Combination Chemotherapy Followed By Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia
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| ClinicalTrials.gov Identifier: NCT00278213 |
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Recruitment Status :
Completed
First Posted : January 18, 2006
Last Update Posted : May 11, 2018
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Prolymphocytic Leukemia | Biological: alemtuzumab Drug: cyclophosphamide Drug: fludarabine phosphate Drug: mitoxantrone hydrochloride | Phase 2 |
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 : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 17 participants |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Consolidation With Campath-1H After FMC Induction in Patients With T-cell Chronic Lymphocytic Leukemia |
| Study Start Date : | September 2002 |
| Actual Primary Completion Date : | February 2007 |
| Actual Study Completion Date : | December 2009 |
- Adverse effects at 2 months after treatment
- Remission rate at 2 months after treatment
- Overall survival at 2 months after treatment
- Progression-free survival at 2 months after treatment
- Remission quality at 2 months after treatment
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00278213
Show 19 study locations
| Study Chair: | Georg Hopfinger | Hanusch-Krankenhaus |
Publications of Results:
| ClinicalTrials.gov Identifier: | NCT00278213 |
| Other Study ID Numbers: |
T-PLL1 EU-20562 |
| First Posted: | January 18, 2006 Key Record Dates |
| Last Update Posted: | May 11, 2018 |
| Last Verified: | May 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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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 |
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Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Prolymphocytic Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, B-Cell Cyclophosphamide Fludarabine Fludarabine phosphate Mitoxantrone |
Alemtuzumab Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antimetabolites, Antineoplastic Antimetabolites Analgesics Sensory System Agents Peripheral Nervous System Agents |