Clinical trial · Interventional
Photodynamic Therapy in Treating Patients With Lymphoma or Chronic Lymphocytic Leukemia
A Pilot Study of Short (1-2.5 h), Medium (4-6 h) and Long (18-24 h) Applications of 20% Topical ALA-PDT for Photodynamic Therapy of Cutaneous T and B Cell Lymphomas and Cutaneous Infiltrates of Early CLL
- 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: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill cancer cells. Photosensitizing drugs such as aminolevulinic acid are absorbed by cancer cells and, when exposed to light, become active and kill the cancer cells. PURPOSE: Randomized phase II trial to study the effectiveness of photodynamic therapy using aminolevulinic acid in treating patients who have cutaneous T-cell lymphoma, B-cell lymphoma, or early chronic lymphocytic leukemia involving the skin.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aminolevulinic acid hydrochloride | Drug | Aminolevulinic Acid | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (6)
- measure
- Pain grade and epidermal toxic response (ETR)
- measure
- Feasibility of maintaining a pain grade of 1 or less and an approximate ETR of 2
- measure
- Maximal irradiance and corresponding exposure
- measure
- Cumulative response achieved at the completion of treatment
- measure
- Number of sessions required to complete treatment
- measure
- Correlation of ETR with incremental treatment response
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* One of the following histologically confirmed diagnoses:
* Cutaneous B-cell or T-cell lymphoma confined to the skin
* No evidence of internal disease other than peripheral adenopathy
* Early chronic lymphocytic leukemia with cutaneous B-cell infiltrates not requiring systemic therapy
* Stable or slowly progressive disease that is not expected to substantially change during treatment
PATIENT CHARACTERISTICS:
Age
* Not specified
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Other
* Not pregnant or nursing
* No porphyria or known hypersensitivity to porphyrins
* No known photosensitivity diseases
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Concurrent clinically necessary interferon alfa allowed
Chemotherapy
* No concurrent systemic multiagent chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* No concurrent local radiotherapy to study lesions
* No concurrent whole body radiotherapy
Surgery
* Not specified
Other
* More than 1 month since prior topical therapy to study lesions
* Concurrent topical therapy to non-study lesions allowedReferences
Publications (0)
Data not yet available