A Phase II Study of Alemtuzumab and Pentostatin In T-Cell Neoplasms
18 Years
N/A
Both
Lymphoma, Leukemia
Trial Information
A Phase II Study of Alemtuzumab and Pentostatin In T-Cell Neoplasms
Alemtuzumab is an antibody protein that is directed towards a marker molecule on the surface
of both B- and T- lymphoid cells. It is currently approved for use in treating patients with
chronic lymphocytic leukemia and has been studied in treating patients with a number of
T-cell malignancies. Alemtuzumab has been found to be effective in these conditions.
Pentostatin is a drug that is approved for treating patients with hairy cell leukemia, a
B-cell malignancy. Pentostatin has also been studied in a number of T-cell cancers and has
been found to be effective. The purpose of this study is to see whether combining these
drugs will prove to be more effective.
If you are found to be eligible to take part in this study, you will receive pentostatin
through a central venous catheter in your vein once a week for 4 weeks and then every 2
weeks until the achievement of best response. A central venous catheter is a sterile
flexible tube that will be placed into a large vein while you are under local anesthesia.
Your physician will explain this procedure to you in more detail and you will be required to
sign a separate consent form for this procedure.
Alemtuzumab will also be given through a vein catheter on Days 1, 2, and 3. The dose of
alemtuzumab that you receive will be increased each day for the first 3 days to make sure
that you tolerate it. It will then be given three times per week until you achieve the best
response. If you develop reactions to alemtuzumab when given through a vein, you may receive
it by injections of the same dose under the skin.
During the treatment, you will have blood (about 2 tablespoons) drawn once a week for the
first 4 weeks for routine blood tests. These blood tests will then be repeated every 2 to 4
weeks for the remainder of the study. At the end of treatment a bone marrow examination will
be repeated to document your response. Also, if you had a chest X-ray or CT scans, these
will be repeated to confirm your level of response.
The maximum amount of time that alemtuzumab will be given is 3 months. The maximum amount of
time that pentostatin will be given is 6 months. You may be able to receive the treatment
will your local oncologists. However, you will have close follow-up at M. D. Anderson. You
will be taken off this treatment if the disease gets worse during treatment or if
unacceptable side effects develop.
You will be continued to be followed either directly or by telephone to evaluate your
long-term response to treatment on this study.
This is an investigational study. Both alemtuzumab and pentostatin are commercially
approved drugs that have been used to treat T-cell malignancies. A total of 60 patients
will take part in this study. All will be enrolled at M. D. Anderson.
This is an investigational study. Both alemtuzumab and pentostatin are commercially
approved drugs that have been used to treat T-cell malignancies. A total of 60 patients will
take part in this study. All will be enrolled at M. D. Anderson.
Inclusion Criteria:
1. Age 18 years and older
2. Diagnosis of T lymphoid malignancy established by peripheral blood, bone marrow or
tissue (skin, lymph node or other) examination and using the standard criteria.
3. Patients with untreated T-cell-prolymphocytic leukemia (T-PLL), peripheral T-cell
lymphoma, hepatosplenic T-cell lymphoma and NK/T cell lymphoma are eligible.
4. Patients with relapsed/refractory T-PLL, T-lineage acute lymphoblastic leukemia
(T-ALL), Adult T-cell leukemia/lymphoma (ATLL), peripheral T-cell lymphoma,
hepatosplenic T-cell lymphoma and NK/T cell lymphoma and other T-lymphoid
malignancies are eligible. Patients who have had prior therapy with either
alemtuzumab or pentostatin as single agents are eligible.
5. Willing to use adequate contraception for the entire duration of the study.
6. Performance status 0-2.
7. Creatinine less than or equal to 2.0 mg/dL and calculated creatinine clearance
greater than 40
8. Bilirubin less than or equal to 3.0 mg/dL, transaminases (aminotransferase (AST or
SGOT) and alanine aminotransferase (ALT or SGPT)) less than 4 x upper limit of normal
unless related to the disease.
9. Left ventricular ejection fraction greater than 30%.
Exclusion Criteria:
1. Unable or unwilling to sign the consent form.
2. Pregnant or lactating
3. Known to be HIV+
4. Active and uncontrolled infection as judged by treating physician
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Participants With Objective Response
Outcome Description:
Objective Responses are Complete or Partial Responses: Complete Response defined as disappearance of all evidence of disease detectable by morphology of peripheral blood and bone marrow and computer tomography scanning at the end of therapy, if indicated; and Partial Response as 50% or more reduction in detectable disease, but short of complete response, maintained for 1 month or at least 50% reduction of sum of the products of the diameter of all lesions for 1 month.
Outcome Time Frame:
After a maximum of 6 months of therapy maintained for one month.
Safety Issue:
No
Principal Investigator
Farhad Ravandi-Kashani, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2004-0408
NCT ID:
NCT00453193
Start Date:
September 2004
Completion Date:
March 2010
Related Keywords:
- Lymphoma
- Leukemia
- T-Cell Neoplasms
- Alemtuzumab
- Pentostatin
- Campath-1H
- Deoxycoformycin
- Lymphoma
- Leukemia
- Neoplasms
- Leukemia
- Lymphoma
Name | Location |
|---|---|
| U.T.M.D. Anderson Cancer Center | Houston, Texas 77030 |
