or progressed within months of finished last dose of brentuximab vedotin)
Refractory to prior brentuximab vedotin (defined as developing progressive disease while on treatment or progressed within month of finished last dose of brentuximab vedotin)
Eligible to receive standard brentuximab vedotin for relapsed Hodgkin lymphoma
Relapsed or refractory CD+ lymphoma that has either achieved < PR to brentuximab vedotin (minimum of cycles), progressed while receiving brentuximab vedotin, or progressed within months of the last dose of brentuximab vedotin
Relapsed or refractory disease after standard therapy including brentuximab vedotin (Adcetris).
Classical Hodgkin lymphoma\r\n* Relapsed or refractory de novo classical Hodgkin lymphoma having failed standard first-line therapy; and\r\n* May have failed to achieve a response or progressed after treatment with brentuximab vedotin or may be brentuximab vedotin nave but is ineligible or unable to receive brentuximab vedotin; and\r\n* May have failed to achieve a response to, progressed after, or is ineligible for autologous stem cell transplant (auto-SCT)
Refractory to prior therapy with brentuximab vedotin (evidence of progression within days of the last dose)
In addition to the inclusion/exclusion criteria outlined, to be eligible for treatment with the higher . mg/kg dose of brentuximab vedotin in the new cohort of additional patients, best response after cycles of brentuximab vedotin administered at the . mg/kg dose, must be partial remission (PR) or stable disease (SD) as determined by radiographic imaging