Clinical trial · Interventional
Alefacept in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma or Peripheral T-Cell Non-Hodgkin's Lymphoma
A Phase I Study of Alefacept (AmeviveTM) in the Treatment of Cutaneous T-cell Lymphoma and Peripheral T-cell NHL
NCT00438802CI-TRIAL-00040030completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alefacept | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- alefacept
- description
- Determine both the maximum tolerated dose level as well as the optimal immunologic dose and toxicity.
- interventionNames
- Drug: Alefacept
Primary outcomes (2)
- measure
- Dose Limiting Toxicity (DLT)
- timeFrame
- 8 weeks from registration
- description
- The Maximum Tolerated Dose (MTD) will be defined as the highest safely-tolerated dose where at most one out of six patients experiences a Dose Limiting Toxicity (DLT) with the next higher dose level having at least 2 patients who have experienced DLT. The MTD determination will be based on toxicities encountered during the first 8 weeks of treatment.\> \> For this protocol, dose-limiting toxicity (DLT) will be defined as an adverse event attributed (definitely, probably, or possibly) to the study treatment and meeting the following criteria:\> * grade 4 toxicity for neutrophils (\<0.5 x 109/L) or platelets (\<25 x 109/L)\> * any grade 3 or higher solid organ toxicity not explainable by another obvious cause.\> * more than 10 x ULN AST toxicity for more than 14 days\> * any grade 4 infection.\> The number of patients who reported a dose limiting toxicity is reported here.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed cutaneous T-cell lymphoma (CTCL) or peripheral T-cell non-Hodgkin's lymphoma
* Diagnostic biopsies must have been obtained within the past 6 months
* Relapsed or refractory disease
* Patients with CTCL must have failed ≥ 2 skin-directed therapies
* No limit on the number of prior therapies
* Measurable disease, defined as at least 1 bidimensionally measurable lesion \> 2 cm by CT scan, MRI, physical exam, or photograph with appended ruler
* At least 2 bidimensionally measurable target lesions required for patients with skin lesions only
* No CNS lymphoma
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Absolute neutrophil count ≥ 1,000/mm\^3
* Platelet count ≥ 75,000/mm\^3
* Hemoglobin ≥ 9 g/dL
* Total bilirubin ≤ 2 times upper limit of normal (ULN) OR direct bilirubin ≤ 1.5 times ULN
* AST ≤ 3 times ULN (≤ 5 times ULN if liver involvement)
* Creatinine ≤ 2 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Willing to provide all research blood samples as required by the protocol
* Willing to undergo repeat biopsy of either an accessible skin lesion or lymph node, if there are no circulating sezary cells, for the purpose of research studies (patients without easily accessible lesions are not required to have a repeat biopsy solely for research purposes but must be willing to provide a portion of the on-study biopsy or a previous lymphoma biopsy, if available)
* No known congenital or acquired immunodeficiency syndromes, including HIV
* No known active viral hepatitis or tuberculosis infection
* No uncontrolled infection
* No other uncontrolled serious medical condition unrelated to lymphoma (e.g., cardiac arrhythmia or diabetes)
* No other active malignancies
* No history of serious allergic reaction to citrate or glycine
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* More than 3 weeks since prior cytotoxic chemotherapy
* More than 3 weeks since prior denileukin diftitox
* More than 3 weeks since prior radiotherapy (less than 3 weeks if the acute side effects of this therapy are resolved)
* More than 2 weeks since prior oral corticosteroids (unless being used to treat adrenal insufficiency)
* More than 2 weeks since prior phototherapy, including ultraviolet B and psoralen with ultraviolet A
* More than 1 week since prior biologic therapy
* No concurrent chemotherapy, other immunotherapy, or radiotherapy
* No other concurrent investigational agentsReferences
Publications (0)
Data not yet available
No reference posted for this study.