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NCT01658319 · ClinicalTrials.gov registry record · Phase 1
Methoxyamine and Fludarabine Phosphate in Treating Patients With Relapsed or Refractory Hematologic Malignancies
A Phase 1 study of Peripheral T-Cell Lymphoma and Anaplastic Large Cell Lymphoma, sponsored by Case Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT01658319: Completed Phase 1 study of Peripheral T-Cell Lymphoma and Anaplastic Large Cell Lymphoma, sponsored by Case Comprehensive Cancer Center.
NCT01658319 is a Phase 1 study of Peripheral T-Cell Lymphoma and Anaplastic Large Cell Lymphoma that has completed, run by Case Comprehensive Cancer Center. The registered enrollment target is 20 participants, below the 106-participant average among 34 other Peripheral T-Cell Lymphoma trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01658319, a Phase 1 study of Peripheral T-Cell Lymphoma and Anaplastic Large Cell Lymphoma, has completed, sponsored by Case Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial is studying the side effects and best dose of methoxyamine when given together with fludarabine phosphate in treating patients with relapsed or refractory hematologic malignancies. Drugs used in chemotherapy, such as methoxyamine and fludarabine phosphate, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving methoxyamine together with fludarabine phosphate may kill more cancer cells.
Primary Outcome
Defined as the highest dose tested in which none or only one subject experiences a dose limiting toxicities attributable to the study drug combination during the first cycle of treatment, when 3-6 subjects were treated at that dose and are evaluable for toxicity.
Conditions Studied
Interventions
- OTHER laboratory biomarker analysis
- DRUG fludarabine phosphate
- OTHER pharmacological study
- DRUG methoxyamine
- GENETIC western blotting
Study Locations (1)
Ohio
- Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2011-05 |
| Est. Completion | 2015-05 |
| Phase | Phase 1 |
What the finished NCT01658319 record still lists
NCT01658319 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 106-participant average among 34 other Peripheral T-Cell Lymphoma trials with a reported enrollment target (81% lower).
The record links to 10 conditions, with Peripheral T-Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT01658319 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT01658319 about?
NCT01658319 is a clinical study titled "Methoxyamine and Fludarabine Phosphate in Treating Patients With Relapsed or Refractory Hematologic Malignancies". This phase I trial is studying the side effects and best dose of methoxyamine when given together with fludarabine phosphate in treating patients with relapsed or refractory hematologic malignancies. Drugs used in chemotherapy, such as methoxyamine and fludarabine phosphate, work in different ways t...
What is the current status of trial NCT01658319?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2011-05. Estimated completion is 2015-05.
What conditions does trial NCT01658319 study?
This clinical trial studies the following conditions: Peripheral T-Cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Adult Nasal Type Extranodal NK/T-cell Lymphoma, Hepatosplenic T-cell Lymphoma.
What interventions are being tested in trial NCT01658319?
The interventions under investigation include: laboratory biomarker analysis (OTHER), fludarabine phosphate (DRUG), pharmacological study (OTHER), methoxyamine (DRUG), western blotting (GENETIC).
Who is sponsoring clinical trial NCT01658319?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01658319 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01658319's enrollment target sits among peer trials
20 26th of 34 higher than 7 of 34 other Peripheral T-Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peripheral T-Cell Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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