Clinical trial · Interventional
Alemtuzumab in Treating Patients With Relapsed or Refractory Advanced Mycosis Fungoides or Sézary Syndrome
Phase II Trial Of Campath-1H In Patients With Relapsed/Refractory Advanced Mycosis Fungoides or Sezary Syndrome
NCT00057967CI-TRIAL-00036978completedPhase 2ClinicalTrials.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: Monoclonal antibodies such as alemtuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: This phase II trial is studying how well alemtuzumab works in treating patients with relapsed or refractory advanced mycosis fungoides or Sézary syndrome.
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 |
|---|---|---|---|
| alemtuzumab | Biological | Alemtuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment arm
- description
- alemtuzumab
- interventionNames
- Biological: alemtuzumab
Primary outcomes (2)
- measure
- Determine response rate associated with Campath-1H therapy in patients with relapsed Mycosis Fungoides/Sezary Syndrome
- timeFrame
- At baseline, weekly while on treatment, then once when patient goes off study
- description
- Response rate associated with Campath-1H therapy in patients with relapsed Mycosis Fungoides/Sezary Syndrome will be assessed by medical photograph (skin lesion) measurements or by CT scan for internal lesions upon study entry, weekly while on study, then once when patient goes off study
- measure
- Collect data on toxicity associated with Campath-1H therapy
- timeFrame
- At baseline and then every 2 weeks while on therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed mycosis fungoides or Sézary syndrome * Stage IB-IVB * Measurable disease * One or more indicator lesions * No prior radiotherapy to areas of measurable disease unless there is clear disease progression at the site or measurable disease outside the area of prior radiotherapy * Generalized erythrodermia patients with evaluable disease only are allowed * Must have failed at least 1 prior systemic therapy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 OR * WHO 0-2 Life expectancy * At least 3 months Hematopoietic * WBC at least 3,000/mm\^3 * Absolute granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than 2.2 mg/dL * AST or ALT no greater than 2 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2 times ULN Renal * Creatinine no greater than 2.0 mg/dL Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No acute infection requiring intravenous antibiotics * No other prior neoplasm except treated squamous cell or basal cell skin cancer, treated carcinoma in situ of the cervix, or other cancer that received surgical treatment only from which patient has been disease free for at least 5 years PRIOR CONCURRENT THERAPY: Biologic therapy * More than 4 weeks since prior biologic therapy Chemotherapy * More than 4 weeks since prior chemotherapy Endocrine therapy * More than 4 weeks since prior topical steroids Radiotherapy * See Disease Characteristics * At least 2 weeks since prior radiotherapy (local control or palliative) * No concurrent radiotherapy to any lesion Surgery * Recovered from prior major surgery Other * Recovered from prior therapy * No other concurrent proven or investigational antineoplastic agents
References
Publications (0)
Data not yet available
No reference posted for this study.