The potential of pralatrexate as a treatment of peripheral T-cell lymphoma

Dondi, Alessandra; Bari, Alessia; Pozzi, Samantha; Ferri, Paola; Sacchi, Stefano

doi:10.1517/13543784.2014.902050

Cited by 4 publications

(4 citation statements)

References 55 publications

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“…Pralatrexate is an anti-folate 9, 10 with demonstrated tolerability and activity in subjects with relapsed/refractory peripheral T cell lymphoma (PTCL) and CTCL However, the approved dose of pralatrexate for PTCL is 30 mg/m2 weekly for 6 of 7 weeks. 10, 11 In a CTCL specific study, the dose of 15 mg/m 2 pralatrexate given weekly 3 of 4 weeks was identified as active and was better tolerated than the full standard dosing with an overall response rate of 45% among patients with relapsed or refractory disease.…”

Section: Introductionmentioning

confidence: 99%

“…10, 11 In a CTCL specific study, the dose of 15 mg/m 2 pralatrexate given weekly 3 of 4 weeks was identified as active and was better tolerated than the full standard dosing with an overall response rate of 45% among patients with relapsed or refractory disease. 12 The dose limiting toxicity for pralatrexate is mucositis; 12 bexarotene induces central hypothyroidism and hypertriglyceridemia.…”

Section: Introductionmentioning

confidence: 99%

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Results from a Phase I/II Open-Label, Dose-Finding Study of Pralatrexate and Oral Bexarotene in Patients with Relapsed/Refractory Cutaneous T-cell Lymphoma

Duvic

Kim

Zinzani

et al. 2017

Clinical Cancer Research

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Pralatrexate is a folic acid analog metabolic inhibitor similar to methotrexate, that has shown tolerability and efficacy with an overall response rate of 45% in a phase 1 dose de-escalation study of patients with relapsed/refractory cutaneous T-cell lymphoma (CTCL). The object of this phase I/II open-label, multi-center clinical trial was to determine the maximum tolerated dose (MTD) and recommended dose of pralatrexate plus oral bexarotene in 34 patients with relapsed/refractory CTCL who had failed prior systemic therapies. Pralatrexate was administered by IV push at 15 mg/m2 given weekly 3 weeks out of 4 weeks with daily oral bexarotene (150 or 300 mg/m2), levothyroxine, atorvastatin, folate, and with B12 every two months. At the maximum tolerated dose (MTD), the response rate was 60% (4 CR, 14 PR), the maximum observed response duration was 28.9+ months, and duration of response for 4 CRs ranged from 9.0-28.3 months. The median progression free survival was 12.8 months (0.5-29.9). Mucositis was the most common adverse event. The combination of pralatrexate (15 mg/m2) and oral bexarotene (150 mg/m2) is active with high response rates and minimal toxicity for cutaneous T-cell lymphomas.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Results from a Phase I/II Open-Label, Dose-Finding Study of Pralatrexate and Oral Bexarotene in Patients with Relapsed/Refractory Cutaneous T-cell Lymphoma

Duvic

Kim

Zinzani

et al. 2017

Clinical Cancer Research

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“…Pralatrexate is the first drug to have been approved by the US Food and Drug Administration specifically for treating patients with relapsed or refractory PTCL. 3 As a folate analog metabolic inhibitor, pralatrexate competitively inhibits dihydrofolate reductase and reduces cellular levels of thymidine monophosphate, which prevents the cell from synthesizing genetic material and triggers it to undergo apoptosis. 4 The agency's approval of pralatrexate was based on results from the PROPEL study, which is possibly the largest prospective study conducted in patients with relapsed or refractory PTCL (109 evaluable patients).…”

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confidence: 99%

Durable response to pralatrexate for aggressive PTCL subtypes

Farhan¹

2018

JCSO

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“…It easily enters malignant cells with overexpression of folate membrane transporters and is efficiently polyglutamylated, which increases intracellular half-life. Owing to this unique nature, the agent has shown durable responses in highly refractory cases even after discontinuation ( 6 7 ). It has little cumulative toxicity and can be administered continuously to patients of old age or ineligible for consolidative stem cell transplantation.…”

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confidence: 99%

Pralatrexate in Combination with Bortezomib for Relapsed or Refractory Peripheral T Cell Lymphoma in 5 Elderly Patients

et al. 2016

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Peripheral T cell lymphoma (PTCL) is a heterogeneous group of aggressive lymphomas with poor prognosis. Elderly (age ≥ 65years) patients generally have impaired bone marrow function, altered drug metabolism, comorbidities, and poor functional status. Thus, treatment of elderly patients with relapsed or refractory PTCL remains a challenge for clinicians. A recent study disclosed that pralatrexate has a synergistic effect in combination with bortezomib. Weekly pralatrexate and bortezomib were administered intravenously for 3 weeks in a 4-week cycle. Of 5 patients, one achieved complete response after 4 cycles which has lasted 12 months until now. Another patient attained partial response after 2 cycles. Only 1 patient experienced grade 3 thrombocytopenia and neutropenia. Two patients suffered from grade 3 mucositis. Combination therapy with pralatrexate and bortezomib may be used as a salvage therapy for relapsed or refractory PTCL in the elderly with a favorable safety profile.

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The potential of pralatrexate as a treatment of peripheral T-cell lymphoma

Cited by 4 publications

References 55 publications

Results from a Phase I/II Open-Label, Dose-Finding Study of Pralatrexate and Oral Bexarotene in Patients with Relapsed/Refractory Cutaneous T-cell Lymphoma

Results from a Phase I/II Open-Label, Dose-Finding Study of Pralatrexate and Oral Bexarotene in Patients with Relapsed/Refractory Cutaneous T-cell Lymphoma

Durable response to pralatrexate for aggressive PTCL subtypes

Pralatrexate in Combination with Bortezomib for Relapsed or Refractory Peripheral T Cell Lymphoma in 5 Elderly Patients

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