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

NCT01191749 | Terminated Phase 2 Results

• 1 other identifier: 2010-0187
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia

Keywords

Hematologic Disorder; Aplastic Anemia; T - Cell Large Granular Lymphocytic Leukemia; T-LGL; Myelodysplastic Syndrome; Chronic Lymphocytic Leukemia; CLL; Chemotherapy; Alemtuzumab

Outcome Measures

Primary Outcomes (1)

• Overall Response - Number of Participants Who Achieved Complete Remission (CR)+Partial Remission (PR) - as Per International Working Group (IWG) Response Criteria

  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.

  Up to 6 months following treatment; response assessed every 2 months

Study Arms (1)

Alemtuzumab

EXPERIMENTAL

Alemtuzumab 10 mg by vein over 2 hours on Days 1 to 10 of a 28 day cycle.

Drug: Alemtuzumab

Interventions

Alemtuzumab DRUG

10 mg by vein over 2 hours on Days 1 to 10 of a 28 day cycle.

Also known as: CAMPATH-1H, Campath

Alemtuzumab

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Leukemia; Hematologic Diseases; Anemia, Aplastic; Leukemia, Large Granular Lymphocytic; Myelodysplastic Syndromes; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Alemtuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemic and Lymphatic Diseases; Anemia; Bone Marrow Failure Disorders; Bone Marrow Diseases; Leukemia, T-Cell; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Tapan Kadia, MD
• Organization: University of Texas (UT) MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

1-877-632-6789

Study Officials

• Tapan Kadia, MD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2010
• First Posted: August 31, 2010
• Study Start: August 1, 2010
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: May 9, 2017
• Results First Posted: May 9, 2017

Record last verified: 2017-03

Locations

US (1)