SWOG clinical trial number
S0350
Phase II Trial of Cisplatin Plus Etoposide Plus Gemcitabine Plus Solumedrol (PEGS) in Peripheral T-Cell Non-Hodgkin's Lymphoma
Closed
Phase
Accrual
100%
Published
Abbreviated Title
NON-HODGKIN: PEGS treatment for Peripheral T-Cell NHL
Activated
09/15/2005
Closed
12/01/2010
Participants
Research committees
Lymphoma
Treatment
Cisplatin
Etoposide
Gemcitabine hydrochloride
Methyl Prednisolone
Eligibility Criteria Expand/Collapse
--Must have either newly diagnosed NHL of T-cell lineage or relapsed or progressing disease after one prior treatment with a non-platinum based chemotherapy (e.g. CHOP). NHL of T-cell lineage includes extranodal types (i.e. extranodal NK/T-cell lymphoma nasal type, enteropathy-type T-cell lymphoma, hepatosplenic T-cell lymphoma, and subcutaneous panniculitis-like T-cell lymphoma) and nodal types (i.e. angioimmunoblastic T-cell lymphoma). Patients with transformed cutaneous T-cell lymphoma (CTCL) to peripheral T-cell lymphoma (PTCL) with systemic involvement (not local skin transformation) are also eligible.
--Must have Stage III, Stage IV, or bulky Stage II extent of disease;
--Must provide adequate sections (one H&E stained section AND a paraffin block, two 0.6 cm tissue corse, or 20 unstained paraffin slides) from the original specimen must be made available for pathology review;
--Consent to the tissue and serum sample submission requirements as outlined in Section 15.4 is encouraged, but not required for study entry.
--Must have bidimensionally measurable disease documented w/in 28 days prior to registration, non-measurable disease must be assessed w/in 42 days prior to registration;
--Must have received no more than one prior treatment with a non-platinum based chemotherapy (e.g. CHOP) for their PTCL-NHL
--Prior biological therapy must be completed at least 3 weeks prior to registration;
--Labs (w/in 28 days prior to registration): : ANC >/= 1,500/mcL, platelets >/=75,000/mcL, serum bilirubin </= 2 X IULN; measured OR estimated creatinine clearance >/= 30 mL/min
--Must have bilateral or unilateral bone marrow aspirate and biopsy performed w/in 42 days prior to registration;
--Must not have plans for other concommitant chemotherapeutic agents or RT;
-Must not be pregnant or nursing;
-Patients with mild hearing loss must be willing to accept the potential for worsening of symptoms;
--Must have chest x-ray or CT scan of the chest and a CT scan or the abdomen and pelvis w/in 28 days prior to registration;
--Must not have clinical evidence of CNS involvement by lymphoma; must not have a history of impaired cardiac status;
--Must be HIV negative;
--Mo prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for 5 years;
--Age 18 or older
--Performance status 0-2
--Must have Stage III, Stage IV, or bulky Stage II extent of disease;
--Must provide adequate sections (one H&E stained section AND a paraffin block, two 0.6 cm tissue corse, or 20 unstained paraffin slides) from the original specimen must be made available for pathology review;
--Consent to the tissue and serum sample submission requirements as outlined in Section 15.4 is encouraged, but not required for study entry.
--Must have bidimensionally measurable disease documented w/in 28 days prior to registration, non-measurable disease must be assessed w/in 42 days prior to registration;
--Must have received no more than one prior treatment with a non-platinum based chemotherapy (e.g. CHOP) for their PTCL-NHL
--Prior biological therapy must be completed at least 3 weeks prior to registration;
--Labs (w/in 28 days prior to registration): : ANC >/= 1,500/mcL, platelets >/=75,000/mcL, serum bilirubin </= 2 X IULN; measured OR estimated creatinine clearance >/= 30 mL/min
--Must have bilateral or unilateral bone marrow aspirate and biopsy performed w/in 42 days prior to registration;
--Must not have plans for other concommitant chemotherapeutic agents or RT;
-Must not be pregnant or nursing;
-Patients with mild hearing loss must be willing to accept the potential for worsening of symptoms;
--Must have chest x-ray or CT scan of the chest and a CT scan or the abdomen and pelvis w/in 28 days prior to registration;
--Must not have clinical evidence of CNS involvement by lymphoma; must not have a history of impaired cardiac status;
--Must be HIV negative;
--Mo prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for 5 years;
--Age 18 or older
--Performance status 0-2
Publication Information Expand/Collapse
2016
T-Cell Lymphoma: Recent Advances in Characterization and New Opportunities for Treatment
PMid: PMID28040682 | PMC number: PMC n/a - Review
2013
PMid: PMID22833464 | PMC number: PMC3485430
2011
Phase II trial of cisplatin plus etoposide plus gemcitabine plus solumedrol (PEGS) in peripheral T-cell non-Hodgkin lymphoma (SWOG S0350)
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