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NCT00924040 · ClinicalTrials.gov registry record · Phase 2
Retreatment Protocol for BL22 Immunotherapy in Relapsed or Refractory Hairy Cell Leukemia
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT00924040: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00924040 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 1 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00924040, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
BL22 is a type of protein that scientists have created to interact with certain cancer cells. Experiments have shown that BL22 can bind with cancer cells that have a particular kind of protein (called CD22 ) on their surface, and can kill those cells. CD22 is present on certain types of hairy cell leukemia (HCL) cancer cells, and researchers have been working on treatments that will use BL22 and other related proteins to interact with and kill these kinds of cancer cells. The primary purpose of this study will be to provide access to and treatment with BL22 for patients who have HCL in order to determine their response to the treatment. In addition, the study will assess potential side effects of BL22 and examine why some patients respond better than others to treatment with BL22 and related therapies. This study will include about 21 to 25 adults who have been diagnosed with forms of HCL that have not responded well to standard treatments such as surgery, chemotherapy, or radiation therapy. These adults also will have received anti-CD22 therapies before, potentially including treatments with BL22, and have not developed immunity or resistance to these treatments. Prior to the study, patients will undergo a 1- to 2-week screening period to assess their eligibility for treatment. Eligible patients will participate in the study for up to 16 cycles of treatment, with each cycle lasting approximately 4 weeks. For each cycle, patients will receive 1 prescribed dose of BL22 every other day for a total of 3 doses per cycle, and will be assessed after every cycle to evaluate the success of the treatment. During the evaluation visits, patients will be required to have a brief physical examination, give blood and urine samples for testing, and undergo other tests as need to check heart and kidney function and assess the state of the leukemia. Patients who agree will give additional blood, urine, or bone marrow samples for future research purposes.
Interventions
- DRUG BL22 (CAT-3888)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2009-02 |
| Est. Completion | 2010-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00924040
The ClinicalTrials.gov registry entry for NCT00924040 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which BL22 (CAT-3888) is the first listed.
NCT00924040 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00924040 about?
NCT00924040 is a clinical study titled "Retreatment Protocol for BL22 Immunotherapy in Relapsed or Refractory Hairy Cell Leukemia". BL22 is a type of protein that scientists have created to interact with certain cancer cells. Experiments have shown that BL22 can bind with cancer cells that have a particular kind of protein (called CD22 ) on their surface, and can kill those cells. CD22 is present on certain types of hairy cell l...
What is the current status of trial NCT00924040?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2009-02. Estimated completion is 2010-08.
What interventions are being tested in trial NCT00924040?
The interventions under investigation include: BL22 (CAT-3888) (DRUG).
Who is sponsoring clinical trial NCT00924040?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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