Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00079313
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2004-03-08
Brief Title:
Imatinib GleevecRegistered Trademark to Treat Chronic Myelomonocytic Leukemia and Atypical Chronic Myelogenous 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 the Safety and Efficacy of Imatinib in Reducing Monocytosis or Leukocytosis in Patients With Chronic Myelomonocytic Leukemia and Atypical Chronic Myelogenous Leukemia Respectively
Status:
COMPLETED
Status Verified Date:
2011-09-23
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 evaluate the safety and effectiveness of imatinib GleevecRegistered Trademark in patients with chronic myelomonocytic leukemia CMML and atypical chronic myelogenous leukemia CML These conditions cause uncontrolled growth of malignant cancerous cells in the bone marrow that prevents the bone marrow from functioning normally in producing blood cells The cancer cells also can spill over into the blood and invade other organs of the body Imatinib has been approved by the Food and Drug Administration for treating chronic myelogenous leukemia which has characteristics similar to atypical CML and to CMML and data from other research suggests this drug may be able to produce a remission in forms of leukemia other than CML
Patients over 18 years of age with atypical CML or CMML may be eligible for this study Candidates are screened with a medical history and physical examination blood tests electrocardiogram chest x-ray and bone marrow aspiration and biopsy removal of a small piece of bone marrow tissue through a needle inserted into the hip bone
Participants take imatinib capsules once a day for 2 years If at any time during the study the patients blood counts begin to rise disease symptoms develop or the disease has progressed the dose of imatinib is increased each week until the disease progression is stopped Any patient whose disease does not response to treatment after 6 weeks of increased dosing and 30 days at the maximum daily dose of 800 mg is taken off the study and referred for different treatment
Patients are seen by their referring physician every week for the first 4 weeks of the study every other week for the next 8 weeks and then monthly until the study is completed At each visit blood is drawn to monitor for drug side effects and response to therapy In addition patients come to the NIH Clinical Center every 3 months for a complete history and physical examination and for a bone marrow aspiration and biopsy every 6 months to assess the effect of treatment on bone marrow cells
Patients who leave the study before 2 years are followed with laboratory monitoring for 6 months after stopping imatinib those who remain on the drug for the full 2 years are monitored for 1 year after stopping the drug
Patients over 18 years of age with atypical CML or CMML may be eligible for this study Candidates are screened with a medical history and physical examination blood tests electrocardiogram chest x-ray and bone marrow aspiration and biopsy removal of a small piece of bone marrow tissue through a needle inserted into the hip bone
Participants take imatinib capsules once a day for 2 years If at any time during the study the patients blood counts begin to rise disease symptoms develop or the disease has progressed the dose of imatinib is increased each week until the disease progression is stopped Any patient whose disease does not response to treatment after 6 weeks of increased dosing and 30 days at the maximum daily dose of 800 mg is taken off the study and referred for different treatment
Patients are seen by their referring physician every week for the first 4 weeks of the study every other week for the next 8 weeks and then monthly until the study is completed At each visit blood is drawn to monitor for drug side effects and response to therapy In addition patients come to the NIH Clinical Center every 3 months for a complete history and physical examination and for a bone marrow aspiration and biopsy every 6 months to assess the effect of treatment on bone marrow cells
Patients who leave the study before 2 years are followed with laboratory monitoring for 6 months after stopping imatinib those who remain on the drug for the full 2 years are monitored for 1 year after stopping the drug
Detailed Description:
The purpose of this study is to evaluate the safety and effectiveness of imatinib for improving blood counts in patients with chronic myelomonocytic leukemia CMML and atypical chronic myelogenous leukemia CML
Although a number of agents have been used to treat these diseases most patients do not respond to treatment Imatinib has been shown in clinical trials to induce high rates of responses in patients with chronic phase CML Imatinib has also been shown to be effective in inducing responses in a subset of patients with CMML and atypical CML and is also effective in a subset of patients with idiopathic hypereosinophilic syndrome HES another myeloproliferative disorder Because patients with several different myeloproliferative diseases have been shown to experience dramatic responses to imatinib we would like to determine what proportion of patients with atypical myeloproliferative diseases CMML and atypical CML will respond to this agent
Prior to enrollment a thorough clinical evaluation will be performed A baseline bone marrow will be obtained to exclude acute leukemia or lymphoma and to assess the degree and nature of the myeloproliferation In order to minimize bone marrow suppression other myelosuppressive drugs will be tapered and discontinued during the first week of therapy with imatinib Complete blood counts will be performed weekly for the first month and every other week thereafter Clinical assessments will be performed every three months to assess for continued response
Although a number of agents have been used to treat these diseases most patients do not respond to treatment Imatinib has been shown in clinical trials to induce high rates of responses in patients with chronic phase CML Imatinib has also been shown to be effective in inducing responses in a subset of patients with CMML and atypical CML and is also effective in a subset of patients with idiopathic hypereosinophilic syndrome HES another myeloproliferative disorder Because patients with several different myeloproliferative diseases have been shown to experience dramatic responses to imatinib we would like to determine what proportion of patients with atypical myeloproliferative diseases CMML and atypical CML will respond to this agent
Prior to enrollment a thorough clinical evaluation will be performed A baseline bone marrow will be obtained to exclude acute leukemia or lymphoma and to assess the degree and nature of the myeloproliferation In order to minimize bone marrow suppression other myelosuppressive drugs will be tapered and discontinued during the first week of therapy with imatinib Complete blood counts will be performed weekly for the first month and every other week thereafter Clinical assessments will be performed every three months to assess for continued response
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 |
|---|---|---|---|
| 04-H-0090 | None | None | None |