High Dose Rituximab for Initial Treatment of Indolent B-Cell Lymphomas
|ClinicalTrials.gov Identifier: NCT00895661|
Recruitment Status : Completed
First Posted : May 8, 2009
Results First Posted : May 9, 2017
Last Update Posted : June 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|B-cell Lymphoma Indolent B-cell Lymphoma||Drug: rituximab||Phase 2|
- All participants will receive increased-dose rituximab through a vein in the arm once a week for 4 weeks (on Days 1, 8, 15, and 22 of the initial 28-day study cycle). This first cycle of study treatment is called the Induction Phase. If the participant responds well to the Induction Phase, they then may continue to the Maintenance Therapy Phase, where they will receive a lower dose of rituximab once every three months for up to 2 years.
- During the Induction Phase, the following procedures will take place before the participant receives each dose of rituximab: medical review, physical exam, performance status, and ECG. Blood tests will be drawn about 30-60 minutes after the first dose of rituximab on Day 1. Samples will be drawn immediately before each dose and again 30-60 minutes after each dose on Days 1, 8, 15 and 22.
- During the Maintenance Therapy Phase, the following procedures will take place before the participant receives each dose of rituximab: medical review, physical exam, performance status, ECG, blood tests and response assessments by CT scan.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Increased Dose Rituximab Plus Maintenance Rituximab for Initial Systemic Treatment of Indolent B-Cell Lymphomas|
|Actual Study Start Date :||July 2009|
|Primary Completion Date :||October 2010|
|Study Completion Date :||August 2015|
single-arm, open-label, interventional
Increased dose (750 mg/m2) intravenously for 4 weekly doses followed by maintenance dosing once every three months for up to 2 years. Maintenance dose is standard (375 mg/m2).
Other Name: Rituxan
- Determine Complete Response Rate (CRR) of Increased Dose Rituximab in Indolent B-cell Lymphomas [ Time Frame: after a median number of 8 maintenance cycles, up to 24 weeks ]
CR requires all of the following:
- Regression to normal size on CT (≤ 1.5 cm in their greatest transverse diameter for nodes ≥ 1.5 cm before therapy). Previously involved nodes that were 1.1 to 1.5 cm in their greatest transverse diameter before treatment must have decreased to <1 cm in their greatest transverse diameter after treatment, or by more than 75% in the sum of the products of the greatest diameters (SPD).
- The spleen, if considered to be enlarged before therapy on the basis of a CT scan, must have regressed in size and must not be palpable on physical examination.
- If bone marrow is known to be involved at the beginning, then repeat biopsy documents clearance
- Overall Response Rate (ORR) [ Time Frame: after a median number of 8 maintenance cycles, up to 24 weeks ]
Complete Response (CR): see definition in primary outcome
Partial Response (PR):
- ≥50% decrease in SPD of up to 6 largest dominant masses
- No new sites of disease or increase in the size of the other nodes, liver, or spleen.
- Splenic and hepatic nodules must regress by at least 50% in the SPD.
Overall Response (OR) = CR + PR.
- Progression-free Survival (PFS) [ Time Frame: 5 years ]
Progressive Disease (PD) or Relapsed Disease (RD):
- Appearance of a new lesion(s) > 1.5 cm in any axis, ≥ 50% increase in SPD of more than one node, or ≥50% increase in longest diameter of a previously identified node > 1 cm in short axis.
- >50% increase from nadir in the SPD of any previous lesions PFS is number of participants who have not died or had PD or RD.
- Incidence of Severity of Infusion Reactions, Infections and Neutropenia [ Time Frame: 24 months ]Toxicity grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00895661
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Jeremy Abramson, MD||Massachusetts General Hospital|