Alemtuzumab in Myelodysplastic Syndrome (MDS), Aplastic Anemia, and T-Cell Large Granular Lymphocytic Leukemia (T-GL)
This study is currently recruiting participants.
Verified September 2013 by M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
First received: August 27, 2010
Last updated: September 30, 2013
Last verified: September 2013
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.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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)
Primary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||August 2015 (Final data collection date for primary outcome measure)
Alemtuzumab 10mg by vein over 2 hours on Days 1 to 10 of a 28 day cycle.
10 mg by vein over 2 hours on Days 1 to 10 of a 28 day cycle.
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
- Patients with the diagnosis of T-LGL who have or have not been previously treated are eligible for inclusion.
- 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.
- 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 ).
- ECOG performance status of < or = 3.
- 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.
- A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.
- 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.
- 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).
- 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.
- Known HIV infection.
- Known Hepatitis B or Hepatitis C infection.
- 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.
- Patient with documented hypersensitivity to alemtuzumab.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01191749
|Contact: Tapan Kadia, MD
|UT MD Anderson Cancer Center
|Houston, Texas, United States, 77030 |
|Contact: Tapan Kadia, MD 713-563-3534 |
|Principal Investigator: Tapan Kadia, MD |
M.D. Anderson Cancer Center
||Tapan Kadia, MD
||UT MD Anderson Cancer Center
No publications provided
||M.D. Anderson Cancer Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 27, 2010
||September 30, 2013
||United States: Institutional Review Board
Keywords provided by M.D. Anderson Cancer Center:
T - Cell Large Granular Lymphocytic Leukemia
Chronic Lymphocytic Leukemia
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 08, 2013
Leukemia, Large Granular Lymphocytic
Bone Marrow Diseases
Neoplasms by Histologic Type
Immune System Diseases
Physiological Effects of Drugs