Stage I/II Nasal NK Cell Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01321008|
Recruitment Status : Terminated (Slow Accrual)
First Posted : March 23, 2011
Results First Posted : June 23, 2014
Last Update Posted : February 5, 2015
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Radiation: Radiation Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Prednisone||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Radiation Therapy Followed by Chemotherapy for Newly Diagnosed Patients With Stage I/II Nasal NK Cell Lymphoma|
|Study Start Date :||May 2011|
|Primary Completion Date :||May 2013|
|Study Completion Date :||May 2013|
Experimental: Radiation + Chemotherapy
Radiation therapy total dose of 50.4 to 54 Gy over 28 to 30 treatments; CHOP Chemotherapy of Cyclophosphamide 750 mg/m2 intravenous piggyback (IVPB), Doxorubicin 50 mg/m2 IVPB, Vincristine 1.4 mg/m2 (max dose 2 mg) IVPB on Day 1, and Oral Prednisone 100 mg daily days 1-5 for four 21-day cycles.
50.4 to 54 Gy delivered 5 days a week for 28 to 30 treatments.
Other Names:Drug: Cyclophosphamide
750 mg/m2 by vein over 1 hour on Day 1 of a 21 day cycle.
Other Names:Drug: Doxorubicin
50 mg/m2 by vein over 15 minutes on Day 1 of a 21 day cycle.
Other Names:Drug: Vincristine
1.4 mg/m2 (max dose 2 mg) by vein over 15 minutes on Day 1 of a 21 day cycle.
Other Name: OncovinDrug: Prednisone
100 mg by mouth daily on Days 1-5 of a 21 day cycle.
- Progression-free Survival (PFS) [ Time Frame: Day 1 to disease progression or death (up to 5+ years) ]Progression-free survival (PFS) defined as time from treatment initiation day to first documented progressive disease or death due to disease. Reviewed with each 21-day treatment cycle, followed every 3-4 months for first 2 years, annually thereafter.
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): NCT01321008
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Bouthaina Dabaja, MD||UT MD Anderson Cancer Center|