Clinical trial · Interventional
RFT5-dgA Immunotoxin in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Non-Hodgkin Lymphoma
Phase II Study of IMTOX25 in Relapsed/Refractory Cutaneous T-Cell Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual.
Summary
Brief summary (as posted)
RATIONALE: Immunotoxins, such as RFT5-dgA immunotoxin (also called anti-CD25 immunotoxin IMTOX25), can find certain cancer cells and kill them without harming normal cells. PURPOSE: This phase II trial is studying the side effects of anti-CD25 immunotoxin IMTOX25 and how well it works in treating patients with relapsed or refractory cutaneous T-cell non-Hodgkin 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorescence activated cell sorting | Other | — | UNRESOLVED |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| RFT5-dgA immunotoxin | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IMTOX25 at 2mg/m²/dose
- description
- Patients will receive IMTOX25 at 2mg/m²/dose, by IV administration, every other day for a total of 3 doses. A total of 6 cycles of treatment will be allowed. A cycle is equal to 6 weeks, with IMTOX25 infusion on Day 1, 3 and 5, followed by a 5 week rest period.
- interventionNames
- Biological: RFT5-dgA immunotoxin
- Other: fluorescence activated cell sorting
- Other: immunohistochemistry staining method
Primary outcomes (1)
- measure
- Response Rate - Cutaneous T Cell Lymphoma (CTCL)
- timeFrame
- Once a week for seven weeks
- description
- Response rate of patients with relapsed/refractory Cutaneous T Cell Lymphoma (CTCL) following treatment with IMTOX25.
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 non-Hodgkin lymphoma (CTCL) * Relapsed or refractory disease, meeting 1 of the following criteria: * Progression of disease following 2 prior chemotherapies * Failure to respond to the second prior chemotherapy * Measurable disease PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy \> 3 months * Serum creatinine \< 1.5 times upper limit of normal (ULN) * Serum AST/ALT \< 2.5 times ULN * Total bilirubin ≤ 2.0 mg/dL (\< 3.0 mg/dL in patients with Gilbert syndrome) * WBC count ≥ 3,000/mm³ * Platelet count ≥ 100,000/mm³ * Serum albumin \> 2.5 g/dL * LVEF ≥ 45% by 2-D ECHO or MUGA scan * Human antimurine antibody \< 1 μg/mL * Patients with a history of electrocardiogram abnormalities, symptoms of cardiac ischemia, or arrhythmias must have a normal cardiac stress test (i.e., stress thallium, stress MUGA, dobutamine echocardiogram, or other stress test) * Must be willing to undergo venipuncture and central line placement * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No HBV surface antigen, HCV, or HIV antibody positivity * No autoimmune disease or immunodeficiency (i.e., HIV) * No history of uncontrolled concurrent illness including, but not limited to, any of the following: * Ongoing or active infection * Ongoing or active cardiac disease (i.e., congestive heart failure, unstable angina pectoris, or cardiac arrhythmia) * Psychiatric illness and/or social situation that would preclude study compliance * No other malignancies except treated basal cell or squamous cell carcinoma of the skin, or treated carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 3 weeks since prior systemic therapy for CTCL * More than 6 months since prior chronic steroid therapy or chronic anti-coagulation therapy * No prior therapy with anti-CD25 immunotoxin IMTOX25 and/or Ontak * No other concurrent cancer chemotherapy, experimental therapy, investigational agent, or immunomodulating agent (including steroids)
References
Publications (0)
Data not yet available