VZCLLPI0146: Study Examining the Combination of Revlimid (Lenalidomide)and Vidaza (Azacitidine) for Relapsed/Refractory CLL and SLL
Study Details
Study Description
Brief Summary
To determine the response to the combination of Revlimid (Lenalidomide)+ Vidaza (Azacitidine) in patients with relapsed/refractory CLL and SLL
Hypothesis- lenalidomide's activity in combination with azacitidine may further enhance its activity and the durability of treatment response.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Detailed Description
Treatment response of lenalidomide's activity in combination with azacitidine may further enhance its activity and the durability of treatment response.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: response to Vidaza + Revlimid response to combination of azacitidine + lenalidomide A Phase II, Single Arm Study Examining the Combination of Revlimid (Lenalidomide) and Vidaza (Azacitidine) (RA-CLL) for the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL) |
Drug: Revlimid
Lenalidomide PO daily Day 1-21. For patients with baseline calculated creatinine clearance ≥ 30 ml/min and < 60 ml/min the starting dose is 5 mg every other day (odd numbered days during Days 1-21). For patients with baseline calculated creatinine clearance ≥ 60 ml/min the starting dose is 5 mg daily on Days 1-21).
Other Names:
Drug: Azacitidine
Azacitidine 75 mg/m2 IV or SC D 1-5
Other Names:
|
Outcome Measures
Primary Outcome Measures
- the Rate of Response to the Combination of Azacitidine + Lenalidomide in Select Patients [9 Months]
the rate of response to the combination of azacitidine + lenalidomide in select patients with relapsed/refractory CLL and small lymphocytic lymphoma (SLL).
Secondary Outcome Measures
- Assess for Treatment Related Toxicity Following Administration of Lenalidomide/ Azacitidine. [30 days after treatment completion (up to 10 Months)]
- The Progression Free Survival of Patients Treated With the Combination of Lenalidomide and Azacitidine [9 Months]
- The Overall Survival of Patients Treated With the Combination of Lenalidomide and Azacitidine [9 Months]
Eligibility Criteria
Criteria
Inclusion Criteria:
Patients must be age ≥ 18 must have an ECOG PS ≤ 2 must understand and voluntarily sign informed consent adhere to the study protocol requirements and schedule must carry the diagnosis of B-CLL/SLL, SLL/CLL must be defined as relapsed or refractory disease Pts. must have received and failed at least one purine-based treatment regimen (ie. FCR, FR, PCR, Fludarabine) or alemtuzumab-based regimen or bendamustine-based regimen prior to study enrollment Serum bilirubin levels <1.5 times the upper limit of the normal range for the laboratory (ULN) Higher levels are acceptable if these can be attributed to active hemolysis, ineffective erythropoiesis or Gilbert's disease.Serum (SGOT) [AST])(SGPT) [ALT]) levels <2 x ULN or <5 x ULN if hepatic metastases are present) Subjects must have calculated creatinine clearance ≥ 30ml/min Absolute neutrophil count > 1.0 x 109 / L Platelet count > 50x 109 / L (unless bone marrow is heavily infiltrated with underlying disease (50% or more) Disease free of prior 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 All participants must be registered into the mandatory RevAssist® program Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin) Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours prior to prescribing lenalidomide (prescriptions must be filled within 7 days) 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.
Exclusion Criteria: - Patient must not have any serious medical condition, laboratory abnormality, or psychiatric illness that would places the subject at unacceptable risk or confound the interpretation of data from the study Patients must be lenalidomide / azacitidine naïve prior to study enrollment Patients must not be HIV, Hepatitis B or Hepatitis C positive, except for Patients who are seropositive because of hepatitis B virus vaccine are eligible Patients must not have received chemotherapy, immunotherapy or any experimental study drug for CLL or SLL at least 4 weeks prior to study enrollment and initiation of treatment Patients with history of B-CLL and the development of prolymphocytic leukemia or Richter's transformation Known or suspected hypersensitivity to azacitidine, mannitol, thalidomide or Lenalidomide Pregnant or breast feeding females are not eligible or lactating females must agree not to breast feed while taking Lenalidomide Evidence of laboratory TLS by Cairo-Bishop Definition of Tumor Lysis Syndrome Subjects may be enrolled upon correction of electrolyte abnormalities Patients with advanced malignant hepatic tumors; Concurrent use of other anti-cancer agents or treatments, or Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
Sponsors and Collaborators
- Hackensack Meridian Health
- Celgene Corporation
Investigators
- Principal Investigator: Anthony Mato, MD, Hackensack Meridian Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00001361
Study Results
Participant Flow
Recruitment Details | A total of five subject participated in the trial. |
---|---|
Pre-assignment Detail | A total of five patients were screened and consented for study and scheduled to start cycle 1 |
Arm/Group Title | Revlimid (Lenalidomide)and Vidaza (Azacitidine) |
---|---|
Arm/Group Description | Study Examining the Combination of Revlimid (Lenalidomide)and Vidaza (Azacitidine) for Relapsed/Refractory CLL and SLL. |
Period Title: Overall Study | |
STARTED | 5 |
COMPLETED | 0 |
NOT COMPLETED | 5 |
Baseline Characteristics
Arm/Group Title | Revlamid + Vidaza |
---|---|
Arm/Group Description | The study was closed early due to poor accrual on 8/17/2011 - therefore we do not have the power to answer the primary question. |
Overall Participants | 5 |
Age (Count of Participants) | |
<=18 years |
0
0%
|
Between 18 and 65 years |
1
20%
|
>=65 years |
4
80%
|
Sex: Female, Male (Count of Participants) | |
Female |
2
40%
|
Male |
3
60%
|
Ethnicity (NIH/OMB) (Count of Participants) | |
Hispanic or Latino |
1
20%
|
Not Hispanic or Latino |
4
80%
|
Unknown or Not Reported |
0
0%
|
Race (NIH/OMB) (Count of Participants) | |
American Indian or Alaska Native |
0
0%
|
Asian |
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
Black or African American |
0
0%
|
White |
4
80%
|
More than one race |
0
0%
|
Unknown or Not Reported |
1
20%
|
Outcome Measures
Title | the Rate of Response to the Combination of Azacitidine + Lenalidomide in Select Patients |
---|---|
Description | the rate of response to the combination of azacitidine + lenalidomide in select patients with relapsed/refractory CLL and small lymphocytic lymphoma (SLL). |
Time Frame | 9 Months |
Outcome Measure Data
Analysis Population Description |
---|
Zero patients achieved a response to the combination |
Arm/Group Title | Study Terminated |
---|---|
Arm/Group Description | Study terminated - closed early |
Measure Participants | 5 |
Number [participants] |
0
0%
|
Title | Assess for Treatment Related Toxicity Following Administration of Lenalidomide/ Azacitidine. |
---|---|
Description | |
Time Frame | 30 days after treatment completion (up to 10 Months) |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Revlamid + Vidaza |
---|---|
Arm/Group Description | The study was closed early due to poor accrual on 8/17/2011 - therefore we do not have the power to answer the primary question. |
Measure Participants | 5 |
Number [participants] |
1
20%
|
Title | The Progression Free Survival of Patients Treated With the Combination of Lenalidomide and Azacitidine |
---|---|
Description | |
Time Frame | 9 Months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Revlamid + Vidaza |
---|---|
Arm/Group Description | The study was closed early due to poor accrual on 8/17/2011 - therefore we do not have the power to answer the primary question. |
Measure Participants | 4 |
Median (Full Range) [Months] |
1
|
Title | The Overall Survival of Patients Treated With the Combination of Lenalidomide and Azacitidine |
---|---|
Description | |
Time Frame | 9 Months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Revlamid + Vidaza |
---|---|
Arm/Group Description | The study was closed early due to poor accrual on 8/17/2011 - therefore we do not have the power to answer the primary question. |
Measure Participants | 5 |
Number [participants] |
5
100%
|
Adverse Events
Time Frame | ||
---|---|---|
Adverse Event Reporting Description | ||
Arm/Group Title | Revlimid + Vidaza | |
Arm/Group Description | Drug: Revlimid Lenalidomide PO daily Day 1-21. For patients with baseline calculated creatinine clearance ≥ 30 ml/min and < 60 ml/min the starting dose is 5 mg every other day (odd numbered days during Days 1-21). For patients with baseline calculated creatinine clearance ≥ 60 ml/min the starting dose is 5 mg daily on Days 1-21). Other Names: Lenalidomide Drug: Azacitidine Azacitidine 75 mg/m2 IV or SC D 1-5 Other Names: Vidaza | |
All Cause Mortality |
||
Revlimid + Vidaza | ||
Affected / at Risk (%) | # Events | |
Total | / (NaN) | |
Serious Adverse Events |
||
Revlimid + Vidaza | ||
Affected / at Risk (%) | # Events | |
Total | 2/5 (40%) | |
Investigations | ||
Disease Progression | 1/5 (20%) | 1 |
Musculoskeletal and connective tissue disorders | ||
Pelvic Pain | 1/5 (20%) | 1 |
Nervous system disorders | ||
Syncope | 1/5 (20%) | 1 |
Other (Not Including Serious) Adverse Events |
||
Revlimid + Vidaza | ||
Affected / at Risk (%) | # Events | |
Total | 0/5 (0%) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Dr. Anthony Mato |
---|---|
Organization | Hackensack University Medical Center |
Phone | 551-996-2000 |
AMato@hackensackumc.org |
- Pro00001361