Hodgkin's DiseasePhase 2NCT00129753
Alemtuzumab (Campath-1H) Monoclonal Antibody in Patients With Relapsed and Resistant Classical Hodgkin's Disease
A Phase 2 study testing Alemtuzumab (Campath-1H) in people with Hodgkin's Disease and Lymphoma, run by M.D. Anderson Cancer Center.
Trial summary
Primary Objective: To determine the safety and efficacy of Campath-1H (Alemtuzumab) in patients with relapsed and resistant classical Hodgkin's lymphoma. Secondary Objectives: 1. To determine the duration of response and time to progression after Campath-1H therapy in this patient population. 2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hodgkin's Disease, Lymphoma
- What is being tested?
- Alemtuzumab (Campath-1H)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 22 Jun 2005to 5 Sep 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Relapsed or refractory Hodgkin's disease with a minimum of 2 prior treatment regimens, including autologous bone marrow transplantation.
- Must have histologically proven diagnosis of nodular sclerosis or mixed cellularity Hodgkin's disease.
- Hodgkin's lymphoma should be limited to lymph nodes, spleen, and bone marrow.
- Must have bi-dimensionally measurable disease defined as a lymph node at least 2 cm by computed tomography (CT) scan.
- Platelet count equal to or greater than 50,000/uL; absolute neutrophil count equal to or greater than 1,000/uL.
- Must sign a consent form.
- Males or females equal to or greater than 18 years of age.
- Patients may be taking voriconazole, itraconazole, or diflucan.
Who cannot join
- No serious inter-current infections requiring therapy.
- No Hodgkin-specific therapy within the last 3 weeks.
- Pregnant women and women of childbearing potential and men of reproductive potential who are not practicing adequate contraception.
- Lymphocyte depletion or lymphocyte predominance histology.
- History of HIV infection.
- Central nervous system (CNS) involvement with lymphoma including epidural disease and cord compression.
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- Prior allogeneic stem cell transplantation.
- Patients receiving steroids within 3 weeks of registration.
- Patients with a history of prior severe opportunistic infections that are controlled by T-cell immunity, such as pneumocystis pneumonia (PCP), herpes virus infections, mycobacterial disease, invasive mold infections or endemic fungi.
- Patients with an ejection fraction of less than 40%.
About this study
Official title: Phase II Study of Alemtuzumab (Campath-1H) Monoclonal Antibody in Patients With Relapsed and Resistant Classical Hodgkin's Disease
Primary Objective:
To determine the safety and efficacy of Campath-1H (Alemtuzumab) in patients with relapsed and resistant classical Hodgkin's lymphoma.
Secondary Objectives:
- To determine the duration of response and time to progression after Campath-1H therapy in this patient population.
- To determine the effect of Campath-1H on serum IL-6, IL-10, and IL-13 levels in patients with relapsed and resistant classical Hodgkin's lymphoma.
Read the detailed description
Alemtuzumab is the type of drug known as a "monoclonal antibody". The antibody binds to a specific protein (antigen) called CD52. CD52 is found on the surface of normal lymphocytes and monocytes. When the antibody binds to the protein on the surface of the lymphocyte or monocyte it causes the cell to die. The goal of the study is to learn if killing normal lymphocytes and monocytes with alemtuzumab will result in regression (lessening) of the cancer cells.
Alemtuzumab is usually given by an infusion into a vein. However, in this study, it will be given as an injection under-the-skin. This method of giving alemtuzumab is not approved by the FDA. The purpose of giving the drug by injection under the skin is to decrease the side effects observed with infusion by vein.
Before you can start treatment on this study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will have a complete medical history and physical exam Blood (about 2 tablespoons) will be collected for routine tests. A bone marrow sample will be collected to learn if your Hodgkin's lymphoma has spread to the bone marrow. To collect a bone marrow sample (biopsy), an area of the hip bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. A CT scan or MRI of the chest, abdomen (stomach), and pelvis (waist area) will be done. You will also have a PET scan or a Gallium scan to check on the status of the disease. You will be required to have a heart scan or an echocardiogram to check how strong your heart muscle is. You will be asked about medications that you are currently taking, including over-the-counter medications. Women who are able to have children must have a negative blood pregnancy test.
If you are found to be eligible to take part in this study, you will receive alemtuzumab 3 times a week as an injection under the skin. Typically these injections will be given on Monday, Wednesday, and Friday. Each dose will be divided into two injections to be given in each thigh. You will be treated for 12 weeks in a row. The treatment doses will be given by a nurse at M. D. Anderson in an outpatient setting. Before each injection, you may receive Tylenol and/or Benadryl to decrease the risk of side effects caused by the study drug.
During the 12-week treatment course, in addition to your study drug injections, you will visit the clinic every 3 weeks for physical exam and routine blood tests (2 tablespoons each). You will also have a blood test (1 tablespoonful) every week to find out if you are having a certain type of viral infection (cytomegalovirus, called CMV). If your blood tests show that your CMV blood levels are increasing, you may need treatment with anti-viral antibiotics to control your viral infection. You doctor will also give you antibiotics to take by mouth to prevent possible infections.
If the tumor grows during treatment or you experience any intolerable (very bad) side effects, you will be taken off study and your doctor will discuss other treatment options with you.
Within 3 weeks of the last dose of alemtuzumab, you will have a physical exam, routine blood tests (2 tablespoons), CT scans of the chest, abdomen, and pelvis, and a bone marrow biopsy (if needed). These tests will help show whether your tumor is shrinking after therapy. If these tests show that your tumor is not growing, you will be placed on observation and your tumor status will be checked up on every 3 months by repeating similar tests.
This is an investigational study. Alemtuzumab is FDA approved for the treatment of chronic lymphocytic leukemia and is commercially available. However, the FDA has not approved alemtuzumab for the treatment of Hodgkin's disease. Furthermore, the FDA has not approved the injection of alemtuzumab under the skin for the treatment of cancer. A maximum of 35 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Hodgkin's Disease, Lymphoma
- Being tested
- Alemtuzumab (Campath-1H)
- Keywords
- Campath-1H Monoclonal Antibody, Alemtuzumab, Campath, Campath-1H, Relapsed and Resistant Classical Hodgkin's Disease, Lymphoma
- Medical subject headings
- Hodgkin Disease, Lymphoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alemtuzumab (Campath-1H)Drug
Also called Campath, Campath-1H, Campath-1H Monoclonal Antibody
Escalating dose 3mg, 10 mg, 30 mg on three consecutive days, then 30 mg three times per week by subcutaneous injections for 12 weeks. Each 30 mg dose will be divided in 2 injections to be administered in each thigh.
| Study group | Role | What they receive |
|---|---|---|
| Alemtuzumab | Experimental | Not described Receives: Drug: Alemtuzumab (Campath-1H) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2005 (estimated)
- Study start22 Jun 2005
- Primary completion5 Sep 2006
- Study completion5 Sep 2006
Why it stopped: Terminated due to slow accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin's DiseaseStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Investigators
- Anas Younes, M.D., Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00129753
- Sponsor's protocol ID
- 2004-0742
- Status last verified
- Nov 2018
- First submitted
- 11 Aug 2005
- Last updated
- 8 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Alemtuzumab (Campath-1H) Monoclonal Antibody in Patients With Relapsed and Resistant Classical Hodgkin's Disease
- ClinicalTrials.gov ID
- NCT00129753
- Acronym / sponsor ID
- 2004-0742
- Conditions
- Hodgkin's Disease, Lymphoma
- Keywords
- Campath-1H Monoclonal Antibody, Alemtuzumab, Campath, Campath-1H, Relapsed and Resistant Classical Hodgkin's Disease, Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Terminated due to slow accrual.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 22 Jun 2005 (actual)
- Primary completion
- 5 Sep 2006 (actual)
- Study completion
- 5 Sep 2006 (actual)
- First posted
- 12 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
To determine the safety and efficacy of Campath-1H (Alemtuzumab) in patients with relapsed and resistant classical Hodgkin's lymphoma.
Secondary Objectives:
- To determine the duration of response and time to progression after Campath-1H therapy in this patient population.
- To determine the effect of Campath-1H on serum IL-6, IL-10, and IL-13 levels in patients with relapsed and resistant classical Hodgkin's lymphoma.
Detailed description
Alemtuzumab is the type of drug known as a "monoclonal antibody". The antibody binds to a specific protein (antigen) called CD52. CD52 is found on the surface of normal lymphocytes and monocytes. When the antibody binds to the protein on the surface of the lymphocyte or monocyte it causes the cell to die. The goal of the study is to learn if killing normal lymphocytes and monocytes with alemtuzumab will result in regression (lessening) of the cancer cells.
Alemtuzumab is usually given by an infusion into a vein. However, in this study, it will be given as an injection under-the-skin. This method of giving alemtuzumab is not approved by the FDA. The purpose of giving the drug by injection under the skin is to decrease the side effects observed with infusion by vein.
Before you can start treatment on this study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will have a complete medical history and physical exam Blood (about 2 tablespoons) will be collected for routine tests. A bone marrow sample will be collected to learn if your Hodgkin's lymphoma has spread to the bone marrow. To collect a bone marrow sample (biopsy), an area of the hip bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. A CT scan or MRI of the chest, abdomen (stomach), and pelvis (waist area) will be done. You will also have a PET scan or a Gallium scan to check on the status of the disease. You will be required to have a heart scan or an echocardiogram to check how strong your heart muscle is. You will be asked about medications that you are currently taking, including over-the-counter medications. Women who are able to have children must have a negative blood pregnancy test.
If you are found to be eligible to take part in this study, you will receive alemtuzumab 3 times a week as an injection under the skin. Typically these injections will be given on Monday, Wednesday, and Friday. Each dose will be divided into two injections to be given in each thigh. You will be treated for 12 weeks in a row. The treatment doses will be given by a nurse at M. D. Anderson in an outpatient setting. Before each injection, you may receive Tylenol and/or Benadryl to decrease the risk of side effects caused by the study drug.
During the 12-week treatment course, in addition to your study drug injections, you will visit the clinic every 3 weeks for physical exam and routine blood tests (2 tablespoons each). You will also have a blood test (1 tablespoonful) every week to find out if you are having a certain type of viral infection (cytomegalovirus, called CMV). If your blood tests show that your CMV blood levels are increasing, you may need treatment with anti-viral antibiotics to control your viral infection. You doctor will also give you antibiotics to take by mouth to prevent possible infections.
If the tumor grows during treatment or you experience any intolerable (very bad) side effects, you will be taken off study and your doctor will discuss other treatment options with you.
Within 3 weeks of the last dose of alemtuzumab, you will have a physical exam, routine blood tests (2 tablespoons), CT scans of the chest, abdomen, and pelvis, and a bone marrow biopsy (if needed). These tests will help show whether your tumor is shrinking after therapy. If these tests show that your tumor is not growing, you will be placed on observation and your tumor status will be checked up on every 3 months by repeating similar tests.
This is an investigational study. Alemtuzumab is FDA approved for the treatment of chronic lymphocytic leukemia and is commercially available. However, the FDA has not approved alemtuzumab for the treatment of Hodgkin's disease. Furthermore, the FDA has not approved the injection of alemtuzumab under the skin for the treatment of cancer. A maximum of 35 patients will take part in this study. All will be enrolled at M. D. 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: Alemtuzumab (Campath-1H) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Relapsed or refractory Hodgkin's disease with a minimum of 2 prior treatment regimens, including autologous bone marrow transplantation.
- Must have histologically proven diagnosis of nodular sclerosis or mixed cellularity Hodgkin's disease.
- Hodgkin's lymphoma should be limited to lymph nodes, spleen, and bone marrow.
- Must have bi-dimensionally measurable disease defined as a lymph node at least 2 cm by computed tomography (CT) scan.
- Platelet count equal to or greater than 50,000/uL; absolute neutrophil count equal to or greater than 1,000/uL.
Key exclusion criteria (10 listed)
- No serious inter-current infections requiring therapy.
- No Hodgkin-specific therapy within the last 3 weeks.
- Pregnant women and women of childbearing potential and men of reproductive potential who are not practicing adequate contraception.
- Lymphocyte depletion or lymphocyte predominance histology.
- History of HIV infection.
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 |
|---|---|---|
| Alemtuzumab (Campath-1H)Also: Campath, Campath-1H, Campath-1H Monoclonal AntibodyEscalating dose 3mg, 10 mg, 30 mg on three consecutive days, then 30 mg three times per week by subcutaneous injections for 12 weeks. Each 30 mg dose will be divided in 2 injections to be administered in each thigh. | Drug | Alemtuzumab |
Primary outcome
Response Rate
Time frame: 1 Year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
- 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.
Anas Younes, M.D. principal investigator
UT MD Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alemtuzumab (Campath-1H) in people with Hodgkin's Disease and Lymphoma, run by M.D. Anderson Cancer Center.
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 8 inclusion and 10 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: withdrawn, as of the sponsor's last update on 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Response Rate (time frame: 1 Year). 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 8 Nov 2018.