Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT01191749 |
Date of registration:
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27/08/2010 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Alemtuzumab in Myelodysplastic Syndrome (MDS), Aplastic Anemia, and T-Cell Large Granular Lymphocytic Leukemia (T-GL)
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Scientific title:
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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) |
Date of first enrolment:
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August 2010 |
Target sample size:
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7 |
Recruitment status: |
Terminated |
URL:
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https://clinicaltrials.gov/show/NCT01191749 |
Study type:
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Interventional |
Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Tapan Kadia, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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UT MD Anderson Cancer Center |
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Key inclusion & exclusion criteria
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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.
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Leukemia
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Intervention(s)
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Drug: Alemtuzumab
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Primary Outcome(s)
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Overall Response - Number of Participants Who Achieved Complete Remission (CR)+Partial Remission (PR) - as Per International Working Group (IWG) Response Criteria
[Time Frame: Up to 6 months following treatment; response assessed every 2 months]
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Secondary ID(s)
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2010-0187
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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