A Dose-Finding Study of Folotyn® (Pralatrexate Injection) Plus CHOP With Peripheral T-Cell Lymphoma (PTCL)

Launched by ACROTECH BIOPHARMA INC. · Oct 30, 2015

Keywords

ClinConnect Summary

This is a Phase 1, open-label, multicenter, two-part, dose-finding, dose-escalation study.

The study is divided into two parts:

Part 1

Up to five sequential dose cohorts will enroll a maximum of 6 patients each. Escalation of the pralatrexate dose, after CHOP administration (Fol-CHOP), will continue in a traditional 3+3 design, until determination of the MTD. If the MTD is not reached, the Maximum Administered Dose (MAD) of pralatrexate in combination with CHOP will be 30 mg/m2 IV on Days 1 and 8 of each 21-day cycle for up to 6 cycles.

The first cohort will begin with three patients wi...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18 years or above
• • 2. Adequate hematologic, hepatic, and renal function
• • 3. Histologically confirmed, new diagnosis of PTCL
• • 4. Eligible for CHOP regimen
• • 5. Measurable disease based on Cheson 2007 criteria
• • 6. Eastern Cooperative Oncology Group (ECOG) performance status \< 2
• • 7. Willing to perform at least two methods of contraception
• • 8. Negative pregnancy test of females with childbearing potential.
• Exclusion Criteria:
• • 1. Active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of the cervix) or life threatening disease. If there is a history of prior malignancies or life threatening diseases, the patient must be disease free for at least 5 years.
• • 2. Congestive heart failure Class III/IV according to the New York Heart Association (NYHA) Functional Classification.
• • 3. Uncontrolled hypertension
• • 4. Central nervous system (CNS) metastases .
• • 5. Active uncontrolled infection, underlying medical condition, or other serious illness that would impair the ability of the patient to receive protocol treatment
• • 6. Major surgery within 30 days prior to enrollment.
• • 7. Use of any investigational drugs, biologics, or devices within 30 days prior or during the study treatment.
• • 8. Previous exposure to pralatrexate.
• • 9. Pregnant or breastfeeding.