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
Recruitment status was Active, not recruiting
Sponsor:
German CLL Study Group
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Biological: alemtuzumab Drug: cyclophosphamide Drug: fludarabine phosphate Drug: mitoxantrone hydrochloride |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Consolidation With Campath-1H After FMC Induction in Patients With T-Cell Chronic Lymphocytic Leukemia |
Resource links provided by NLM:
Drug Information available for:
Cyclophosphamide
Fludarabine
Mitoxantrone
Mitoxantrone hydrochloride
Fludarabine phosphate
Alemtuzumab
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Adverse effects at 2 months after treatment [ Designated as safety issue: Yes ]
- Remission rate at 2 months after treatment [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 17 |
| Study Start Date: | September 2002 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00278213
Locations
| Austria | |
| Allgemeines Krankenhaus - Universitatskliniken | |
| Vienna, Austria, A-1090 | |
| Hanuschkrankenhaus | |
| Vienna, Austria, A-1140 | |
| Germany | |
| Allgemeinen Krankenhaus Celle Kinderklinik | |
| Celle, Germany, 29223 | |
| St. Johannes Hospital - Medical Klinik II | |
| Duisburg, Germany, D-47166 | |
| Helios Klinikum Erfurt | |
| Erfurt, Germany, D-99089 | |
| Universitaetsklinikum Essen | |
| Essen, Germany, D-45147 | |
| Klinikum Garmisch - Partenkirchen GmbH | |
| Garmisch-Partenkirchen, Germany, N 82467 | |
| Sana Klinikum Hof | |
| Hof, Germany, 95032 | |
| University Hospital Schleswig-Holstein - Kiel Campus | |
| Kiel, Germany, D-24116 | |
| Internistische Praxis - Ludwigsburg | |
| Ludwigsburg, Germany, 71638 | |
| Sana Kliniken Luebeck | |
| Luebeck, Germany, D-23560 | |
| Haematologische Praxis - Moenchengladbach | |
| Moenchengladbach, Germany, 41239 | |
| Gemeinschaftliche Schwerpunktpraxis - Osnabrueck | |
| Osnabrueck, Germany, 49074 | |
| Caritasklinik St. Theresia | |
| Saarbrucken, Germany, D-66113 | |
| Schwerpunktpraxis fuer Haematologie und Onkologie | |
| Saarbruecken, Germany, 66113 | |
| Southwest German Cancer Center at Eberhard-Karls-University | |
| Tuebingen, Germany, D-72076 | |
| Dr. Horst-Schmidt-Kliniken | |
| Wiesbaden, Germany, D-65199 | |
| Hamatologisch - Onkologische Praxis Wurzburg | |
| Wurzburg, Germany, 97070 | |
| Klinikum des Landkreises Loebau-Zittau GmbH | |
| Zittau, Germany, 02763 | |
Sponsors and Collaborators
German CLL Study Group
Investigators
| Study Chair: | Georg Hopfinger | Hanusch-Krankenhaus |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00278213 History of Changes |
| Other Study ID Numbers: | CDR0000454588, GCLLSG-T-PLL1, EU-20562 |
| Study First Received: | January 16, 2006 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
prolymphocytic leukemia refractory chronic lymphocytic leukemia stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia |
stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia T-cell large granular lymphocyte leukemia |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Prolymphocytic Leukemia, Prolymphocytic, T-Cell Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, T-Cell Cyclophosphamide Fludarabine monophosphate |
Campath 1G Fludarabine Alemtuzumab Mitoxantrone Vidarabine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 17, 2013