CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 23 enrolled
Drug / intervention
Alefaceptdrug
Likely dose
Alefacept 0.075–0.30 mg/kg IV weekly × 8 weeks (dose escalation)AI-extracted
Key inclusion· 4
  • ✓Histologically confirmed cutaneous T-cell lymphoma (CTCL) or peripheral T-cell non-Hodgkin's lymphoma with diagnostic biopsy within past 6 months
  • ✓Relapsed or refractory disease; CTCL patients must have failed ≥2 skin-directed therapies
  • ✓Measurable disease: ≥1 bidimensionally measurable lesion >2 cm by imaging or physical exam; ≥2 bidimensional target lesions required for skin-lesion-only patients
  • ✓ECOG performance status 0–2
Key exclusion· 6
  • ✕CNS lymphoma
  • ✕Known congenital or acquired immunodeficiency syndromes, including HIV
  • ✕Active viral hepatitis or tuberculosis infection
  • ✕Uncontrolled infection or serious medical condition unrelated to lymphoma (e.g., cardiac arrhythmia, diabetes)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00438802
NCT00438802Phase 1Completed
CompareCT.gov

A Phase I Study of Alefacept (AmeviveTM) in the Treatment of Cutaneous T-cell Lymphoma and Peripheral T-cell NHL

Mayo Clinic·interventional·Posted Feb 22, 2007·Updated Aug 13, 2019

In Brief

A Phase 1 clinical trial evaluating Alefacept for Lymphoma. Completed, enrolled 23 participants across 3 sites.

Detailed Summary

RATIONALE: Combinations of biological substances in alefacept may be able to carry cancer-killing substances directly to cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of alefacept in treating patients with relapsed or refractory cutaneous T-cell lymphoma or peripheral T-cell non-Hodgkin's lymphoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 1CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 22, 2007
Enrollment StartMar 1, 2006
Primary CompletionAug 24, 2010
Study CompletionJul 25, 2019
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 19.4 years ago

Interventions

Alefaceptdrug

Dose escalation theme. 0.075mg/kg by IV Weekly x 8 to 0.30mg/kg IV Weekly x 8