LeukemiaPhase 2NCT01191749
Alemtuzumab in Myelodysplastic Syndrome (MDS), Aplastic Anemia, and T-Cell Large Granular Lymphocytic Leukemia (T-GL)
A Phase 2 study testing Alemtuzumab in people with Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Leukemia
- What is being tested?
- Alemtuzumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Nov 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the detailed description
The Study Drug:
Alemtuzumab is designed to attach to a protein that is found on certain immune cells, which may cause the cell to die.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive alemtuzumab on Days 1-10 of one 28-day cycle. It will be given either by vein over 2 hours or by injection under the skin 1 time a day. Your doctor will tell you how the drug will be given.
In order to get alemtuzumab provided for your treatment, the study staff will be filling out a form with your name and medical information (protected health information) for the company as part of the Campath Distribution Program.
All participants will receive the same dose of alemtuzumab unless the starting dose causes intolerable side effects. If this happens, all future participants will receive a lower dose.
Depending on your doctor's decision, to lower the risk of side effects you will receive Tylenol (acetaminophen) and Benadryl (diphenhydramine) or other drugs such as steroids (either by mouth or by a short infusion by vein), 30 minutes before each alemtuzumab dose.
If you are receiving alemtuzumab and have chills during the infusion, you may receive Demerol (meperidine hydrochloride, a painkiller) to help control them.
Starting on Day 1 and continuing at least 8 weeks after the last dose of study drug, you will be given 2 antibiotics to help fight infection. You will take Valacyclovir (or a similar drug) 1 time each day. You will take Trimethoprim/Sulfamethoxazole (or a similar drug) 2 times a day, 3 times per week. You will take both antibiotics by mouth.
Study Visits:
At Week 1:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 1 tablespoon) will be drawn for routine tests.
At Weeks 2-4, blood (about 1 tablespoon) will be drawn for routine tests.
Beginning at Week 5 (+/- 3 days) and then 1 time monthly:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 1 tablespoon) will be drawn for routine tests.
At Week 12 (+/- 3 days) (end of the 3rd month), you will have a bone marrow aspiration and/or biopsy to test for chromosome abnormalities (if chromosomes were abnormal at screening) and to check the status of the disease. You may have additional bone marrow aspirations or biopsies if your doctor feels they are necessary.
You will be asked about any side effects you may be having at each of your study visits. At any time during the study, if the doctor thinks it is needed, you will have a chest x-ray, a CT scan, or a PET scan to check the status of the disease.
Length of Study:
You will receive only one cycle of the study drug. Your participation on the study will be over after you have completed the end-of-study visit. You will be taken off study early if the disease gets worse or intolerable side effects occur.
End-of Study-Visit:
When you come off study you will have an end-of-study visit. At this visit, the following tests and procedures will be performed:
- Blood (about 2 tablespoons) will be drawn for routine tests.
- You will have a physical exam, including measurement of your vital signs.
- Your performance status will be recorded.
- You will have a bone marrow aspiration and/or biopsy to check for chromosome abnormalities, test for low levels of leukemia or lymphoma, to check the status of the disease, and molecular testing. Molecular tests are designed to look at the way the different parts of a cell (including DNA, RNA, and proteins) work together.
- Blood (about 2 teaspoons) will be drawn to check levels of T-cells and immunoglobulins.
This is an investigational study. Alemtuzumab is FDA-approved for the treatment of some patients with B-cell chronic lymphocytic leukemia (CLL). The use of alemtuzumab to treat MDS, aplastic anemia, or T-cell large granular lymphocytic leukemia is investigational.
Up to 29 participants will take part in this study. All participants will be enrolled at MD Anderson.
- Conditions
- Leukemia
- Being tested
- Alemtuzumab
- Keywords
- Hematologic Disorder, Aplastic Anemia, T - Cell Large Granular Lymphocytic Leukemia, T-LGL, Myelodysplastic Syndrome, Chronic Lymphocytic Leukemia, CLL, Chemotherapy, Alemtuzumab
- Medical subject headings
- Leukemia, Hematologic Diseases, Anemia, Aplastic, Leukemia, Large Granular Lymphocytic, Myelodysplastic Syndromes, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlemtuzumabDrug
Also called CAMPATH-1H, Campath
10 mg by vein over 2 hours on Days 1 to 10 of a 28 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Alemtuzumab | Experimental | Alemtuzumab 10 mg by vein over 2 hours on Days 1 to 10 of a 28 day cycle. Receives: Drug: Alemtuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 months following treatment; response assessed every 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionNov 2013
- Study completionNov 2013
Why it stopped: Low Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tapan Kadia, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01191749
- Sponsor's protocol ID
- 2010-0187
- Status last verified
- Mar 2017
- First submitted
- 27 Aug 2010
- Last updated
- 9 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01191749
- Acronym / sponsor ID
- 2010-0187
- Conditions
- Leukemia
- Keywords
- Hematologic Disorder, Aplastic Anemia, T - Cell Large Granular Lymphocytic Leukemia, T-LGL, Myelodysplastic Syndrome, Chronic Lymphocytic Leukemia, CLL, Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low Accrual
- Enrolment
- 7 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 31 Aug 2010 (estimated)
- Results
- Posted 9 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Study Drug:
Alemtuzumab is designed to attach to a protein that is found on certain immune cells, which may cause the cell to die.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive alemtuzumab on Days 1-10 of one 28-day cycle. It will be given either by vein over 2 hours or by injection under the skin 1 time a day. Your doctor will tell you how the drug will be given.
In order to get alemtuzumab provided for your treatment, the study staff will be filling out a form with your name and medical information (protected health information) for the company as part of the Campath Distribution Program.
All participants will receive the same dose of alemtuzumab unless the starting dose causes intolerable side effects. If this happens, all future participants will receive a lower dose.
Depending on your doctor's decision, to lower the risk of side effects you will receive Tylenol (acetaminophen) and Benadryl (diphenhydramine) or other drugs such as steroids (either by mouth or by a short infusion by vein), 30 minutes before each alemtuzumab dose.
If you are receiving alemtuzumab and have chills during the infusion, you may receive Demerol (meperidine hydrochloride, a painkiller) to help control them.
Starting on Day 1 and continuing at least 8 weeks after the last dose of study drug, you will be given 2 antibiotics to help fight infection. You will take Valacyclovir (or a similar drug) 1 time each day. You will take Trimethoprim/Sulfamethoxazole (or a similar drug) 2 times a day, 3 times per week. You will take both antibiotics by mouth.
Study Visits:
At Week 1:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 1 tablespoon) will be drawn for routine tests.
At Weeks 2-4, blood (about 1 tablespoon) will be drawn for routine tests.
Beginning at Week 5 (+/- 3 days) and then 1 time monthly:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 1 tablespoon) will be drawn for routine tests.
At Week 12 (+/- 3 days) (end of the 3rd month), you will have a bone marrow aspiration and/or biopsy to test for chromosome abnormalities (if chromosomes were abnormal at screening) and to check the status of the disease. You may have additional bone marrow aspirations or biopsies if your doctor feels they are necessary.
You will be asked about any side effects you may be having at each of your study visits. At any time during the study, if the doctor thinks it is needed, you will have a chest x-ray, a CT scan, or a PET scan to check the status of the disease.
Length of Study:
You will receive only one cycle of the study drug. Your participation on the study will be over after you have completed the end-of-study visit. You will be taken off study early if the disease gets worse or intolerable side effects occur.
End-of Study-Visit:
When you come off study you will have an end-of-study visit. At this visit, the following tests and procedures will be performed:
- Blood (about 2 tablespoons) will be drawn for routine tests.
- You will have a physical exam, including measurement of your vital signs.
- Your performance status will be recorded.
- You will have a bone marrow aspiration and/or biopsy to check for chromosome abnormalities, test for low levels of leukemia or lymphoma, to check the status of the disease, and molecular testing. Molecular tests are designed to look at the way the different parts of a cell (including DNA, RNA, and proteins) work together.
- Blood (about 2 teaspoons) will be drawn to check levels of T-cells and immunoglobulins.
This is an investigational study. Alemtuzumab is FDA-approved for the treatment of some patients with B-cell chronic lymphocytic leukemia (CLL). The use of alemtuzumab to treat MDS, aplastic anemia, or T-cell large granular lymphocytic leukemia is investigational.
Up to 29 participants will take part in this study. All participants will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alemtuzumab | Experimental | Drug: AlemtuzumabAlemtuzumab 10 mg by vein over 2 hours on Days 1 to 10 of a 28 day cycle. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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 ).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlemtuzumabAlso: CAMPATH-1H, Campath10 mg by vein over 2 hours on Days 1 to 10 of a 28 day cycle. | Drug | Alemtuzumab |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tapan Kadia, MD principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alemtuzumab in people with Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.