Clinical trial · Interventional
Alemtuzumab and Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia
A Phase I/II Dose Escalation Study of Subcutaneous Campath-1H (NSC #715969, IND #10864) During Intensification Therapy in Adults With Untreated Acute Lymphoblastic Leukemia (ALL)
- 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)
This phase I/II trial studies the side effects and best dose of alemtuzumab when given together with combination chemotherapy and to see how well it works in treating patients with untreated acute lymphoblastic leukemia. Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy also work in different ways to kill cancer cells or stop them from growing. Giving alemtuzumab together with combination chemotherapy may be a better way to block cancer growth.
Conditions
Conditions (14)
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 Undifferentiated Leukemia | Acute Undifferentiated Leukemia | ONTOLOGY_EXACT | 0.90 |
| B-cell Adult Acute Lymphoblastic Leukemia | Adult B Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| B-cell Childhood Acute Lymphoblastic Leukemia | Childhood B Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| L1 Adult Acute Lymphoblastic Leukemia | — | UNRESOLVED | — |
| L1 Childhood Acute Lymphoblastic Leukemia | — | UNRESOLVED | — |
| L2 Adult Acute Lymphoblastic Leukemia | — | UNRESOLVED | — |
| L2 Childhood Acute Lymphoblastic Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (17)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| acyclovir | Drug | — | UNRESOLVED |
| alemtuzumab | Biological | Alemtuzumab | ALIAS |
| allopurinol | Drug | — | UNRESOLVED |
| asparaginase | Drug | Asparaginase | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| daunorubicin hydrochloride | Drug | Daunorubicin | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (alemtuzumab and combination chemotherapy)
- description
- See detailed description.
- interventionNames
- Drug: allopurinol
- Drug: cyclophosphamide
- Drug: daunorubicin hydrochloride
- Drug: vincristine sulfate
- Drug: dexamethasone
- Drug: asparaginase
- Biological: filgrastim
- Drug: imatinib mesylate
- Drug: methotrexate
- Drug: cytarabine
- Drug: trimethoprim-sulfamethoxazole
- Drug: mercaptopurine
- Drug: leucovorin calcium
- Biological: alemtuzumab
- Drug: acyclovir
- Other: laboratory biomarker analysis
- Other: pharmacological study
Primary outcomes (2)
- measure
- Maximum Tolerated Dose (MTD) of Alemtuzumab (Phase I)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
Inclusion Criteria: * Unequivocal histologic diagnosis of precursor B or precursor T lymphoblastic leukemia (World Health Organization \[WHO\] classification), L1 or L2 ALL or acute undifferentiated leukemia (AUL) (French-American-British Cooperative group \[FAB\] Classification); Burkitt-type ALL (FAB L3, surface immunoglobulin \[SIg\]+) are excluded * No prior treatment for leukemia with three permissible exceptions: * Emergency leukapheresis II. Emergency treatment for hyperleukocytosis with hydroxyurea III. Cranial radiation therapy (RT) for central nervous system (CNS) leukostasis (one dose only) * All patients must have a pre-treatment bone marrow or peripheral blood sample submitted for central immunophenotyping; only those patients who express CD52 \>= 10% in the leukemia blast cell channel will be eligible to receive Campath-1H during module D, course IV
References
Publications (0)
Data not yet available