Clinical trial · Interventional
Alemtuzumab (CAMPATH 1H) Associated to G-CSF in Adult Patients With Refractory Acute Lymphocytic Leukemia
Phase I/II Study of Alemtuzumab (CAMPATH 1H) Associated to G-CSF in Adult Patients With Refractory Acute Lymphocytic Leukemia (ALL) or ALL in Relapse.
- 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)
Alemtuzumab is an anti CD52 monoclonal antibody. The CD52 antigen is present at the surface of B,T NK lymphocytes. It is expressed at various levels at the surface of ALL blast cells. Adult patients with ALL in relapse have less than 10% probability of long term survival. The present study will test the response rate (partial and complete remission) of refractory ALL or ALL in relapse. It is hoped that if a CR can be achieved, further consideration will be given for a hematopoietic stem cell transplant. The use of G-CSF is justified by a possible increase in ADCC.
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 |
|---|---|---|---|
| Acute Lymphocytic Leukemia | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alemtuzumab (CAMPATH 1H) associated to G-CSF | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- all included patients
- interventionNames
- Drug: Alemtuzumab (CAMPATH 1H) associated to G-CSF
Primary outcomes (1)
- measure
- Partial and complete remission, overall response rates
- timeFrame
- At 2 years
Secondary outcomes (2)
- measure
- Valuation of tolerance, more particularly targeted at the immunodeficiency shortage, contagious complications and neurotoxicity assessed according to the NCI (National Cancer Institute) classification.
- timeFrame
- At 2 years
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
Inclusion Criteria: * Patients older than 15 years * Refractory ALL * ALL in relapse post chemotherapy or post transplant * ALL blast cells expressing CD 52 antigen at any time during the evolution of the disease. * Signed informed consent * Patients under social security coverage * Anti conceptional tablets in pre menopausal women. Exclusion Criteria: * Children below 15 years of age or aged 15 * Blast cells not expressing CD52 antigen (at all evaluations) * HIV positivity * ECOG Score 3 and 4 * Hypersensitivity to Alemtuzumab. * Pregnancy or breast feeding. * Other malignant disease in addition to ALL.
References
Publications (0)
Data not yet available