A Single Arm Study Evaluating the Efficacy and Safety of Pralatrexate in Subjects With Relapsed or Refractory PTCL

What Was Tested

In this phase 3 trial, researchers set out to test Cyanocobalamin (Vitamin B12).

It had 1 arm (groups): pralatrexate (experimental).

Vitamin B12 and folic acid will be taken concurrently with pralatrexate.

The registry classes the interventions as dietary supplement and drug.

More on the Plan

Screening Phase: The screening phase will be up to 28 days duration (depending on availability of lab results).

Treatment (pralatrexate) Phase: The start of study treatment (pralatrexate) is defined as the initiation of pralatrexate.

Patients will attend the clinic weekly for 6 weeks of a 7-week cycle to receive pralatrexate, and will be examined by the treating physician.

Although radiological response assessments have been scheduled every 14 weeks, unscheduled radiological response assessments will be performed earlier if clinical progression is suspected.

Who Took Part

85 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Subject has histologically/cytologically confirmed PTCL, using the World Health Organization (WHO) disease classification:. PTCL not otherwise specified (NOS). Angioimmunoblastic T-cell lymphoma. Anaplastic large cell lymphoma, ALK+. Anaplastic large cell lymphoma, ALK-.

The full record lists 25 inclusion and 20 exclusion criteria; among the exclusions: subject has:; precursor t-cell lymphoma or leukemia; T-cell prolymphocytic leukemia (T-PLL).

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Cyanocobalamin (Vitamin B12) study did not mask who received what.

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

It started in 2015-09-10 with completion listed for 2017-07-21.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Objective Response Rate(ORR) by International Working Group Criteria (time frame: 2 years).

It also tracked 17 secondary outcomes, for example Time to Response (TTR), Progression-Free Survival (PFS), Overall Survival (OS), Duration of Responses, Percentage of Participants With Treatment Emergent Adverse Events and Area Under the Curve [AUC] for R-pralatrexate.

What This Means in Plain Language

Put simply, this is a phase 3 trial of Cyanocobalamin (Vitamin B12) in 85 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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