PHASE II PILOT STUDY OF ALEMTUZUMAB IN PATIENTS WITH LOW OR INT - 1 RISK MEYLODYSPLASTIC SYNDROME (MDS), APLASTIC ANEMIA (AA), OR T - CELL LARGE GRANULAR LYMPHOCYTIC LEUKEMIA (T - LGL)
The goal of this clinical research study is to determine the effectiveness of alemtuzumab in patients with aplastic anemia, MDS, or T-Cell large granular lymphocytic leukemia. The safety of alemtuzumab will also be studied.
Disease Group: Hematologic Disorder
Treatment Agent: Campath-1H
Treatment Location: Only at MD Anderson
Primary Objectives 1. To evaluate the rates of overall response achieved with alemtuzumab in patients with MDS, Aplastic Anemia, or T-LGL. Secondary Objectives 1. To assess the safety, tolerability, and toxicities of alemtuzumab in patients with MDS, Aplastic Anemia (AA), or T-LGL. 2. To evaluate the rates of cytogenetic response, if applicable achieved with alemtuzumab in patients with MDS. 3. To evaluate the duration of remission and overall survival achieved with alemtuzumab in patients with MDS, Aplastic Anemia, or T-LGL.
IRB Review and Approval Date: 08/27/2010
Recruitment Status: Not Accepting
Projected Accrual: 24-32
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).
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.