Bortezomib in Combination With Liposomal Doxorubicin and Dexamethasone to Treat Plasma Cell Leukemia
NCT ID: NCT01328236
Last Updated: 2011-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
20 participants
INTERVENTIONAL
2010-09-30
2015-09-30
Brief Summary
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The present study is designed to assessment the efficacy and safety study of Bortezomib in combination with Liposomal Doxorubicin and Dexamethasone in treatment of Plasma Cell Leukemia (PCL).
Primary study endpoint is the overall response rate (sCR+CR+VGPR+PR). Secondary endpoints is the rate of complete response (sCR+CR), partial remission rate (VGPR + PR), duration of response (DOR), overall survival (OS).
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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V-DD single arm
INDUCTION THERAPY: V-DD induction therapy for 6 cycles，28 Days per Cycle. Bortezomib - 1.3 mg/m2 IV, Days 1, 4, 8 , 11 of every treatment; Liposomal Doxorubicin - 30 mg/m2 IV, Day 4 of every treatment; Dexamethasone - 40 mg/d IV, Days 1 - 4 of every treatment.
Maintenance treatment for 4 cycles,28 Days per Cycle. Thalidomide - 100mg Qn ; Bortezomib - 1.3 mg/m2 IV ,Days 1, 4, 8 and 11 of every treatment; Dexamethasone - 40 mg/d IV ,Days 1 - 4; Interferon - 300 u Qod,（Specially for IgA type）. Interval between every two cycles for 6 months, until progression or unacceptable toxicity develops.
Bortezomib
INDUCTION THERAPY: 1.3 mg/m2, IV (in the vein) on day 1， 4， 8， 11 of each 28 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.
MAINTENANCE THERAPY: 1.3 mg/m2, IV (in the vein) on day 1， 4， 8， 11 of each 28 day cycle. 4 Cycles: interval between every two cycles for 6 months, until progression or unacceptable toxicity develops.
Liposome doxorubicin
INDUCTION THERAPY: 30 mg/m2, IV (in the vein) on day 4 of each 28 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.
Dexamethasone
INDUCTION THERAPY: 40 mg/d, IV (in the vein) on day 1- 4 of each 28 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.
MAINTENANCE THERAPY: 40 mg/d, IV (in the vein) on day 1- 4 of each 28 day cycle. 4 Cycles: interval between every two cycles for 6 months, until progression or unacceptable toxicity develops.
Interventions
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Bortezomib
INDUCTION THERAPY: 1.3 mg/m2, IV (in the vein) on day 1， 4， 8， 11 of each 28 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.
MAINTENANCE THERAPY: 1.3 mg/m2, IV (in the vein) on day 1， 4， 8， 11 of each 28 day cycle. 4 Cycles: interval between every two cycles for 6 months, until progression or unacceptable toxicity develops.
Liposome doxorubicin
INDUCTION THERAPY: 30 mg/m2, IV (in the vein) on day 4 of each 28 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.
Dexamethasone
INDUCTION THERAPY: 40 mg/d, IV (in the vein) on day 1- 4 of each 28 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.
MAINTENANCE THERAPY: 40 mg/d, IV (in the vein) on day 1- 4 of each 28 day cycle. 4 Cycles: interval between every two cycles for 6 months, until progression or unacceptable toxicity develops.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* KPS ≥ 60
* Adequate liver and renal function within 2 weeks of Screening:
* Bilirubin ≤ 1.5 × the upper limit of normal (ULN)
* Alanine aminotransferase (ALT) ≤ 2.5 × the upper limit of normal (ULN)
* Aspartate aminotransferase (AST) ≤ 2.5 × the upper limit of normal (ULN)
* Cardiac function \> Ⅲ grade and ejection fraction \> 45%
* Signed informed consent prior to initiation of any study-related procedures that are not considered standard of care
Exclusion Criteria
* KPS ≤ 60 scores
* mental illness
18 Years
75 Years
ALL
Yes
Sponsors
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Harbin Hematology and Oncology Institute
OTHER
Shanghai Changzheng Hospital
OTHER
Chinese PLA General Hospital
OTHER
307 Hospital of PLA
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Beijing Chao Yang Hospital
OTHER
Henan Provincial People's Hospital
OTHER
Peking University Third Hospital
OTHER
Clinical Service, China
INDUSTRY
Responsible Party
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wangzhao
Beijing Friendship Hospital
Principal Investigators
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zhao wang, Master
Role: PRINCIPAL_INVESTIGATOR
Beijing Friendship Hospital
Locations
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Beijing Clinical Service Center
Beijing, Beijing Municipality, China
Countries
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Facility Contacts
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Other Identifiers
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26866138CAN2026
Identifier Type: -
Identifier Source: org_study_id
NCT01327716
Identifier Type: -
Identifier Source: nct_alias