Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00366418
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-08-17
Brief Title:
Lower But More Frequent Dose Rituximab to Treat Chronic Lymphocytic Leukemia
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Pilot Study of Fractionated Dose Subcutaneous Rituximab RTX RituxanRegistered Trademark in Patients With Refractory or Relapsed Chronic Lymphocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2011-02-23
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will test the safety and effectiveness of using lower-dose rituximab given more frequently for treating chronic lymphocytic leukemia CLL Studies have shown that used once a week for 4 weeks rituximab was effective in up to 25 percent of patients with CLL New evidence shows that using lower and more frequent doses of rituximab can be more effective in destroying leukemia cells and produce a better treatment response
Patients 21 years of age and older with CLL who have received treatment with fludarabine may be eligible for this study
Participants take rituximab for 12 weeks One dose of the drug is infused through an arm vein over about 30 minutes on either day 1 the first dose or day 3 the second dose All other doses are given as an injection under the skin After the first week patients can choose to do these injections at home Rituximab will be given 3 times a week for a total of 12 weeks Other medications are given to reduce the side effects and allergic reactions to the drug In addition to treatment patients undergo the following tests and procedures
Before treatment
Medical history physical examination electrocardiogram EKG and blood tests
Bone marrow and lymph node biopsies surgical removal of a small tissue sample
Computed tomography CT and positron emission tomography PET scans CT uses special x-rays to provide images of the neck chest abdomen and pelvis PET uses a radioactive sugar to identify areas of disease
During treatment study weeks 1-12
Medical history and physical examinations at weeks 3 6 and 12 to evaluate drug side effects plus weekly telephone checks and interim visits when needed
Blood tests every other week to evaluate blood counts
Evaluations after treatment follow-up 3 months to 12 months
Blood tests at follow-up visits at 3 6 9 and 12 months after treatment to evaluate blood counts
Bone marrow aspiration and biopsy at 3 months after treatment to examine the effects of rituximab on bone marrow cells
CT scans of the neck chest abdomen and pelvis at 3 6 9 and 12 months after treatment to evaluate the response to treatment
Patients 21 years of age and older with CLL who have received treatment with fludarabine may be eligible for this study
Participants take rituximab for 12 weeks One dose of the drug is infused through an arm vein over about 30 minutes on either day 1 the first dose or day 3 the second dose All other doses are given as an injection under the skin After the first week patients can choose to do these injections at home Rituximab will be given 3 times a week for a total of 12 weeks Other medications are given to reduce the side effects and allergic reactions to the drug In addition to treatment patients undergo the following tests and procedures
Before treatment
Medical history physical examination electrocardiogram EKG and blood tests
Bone marrow and lymph node biopsies surgical removal of a small tissue sample
Computed tomography CT and positron emission tomography PET scans CT uses special x-rays to provide images of the neck chest abdomen and pelvis PET uses a radioactive sugar to identify areas of disease
During treatment study weeks 1-12
Medical history and physical examinations at weeks 3 6 and 12 to evaluate drug side effects plus weekly telephone checks and interim visits when needed
Blood tests every other week to evaluate blood counts
Evaluations after treatment follow-up 3 months to 12 months
Blood tests at follow-up visits at 3 6 9 and 12 months after treatment to evaluate blood counts
Bone marrow aspiration and biopsy at 3 months after treatment to examine the effects of rituximab on bone marrow cells
CT scans of the neck chest abdomen and pelvis at 3 6 9 and 12 months after treatment to evaluate the response to treatment
Detailed Description:
Rituximab is FDA approved for the treatment of relapsed or refractory low grade or follicular CD20 B cell non Hodgkins lymphoma 375 mgm2 IV infusion once weekly for 4 or 8 doses Recently rituximab anti CD20 has been introduced to CLL treatment regimens and has become an attractive choice in combination chemotherapy or as single agent treatment Rituximab has been shown to be effective at lower doses than 375 mgm2 when given more frequently
Several theoretical considerations and supporting laboratory evidence suggest that a fractionated dosing schedule using low-dose rituximab could be more effective than the current iv schedule of high-dose rituximab Indeed preliminary clinical evidence suggests that low-dose rituximab at 20mgm2 iv 3-times per week can lead to steady clearance of leukemic cells without inducing substantial loss of targeted CD20
This is a Phase III single agent study which will evaluate the safety and feasibility of subcutaneous rituximab Rituxan administered at 20 mgday three times a week for 12 weeks in subjects with CLL Patients need to have had prior treatment with fludarabine and have an elevated absolute lymphocyte count The primary objective will be to test the safety and feasibility of giving rituximab subcutaneously We will also obtain as a secondary endpoint an early estimate of efficacy as evidenced by a shrinkage of lymphadenopathy andor b improvement in blood values and bone marrow biopsy findings
Several theoretical considerations and supporting laboratory evidence suggest that a fractionated dosing schedule using low-dose rituximab could be more effective than the current iv schedule of high-dose rituximab Indeed preliminary clinical evidence suggests that low-dose rituximab at 20mgm2 iv 3-times per week can lead to steady clearance of leukemic cells without inducing substantial loss of targeted CD20
This is a Phase III single agent study which will evaluate the safety and feasibility of subcutaneous rituximab Rituxan administered at 20 mgday three times a week for 12 weeks in subjects with CLL Patients need to have had prior treatment with fludarabine and have an elevated absolute lymphocyte count The primary objective will be to test the safety and feasibility of giving rituximab subcutaneously We will also obtain as a secondary endpoint an early estimate of efficacy as evidenced by a shrinkage of lymphadenopathy andor b improvement in blood values and bone marrow biopsy findings
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-H-0228 | None | None | None |