Overview

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

Status:
Completed
Trial end date:
2020-10-08
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the Maximum Tolerated Dose (MTD) of pralatrexate in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) regimen in patients with newly diagnosed peripheral T-cell lymphoma (PTCL).
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Acrotech Biopharma LLC
Spectrum Pharmaceuticals, Inc
Collaborator:
Axis Clinicals Limited
Treatments:
Aminopterin
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Prednisone
Vincristine
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.