Chronic Lymphocytic LeukemiaPhase 2NCT00771602
Alemtuzumab + Rituximab Consolidation in CLL
A Phase 2 study testing Rituximab and Alemtuzumab in people with Chronic Lymphocytic Leukemia and 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 find out how well Campath (alemtuzumab), Rituxan (rituximab), or a combination of the 2 drugs may control Chronic Lymphocytic Leukemia (CLL) that is left after chemotherapy. The safety of these drugs will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Leukemia
- What is being tested?
- Rituximab and Alemtuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Dec 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with CLL, CLL/prolymphocytic leukemia (PLL), or Small Lymphocytic Lymphoma (SLL) who have achieved an National Cancer Institute-Working Group (NCI-WG) nodular partial (nPR) or complete response (CR) with documentation of residual disease by MRD flow cytometry following chemotherapy or chemoimmunotherapy.
- Patients with CLL, CLL/PLL, or SLL who have achieved an NCI-WG partial response (PR) following prior chemotherapy or chemoimmunotherapy.
- Age >/=18 years.
- ECOG performance status </=2.
- Serum creatinine </= 2 mg/dL; serum total bilirubin </= 2 mg/dL; serum AST or ALT <4 x ULN.
- Signed informed consent.
- Male and female patients who are fertile agree to use an effective barrier method of birth control (ie, latex condom, diaphragm, cervical cap, etc.) to avoid pregnancy. Female patients of childbearing potential (non-childbearing is defined as >/= 1 year post-menopausal or surgically sterilized) need a negative serum or urine pregnancy test within 14 days of study enrollment.
Who cannot join
- Past history of anaphylaxis following exposure to rat or mouse derived complementarity determining region (CDR)-grafted humanized monoclonal antibodies.
- Hormonal therapy within 2 weeks prior to study start. Hormonal replacement therapy is permitted.
- Active Hepatitis B (at least one of the following markers positive: HBsAg, HBeAg, IgM anti-HBc, HBV DNA).
- Previous treatment with alemtuzumab plus rituximab in combination.
- Pregnant or nursing women.
- History of HIV infection.
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- Active uncontrolled infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
- Less than 6 months from the completion of prior chemotherapy or chemoimmunotherapy. Completion of prior chemoimmunotherapy is defined as the last day of therapy of the respective treatment regimen.
- Symptomatic CNS disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial of Rituximab vs Alemtuzumab vs Alemtuzumab + Rituximab as Consolidation Therapy for Patients With Chronic Lymphocytic Leukemia (CLL) With Evidence of Residual Disease Following Prior Chemo(Immuno)Therapy
The goal of this clinical research study is to find out how well Campath (alemtuzumab), Rituxan (rituximab), or a combination of the 2 drugs may control Chronic Lymphocytic Leukemia (CLL) that is left after chemotherapy. The safety of these drugs will also be studied.
Read the detailed description
Study Drugs:
Alemtuzumab and rituximab are both monoclonal antibodies. Monoclonal antibodies are proteins designed to attach to a protein on the surface of the leukemia cell. By attaching to the leukemia cell, monoclonal antibodies alert the immune system to target that cell and kill it.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of a dice) to 1 of 3 groups. Group 1 will receive rituximab alone. Group 2 will receive alemtuzumab alone. Group 3 will receive both drugs together.
At the beginning of the study, the chance of being assigned into any of the groups is about equal. However, once enough participants are on study and the response rate in each group is known, you will have a slightly better chance of being assigned to the group with the highest response rate.
Study Drug Administration:
Group 1:
If you are in Group 1, rituximab will be given through a needle in your vein 1 time a week for 4 weeks. The first time you receive rituximab, it will be given over about 4-6 hours. Depending on any side effects you may have, the later infusions may be given over about 2-4 hours.
Before each dose of rituximab, you will receive drugs such as benadryl (diphenhydramine), Tylenol (acetaminophen), and sometimes steroids (either by mouth or into your vein) to try and prevent and/or help control side effects such as fevers and chills.
To help prevent infections, you will take the antibiotic valacyclovir (or a similar drug). Valacyclovir is taken 1 time a day every day. Your doctor will describe this to you in more detail.
Group 2:
If you are in Group 2, alemtuzumab will be given as an injection under your skin 3 times a week for 13 weeks. You will have to come to the clinic for each dose, learn how to inject it yourself, or have someone else taught how to inject you.
To help prevent infections, you will take the antibiotic trimethoprin/sulfamethoxazole (SMX). Your doctor will tell you if you will take the tablet 2 times a day either 3 times a week (Monday, Wednesday, and Friday) or 2 times a week (Saturday and Sunday). You will also take either the antibiotic valganciclovir or valacyclovir. Valganciclovir tablets are taken 2 times every day. Valacyclovir is taken 1 time a day every day. You will continue to take the antibiotics for at least 3 months after your last dose of alemtuzumab.
Group 3:
If you are in Group 3, rituximab will be given through a needle in your vein 1 time a week for 4 weeks. The first time you receive the rituximab, it will be given over about 4-6 hours. Depending on any side effects you may have, the later infusions may be given over about 2-4 hours.
Alemtuzumab will be given as an injection under your skin 3 times a week for 13 weeks. You will have to come to the clinic for each dose, learn how to inject it yourself, or have someone else taught how to inject you.
Before each dose of rituximab, you will receive drugs such as benadryl (diphenhydramine), Tylenol (acetaminophen), and sometimes steroids (either by mouth or into your vein) to try and prevent and/or help control side effects.
To help prevent infections, you will take the antibiotic trimethoprin/sulfamethoxazole (SMX). Your doctor will tell you if you will take the tablet 2 times a day either 3 times a week (Monday, Wednesday, and Friday) or 2 times a week (Saturday and Sunday). You will also take either the antibiotic valganciclovir or valacyclovir. Valganciclovir tablets are taken 2 times every day. Valacyclovir is taken 1 time a day every day. You will continue to take the antibiotics for at least 3 months after your last dose of alemtuzumab.
Study Visits:
Every week while you are receiving therapy, blood (about 1 tablespoon) will be drawn for routine tests.
Six (6), 12, and 18 weeks (+/- 1 week) after you begin receiving the study drug(s) and then every 6 months (+/- 1 month) after that, you will have bone marrow biopsies and/or aspirates to check the status of the disease and to check for residual disease.
Every 6 months (+/- 3 months) after you have stopped receiving therapy, you will have a physical exam and blood (about 1 tablespoon) will be drawn for routine tests.
If you are in Group 2 or 3, during Week 3 and 6, blood (about 1 teaspoon) will be drawn to check for the cytomegalovirus (CMV) infection. This infection may occur in people with weakened immune systems.
If your doctor thinks it is necessary, you will have a chest x-ray and/or other scans.
Length of Study:
If you are in Group 1, you will take the study drug for up to 4 weeks. If you are in Groups 2 or 3, you will take the study drug(s) for up to 13 weeks. You will be taken off treatment early if you have intolerable side effects.
You will remain on study as long as the disease does not get worse.
This is an investigational study. Rituximab is FDA approved and commercially available for non-Hodgkin's lymphoma. However, it is not approved for the treatment of CLL.
Alemtuzumab is FDA approved and commercially available. It has been approved for the treatment of CLL when given by vein. It has not been approved to be given as an injection under the skin or for treatment after chemotherapy.
Up to 100 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Chronic Lymphocytic Leukemia, Leukemia
- Being tested
- Rituximab, Alemtuzumab
- Keywords
- Chronic Lymphocytic Leukemia, Leukemia, CLL, PLL, SLL, Rituximab, Rituxan, Alemtuzumab, Campath
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called Rituxan®
375 mg/m^2 by standard IV (intravenous) infusion on days 1, 8, 15, and 22 of weeks 1-4.
AlemtuzumabDrug
Also called Campath®, Campath-1H
Dose escalation of 3, 10 and 30 mg subcutaneously (SQ) during week 1, followed by dose of 30 mg subcutaneously three times weekly (e.g. Monday-Wednesday - Friday) starting on week 2 for a total of 12 weeks (2-13).
| Study group | Role | What they receive |
|---|---|---|
| Rituximab | Experimental | Group 1: 375 mg/m^2 IV Rituximab Alone Receives: Drug: Rituximab |
| Alemtuzumab | Experimental | Group 2: 30 mg SQ Alemtuzumab Alone Receives: Drug: Alemtuzumab |
| Rituximab + Alemtuzumab | Experimental | Group 3: 375 mg/m^2 Rituximab + 30 mg SQ Alemtuzumab Receives: Drug: Rituximab; Drug: Alemtuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Molecular Remissions at 52 Weeks
Molecular Remissions (minimal residual disease (MRD) flow cytometry-negative) after monoclonal antibody consolidation therapy. Molecular remission is defined as resolution of all detectable disease below the limits of the MRD flow cytometry assay sensitivity.
Measured: 52 weeks
Secondary outcomes (2)
Progression-free Survival
Progression-free survival (PFS) is measured from date of trial entry until documented progression of disease or death from any cause.
Measured: 52 weeks or until disease progression
52 Week Toxicity Rate
The definition of toxicities include any >/= grade 3 non-hematologic toxicity, >/= grade 3 infection, and any symptomatic (i.e. febrile) documented CMV (cytomegalovirus) reactivation, according to NCI-WG definitions.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2008 (estimated)
- Study startAug 2008
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: Lack of 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 Chronic Lymphocytic 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Responsible party
- Sponsor
- Investigators
- Stefan Faderl, M.D., Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00771602
- Sponsor's protocol ID
- 2006-0767
- Status last verified
- May 2015
- First submitted
- 10 Oct 2008
- Last updated
- 23 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Rituximab vs Alemtuzumab vs Alemtuzumab + Rituximab as Consolidation Therapy for Patients With Chronic Lymphocytic Leukemia (CLL) With Evidence of Residual Disease Following Prior Chemo(Immuno)Therapy
- ClinicalTrials.gov ID
- NCT00771602
- Acronym / sponsor ID
- 2006-0767
- Conditions
- Chronic Lymphocytic Leukemia, Leukemia
- Keywords
- Chronic Lymphocytic Leukemia, Leukemia, CLL, PLL, SLL, Rituximab, Rituxan, Alemtuzumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of accrual.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Study start
- Aug 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 13 Oct 2008 (estimated)
- Results
- Posted 29 Apr 2011
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 find out how well Campath (alemtuzumab), Rituxan (rituximab), or a combination of the 2 drugs may control Chronic Lymphocytic Leukemia (CLL) that is left after chemotherapy. The safety of these drugs will also be studied.
Detailed description
Study Drugs:
Alemtuzumab and rituximab are both monoclonal antibodies. Monoclonal antibodies are proteins designed to attach to a protein on the surface of the leukemia cell. By attaching to the leukemia cell, monoclonal antibodies alert the immune system to target that cell and kill it.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of a dice) to 1 of 3 groups. Group 1 will receive rituximab alone. Group 2 will receive alemtuzumab alone. Group 3 will receive both drugs together.
At the beginning of the study, the chance of being assigned into any of the groups is about equal. However, once enough participants are on study and the response rate in each group is known, you will have a slightly better chance of being assigned to the group with the highest response rate.
Study Drug Administration:
Group 1:
If you are in Group 1, rituximab will be given through a needle in your vein 1 time a week for 4 weeks. The first time you receive rituximab, it will be given over about 4-6 hours. Depending on any side effects you may have, the later infusions may be given over about 2-4 hours.
Before each dose of rituximab, you will receive drugs such as benadryl (diphenhydramine), Tylenol (acetaminophen), and sometimes steroids (either by mouth or into your vein) to try and prevent and/or help control side effects such as fevers and chills.
To help prevent infections, you will take the antibiotic valacyclovir (or a similar drug). Valacyclovir is taken 1 time a day every day. Your doctor will describe this to you in more detail.
Group 2:
If you are in Group 2, alemtuzumab will be given as an injection under your skin 3 times a week for 13 weeks. You will have to come to the clinic for each dose, learn how to inject it yourself, or have someone else taught how to inject you.
To help prevent infections, you will take the antibiotic trimethoprin/sulfamethoxazole (SMX). Your doctor will tell you if you will take the tablet 2 times a day either 3 times a week (Monday, Wednesday, and Friday) or 2 times a week (Saturday and Sunday). You will also take either the antibiotic valganciclovir or valacyclovir. Valganciclovir tablets are taken 2 times every day. Valacyclovir is taken 1 time a day every day. You will continue to take the antibiotics for at least 3 months after your last dose of alemtuzumab.
Group 3:
If you are in Group 3, rituximab will be given through a needle in your vein 1 time a week for 4 weeks. The first time you receive the rituximab, it will be given over about 4-6 hours. Depending on any side effects you may have, the later infusions may be given over about 2-4 hours.
Alemtuzumab will be given as an injection under your skin 3 times a week for 13 weeks. You will have to come to the clinic for each dose, learn how to inject it yourself, or have someone else taught how to inject you.
Before each dose of rituximab, you will receive drugs such as benadryl (diphenhydramine), Tylenol (acetaminophen), and sometimes steroids (either by mouth or into your vein) to try and prevent and/or help control side effects.
To help prevent infections, you will take the antibiotic trimethoprin/sulfamethoxazole (SMX). Your doctor will tell you if you will take the tablet 2 times a day either 3 times a week (Monday, Wednesday, and Friday) or 2 times a week (Saturday and Sunday). You will also take either the antibiotic valganciclovir or valacyclovir. Valganciclovir tablets are taken 2 times every day. Valacyclovir is taken 1 time a day every day. You will continue to take the antibiotics for at least 3 months after your last dose of alemtuzumab.
Study Visits:
Every week while you are receiving therapy, blood (about 1 tablespoon) will be drawn for routine tests.
Six (6), 12, and 18 weeks (+/- 1 week) after you begin receiving the study drug(s) and then every 6 months (+/- 1 month) after that, you will have bone marrow biopsies and/or aspirates to check the status of the disease and to check for residual disease.
Every 6 months (+/- 3 months) after you have stopped receiving therapy, you will have a physical exam and blood (about 1 tablespoon) will be drawn for routine tests.
If you are in Group 2 or 3, during Week 3 and 6, blood (about 1 teaspoon) will be drawn to check for the cytomegalovirus (CMV) infection. This infection may occur in people with weakened immune systems.
If your doctor thinks it is necessary, you will have a chest x-ray and/or other scans.
Length of Study:
If you are in Group 1, you will take the study drug for up to 4 weeks. If you are in Groups 2 or 3, you will take the study drug(s) for up to 13 weeks. You will be taken off treatment early if you have intolerable side effects.
You will remain on study as long as the disease does not get worse.
This is an investigational study. Rituximab is FDA approved and commercially available for non-Hodgkin's lymphoma. However, it is not approved for the treatment of CLL.
Alemtuzumab is FDA approved and commercially available. It has been approved for the treatment of CLL when given by vein. It has not been approved to be given as an injection under the skin or for treatment after chemotherapy.
Up to 100 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rituximab | Experimental | Drug: RituximabGroup 1: 375 mg/m^2 IV Rituximab Alone |
| Alemtuzumab | Experimental | Drug: AlemtuzumabGroup 2: 30 mg SQ Alemtuzumab Alone |
| Rituximab + Alemtuzumab | Experimental | Drug: Rituximab, Drug: AlemtuzumabGroup 3: 375 mg/m^2 Rituximab + 30 mg SQ Alemtuzumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with CLL, CLL/prolymphocytic leukemia (PLL), or Small Lymphocytic Lymphoma (SLL) who have achieved an National Cancer Institute-Working Group (NCI-WG) nodular partial (nPR) or complete response (CR) with documentation of residual disease by MRD flow cytometry following chemotherapy or chemoimmunotherapy.
- Patients with CLL, CLL/PLL, or SLL who have achieved an NCI-WG partial response (PR) following prior chemotherapy or chemoimmunotherapy.
- Age >/=18 years.
- ECOG performance status </=2.
- Serum creatinine </= 2 mg/dL; serum total bilirubin </= 2 mg/dL; serum AST or ALT <4 x ULN.
Key exclusion criteria (9 listed)
- Past history of anaphylaxis following exposure to rat or mouse derived complementarity determining region (CDR)-grafted humanized monoclonal antibodies.
- Hormonal therapy within 2 weeks prior to study start. Hormonal replacement therapy is permitted.
- Active Hepatitis B (at least one of the following markers positive: HBsAg, HBeAg, IgM anti-HBc, HBV DNA).
- Previous treatment with alemtuzumab plus rituximab in combination.
- Pregnant or nursing women.
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 |
|---|---|---|
| RituximabAlso: Rituxan®375 mg/m^2 by standard IV (intravenous) infusion on days 1, 8, 15, and 22 of weeks 1-4. | Drug | Rituximab, Rituximab + Alemtuzumab |
| AlemtuzumabAlso: Campath®, Campath-1HDose escalation of 3, 10 and 30 mg subcutaneously (SQ) during week 1, followed by dose of 30 mg subcutaneously three times weekly (e.g. Monday-Wednesday - Friday) starting on week 2 for a total of 12 weeks (2-13). | Drug | Alemtuzumab, Rituximab + Alemtuzumab |
Primary outcome
Number of Patients With Molecular Remissions at 52 Weeks
Time frame: 52 weeks
Molecular Remissions (minimal residual disease (MRD) flow cytometry-negative) after monoclonal antibody consolidation therapy. Molecular remission is defined as resolution of all detectable disease below the limits of the MRD flow cytometry assay sensitivity.
2 secondary outcomes
Progression-free Survival
Time frame: 52 weeks or until disease progression
52 Week Toxicity Rate
Time frame: 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- M.D. Anderson's 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.
Stefan Faderl, M.D. principal investigator
M.D. 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 Rituximab and Alemtuzumab in people with Chronic Lymphocytic Leukemia and 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 7 inclusion and 9 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 23 Jun 2015. 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 29 Apr 2011). 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?
Number of Patients With Molecular Remissions at 52 Weeks (time frame: 52 weeks). 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 23 Jun 2015.