Phase II Study of Folotyn With Leucovorin to Prevent/Reduce Mucositis in Patients With Hematological Malignancies

What Was Tested

This registered phase 2 trial tested Cyanocobalamin (Vitamin B12).

It had 1 arm (groups): Folotyn and Leucovorin (experimental).

The registry classes the interventions as drug.

More on the Plan

Patients with hematological malignancies, including PTCL and CTCL, will be enrolled based on meeting all protocol eligibility criteria.

The primary endpoint will be evaluated in the first 7-week treatment cycle.

Approximately 37 patients will be enrolled.

Safety, as assessed by reported SAEs, will continue to be monitored during the optional treatment period.

Who Took Part

Enrollment: 36 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: Patient is at least 18 years of age. Patient has recovered from the toxic effects of prior therapy, and is at least 30 days from the most recent cytotoxic therapy, prior to enrollment. Patient has adequate hematologic, hepatic, and renal function as defined by:. Platelet count ≥100,000/µL. Aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT), alanine aminotransferase/serum glutamic-pyruvic transaminase (ALT/SGPT), and gamma-glutamyltransferase (GGT) ≤2.5 xupper limit of normal (ULN) (AST/ALT/GGT ≤5 xULN if documented hepatic involvement with lymphoma).

The full record lists 13 inclusion and 9 exclusion criteria; among the exclusions: patient has congestive heart failure class iii/iv according to the new york heart association (nyha) functional classification; patient has uncontrolled hypertension; patient has known, uncontrolled human immunodeficiency virus (hiv)-positive diagnosis.

How the Study Was Run

It was run as a single-group and open-label study.

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 2014-07 with completion listed for 2018-10.

It ran at 3 sites in United States (3).

Its stated primary purpose is prevention.

What Was Measured

It also tracked 5 secondary outcomes, for example Grade 2 Oral Mucositis Duration of first occurrence, Grade 2 Oral Mucositis Duration and Objective Response Rate.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Cyanocobalamin (Vitamin B12) in 36 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.