Gemcitabine, cisplatin, and dexamethasone (GDP) in combination with methotrexate and pegaspargase is active in newly diagnosed peripheral T cell lymphoma patients: a phase 2, single-center, open-label study in China

2018 ◽  
Vol 98 (1) ◽  
pp. 143-150 ◽  
Author(s):  
Yan Zhang ◽  
Wei Zhang ◽  
Jian Li ◽  
Minghui Duan ◽  
Bing Han ◽  
...  
Keyword(s):  
T Cell ◽  
Cell Lymphoma ◽  
T Cell Lymphoma ◽  
Phase 2 ◽  
Newly Diagnosed ◽  
Single Center ◽  
Open Label ◽  
Peripheral T Cell Lymphoma ◽  
Open Label Study ◽  
Label Study

scholarly journals CEOP/IVE/GDP Alternating Regimen Compared with CEOP As the First-Line Therapy for Newly Diagnosed Patients with Peripheral T-Cell Lymphoma: Results from a Phase 2, Multi-Center, Randomized, Controlled Clinical Trial

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 1556-1556 ◽  
Author(s):  
Mingci Cai ◽  
Shu Cheng ◽  
Wang Xin ◽  
Jianda Hu ◽  
Yongping Song ◽  
...  
Keyword(s):  
T Cell ◽  
Response Rate ◽  
Cell Lymphoma ◽  
Study Groups ◽  
T Cell Lymphoma ◽  
Phase 2 ◽  
Newly Diagnosed ◽  
Efficacy And Safety ◽  
Peripheral T Cell Lymphoma ◽  
Randomized Controlled

Background Cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP) or CHOP-like chemotherapy is widely used for treatment of peripheral T-cell lymphoma (PTCL). Given the poor response to CHOP-based regimens and the potential anti-lymphoma activity by alternating chemotherapy in PTCL, we conducted a phase 2, multi-center, randomized, controlled trial, comparing the efficacy and safety of CEOP/IVE/GDP alternating regimen with CEOP in a Chinese cohort of newly diagnosed patients with PTCL. Methods The primary endpoint of the study was the complete response rate (CRR). Patients with newly diagnosed PTCL, except for anaplastic large cell lymphoma (ALCL)- anaplastic lymphoma kinase (ALK) positive, were 1:1 randomly assigned. Patients in the CEOP/IVE/GDP group received intravenous cyclophosphamide 750 mg/m², epirubicin 70 mg/m², and vincristine 1.4 mg/m² (up to a maximum of 2 mg) on day 1, and oral prednisone 60 mg/m2 (up to a maximum of 100 mg) on day 1-5 every 21 days, at the 1st and 4th cycle with CEOP. Intravenous ifosfamide 2000 mg/m2 on day 1-3, epirubicin 70 mg/m2 on day 1, and etoposide 100 mg/m2 on day 1-4 every 21 days, at the 2nd and 5th cycle with IVE. Intravenous gemcitabine 1000 mg/m² on day 1, and 8, cisplatin 25 mg/m² on day 1-3, and dexamethasone 40mg on day 1-4 every 21 days, at the 3rd and 6th cycle with GDP, for a total of 6 cycles. Patients in the CEOP group received standard CEOP regimen every 21 days for 6 cycles. Analysis of efficacy and safety was of the intent-to-treat population. The study was registered with ClinicalTrials.gov, number NCT02533700. Findings Between Sep 22, 2015 and Sep 23, 2018, 102 patients were randomly assigned to two treatment groups: 51 each to the CEOP/IVE/GDP and the CEOP group. One patient was excluded because of the change of diagnosis and 3 patients withdrew informed consent before treatment in both study groups. 49 patients in the CEOP/IVE/GDP group and 49 patients in the CEOP group were included into efficacy and safety analysis as intent-to-treatment population. CRR at the end of treatment (EOT) in the CEOP/IVE/GDP group was similar as the CEOP group (36.7% vs. 32.7%, OR 0.84, 95% CI 0.36-1.88; p=0.835), while overall response rate (ORR) at EOT was higher in the CEOP/IVE/GDP group (73.5% vs. 51.0%, OR 0.38, 95% CI 0.17-0.86; p=0.037). There was no difference in median progression-free survival (15.4 months [95% CI 9.8-21.1] vs 10.7 months [4.5-16.8]; HR 0.73, 95% CI 0.45-1.18; p=0.20) or overall survival (24.3 months [95% CI 17.0-31.6] vs 21.9 months [7.5-36.2]; HR 0.69, 95% CI 0.41-1.17; p=0.17) between the CEOP/IVE/GDP and the CEOP group. Grade 3-4 hematological and non-hematological adverse events were similar between two study groups. Interpretation CEOP/IVE/GDP regimen showed similar CRR at EOT as CEOP regimen in PTCL. Nevertheless, CEOP/IVE/GDP increased ORR at EOT and could potentially bridge more patients to hematopoietic stem cell transplantation. Disclosures No relevant conflicts of interest to declare.

Panobinostat in combination with bortezomib in patients with relapsed or refractory peripheral T-cell lymphoma: an open-label, multicentre phase 2 trial

2015 ◽  
Vol 2 (8) ◽  
pp. e326-e333 ◽  
Author(s):  
Daryl Tan ◽  
Colin Phipps ◽  
William Y K Hwang ◽  
Soo Yong Tan ◽  
Chun Hsien Yeap ◽  
...  
Keyword(s):  
T Cell ◽  
Cell Lymphoma ◽  
T Cell Lymphoma ◽  
Phase 2 ◽  
Open Label ◽  
Peripheral T Cell Lymphoma ◽  
Multicentre Phase ◽  
Phase 2 Trial

A phase II open-label multicenter study to assess the efficacy and safety of AFM13 in patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma or transformed mycosis fungoides: The REDIRECT study design and rationale.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. TPS3148-TPS3148
Author(s):  
Cassandra Choe-Juliak ◽  
Karenza M. Alexis ◽  
Sylvia Schwarz ◽  
Linta Garcia ◽  
Ahmed Sawas
Keyword(s):  
T Cell ◽  
Hodgkin Lymphoma ◽  
Mycosis Fungoides ◽  
Systemic Therapy ◽  
Cell Lymphoma ◽  
T Cell Lymphoma ◽  
Phase 2 ◽  
Efficacy And Safety ◽  
Open Label ◽  
Peripheral T Cell Lymphoma

TPS3148 Background: AFM13 is a tetravalent, bispecific (anti-CD30/anti-CD16A) recombinant antibody being developed for the treatment of CD30-positive T-cell malignancies and Hodgkin lymphoma. AFM13 selectively kills CD30-positive tumor cells by engaging and activating natural killer cells and macrophages. AFM13 was well tolerated at doses of 0.01 to 7 mg/kg and showed clinical activity in patients with relapsed/refractory (R/R) Hodgkin lymphoma in a Phase 1 study. In an ongoing biomarker Phase 1b/2a study in patients with R/R CD30-positive lymphomas with cutaneous involvement, 4 of 8 patients responded (at different doses) including one CR. Based on these findings, this Phase 2 study (REDIRECT) has been initiated. Methods: This is a Phase 2, open-label, multicenter global study investigating the efficacy and safety of AFM13 in patients with R/R CD30-positive peripheral T cell lymphoma (PTCL) or transformed mycosis fungoides (TMF). AFM13 is administered at 200 mg weekly via an intravenous infusion until disease progression, unacceptable toxicity, investigator discretion or withdrawal of consent. Cohorts A and B include PTCL patients with ≥10%, and ≥1% to <10% CD30 expression by IHC, respectively. Cohort C includes patients with TMF who express ≥1% CD30. Eligible PTCL patients must have received at least 1 prior line of systemic therapy and, if diagnosed with systemic anaplastic large cell lymphoma, must have failed or be intolerant to brentuximab vedotin. Eligible patients with TMF must have received at least 1 prior line of systemic therapy and have exhausted systemic therapies with regular approval for their disease. This global trial started enrollment in Oct 2019. The primary endpoint is objective response rate as confirmed by an Independent Review Committee for all cohorts. The study will also assess investigator-measured efficacy parameters, safety, PK, immunogenicity and QOL. Disease assessment will be done at screening and every 8 weeks for the first 3 assessments, then every 12 weeks thereafter, regardless of any treatment/cycle delays that may occur. ClinicalTrials.gov identifier: NCT04101331. References: Reusch U et al. mAbs. 2014;6(3):728-739. Rothe A et al. Blood. 2015;125(26):4024-4031. Clinical trial information: NCT04101331 .

GDPT Versus CHOP in Newly Diagnosed Peripheral T-Cell Lymphoma: A Prospective Randomized Controlled, Open-Label Study (No.NCT01664975)

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 2989-2989
Author(s):  
Ling Li ◽  
Wenjing Duan ◽  
Ken H. Young ◽  
Zhaoming Li ◽  
Lei Zhang ◽  
...  
Keyword(s):  
T Cell ◽  
Cell Lymphoma ◽  
Oral Prednisone ◽  
Progression Free Survival ◽  
T Cell Lymphoma ◽  
Newly Diagnosed ◽  
Open Label ◽  
Peripheral T Cell Lymphoma ◽  
Free Survival ◽  
Randomized Controlled

Abstract Background: Peripheral T-cell lymphoma is a distinct lymphoid neoplasm with aggressive course and poor outcome. Optimal treatment strategies for peripheral T-cell lymphoma have not been well defined. We compared the efficacy and safety of GDPT and CHOP regimens for patients with newly diagnosed peripheral T-cell lymphoma in a prospective randomized controlled and open-label clinical trial (No.NCT01664975). Methods: All eligible patients with newly diagnosed peripheral T-cell lymphoma had measurable disease with an ECOG performance status ≤ 2 and adequate organ function. GDPT or CHOP chemotherapy were randomly assigned to patients. Patients in arm GDPT received intravenous gemcitabine (0.8g/m2) in 30 min on days 1 and 8, cisplatin (25mg/m2) on days 1-3, and oral prednisone (60 mg/m2) on days 1-5, thalidomide (200 mg) until the end of the whole chemotherapy. Patients in group CHOP received intravenous cyclophosphamide (750 mg/m2), doxorubicin(50 mg/m2) and vincristine (1.4 mg/m2, maximum 2 mg) on day 1, and oral prednisone (60 mg/m2) on days 1-5. Each cycle was repeated six times every 3 weeks. Efficacy was evaluated every two cycles. The primary endpoint was to evaluate the efficacy assessed by progression-free survival. Secondary end points included response rate and overall survival. Results: Between July 2010 and June 2016, 103 patients allocated into two groups randomly, of whom 52 were treated with GDPT therapy and 51 were treated with CHOP therapy. Patient characteristics were well balanced within the two arms of treatment at enrollment (Table 1). The 2-year progression-free survival (PFS) and overall survival (OS) rates were better in GDPT group than that in CHOP group (57% versus 35% for 2-year PFS, P=0.0035; 71% versus 50% for 2-year OS, P =0.0001) (Figure 1). Complete remission (CR) rate and overall response rate (ORR) of GDPT group were higher than that in CHOP group (52% versus 33%, P =0.044 for CR rate; 67% versus 49%, P =0.046 for ORR) (Table 2). Adverse effects of chemotherapy was hemocytopenia predominantly in both arms. No differences were observed between the two arms in terms of grade 3/4 myelosuppression, digestive tract, hepatic, renal, cardiac or neurological toxicity (Table 3). Acute toxicity was moderate, tolerable and well managed in both arms. Conclusions: GDPT chemotherapy resulted in significant improvement in PFS and OS compared with CHOP chemotherapy and side effects of chemotherapy was well tolerated for newly diagnosed peripheral T-cell lymphoma patients. Therefore, GDPT is a promising new regimen as potential first-line therapy against peripheral T-cell lymphoma. Disclosures No relevant conflicts of interest to declare.

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