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NCT00439361 · ClinicalTrials.gov registry record · Phase 1
Velcade Plus ICE for Patients With Relapsed Classical Hodgkin Lymphoma
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT00439361: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00439361 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00439361, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
Primary Objectives: 1. To determine the toxicity profile of multiple doses of bortezomib when given with ICE in patients with relapsed and refractory classical Hodgkin lymphoma (HL). 2. To determine the maximum tolerated dose (MTD) of bortezomib when given in combination with ICE chemotherapy in patients with relapsed and refractory classical Hodgkin lymphoma (HL). Secondary Objectives: \- To determine the overall response rate and complete response rate in patients with relapsed and refractory classical Hodgkin lymphoma (HL).
Primary Outcome
MTD dose escalation stops either at the highest indicated dose of bortezomib (1.5 mg/m2), or when a Dose limiting toxicity (DLT) has been observed in at least one third of the patients at any dose level.
Interventions
- DRUG Carboplatin
- DRUG Mesna
- DRUG Etoposide
- DRUG Ifosfamide
- DRUG Bortezomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2007-02 |
| Est. Completion | 2012-06 |
| Phase | Phase 1 |
What the finished NCT00439361 record still lists
NCT00439361 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.
NCT00439361 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00439361 about?
NCT00439361 is a clinical study titled "Velcade Plus ICE for Patients With Relapsed Classical Hodgkin Lymphoma". Primary Objectives: 1. To determine the toxicity profile of multiple doses of bortezomib when given with ICE in patients with relapsed and refractory classical Hodgkin lymphoma (HL). 2. To determine the maximum tolerated dose (MTD) of bortezomib when given in combination with ICE chemotherapy in pa...
What is the current status of trial NCT00439361?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2007-02. Estimated completion is 2012-06.
What interventions are being tested in trial NCT00439361?
The interventions under investigation include: Carboplatin (DRUG), Mesna (DRUG), Etoposide (DRUG), Ifosfamide (DRUG), Bortezomib (DRUG).
Who is sponsoring clinical trial NCT00439361?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00439361's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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