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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00278213
First received: January 16, 2006
Last updated: November 5, 2013
Last verified: July 2007

January 16, 2006
November 5, 2013
September 2002
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  • Adverse effects at 2 months after treatment [ Designated as safety issue: Yes ]
  • Remission rate at 2 months after treatment [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00278213 on ClinicalTrials.gov Archive Site
  • Overall survival at 2 months after treatment [ Designated as safety issue: No ]
  • Progression-free survival at 2 months after treatment [ Designated as safety issue: No ]
  • Remission quality at 2 months after treatment [ Designated as safety issue: No ]
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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

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.

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.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Leukemia
  • Biological: alemtuzumab
  • Drug: cyclophosphamide
  • Drug: fludarabine phosphate
  • Drug: mitoxantrone hydrochloride
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
17
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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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany
 
NCT00278213
CDR0000454588, GCLLSG-T-PLL1, EU-20562
Not Provided
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German CLL Study Group
Not Provided
Study Chair: Georg Hopfinger Hanusch-Krankenhaus
National Cancer Institute (NCI)
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP