LeukemiaPhase 2NCT00833534
Lenalidomide With or Without Rituximab in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Who Have Undergone Autologous or Syngeneic Stem Cell Transplant
A Phase 2 study testing rituximab and lenalidomide in people with Leukemia and Lymphoma, run by Fred Hutchinson Cancer Center.
Trial summary
RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- rituximab and lenalidomide
- Type of treatment
- Pill or oral medicine, 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
- Feb 2009to not given
- 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
DISEASE CHARACTERISTICS:
- Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
- Any stage disease
- Prior histological documentation of CD20+ CLL or SLL
- Has undergone autologous or syngeneic stem cell transplantation comprising high-dose therapy with peripheral blood stem cell rescue within the past 30-120 days
- No progressive disease after transplantation
- Has had stable disease or some degree of response to transplantation
- No history of CNS involvement
PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- Platelet count ≥ 50,000/mm³* (transfusion independent)
- ANC ≥ 1,500/mm³*
- Total bilirubin ≤ 2 mg/mL (unless due to Gilbert's disease)
- SGOT/SGPT ≤ 2.5 times upper limit of normal
- Serum creatinine ≤ 2 mg/mL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use 2 effective methods of contraception for at least 28 days before, during, and for at least 28 days after completion of study therapy
- Patients and their physician must be registered in the RevAssist® program and be willing and able to comply with the requirements of RevAssist®
- LVEF ≥ 45% immediately prior to transplant
- No uncontrolled congestive heart disease
- No history of myocardial infarction or coronary artery disease
- No peripheral neuropathy ≥ grade 3
- No allergy to lenalidomide, thalidomide, allopurinol, or rituximab
- No known hepatitis B, hepatitis C, or HIV seropositivity
- No other malignancies within the past 5 years, except for adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast
- No concurrent serious uncontrolled medical or psychiatric illness, including serious infection NOTE: *For 5 calendar days after transplant
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior CD34-selected stem cell product
- No chemotherapy or biologic therapy for CLL after transplant
- Prior rituximab administered before stem cell collection allowed
- Prior lenalidomide administered before transplant allowed provided patient responded to lenalidomide
- No concurrent sargramostim (GM-CSF)
- No other concurrent anticancer therapies, including radiotherapy or thalidomide
- No other concurrent investigational agents
About this study
Official title: Consolidation Therapy With Lenalidomide (Revlimid®) With or Without Rituximab Followed by Maintenance Therapy With Revlimid® After Autologous/Syngeneic Transplant for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether lenalidomide is more effective with or without rituximab in treating chronic lymphocytic leukemia or small lymphocytic lymphoma.
PURPOSE: This phase II trial is studying how well lenalidomide works when given with or without rituximab in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have undergone autologous or syngeneic stem cell transplant.
Read the detailed description
OBJECTIVES:
Primary
- To evaluate the efficacy of consolidation therapy comprising lenalidomide with or without rituximab followed by maintenance therapy comprising lenalidomide in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have undergone autologous or syngeneic stem cell transplantation.
OUTLINE:
- Consolidation phase: Patients are assigned to 1 of 2 treatment groups.
- Group I: Patients receive oral lenalidomide once daily on days 1-14. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
- Group II: Patients receive lenalidomide as in group I. Patients also receive rituximab IV once on the day before the start of lenalidomide and then once between days 25-30, 50-55, and 75-80 for a total of 4 doses in the absence of disease progression or unacceptable toxicity.
- Maintenance phase: Beginning 2 months after completion of consolidation therapy, all patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 18 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 28 days and then annually thereafter.
- Being tested
- rituximab, lenalidomide
- Keywords
- stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, stage I small lymphocytic lymphoma, stage III small lymphocytic lymphoma, stage IV small lymphocytic lymphoma, contiguous stage II small lymphocytic lymphoma, noncontiguous stage II small lymphocytic lymphoma
- Medical subject headings
- Leukemia, Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximabBiological
Given IV
lenalidomideDrug
Given orally
| Study group | Role | What they receive |
|---|---|---|
| Group I (consolidation phase) | Experimental | Patients receive oral lenalidomide once daily on days 1-14. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: lenalidomide |
| Group II (consolidation phase) | Experimental | Patients receive lenalidomide as in group I. Patients also receive rituximab IV once on the day before the start of lenalidomide and then once between days 25-30, 50-55, and 75-80 for a total of 4 doses in the absence of disease progression or unacceptable toxicity. Receives: Biological: rituximab; Drug: lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of lenalidomide with or without rituximab as consolidation therapy and lenalidomide as maintenance therapy
Disease-free survival at 2 years after transplant
Secondary outcomes (5)
Toxicity during consolidation and maintenance therapy as assessed by NCI CTCAE v3.0
Ability to complete planned therapy
Complete hematological remission, including bone marrow IgH remission status as assessed by PCR after consolidation and maintenance therapy
Time to disease progression
Relapse rates
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2009 (estimated)
- Study startFeb 2009
Why it stopped: No patient enrolled on study. Did not get patients in timely fashion. All referrals for study when assessed were not eligible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Leona A. Holmberg, MD, PhD, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833534
- Sponsor's protocol ID
- 2150.00
- Other IDs
- P30CA015704, FHCRC-2150.00, IR-6846, CDR0000633628
- Status last verified
- Mar 2015
- First submitted
- 30 Jan 2009
- Last updated
- 6 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consolidation Therapy With Lenalidomide (Revlimid®) With or Without Rituximab Followed by Maintenance Therapy With Revlimid® After Autologous/Syngeneic Transplant for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- ClinicalTrials.gov ID
- NCT00833534
- Acronym / sponsor ID
- 2150.00
- Keywords
- stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, stage I small lymphocytic lymphoma, stage III small lymphocytic lymphoma, stage IV small lymphocytic lymphoma, contiguous stage II small lymphocytic lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patient enrolled on study. Did not get patients in timely fashion. All referrals for study when assessed were not eligible.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2009
- First posted
- 2 Feb 2009 (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.
RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether lenalidomide is more effective with or without rituximab in treating chronic lymphocytic leukemia or small lymphocytic lymphoma.
PURPOSE: This phase II trial is studying how well lenalidomide works when given with or without rituximab in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have undergone autologous or syngeneic stem cell transplant.
Detailed description
OBJECTIVES:
Primary
- To evaluate the efficacy of consolidation therapy comprising lenalidomide with or without rituximab followed by maintenance therapy comprising lenalidomide in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have undergone autologous or syngeneic stem cell transplantation.
OUTLINE:
- Consolidation phase: Patients are assigned to 1 of 2 treatment groups.
- Group I: Patients receive oral lenalidomide once daily on days 1-14. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
- Group II: Patients receive lenalidomide as in group I. Patients also receive rituximab IV once on the day before the start of lenalidomide and then once between days 25-30, 50-55, and 75-80 for a total of 4 doses in the absence of disease progression or unacceptable toxicity.
- Maintenance phase: Beginning 2 months after completion of consolidation therapy, all patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 18 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 28 days and then annually thereafter.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (consolidation phase) | Experimental | Drug: lenalidomidePatients receive oral lenalidomide once daily on days 1-14. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. |
| Group II (consolidation phase) | Experimental | Biological: rituximab, Drug: lenalidomidePatients receive lenalidomide as in group I. Patients also receive rituximab IV once on the day before the start of lenalidomide and then once between days 25-30, 50-55, and 75-80 for a total of 4 doses in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| rituximabGiven IV | Biological | Group II (consolidation phase) |
| lenalidomideGiven orally | Drug | Group I (consolidation phase), Group II (consolidation phase) |
Primary outcome
Efficacy of lenalidomide with or without rituximab as consolidation therapy and lenalidomide as maintenance therapy
Disease-free survival at 2 years after transplant
5 secondary outcomes
Toxicity during consolidation and maintenance therapy as assessed by NCI CTCAE v3.0
Ability to complete planned therapy
Complete hematological remission, including bone marrow IgH remission status as assessed by PCR after consolidation and maintenance therapy
Time to disease progression
Relapse rates
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 6 Mar 2015.
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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.
Leona A. Holmberg, MD, PhD principal investigator
Fred Hutchinson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rituximab and lenalidomide in people with Leukemia and Lymphoma, run by Fred Hutchinson Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 6 Mar 2015. 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?
Efficacy of lenalidomide with or without rituximab as consolidation therapy and lenalidomide as maintenance therapy. The study lists 2 primary outcomes in all. 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 6 Mar 2015.