Phase I/II Clinical Study of Pralatrexate in Japanese Patients With Relapsed or Refractory Peripheral T-cell Lymphoma

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test Cyanocobalamin (Vitamin B12).

It had 1 arm (groups): Pralatrexate injection (experimental).

Dietary Supplement: Vitamin B12, Folic Acid.

The registry classes the interventions as dietary supplement and drug.

Who Took Part

The registry lists 25 actual participants took part.

It was open to people of any sex aged from 20 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Japanese patients at least 20 years of age. Patients histologically diagnosed with peripheral T-cell lymphoma by pathological diagnosis of biopsied lesion. Relapsed or refractory patients with a treatment history of at least one regimen. Patients with an enlarged lymph node or extranodal mass lesion clearly measurable in two perpendicular directions and greater than 1.5 cm in maximum diameter on computed tomography performed. Patients expected to survive for at least 3 months.

The full record lists 8 inclusion and 12 exclusion criteria; among the exclusions: patients who received radiation therapy, phototherapy, or electron beam therapy within 21 days prior to initial administration of the study drug; patients who received another study drug within 28 days prior to initial administration of the study drug; patients who received antibody therapy within 100 days prior to initial administration of the study drug.

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label Cyanocobalamin (Vitamin B12) study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2014-03 with completion listed for 2015-12.

It ran at 3 sites in Japan (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Objective response rate (ORR) per independent central review committee.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2 trial of Cyanocobalamin (Vitamin B12) in 25 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.