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Phase II Pilot Study Of Alemtuzumab In Patients With Low Or INT-1 Risk Myelodysplastic Syndrome (MDS), Aplastic Anemia (AA), Or T-Cell Large Granular Lymphocytic Leukemia (T-LGL)


Phase 2
N/A
N/A
Open (Enrolling)
Both
Leukemia

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Trial Information

Phase II Pilot Study Of Alemtuzumab In Patients With Low Or INT-1 Risk Myelodysplastic Syndrome (MDS), Aplastic Anemia (AA), Or T-Cell Large Granular Lymphocytic Leukemia (T-LGL)


The Study Drug:

Alemtuzumab is designed to attach to a protein that is found on certain immune cells, which
may cause the cell to die.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive alemtuzumab on
Days 1-10 of one 28-day cycle. It will be given either by vein over 2 hours or by injection
under the skin 1 time a day. Your doctor will tell you how the drug will be given.

In order to get alemtuzumab provided for your treatment, the study staff will be filling out
a form with your name and medical information (protected health information) for the company
as part of the Campath Distribution Program.

All participants will receive the same dose of alemtuzumab unless the starting dose causes
intolerable side effects. If this happens, all future participants will receive a lower
dose.

Depending on your doctor's decision, to lower the risk of side effects you will receive
Tylenol (acetaminophen) and Benadryl (diphenhydramine) or other drugs such as steroids
(either by mouth or by a short infusion by vein), 30 minutes before each alemtuzumab dose.

If you are receiving alemtuzumab and have chills during the infusion, you may receive
Demerol (meperidine hydrochloride, a painkiller) to help control them.

Starting on Day 1 and continuing at least 8 weeks after the last dose of study drug, you
will be given 2 antibiotics to help fight infection. You will take Valacyclovir (or a
similar drug) 1 time each day. You will take Trimethoprim/Sulfamethoxazole (or a similar
drug) 2 times a day, 3 times per week. You will take both antibiotics by mouth.

Study Visits:

At Week 1:

- You will have a physical exam, including measurement of your weight and vital signs.

- Your performance status will be recorded.

- Blood (about 1 tablespoon) will be drawn for routine tests.

At Weeks 2-4, blood (about 1 tablespoon) will be drawn for routine tests.

Beginning at Week 5 (+/- 3 days) and then 1 time monthly:

- You will have a physical exam, including measurement of your weight and vital signs.

- Your performance status will be recorded.

- Blood (about 1 tablespoon) will be drawn for routine tests.

At Week 12 (+/- 3 days) (end of the 3rd month), you will have a bone marrow aspiration
and/or biopsy to test for chromosome abnormalities (if chromosomes were abnormal at
screening) and to check the status of the disease. You may have additional bone marrow
aspirations or biopsies if your doctor feels they are necessary.

You will be asked about any side effects you may be having at each of your study visits. At
any time during the study, if the doctor thinks it is needed, you will have a chest x-ray, a
CT scan, or a PET scan to check the status of the disease.

Length of Study:

You will receive only one cycle of the study drug. Your participation on the study will be
over after you have completed the end-of-study visit. You will be taken off study early if
the disease gets worse or intolerable side effects occur.

End-of Study-Visit:

When you come off study you will have an end-of-study visit. At this visit, the following
tests and procedures will be performed:

- Blood (about 2 tablespoons) will be drawn for routine tests.

- You will have a physical exam, including measurement of your vital signs.

- Your performance status will be recorded.

- You will have a bone marrow aspiration and/or biopsy to check for chromosome
abnormalities, test for low levels of leukemia or lymphoma, to check the status of the
disease, and molecular testing. Molecular tests are designed to look at the way the
different parts of a cell (including DNA, RNA, and proteins) work together.

- Blood (about 2 teaspoons) will be drawn to check levels of T-cells and immunoglobulins.

This is an investigational study. Alemtuzumab is FDA-approved for the treatment of some
patients with B-cell chronic lymphocytic leukemia (CLL). The use of alemtuzumab to treat
MDS, aplastic anemia, or T-cell large granular lymphocytic leukemia is investigational.

Up to 29 participants will take part in this study. All participants will be enrolled at MD
Anderson.


Inclusion Criteria:



1. Patients with the diagnosis of MDS (Low, Int-1 by IPSS, or hypocellular) who are
either previously untreated or who have been previously treated are eligible for this
trial.

2. Patients with the diagnosis of aplastic anemia who have or have not been previously
treated are eligible for inclusion if they are not currently candidates for an
allogeneic stem cell transplant.

3. Patients with the diagnosis of T-LGL who have or have not been previously treated are
eligible for inclusion.

4. Patients must have been off of cytotoxic, immunosuppressive, or targeted therapy
(except hydroxyurea) for at least 2 weeks prior to entering this study, and have
recovered from the toxic effects of that therapy to grade 1 or less.

5. Adequate organ function as defined: liver function (bilirubin < or = 2mg/dL, AST
and/or ALT < or = 3 x ULN) ; kidney function (creatinine < or = 2.5 x ULN ).

6. ECOG performance status of < or = 3.

7. The effects of alemtuzumab on the developing human fetus are unknown. For this
reason, women of child-bearing potential and men must agree to use adequate
contraception (hormonal or barrier method of birth control; abstinence) prior to
study entry and for the duration of study participation. Should a woman become
pregnant or suspect she is pregnant while participating in this study, she should
inform her treating physician immediately.

8. A negative urine pregnancy test is required within 1 week for all women of
childbearing potential prior to enrolling on this trial.

9. Patient must have the ability to understand the requirements of the study and signed
informed consent. A signed informed consent by the patient or his legally authorized
representative is required prior to their enrollment on the protocol.

10. Patients should have an indication for therapy for their disease such as transfusion
dependence or morbidity associated with their cytopenia(s) such as bleeding, severe
fatigue, or frequent/multiple infections (eg. neutropenia).

Exclusion Criteria:

1. Pregnant women are excluded from this study because alemtuzumab is an agent with the
potential for teratogenic or abortifacient effects. Because there is an unknown but
potential risk for adverse events in nursing infants secondary to treatment of the
mother with alemtuzumab, breastfeeding should be discontinued if the mother is
treated with alemtuzumab. These potential risks may also apply to other agents used
in this study.

2. Known HIV infection.

3. Known Hepatitis B or Hepatitis C infection.

4. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

5. Patient with documented hypersensitivity to alemtuzumab.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response

Outcome Description:

Overall response (OR) defined as complete/partial remission for at least 4 weeks or hematologic improvement for at least 8 weeks.

Outcome Time Frame:

Every 2 months

Safety Issue:

Yes

Principal Investigator

Tapan Kadia, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2010-0187

NCT ID:

NCT01191749

Start Date:

August 2010

Completion Date:

Related Keywords:

  • Leukemia
  • Hematologic Disorder
  • Aplastic Anemia
  • T - Cell Large Granular Lymphocytic Leukemia
  • T-LGL
  • Myelodysplastic Syndrome
  • Chronic Lymphocytic Leukemia
  • CLL
  • Chemotherapy
  • Alemtuzumab
  • Anemia
  • Anemia, Aplastic
  • Leukemia
  • Leukemia, Lymphoid
  • Myelodysplastic Syndromes
  • Preleukemia
  • Leukemia, Large Granular Lymphocytic

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030