Phase II Study of Chlorambucil and Subcutaneous Rituximab in Patients With Extranodal MALT 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: NCT01808599|
Recruitment Status : Active, not recruiting
First Posted : March 11, 2013
Last Update Posted : November 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|MALT Lymphoma||Drug: Chlorambucil Drug: Rituximab i.v. Drug: Rituximab s.c.||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||112 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Chlorambucil in Combination With Subcutaneous Rituximab Followed by Maintenance Therapy With Subcutaneous Rituximab in Patients With Extranodal Marginal Zone B-cell Lymphoma of Mucosa Associated Lymphoid Tissue (MALT Lymphoma)|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||March 2016|
|Estimated Study Completion Date :||September 2028|
Experimental: Chlorambucil, Rituximab i.v., Rituximab s.c.
Chlorambucil 6 mg/m2 daily p.o for 42 consecutive days (weeks 1-6) in combination with intravenous Rituximab 375mg/m2 on days 1, 8, 15 and 22 (day 1 of weeks 1, 2, 3 and 4).
Starting from d56, (month 3) patients will receive Chlorambucil 6 mg/m2 daily p.o for 14 consecutive days (d1-14) every 28 days for 4 cycles in combination with subcutaneous Rituximab 1400mg on day 1 of each 28-day cycle. Therefore subcutaneous Rituximab 1400mg every two months for 2 years (in total 12 injections).
Drug: Rituximab i.v.
Drug: Rituximab s.c.
- Complete remission rate [ Time Frame: week 25 ]
- Response Rate [ Time Frame: week 25 ]Response rate (Complete and partial remission rates) for all patients
- Event-free-survival (EFS) [ Time Frame: at 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): NCT01808599
|Principal Investigator:||Emanuele Zucca, MD||IOSI Oncology Institute of Southern Switzerland|