Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00472849
Status:
COMPLETED
Last Update Posted:
2013-11-26
First Post:
2007-05-11
Brief Title:
Oxaliplatin Fludarabine Cytarabine and Rituximab in Patients With Richters Transformation and Leukemias
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase I-II Study of Oxaliplatin Fludarabine Cytarabine and Rituximab in Patients With Richters Transformation Prolymphocytic Leukemia Aggressive Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2013-11
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:
The goal of this clinical research study is to find the highest tolerable dose of fludarabine and cytarabine that can be given in combination with oxaliplatin and rituximab in the treatment of chronic lymphocytic leukemia CLL prolymphocytic leukemia or Richters transformation Once the highest tolerable dose for this drug combination is found the next goal of the study will be to find out if this combination therapy is effective in shrinking or slowing the growth of these diseases
Detailed Description:
Cytarabine is designed to insert itself into DNA the genetic material of cells and stop the DNA from repairing itself
Oxaliplatin is designed to kill cancer cells by damaging their DNA
Fludarabine is designed to make cancer cells less able to repair damaged DNA This may increase the likelihood of the cells dying
Rituximab is designed to attach to lymphoma cells which may cause them to die
During the Phase I portion of the study researchers will be testing different doses of the study drug combination Oxaliplatin and rituximab will be given at the same dose level However fludarabine and cytarabine will be given daily for 2 days to the first 3 participants daily for 3 days to the next 3 participants and daily for 4 days to the next 3 participants Although the plan is to treat 3 up to 6 participants may be treated in each of these groups
If participants who receive the fludarabine and cytarabine for 2 or 3 days do not experience intolerable side effects after the second cycle they may receive the next higher dose an additional day of fludarabine and cytarabine for the following cycles
Once the highest tolerated dose of fludarabine and cytarabine given in combination with oxaliplatin and rituximab is found the next group of participants entering the study will take part in the Phase II portion of the study Participants in the Phase II portion will receive the study drugs at the highest tolerated dose found in the Phase I portion of the study The goal of this part of the study is to look at how effective the drug combination is in treating patients with Richters syndrome prolymphocytic leukemia and aggressive relapsed or refractory CLL The same dose levels for all 4 drugs will be used throughout the Phase II portion of the study unless intolerable side effects occur In that case the dose may be lowered or the treatment may be stopped
Each cycle will be repeated every 4-6 weeks depending on your blood counts and your medical condition
You will receive oxaliplatin through a needle in your vein over about 2 hours on Days 1-4 of every 28-day study cycle
You will receive rituximab by vein over about 4-6 hours on Day 3 of the first cycle and on Day 1 on every cycle after that
Starting on Day 2 you will receive fludarabine by vein over about 30 minutes and cytarabine by vein over about 2 hours for 2 3 or 4 days
On Day 6 you will receive peg-filgrastim subcutaneously through a needle just under your skin to help increase your white blood cell count
On the days that you receive the study drugs you will also be given fluids such as saline by vein to keep you from becoming dehydrated If you receive the treatment as an outpatient this means that the visit may take up to 8 hours
Additional drugs will be given before each dose of rituximab to lower the risk of side effects If side effects do occur rituximab may have to be stopped until the side effects go away at which point the drug may be restarted This may make your time in the outpatient area longer
The first study cycle will be given at MD Anderson Depending on your response up to 5 more cycles will be given either at MD Anderson or at home with your regular doctor
Every 1-2 weeks blood samples about 1 teaspoon each will be drawn for routine tests
At the end of every cycle you will have a physical exam and blood about 1 teaspoon will be drawn to determine whether you should receive another cycle
You will have a bone marrow biopsyaspirate at the end of the 3rd and 6th cycles The biopsy at the end of cycle 3 will be used to determine if you are responding to treatment and will determine whether you should continue to receive the study drug combination
You may remain on study for up to 6 cycles You will be taken off-study early if the disease gets worse or intolerable side effects occur
Once you are no longer receiving treatment you will have an end-of-treatment visit At this visit you will have a physical exam and blood about 1 teaspoon will be drawn for routine tests
If you achieve remission after your last cycle is complete you will have blood drawn about 2 teaspoons each every 3 months for routine tests These tests will continue for as long as you are in remission
This is an investigational study Fludarabine cytarabine oxaliplatin and rituximab are all FDA approved and commercially available The use of these drugs together is investigational Up to 102 patients will take part in this multicenter study Up to 90 will be enrolled at The University of Texas UT MD Anderson Cancer Center
Oxaliplatin is designed to kill cancer cells by damaging their DNA
Fludarabine is designed to make cancer cells less able to repair damaged DNA This may increase the likelihood of the cells dying
Rituximab is designed to attach to lymphoma cells which may cause them to die
During the Phase I portion of the study researchers will be testing different doses of the study drug combination Oxaliplatin and rituximab will be given at the same dose level However fludarabine and cytarabine will be given daily for 2 days to the first 3 participants daily for 3 days to the next 3 participants and daily for 4 days to the next 3 participants Although the plan is to treat 3 up to 6 participants may be treated in each of these groups
If participants who receive the fludarabine and cytarabine for 2 or 3 days do not experience intolerable side effects after the second cycle they may receive the next higher dose an additional day of fludarabine and cytarabine for the following cycles
Once the highest tolerated dose of fludarabine and cytarabine given in combination with oxaliplatin and rituximab is found the next group of participants entering the study will take part in the Phase II portion of the study Participants in the Phase II portion will receive the study drugs at the highest tolerated dose found in the Phase I portion of the study The goal of this part of the study is to look at how effective the drug combination is in treating patients with Richters syndrome prolymphocytic leukemia and aggressive relapsed or refractory CLL The same dose levels for all 4 drugs will be used throughout the Phase II portion of the study unless intolerable side effects occur In that case the dose may be lowered or the treatment may be stopped
Each cycle will be repeated every 4-6 weeks depending on your blood counts and your medical condition
You will receive oxaliplatin through a needle in your vein over about 2 hours on Days 1-4 of every 28-day study cycle
You will receive rituximab by vein over about 4-6 hours on Day 3 of the first cycle and on Day 1 on every cycle after that
Starting on Day 2 you will receive fludarabine by vein over about 30 minutes and cytarabine by vein over about 2 hours for 2 3 or 4 days
On Day 6 you will receive peg-filgrastim subcutaneously through a needle just under your skin to help increase your white blood cell count
On the days that you receive the study drugs you will also be given fluids such as saline by vein to keep you from becoming dehydrated If you receive the treatment as an outpatient this means that the visit may take up to 8 hours
Additional drugs will be given before each dose of rituximab to lower the risk of side effects If side effects do occur rituximab may have to be stopped until the side effects go away at which point the drug may be restarted This may make your time in the outpatient area longer
The first study cycle will be given at MD Anderson Depending on your response up to 5 more cycles will be given either at MD Anderson or at home with your regular doctor
Every 1-2 weeks blood samples about 1 teaspoon each will be drawn for routine tests
At the end of every cycle you will have a physical exam and blood about 1 teaspoon will be drawn to determine whether you should receive another cycle
You will have a bone marrow biopsyaspirate at the end of the 3rd and 6th cycles The biopsy at the end of cycle 3 will be used to determine if you are responding to treatment and will determine whether you should continue to receive the study drug combination
You may remain on study for up to 6 cycles You will be taken off-study early if the disease gets worse or intolerable side effects occur
Once you are no longer receiving treatment you will have an end-of-treatment visit At this visit you will have a physical exam and blood about 1 teaspoon will be drawn for routine tests
If you achieve remission after your last cycle is complete you will have blood drawn about 2 teaspoons each every 3 months for routine tests These tests will continue for as long as you are in remission
This is an investigational study Fludarabine cytarabine oxaliplatin and rituximab are all FDA approved and commercially available The use of these drugs together is investigational Up to 102 patients will take part in this multicenter study Up to 90 will be enrolled at The University of Texas UT MD Anderson Cancer Center
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