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Study of Pralatrexate to Treat Participants With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
Plain-language guide to NCT00998946: phase 2 interventional trial of Cyanocobalamin (Vitamin B12), 29 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00998946
- Phase
- phase 2
- Status
- completed
- Start
- 2009-09
- Completion (planned or actual)
- 2012-08
- Participants
- 29 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Lymphoma, B-Cell
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 2 trial, researchers set out to test Cyanocobalamin (Vitamin B12).
The study will also investigate the safety of pralatrexate with vitamin B12 and folic acid in this participant population.
It had 1 arm (groups): Pralatrexate (experimental).
The registry classes the interventions as dietary supplement and drug.
Who Took Part
29 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: Progressive or persistent disease after ≥ 1 prior treatment(s). Recovered from toxic effects of prior treatment. At least 4 weeks since most recent cytotoxic therapy. Easter Cooperative Oncology Group (ECOG) performance status ≤ 2. Adequate blood, liver, and kidney functions as defined by laboratory levels.
The full record lists 11 inclusion and 16 exclusion criteria; among the exclusions: congestive heart failure class iii/iv according to the new york heart association functional classification; uncontrolled hypertension; known human immunodeficiency virus (hiv)-positive diagnosis.
How the Study Was Run
Design: 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 2009-09 with completion listed for 2012-08.
It ran at 11 sites in United States (11).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Objective Response Rate (ORR) (time frame: Up to 24 months).
It also tracked 3 secondary outcomes, for example Duration of Response (DOR), Progression Free Survival (PFS) and Overall Survival (OS).
What This Means in Plain Language
Put simply, this is a phase 2 trial of Cyanocobalamin (Vitamin B12) in 29 people.
Its size is small, so on its own it can only give an early look.
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.
Our Notes on the Compound
Cyanocobalamin (Vitamin B12): A synthetic form of vitamin B12 (cobalamin), an essential nutrient for DNA synthesis, red blood cell formation and neurological function.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.