B-Cell Chronic Lymphocytic LeukemiaPhase 2CRC005NCT00800943
Study of Subcutaneous Campath-1H in Patients With B-Cell CLL and Residual Disease After Chemotherapy
A Phase 2 study testing Alemtuzumab (Campath-1H) in people with B-Cell Chronic Lymphocytic Leukemia, run by Chronic Lymphocytic Leukemia Research Consortium at 3 sites in United States.
Trial summary
To evaluate whether CAMPATH-1H given to patients with CLL after maximum response to chemotherapy will: a) eliminate minimal residual disease (documented by flow cytometry) in patients who have achieved a complete remission (CR) or b) convert partial remission to complete remission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-Cell Chronic Lymphocytic Leukemia
- 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
- 31 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2003to Aug 2010
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, at least 18 years old.
- Signed informed consent.
- Zubrod performance status of 0, 1, or 2 (Appendix C).
- Patients with CLL, CLL/PLL or PLL (prolymphocytic) who have achieved a clinical complete remission by NCI-WG criteria with chemotherapy, eg., alkylating agents, fludarabine or chemoimmunotherapy but have documentation of residual disease by immunophenotyping showing: (a) a residual population of CD5 and CD19 positive cells that comprise ≥ 10% of the marrow mononuclear cell population; or (b) a residual population of CD5 and CD19 positive cells that comprise <10% of the marrow mononuclear cells and have a Kappa/Lambda ratio >6 or <.33.
- Patients with CLL who have achieved a partial remission (PR) or nodular partial remission (nPR) by NCI-WG criteria after chemotherapy.
- Creatinine, bilirubin, AST or ALT and alkaline phosphatase ≤2 x the upper limit of normal.
Who cannot join
- Active infection.
- Past history of anaphylaxis, following exposure to rat or mouse derived CDR-grafted humanized monoclonal antibodies.
- Less than 2 months since prior chemotherapy.
- Previous treatment with CAMPATH-1H.
- Pregnant or nursing women.
- Patients on corticosteroids.
- Uncontrolled autoimmune hemolytic anemia.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, 77030-4009
University of California San Diego
La Jolla, California, 92093
About this study
Official title: A Clinical Research Consortium (CRC) Phase II Study of Subcutaneous Campath-1H in Patients With B-Cell Chronic Lymphocytic Leukemia and Residual Disease After Chemotherapy
To evaluate whether CAMPATH-1H given to patients with CLL after maximum response to chemotherapy will: a) eliminate minimal residual disease (documented by flow cytometry) in patients who have achieved a complete remission (CR) or b) convert partial remission to complete remission.
To evaluate the time-to-progression of patients according to pretreatment characteristics and response status at study entry.
To evaluate whether CAMPATH-1H given to patients with CLL after maximum response to chemotherapy will eliminate minimal residual disease as determined by real-time quantitative PCR.
Read the detailed description
Approximately 95% of cases involve the clonal proliferation of B cells. Paraproteins, often of the IgM class, can be detected in the serum and/or urine of most patients with CLL. Unique cell surface markers are increasingly being used to diagnose the disease, and in approximately 40% of patients, cytogenetic abnormalities (for example, trisomy 12) can be found. Patients commonly present with lymphocytosis, lymphadenopathy, splenomegaly and symptoms of fatigue, weight loss, and malaise. In more advanced cases anemia and thrombocytopenia can also occur. The clinical course of CLL is unpredictable, with survival from initial diagnosis varying from 1 to 20 years (2). In addition, there is a subset of patients with indolent CLL whose absolute lymphocyte count is less than 30 x 109/L and who rarely die from the disease.
CLL is commonly staged according to the 5-point system proposed by Rai (Appendix B) and co-workers. While Rai staging is a relatively good predictor of overall survival, it cannot predict the prognosis in individual patients.
- Conditions
- B-Cell Chronic Lymphocytic Leukemia
- Being tested
- Alemtuzumab (Campath-1H)
- Keywords
- Leukemia, Chronic, Chronic Lymphocytic Leukemia, CAMPATH, Alemtuzumab, MabCampath, Subcutaneous, CLL, C-CLL, Residual
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alemtuzumab (Campath-1H)Biological
Campath is administered using escalating doses and alternating injection sites. The dose is escalated as tolerated using 3mg,10mg,and 30mg, administered subcutaneously (SC) (if tolerated). When escalation to 30 mg dose is tolerated, all subsequent doses are administered at 30 mg SC 3 times per week at alternating injection sites for up to 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Campath-1H | Experimental | Not described Receives: Biological: Alemtuzumab (Campath-1H) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate whether CAMPATH-1H given to patients with CLL after maximum response to chemotherapy will: a) eliminate residual disease (documented by flow cytometry) or b) convert partial remission to complete remission
Measured: Response evaluation at end of each course (4 weeks of therapy) (within 0-8 weeks). Patients followed until progressive disease is documented or death
Secondary outcomes (2)
To evaluate the time-to-progression of patients according to pretreatment characteristics and response status at study entry.
Measured: Response evaluation at end of each course (4 weeks of therapy) (within 0-8 weeks). Patients followed until progressive disease is documented or death.
To evaluate whether CAMPATH-1H given to patients with CLL after maximum response to chemotherapy will eliminate minimal residual disease as determined by real-time quantitative PCR.
Measured: Response evaluation at end of each course (4 weeks of therapy) (within 0-8 weeks). Patients followed until progressive disease is documented or death.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study startDec 2003
- Primary completionAug 2010 (estimated)
- Study completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-Cell Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chronic Lymphocytic Leukemia Research Consortium
- Sponsor type
- Research network
- Collaborators
- Bayer
- Investigators
- Thomas Kipps, MD, PhD, Principal investigator, Director, Chronic Lymphocytic Leukemia Research Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800943
- Sponsor's protocol ID
- CRC005
- Acronym
- CRC005
- Status last verified
- Dec 2008
- First submitted
- 1 Dec 2008
- Last updated
- 3 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Research Consortium (CRC) Phase II Study of Subcutaneous Campath-1H in Patients With B-Cell Chronic Lymphocytic Leukemia and Residual Disease After Chemotherapy
- ClinicalTrials.gov ID
- NCT00800943
- Acronym / sponsor ID
- CRC005 / CRC005
- Conditions
- B-Cell Chronic Lymphocytic Leukemia
- Keywords
- Leukemia, Chronic, Chronic Lymphocytic Leukemia, CAMPATH, Alemtuzumab, MabCampath, Subcutaneous, CLL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Chronic Lymphocytic Leukemia Research ConsortiumResearch network
- Collaborators
- Bayer
- Study start
- Dec 2003
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Aug 2010 (estimated)
- First posted
- 3 Dec 2008 (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.
To evaluate whether CAMPATH-1H given to patients with CLL after maximum response to chemotherapy will: a) eliminate minimal residual disease (documented by flow cytometry) in patients who have achieved a complete remission (CR) or b) convert partial remission to complete remission.
To evaluate the time-to-progression of patients according to pretreatment characteristics and response status at study entry.
To evaluate whether CAMPATH-1H given to patients with CLL after maximum response to chemotherapy will eliminate minimal residual disease as determined by real-time quantitative PCR.
Detailed description
Approximately 95% of cases involve the clonal proliferation of B cells. Paraproteins, often of the IgM class, can be detected in the serum and/or urine of most patients with CLL. Unique cell surface markers are increasingly being used to diagnose the disease, and in approximately 40% of patients, cytogenetic abnormalities (for example, trisomy 12) can be found. Patients commonly present with lymphocytosis, lymphadenopathy, splenomegaly and symptoms of fatigue, weight loss, and malaise. In more advanced cases anemia and thrombocytopenia can also occur. The clinical course of CLL is unpredictable, with survival from initial diagnosis varying from 1 to 20 years (2). In addition, there is a subset of patients with indolent CLL whose absolute lymphocyte count is less than 30 x 109/L and who rarely die from the disease.
CLL is commonly staged according to the 5-point system proposed by Rai (Appendix B) and co-workers. While Rai staging is a relatively good predictor of overall survival, it cannot predict the prognosis in individual patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Campath-1H | Experimental | Biological: Alemtuzumab (Campath-1H) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, at least 18 years old.
- Signed informed consent.
- Zubrod performance status of 0, 1, or 2 (Appendix C).
- Patients with CLL, CLL/PLL or PLL (prolymphocytic) who have achieved a clinical complete remission by NCI-WG criteria with chemotherapy, eg., alkylating agents, fludarabine or chemoimmunotherapy but have documentation of residual disease by immunophenotyping showing: (a) a residual population of CD5 and CD19 positive cells that comprise ≥ 10% of the marrow mononuclear cell population; or (b) a residual population of CD5 and CD19 positive cells that comprise <10% of the marrow mononuclear cells and have a Kappa/Lambda ratio >6 or <.33.
- Patients with CLL who have achieved a partial remission (PR) or nodular partial remission (nPR) by NCI-WG criteria after chemotherapy.
Key exclusion criteria (7 listed)
- Active infection.
- Past history of anaphylaxis, following exposure to rat or mouse derived CDR-grafted humanized monoclonal antibodies.
- Less than 2 months since prior chemotherapy.
- Previous treatment with CAMPATH-1H.
- 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 |
|---|---|---|
| Alemtuzumab (Campath-1H)Campath is administered using escalating doses and alternating injection sites. The dose is escalated as tolerated using 3mg,10mg,and 30mg, administered subcutaneously (SC) (if tolerated). When escalation to 30 mg dose is tolerated, all subsequent doses are administered at 30 mg SC 3 times per week at alternating injection sites for up to 8 weeks | Biological | Campath-1H |
Primary outcome
To evaluate whether CAMPATH-1H given to patients with CLL after maximum response to chemotherapy will: a) eliminate residual disease (documented by flow cytometry) or b) convert partial remission to complete remission
Time frame: Response evaluation at end of each course (4 weeks of therapy) (within 0-8 weeks). Patients followed until progressive disease is documented or death
2 secondary outcomes
To evaluate the time-to-progression of patients according to pretreatment characteristics and response status at study entry.
Time frame: Response evaluation at end of each course (4 weeks of therapy) (within 0-8 weeks). Patients followed until progressive disease is documented or death.
To evaluate whether CAMPATH-1H given to patients with CLL after maximum response to chemotherapy will eliminate minimal residual disease as determined by real-time quantitative PCR.
Time frame: Response evaluation at end of each course (4 weeks of therapy) (within 0-8 weeks). Patients followed until progressive disease is documented or death.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2008.
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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.
Thomas Kipps, MD, PhD principal investigator
Director, Chronic Lymphocytic Leukemia Research Consortium
3 sites 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 (Campath-1H) in people with B-Cell Chronic Lymphocytic Leukemia, run by Chronic Lymphocytic Leukemia Research Consortium at 3 sites 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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 3 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
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?
To evaluate whether CAMPATH-1H given to patients with CLL after maximum response to chemotherapy will: a) eliminate residual disease (documented by flow cytometry) or b) convert partial remission to complete remission (time frame: Response evaluation at end of each course (4 weeks of therapy) (within 0-8 weeks). Patients followed until progressive disease is documented or death). 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 3 Dec 2008.