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Study of Pralatrexate in Patients With Relapsed or Refractory Cutaneous T-cell Lymphoma
Plain-language guide to NCT00554827: phase 1 interventional trial of Cyanocobalamin (Vitamin B12), 55 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00554827
- Phase
- phase 1
- Status
- completed
- Start
- 2007-08
- Completion (planned or actual)
- 2012-01
- Participants
- 55 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Cutaneous T-cell Lymphoma
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1) is built around Cyanocobalamin (Vitamin B12).
It had 1 arm (groups): Pralatrexate Injection (FOLOTYN,PDX,Pralatrexate(R (experimental).
The registry classes the interventions as dietary supplement and drug.
More on the Plan
The start of study treatment is defined as the initiation of pralatrexate.
If a patient has elevated MMA and/or Hcy concentrations, vitamin supplementation will be initiated at least 10 days prior to pralatrexate initiation.
Who Took Part
The registry lists 55 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: Confirmed relapsed or refractory cutaneous T-cell lymphoma (CTCL):. Mycosis fungoides Stage IB or higher. Primary cutaneous anaplastic large cell. No curative treatment options. Progression of disease (PD) or relapse of disease after at least 1 previous systemic therapy, PD after last prior treatment regimen, and recovered from the toxic effects of prior therapy.
The full record lists 14 inclusion and 15 exclusion criteria; among the exclusions: congestive heart failure class iii/iv per the new york heart association heart failure guidelines; uncontrolled hypertension; symptomatic central nervous system metastases or lesions for which treatment is required.
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 2007-08 with completion listed for 2012-01.
It ran at 10 sites in United States (10).
Its stated primary purpose is treatment.
What Was Measured
It also tracked 1 secondary outcome, for example Characterize the Safety Profile of Pralatrexate in Patients with Relapsed or Refractory CTCL.
What This Means in Plain Language
Put simply, this is a phase 1 trial of Cyanocobalamin (Vitamin B12) in 55 people.
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.
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.