Clinical trial · Interventional
Campath-1H + FK506 and Methylprednisolone for GVHD
Phase II Clinical Trial Incorporating Alemtuzumab (Campath-1H) in Combination With FK506 and Methylprednisolone for Treatment of Severe Acute Graft vs Host Disease
- 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: Alemtuzumab, tacrolimus, and methylprednisolone may be an effective treatment for graft-versus-host disease caused by a donor stem cell transplant. PURPOSE: This phase II trial is studying how well giving alemtuzumab together with tacrolimus and methylprednisolone works in treating acute graft-versus-host disease in patients who have undergone donor stem cell transplant.
Conditions
Conditions (12)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chronic Myeloproliferative Disorders | Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Gestational Trophoblastic Tumor | Gestational Trophoblastic Tumor | ONTOLOGY_EXACT | 0.98 |
| Graft Versus Host Disease | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
| Myelodysplastic/Myeloproliferative Diseases | Myelodysplastic/Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alemtuzumab | Biological | Alemtuzumab | ALIAS |
| methylprednisolone | Drug | — | UNRESOLVED |
| tacrolimus | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Graft-vs-host disease response
- timeFrame
- 1, 2, 3, and 4 months
Secondary outcomes (1)
- measure
- Incidence of serious infections by clinical, radiologic, and microbiologic assessments
- timeFrame
- 1,2,3, and 4 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of acute graft-vs-host disease (GVHD)
* Clinical grade C or D disease
* No grade C disease with single organ skin involvement
* Has undergone allogeneic stem cell transplantation within the past 100 days
* Absolute neutrophil count \> 500/mm\^3 (donor-derived \[\> 60% by peripheral blood lymphocyte chimerism analyses\])
* No development of GVHD after prior donor lymphocyte infusion
* Must have received prior prophylactic cyclosporine or tacrolimus at the onset of acute GVHD
PATIENT CHARACTERISTICS:
Age
* Over 18
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* See Disease Characteristics
Hepatic
* No serologic evidence of active hepatitis B or C infection
Renal
* Creatinine ≤ 3.5 mg/dL
* No requirement for dialysis
Cardiovascular
* No requirement for vasopressors
Pulmonary
* No requirement for a ventilator
Other
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after completion of study treatment
* No known HIV positivity
* No active uncontrolled infection
* No other organ dysfunction
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specifiedReferences
Publications (0)
Data not yet available