Alemtuzumab in Myelodysplastic Syndrome (MDS), Aplastic Anemia, and T-Cell Large Granular Lymphocytic Leukemia (T-GL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01191749
Recruitment Status : Terminated (Low Accrual)
First Posted : August 31, 2010
Results First Posted : May 9, 2017
Last Update Posted : May 9, 2017
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Leukemia Drug: Alemtuzumab Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : August 2010
Primary Completion Date : November 2013
Study Completion Date : November 2013

Arm Intervention/treatment
Experimental: Alemtuzumab
Alemtuzumab 10 mg by vein over 2 hours on Days 1 to 10 of a 28 day cycle.
Drug: Alemtuzumab
10 mg by vein over 2 hours on Days 1 to 10 of a 28 day cycle.
Other Names:
  • Campath

Primary Outcome Measures :
  1. 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 ]
    Overall response (OR) defined as complete/partial remission for at least 4 weeks or hematologic improvement for at least 8 weeks. Response Criteria are according to the Modified IWG Response Criteria in Myelodysplasia. IWG 2006 response criteria - CR: bone marrow evaluation shows less than or equal to (<=) 5% blasts; normal maturation of all cells lines (mCR), peripheral blood evaluation shows hemoglobin >= 11 gram per deciliter (g/dL), neutrophils >= 1000/mL, platelets >= 100,000/mL, 0% blasts; PR: Same as CR, except blasts decrease by >=50%, still greater than 5% in bone marrow. Hematologic improvement are measured in participants with pretreatment abnormal values: hemoglobin level less than 110 g/L (11 g/dL) or red blood count (RBC)-transfusion dependence, platelet count <100 x 10^9/L or platelet-transfusion dependence, absolute neutrophil count (ANC) less than 1.0 x 10^9/L.

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01191749

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Tapan Kadia, MD UT MD Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01191749     History of Changes
Other Study ID Numbers: 2010-0187
First Posted: August 31, 2010    Key Record Dates
Results First Posted: May 9, 2017
Last Update Posted: May 9, 2017
Last Verified: March 2017

Keywords provided by M.D. Anderson Cancer Center:
Hematologic Disorder
Aplastic Anemia
T - Cell Large Granular Lymphocytic Leukemia
Myelodysplastic Syndrome
Chronic Lymphocytic Leukemia

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Leukemia, Lymphoid
Anemia, Aplastic
Leukemia, Large Granular Lymphocytic
Neoplasms by Histologic Type
Hematologic Diseases
Bone Marrow Diseases
Precancerous Conditions
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, T-Cell
Antineoplastic Agents