Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081874
Status:
COMPLETED
Last Update Posted:
2023-10-13
First Post:
2004-04-23
Brief Title:
RAD001 in Relapsed or Refractory AML ALL CML in Blastic-Phase Agnogenic Myeloid Metaplasia CLL T-Cell Leukemia or Mantle Cell Lymphoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase III Study of RAD001 in Patients With Relapsed or Refractory Acute Myeloid Leukemia Acute Lymphocytic Leukemia Chronic Myeloid Leukemia in Blastic-Phase Agnogenic Myeloid Metaplasia Chronic Lymphocytic Leukemia T-Cell Leukemia or Mantle Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2012-10
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 safe dose of RAD001 that can be given as a treatment for leukemia mantle cell lymphoma or myelofibrosis Another goal is to learn how effective the dose that is found is as a treatment
Detailed Description:
RAD001 is a new drug that was designed to block proteins that are important in the development and growth of cancer
If you are eligible to take part in this study you will receive treatment with RAD001 by mouth every day for as long as you stay on study Four weeks 28 days of treatment is considered one course of therapy The first 3 to 6 participants on study will receive the lowest dose of RAD001 If that dose is safe the next group of 3 to 6 patients will receive double the dose as the first 3-6 participants If that dose is safe all further participants will start treatment at that dose
While on study you will have weekly blood tests about 2 teaspoons Bone marrow aspirates andor biopsies x-rays andor scans will be performed every 4-12 weeks and as often as the physician feels it is necessary A physical exam will be done at Weeks 5 7 9 11 and anytime the physician sees fit Vital signs will be taken every week
You may be removed from this study if you dont respond after 4 courses of therapy intolerable side effects occur or if the disease worsens Your dose may be temporarily held or decreased if certain side effects occur If you are benefitting from the therapy you may continue on it indefinitely as long as continue to benefit
Once you come off study a physical exam measurement of vital signs a blood test about 2 teaspoons a bone marrow aspirate andor biopsy x-rays andor scans will be done
This is an investigational study The FDA has authorized RAD001 for use in research only A total of 70 -125 patients will take part in this study All will be enrolled at M D Anderson
If you are eligible to take part in this study you will receive treatment with RAD001 by mouth every day for as long as you stay on study Four weeks 28 days of treatment is considered one course of therapy The first 3 to 6 participants on study will receive the lowest dose of RAD001 If that dose is safe the next group of 3 to 6 patients will receive double the dose as the first 3-6 participants If that dose is safe all further participants will start treatment at that dose
While on study you will have weekly blood tests about 2 teaspoons Bone marrow aspirates andor biopsies x-rays andor scans will be performed every 4-12 weeks and as often as the physician feels it is necessary A physical exam will be done at Weeks 5 7 9 11 and anytime the physician sees fit Vital signs will be taken every week
You may be removed from this study if you dont respond after 4 courses of therapy intolerable side effects occur or if the disease worsens Your dose may be temporarily held or decreased if certain side effects occur If you are benefitting from the therapy you may continue on it indefinitely as long as continue to benefit
Once you come off study a physical exam measurement of vital signs a blood test about 2 teaspoons a bone marrow aspirate andor biopsy x-rays andor scans will be done
This is an investigational study The FDA has authorized RAD001 for use in research only A total of 70 -125 patients will take part in this study All will be enrolled at M D Anderson
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