Combination Chemotherapy Followed By Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia

Overview

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.

Full Title of Study: “Consolidation With Campath-1H After FMC Induction in Patients With T-cell Chronic Lymphocytic Leukemia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2007

Detailed Description

OBJECTIVES: Primary – Determine the number of severe adverse events and life-threatening infections in patients with T-cell chronic lymphocytic leukemia or T-cell prolymphocytic leukemia treated with induction chemotherapy comprising fludarabine, cyclophosphamide, and mitoxantrone hydrochloride followed by consolidation therapy comprising alemtuzumab. – Determine the remission rate in patients treated with this regimen. Secondary – Determine the overall and progression-free survival of patients treated with this regimen. – Determine the quality of remission in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive induction chemotherapy comprising fludarabine IV and cyclophosphamide IV for 3 days and mitoxantrone hydrochloride IV on 1 day. Treatment repeats every 28 days for up to 4 courses. Patients then receive consolidation therapy comprising alemtuzumab IV 3 times in week 1 and then weekly for up to 11 weeks. PROJECTED ACCRUAL: A total of 17 patients will be accrued for this study.

Interventions

  • Biological: alemtuzumab
  • Drug: cyclophosphamide
  • Drug: fludarabine phosphate
  • Drug: mitoxantrone hydrochloride

Clinical Trial Outcome Measures

Primary Measures

  • Adverse effects at 2 months after treatment
  • Remission rate at 2 months after treatment

Secondary Measures

  • Overall survival at 2 months after treatment
  • Progression-free survival at 2 months after treatment
  • Remission quality at 2 months after treatment

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • German CLL Study Group
  • Overall Official(s)
    • Georg Hopfinger, Study Chair, Hanusch-Krankenhaus

Citations Reporting on Results

Hopfinger 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.

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