Clinical trial · Interventional
Combination Chemotherapy Followed By Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia
Consolidation With Campath-1H After FMC Induction in Patients With T-cell Chronic Lymphocytic Leukemia
- 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: Drugs used in chemotherapy, such as fludarabine, cyclophosphamide, and mitoxantrone, 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 can find cancer cells and help kill them or carry cancer-killing substances to them. Combination chemotherapy followed by alemtuzumab may be effective in treating chronic lymphocytic leukemia and prolymphocytic leukemia. PURPOSE: This phase II trial is studying how well giving combination chemotherapy followed by alemtuzumab works in treating patients with T-cell chronic lymphocytic leukemia or prolymphocytic leukemia.
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 |
|---|---|---|---|
| Prolymphocytic Leukemia | Prolymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alemtuzumab | Biological | Alemtuzumab | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| mitoxantrone hydrochloride | Drug | Mitoxantrone | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Adverse effects at 2 months after treatment
- measure
- Remission rate at 2 months after treatment
Secondary outcomes (3)
- measure
- Overall survival at 2 months after treatment
- measure
- Progression-free survival at 2 months after treatment
- measure
- Remission quality at 2 months after treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of T-cell chronic lymphocytic leukemia (T-CLL) or T-cell prolymphocytic leukemia (T-PLL) * Previously untreated disease OR patient may have received up to 2 therapies PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy \> 6 months * No severe organ dysfunction * No other concurrent or previous neoplasm * No autoimmune hemolytic anemia or thrombocytopenia PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior fludarabine, mitoxantrone hydrochloride, cyclophosphamide, or alemtuzumab
References
Publications (1)
- RESULTHopfinger G, Busch R, Pflug N, Weit N, Westermann A, Fink AM, Cramer P, Reinart N, Winkler D, Fingerle-Rowson G, Stilgenbauer S, Dohner H, Kandler G, Eichhorst B, Hallek M, Herling M. Sequential chemoimmunotherapy of fludarabine, mitoxantrone, and cyclophosphamide induction followed by alemtuzumab consolidation is effective in T-cell prolymphocytic leukemia. Cancer. 2013 Jun 15;119(12):2258-67. doi: 10.1002/cncr.27972. Epub 2013 Mar 19. PMID 23512246