Study of Pralatrexate & Gemcitabine With B12 & Folic Acid to Treat Relapsed/Refractory Lymphoproliferative Malignancies

What Was Tested

The trial (phase 1, phase 2) is built around Cyanocobalamin (Vitamin B12).

This study is for patients with lymphoproliferative malignancies that have progressed after receiving a previous treatment (relapsed) or are no longer responding to treatment (refractory).

To be in this study, patients must have certain types of Hodgkin's lymphoma (HL), peripheral T-cell lymphoma (PTCL), or B-cell lymphoma, including Waldenstrom's macroglobulinemia.

It had two arms (groups): Pralatrexate & Gemcitabine - Sequential Days (experimental) and Pralatrexate & Gemcitabine - Same Day (experimental).

The registry classes the interventions as dietary supplement and drug.

Who Took Part

Enrollment: 119 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: Phase 1: Histologically/cytologically confirmed lymphoproliferative malignancy. Patients with Hodgkin lymphoma (HL) or non-HL are eligible, with exceptions per.

The full record lists 1 inclusion and 29 exclusion criteria; among the exclusions: phase 2a: histologically/cytologically confirmed hl, peripheral t-cell lymphoma (ptcl), or b-cell lymphoma including waldenström's macroglobulinemia, with exceptions per exclusion criteria; PTCL patients must have received single-agent pralatrexate as a prior therapy; eastern cooperative oncology group performance status ≤ 2.

How the Study Was Run

Design: randomized, single-group and open-label.

Because people in this Cyanocobalamin (Vitamin B12) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2007-05 with completion listed for 2011-05.

It ran at 15 sites in United States (15).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Objective Responses Assessed by International Workshop Criteria (IWC) (time frame: Assessed every 8 weeks (+/- 1 week) for Phase II and no less than every 3 cycles for Phase I).

It also tracked 2 secondary outcomes, for example Duration of Response and Progression-free Survival (PFS) Time.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Cyanocobalamin (Vitamin B12) in 119 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.