To assess the feasibility of using intra-tumoral PF-3512676 in combination with local radiation as a therapy for lowgrade b-cell lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
18 mg injection
2 gray (2 Gy) on each of Days 1 and 2
Stanford University School of Medicine
Stanford, California, United States
Overall ObjectiveResponse (ORR) Rate
Overall objective response rate (OOR) at time of best response was assessed as the sum of the Complete Response (CR) rate and the Partial Response (CR, PR) rate. Response was assessed per the Cheson Criteria, as below. * Complete Response (CR) = Complete disappearance of all lesions, evidence, and effects of disease * CR/unconfirmed (CRu) = residual lymph node mass \>1.5 cm but regressed \>75%, with 1 residual lymph node mass \>1.5 cm that has regressed by \>75% and/or increased number or size of bone marrow aggregates without cytologic or architectural atypia * Partial Response (PR) = ≥50% decrease in SPD of the 6 largest lesions with no increase in the size of the other nodes; splenic / hepatic nodules regress ≥50%, and with no new sites of disease Stable disease (SD) = less than PR.
Time frame: 12 weeks
Response Rate After Cycle 2
Response after a second cycle of treatment was assessed per the Cheson Criteria, as below. * Complete Response (CR) = Complete disappearance of all lesions, evidence, and effects of disease * CR/unconfirmed (CRu) = residual lymph node mass \>1.5 cm but regressed \>75%, with 1 residual lymph node mass \>1.5 cm that has regressed by \>75% and/or increased number or size of bone marrow aggregates without cytologic or architectural atypia * Partial Response (PR) = ≥50% decrease in SPD of the 6 largest lesions with no increase in the size of the other nodes; splenic / hepatic nodules regress ≥50%, and with no new sites of disease Stable disease (SD) = less than PR.
Time frame: 6 months
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