Clinical trial · Interventional
Combination Chemotherapy and Alemtuzumab in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
A Phase II Study of MOAD (Methotrexate, Vincristine, L-asparaginase and Dexamethasone) With Subcutaneous Campath for Adults With Relapsed or Refractory Acute Leukemia (ALL)
- 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)
This phase II trial is studying how well giving combination chemotherapy together with alemtuzumab works in treating patients with relapsed or refractory acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. 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. Giving combination chemotherapy together with alemtuzumab may kill more cancer cells.
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 |
|---|---|---|---|
| Recurrent Adult Acute Lymphoblastic Leukemia | Adult Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alemtuzumab | Biological | Alemtuzumab | ALIAS |
| asparaginase | Drug | Asparaginase | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| mercaptopurine | Drug | Mercaptopurine | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
| vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (chemotherapy, enzyme inhibitor therapy)
- description
- INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM ; oral dexamethasone ; and alemtuzumab SC. CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM. CYTOREDUCTION THERAPY: Patients receive vincristine IV and methotrexate IV; leucovorin calcium IV; and oral dexamethasone. MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone.
- interventionNames
- Biological: alemtuzumab
- Drug: asparaginase
- Drug: methotrexate
- Drug: dexamethasone
- Drug: leucovorin calcium
- Drug: mercaptopurine
- Drug: vincristine
Primary outcomes (1)
- measure
- Complete Response Rate
- timeFrame
- assessed before the first consolidation cycle and first cytoreduction cycle, before the first and after the last maintenance cycle; after discontinuing treatment, assessed every 3 months if < 2 years and every 6 months if 2-5 years from study entry
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Refractory or relapsed acute lymphoblastic leukemia * Must be in first relapse or have failed to achieve complete remission with 1 prior regimen * Prior central nervous system (CNS) leukemia allowed provided cerebrospinal fluid is normal * ECOG Performance status of 0-3 * Bilirubin normal * Creatinine normal * Human immunodeficiency virus (HIV) negative * Negative pregnancy test * Fertile patients must use effective contraception Exclusion criteria: * Hepatitis B positivity * Bacterial or fungal infection * Infection requiring treatment with antibiotics * Active cytomegalovirus infection by molecular detection methods * Known hypersensitivity to alemtuzumab or its components * Pregnant or nursing * Other malignancy within the past 5 years except adequately treated basal cell skin cancer or cervical carcinoma
References
Publications (0)
Data not yet available