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NCT00924170 · ClinicalTrials.gov registry record · Phase 1
Phase II Trial of LMB-2, Fludarabine and Cyclophosphamide for Adult T-Cell Leukemia
A Phase 1 study of Adult T-Cell Leukemia (ATL), sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT00924170 is a Phase 1 study of Adult T-Cell Leukemia (ATL) that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 18 participants. The trial reports 1 study location across 1 state.
The verdict
NCT00924170, a Phase 1 study of Adult T-Cell Leukemia (ATL), has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
BACKGROUND: * Cluster of differentiation 25 (CD25) (p55, Tac or interleukin 2 receptor (IL2R) alpha) is strongly expressed in virtually 100% of patients with adult T-cell leukemia/lymphoma (ATL), a highly aggressive human T-lymphotropic virus type 1 (HTLV-1) related malignancy responding poorly to chemotherapy. * In ATL, the humanized anti-CD25 monoclonal antibody (Mab) daclizumab produced 13-14% responses, and the anti-CD52 Mab Alemtuzumab (Campath-1H) produced response lasting greater than 2 months in 30% of 23 patients. * LMB-2 is an anti-CD25 recombinant immunotoxin containing variable domains of murine MAb anti-Tac and truncated Pseudomonas exotoxin. * In a phase I trial at National Cancer Institute (NCI), the maximum tolerated dose (MTD) of LMB-2 was 40 microg/Kg intravenous (IV) given every other day for 3 doses (every other day (QOD) times 3). LMB-2 induced greater than 90% tumor reduction rapidly in all 3 ATL patients on protocol, but achieved only 1 partial response due to rapid tumor progression and/or immunogenicity. * In preclinical models, response from recombinant immunotoxins is limited by high concentrations of soluble receptor in the blood and especially in the interstitial space of the tumor. Synergism was observed with chemotherapy and immunotoxins, possibly due to reduction of soluble receptor in tumor interstitium. OBJECTIVES: -To determine, in nonrandomized fashion, if after verifying its safety, fludarabine and cyclophosphamide (FC) prior to LMB2 for ATL can result in low immunogenicity and a rate of major response lasting greater than 2 months, which may be an improvement over that demonstrated previously from Alemtuzumab (CAMPATH). Secondary objectives: * To determine the effect of 1 cycle of FC alone in ATL. * To examine progression-free and overall survival in ATL after FC/LMB-2. * Evaluate pharmacokinetics, toxicity, and monitor soluble CD25 and other tumor marker levels in the serum. * To study the effects of LMB-2 plus FC on norma
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG LMB-2
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2008-10-31 |
| Est. Completion | 2021-05-05 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00924170
The ClinicalTrials.gov registry entry for NCT00924170 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 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 1 condition, with Adult T-Cell Leukemia (ATL) appearing as the primary indexed condition, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT00924170 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00924170 about?
NCT00924170 is a clinical study titled "Phase II Trial of LMB-2, Fludarabine and Cyclophosphamide for Adult T-Cell Leukemia". BACKGROUND: * Cluster of differentiation 25 (CD25) (p55, Tac or interleukin 2 receptor (IL2R) alpha) is strongly expressed in virtually 100% of patients with adult T-cell leukemia/lymphoma (ATL), a highly aggressive human T-lymphotropic virus type 1 (HTLV-1) related malignancy responding poorly to ...
What is the current status of trial NCT00924170?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2008-10-31. Estimated completion is 2021-05-05.
What conditions does trial NCT00924170 study?
This clinical trial studies the following conditions: Adult T-Cell Leukemia (ATL).
What interventions are being tested in trial NCT00924170?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), LMB-2 (DRUG).
Who is sponsoring clinical trial NCT00924170?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00924170 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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