Proteasome Inhibition in Acute Promyelocytic Leukemia (PIAPL)
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|ClinicalTrials.gov Identifier: NCT01950611|
Recruitment Status : Unknown
Verified September 2013 by Vikram Mathews, Christian Medical College, Vellore, India.
Recruitment status was: Recruiting
First Posted : September 25, 2013
Last Update Posted : September 25, 2013
|Condition or disease||Intervention/treatment||Phase|
|Relapsed Acute Promyelocytic Leukemia||Drug: Bortezomib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study to Evaluate the Role of Bortezomib in the Management of Relapsed Acute Promyelocytic Leukemia|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||May 2018|
|Experimental: Bortezomib in treatment||
Combination of arsenic trioxide with bortezomib in the treatment of relapsed acute promyelocytic leukemia
- Safety [ Time Frame: 5 years ]Non hematological toxicity to be monitored
- Efficacy [ Time Frame: 5 years ]
- Proportion of patients that achieve molecular remission at the end of induction
- Relapse free, event free and overall survival on long term follow up with this protocol.
- Long term toxicity profile of this combination therapy
- Duration of cytopenia with this combination in induction
- Documentation of support care required and total cost of administering this regimen.
- Performance status prior to consolidation therapy, each maintenance course and at the end of the regimen.
- Molecular remission status on follow up for 5 years
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): NCT01950611
|Contact: Vikram Mathews, MD. DMfirstname.lastname@example.org|
|Department of Haematology, Christian Medical College||Recruiting|
|Vellore, TN, India, 632004|
|Contact: Vikram Mathews 914162282891 email@example.com|
|Sub-Investigator: Biju George, MD. DM|
|Sub-Investigator: Auro Viswabandya, MD. DM|
|Sub-Investigator: Poonkuzhali Balasubramanian, PhD|
|Sub-Investigator: Alok Srivastava, MD|
|Sub-Investigator: Aby Abraham, MD. DM|