Leukemia, Lymphocytic, Chronic, B-CellPhase 1NCT01005979
A Phase I Trial Using Cyclophosphamide, Rituximab and Revlimid (CR2) for the Treatment of Relapsed/Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL) and Small Lymphocytic Lymphoma (SLL)
A Phase 1 study testing Lenalidomide, Rituximab, and Cyclophosphamide in people with Leukemia, Lymphocytic, Chronic, B-Cell and Chronic Lymphocytic Leukemia, run by Emory University at 1 site in United States.
Trial summary
The purpose of this study is to determine the maximum tolerated dose (MTD), safety and toxicity when cyclophosphamide, rituximab and lenalidomide (Revlimid) are combined for the treatment of relapsed/refractory of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Lymphocytic, Chronic, B-Cell, Chronic Lymphocytic Leukemia, Lymphoma, Small Lymphocytic
- What is being tested?
- Lenalidomide, Rituximab, and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Oct 2012
- Phase
- Phase 1
- 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
- Understand and voluntarily sign an informed consent form.
- Age ≥ 18 years at the time of signing the informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements.
- Relapsed/refractory B-cell CLL or SLL
- All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 2 weeks prior to treatment in this study.
- Patients must have received at least one prior therapy and must meet the NCI Working Group (NCI WG) Criteria for treatment of B-CLL as described in Appendix D.
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- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 at study entry (see Appendix C).
- Laboratory test results within these ranges (unless related to CLL involvement):
- Absolute neutrophil count ≥ 1000 /mm3
- Platelet count ≥ 50,000/mm³
- Serum creatinine ≤ 1.5 mg/dL. Serum creatinine > 1.5 mg/dL requires creatinine clearance of ≥ 60 mL/min by Cockroft-Gault formula.
- Total bilirubin ≤ 1.5 mg/dL
- Aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) ≤ 2 x upper limit of normal (ULN) or ≤ 5 x ULN if hepatic metastases are present.
- Disease free of second malignancies for ≥ 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast.
- Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 milli-International Units (mIU)/mL within 10 - 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. See Appendix A: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods, AND also Appendix B: Education and Counseling Guidance Document.
- Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use warfarin or low molecular weight heparin).
Who cannot join
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Evidence of laboratory tumor lysis syndrome (TLS) by Cairo-Bishop criteria (Appendix J) (subjects may be enrolled upon correction of electrolyte abnormalities).
- Use of any other experimental drug or therapy within 28 days of baseline.
- Known hypersensitivity to thalidomide.
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- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- Any prior use of lenalidomide.
- Concurrent use of other anti-cancer agents or treatments.
- Known positive for HIV or infectious hepatitis, type A, B or C.
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322
About this study
Official title: A Phase I Trial Using Cyclophosphamide, Rituximab and Revlimid (CR2) for the Treatment of Relapsed/Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL) and SLL
The purpose of this study is to determine the maximum tolerated dose (MTD), safety and toxicity when cyclophosphamide, rituximab and lenalidomide (Revlimid) are combined for the treatment of relapsed/refractory of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
- Conditions
- Leukemia, Lymphocytic, Chronic, B-Cell, Chronic Lymphocytic Leukemia, Lymphoma, Small Lymphocytic
- Being tested
- Lenalidomide, Rituximab, and Cyclophosphamide
- Keywords
- Leukemia, Lymphocytic, Chronic, B-Cell, Chronic Lymphocytic Leukemia, Lymphoma, Small Lymphocytic, Lymphoma, Leukemia
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenalidomide, Rituximab, and CyclophosphamideDrug
Also called Revlimid, Rituxan, Mab Thera, Endoxan
COHORT 1: Cyclophosphamide 250 mg/m2 day 1, 2 and 3, Rituximab 500 mg/m2 i.v. day 1, Lenalidomide 2.5 mg/day starting day 8-28 of Cycle 1 and then daily on Days 1-28 of subsequent cycles
COHORT 2: Cyclophosphamide 250mg/m2 day 1, 2 and 3. Rituximab 500 mg.m2 i.v. daY Lenalidomide 5 mg/day starting day 8 -28 of Cycle 1 and then daily on Days 1-28 of subsequent cycles
COHORT 3: Cyclophosphamide 250mg/m2 day 1, 2 and 3, Rituximab 500 mg.m2 i.v. day 1, Lenalidomide 10 mg/day starting day 8 -28 of Cycle 1 and then daily on Days 1-28 of subsequent cycles
COHORT 4: Cyclophosphamide 250mg/m2 day 1, 2 and 3, Rituximab 500 mg.m2 i.v. day 1, Lenalidomide 15 mg/day starting day 8 -28 of Cycle 1 and then daily on Days 1-28 of subsequent cycles
Patients will receive a total of 6-8 cycles.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Lenalidomide, Rituximab, and Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is to determine the maximum tolerated dose of lenalidomide in combination with cyclophosphamide and rituximab for the treatment of CLL or SLL.
Measured: Day 28 of the first cycle of chemotherapy
Secondary outcomes (1)
Assess response criteria, including complete response rate, survival at 1 year, time to progression, duration of response, and eradication of minimal residual disease.
Measured: Response will be measured after 4 cycles, at the end of treatment and then every 3 months post treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startJul 2010
- Primary completionOct 2012
Why it stopped: Slow Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Lymphocytic, Chronic, B-CellStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Principal investigator, Christopher R. Flowers, Emory University
- Investigators
- Rajni Sinha, MD, Principal investigator, Emory University Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005979
- Sponsor's protocol ID
- IRB00024085
- Other IDs
- WCI1642-09
- Status last verified
- Aug 2014
- First submitted
- 30 Sep 2009
- Last updated
- 13 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial Using Cyclophosphamide, Rituximab and Revlimid (CR2) for the Treatment of Relapsed/Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL) and SLL
- ClinicalTrials.gov ID
- NCT01005979
- Acronym / sponsor ID
- IRB00024085
- Conditions
- Leukemia, Lymphocytic, Chronic, B-Cell, Chronic Lymphocytic Leukemia, Lymphoma, Small Lymphocytic
- Keywords
- Leukemia, Lymphocytic, Chronic, B-Cell, Chronic Lymphocytic Leukemia, Lymphoma, Small Lymphocytic, Lymphoma, Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Accrual
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Jul 2010
- Primary completion
- Oct 2012 (actual)
- First posted
- 2 Nov 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.
The purpose of this study is to determine the maximum tolerated dose (MTD), safety and toxicity when cyclophosphamide, rituximab and lenalidomide (Revlimid) are combined for the treatment of relapsed/refractory of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Lenalidomide, Rituximab, and Cyclophosphamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Understand and voluntarily sign an informed consent form.
- Age ≥ 18 years at the time of signing the informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements.
- Relapsed/refractory B-cell CLL or SLL
- All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 2 weeks prior to treatment in this study.
Key exclusion criteria (10 listed)
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Evidence of laboratory tumor lysis syndrome (TLS) by Cairo-Bishop criteria (Appendix J) (subjects may be enrolled upon correction of electrolyte abnormalities).
- Use of any other experimental drug or therapy within 28 days of baseline.
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 |
|---|---|---|
| Lenalidomide, Rituximab, and CyclophosphamideAlso: Revlimid, Rituxan, Mab Thera, EndoxanCOHORT 1: Cyclophosphamide 250 mg/m2 day 1, 2 and 3, Rituximab 500 mg/m2 i.v. day 1, Lenalidomide 2.5 mg/day starting day 8-28 of Cycle 1 and then daily on Days 1-28 of subsequent cycles COHORT 2: Cyclophosphamide 250mg/m2 day 1, 2 and 3. Rituximab 500 mg.m2 i.v. daY Lenalidomide 5 mg/day starting day 8 -28 of Cycle 1 and then daily on Days 1-28 of subsequent cycles COHORT 3: Cyclophosphamide 250mg/m2 day 1, 2 and 3, Rituximab 500 mg.m2 i.v. day 1, Lenalidomide 10 mg/day starting day 8 -28 of Cycle 1 and then daily on Days 1-28 of subsequent cycles COHORT 4: Cyclophosphamide 250mg/m2 day 1, 2 and 3, Rituximab 500 mg.m2 i.v. day 1, Lenalidomide 15 mg/day starting day 8 -28 of Cycle 1 and then daily on Days 1-28 of subsequent cycles Patients will receive a total of 6-8 cycles. | Drug | A |
Primary outcome
The primary endpoint is to determine the maximum tolerated dose of lenalidomide in combination with cyclophosphamide and rituximab for the treatment of CLL or SLL.
Time frame: Day 28 of the first cycle of chemotherapy
1 secondary outcome
Assess response criteria, including complete response rate, survival at 1 year, time to progression, duration of response, and eradication of minimal residual disease.
Time frame: Response will be measured after 4 cycles, at the end of treatment and then every 3 months post treatment.
Results and safety
The study was stopped early (reason given: Slow Accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2014.
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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.
Rajni Sinha, MD principal investigator
Emory University Winship Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lenalidomide, Rituximab, and Cyclophosphamide in people with Leukemia, Lymphocytic, Chronic, B-Cell and Chronic Lymphocytic Leukemia, run by Emory University 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 16 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: stopped early, as of the sponsor's last update on 13 Aug 2014. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 stopped early (reason given: Slow Accrual). 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?
The primary endpoint is to determine the maximum tolerated dose of lenalidomide in combination with cyclophosphamide and rituximab for the treatment of CLL or SLL. (time frame: Day 28 of the first cycle of chemotherapy). 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 13 Aug 2014.