Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT00816114 |
| Other study ID # |
RCR05-0444 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 8, 2005 |
| Est. completion date |
April 30, 2025 |
Study information
| Verified date |
May 2024 |
| Source |
M.D. Anderson Cancer Center |
| Contact |
Koji Sasaki, M.D. |
| Phone |
(713) 745-2882 |
| Email |
ksasaki1[@]mdanderson.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
In this study researchers propose to do a chart review of all patients that are treated
outside of a clinical trial with imatinib, dasatinib, nilotinib, or any other tyrosine kinase
inhibitor that becomes FDA approved for the managements of CML that come to MDACC for a
second opinion. This is an important population of patients that differs in their management
from patients treated in clinical trials for several reasons including but not limited to:
1. It represents a very large patient population receiving standard-dose therapy with TKI.
We estimate that we have evaluated over 300 patients that fall in this category.
2. The follow-up for patients in the largest trial using standard-dose imatinib (the IRIS
trial, with 553 patients in treated with imatinib) has been limited after the first 12
months. For example, the rate of molecular responses after the first 12 months of
therapy was not obtained as samples stopped being collected at that time point.
3. Registration studies for dasatinib and nilotinib have similar limitations with limited
follow-up and available information coming only from databases from the sponsors to
which there is limited access to investigate dosing, chronic toxicities, second
malignancies and other important aspects of therapy.
4. Patients who are or become pregnant during therapy with TKI have not been eligible for
clinical trials with TKI or had to be taken off study. Thus, there is no information on
the effect of TKI on imatinib on pregnancy and conception. We have followed several such
patients at MDACC.
5. This is a patient population that follows therapy mostly as directed by their local
oncologists. This is frequently less stringently adhered to the recommended guidelines
for TKI therapy, with more frequent treatment interruptions, and frequently using
suboptimal doses of imatinib (i.e., less than 300mg daily). The effect of these
treatment interruptions and suboptimal dosing on response and development of resistance
is unclear.
Researchers plan to conduct a chart review of these patients to study their treatment course
before their initial evaluation at MDACC, and between and during visits to MDACC.
Description:
PATIENT POPULATION:
All patients with CML in any phase of the disease (chronic, accelerated or blast phase) that
has received treatment with any tyrosine kinase inhibitor (eg, imatinib, dasatinib,
nilotinib) regardless of prior treatment history that has had at least one clinic visit at
MDACC will be eligible.
STUDY PLAN:
The following information will be collected:
- Demographic information including age, gender, ethnicity, education, and work history.
- All laboratory values obtained at MDACC or other institutions, including CBC, blood
chemistries, electrolytes, bone marrow aspirations and biopsies, cytogenetic analyses,
mutation analysis, FISH, and PCR, and other tests obtained during regular care of these
patients.
- Treatment history including starting and stopping dates, doses, treatment interruptions,
dose changes and reasons for dose modifications.
- Information about toxicity including type, grade, dates of onset and resolution,
interventions to manage toxicity, and sequelae.
- Information regarding pregnancy or conception during imatinib therapy for both male and
female patients, including dates of pregnancy, outcome of pregnancy, interventions
during pregnancy, management of CML during pregnancy, complications during pregnancy,
status of the product, condition of the born child, and information on lactation.
- This information will be reviewed from the documents received as part of the routine
communication with the local oncologist or from the studies obtained at MDACC.
- There will be no treatment changes or recommendations as a result of this study. This
study will be strictly limited to review of charts. Patients will continue their
treatment as recommended by their local oncologist and treating physician at MDACC.
- These results will be compared to similar patients treated with imatinib in the context
of clinical trials both from published literature and from other studies conducted at
MDACC. The efficacy, safety and prognostic markers will be compared.
- We will review data from July 1, 1998 to August 1, 2019.
SAMPLE SIZE:
Approximately 3000 charts will be reviewed.
