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: February 6, 2009

Last verified: July 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

January 16, 2006

Last Updated Date

February 6, 2009

Start Date ^ICMJE

September 2002

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Adverse effects at 2 months after treatment [ Designated as safety issue: Yes ]
Remission rate at 2 months after treatment [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00278213 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Consolidation With Campath-1H After FMC Induction in Patients With T-Cell Chronic Lymphocytic Leukemia

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Leukemia

Intervention ^ICMJE

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

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Austria, Germany

Administrative Information

NCT Number ^ICMJE

NCT00278213

Other Study ID Numbers ^ICMJE

CDR0000454588, GCLLSG-T-PLL1, EU-20562

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

German CLL Study Group

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Georg Hopfinger

Hanusch-Krankenhaus

Information Provided By

National Cancer Institute (NCI)

Verification Date

July 2007

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

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