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Chronic Lymphocytic LeukemiaPhase 1/2NCT00829647

A Study Using Two Oral Chemotherapy Agents for Chronic Lymphocytic Leukemia

A Phase 1/2 study testing dasatinib and lenalidomide in people with Chronic Lymphocytic Leukemia and Leukemia, run by Scripps Health.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Dasatinib and lenalidomide are both prescribed for use in patients with different cancers of the blood. This study is experimental because neither drug has been approved by the Food and Drug Administration for the treatment of chronic lymphocytic leukemia. 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?
dasatinib and lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jan 2009to 1 Mar 2016
Phase
Phase 1/2
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

  • Understand and voluntarily sign a written informed consent including a HIPAA form according to institutional guidelines
  • Age ≥18 years at the time of signing the informed consent form.
  • Able to adhere to the study visit schedule and other protocol requirements.
  • Immunophenotypically confirmed diagnosis of B-CLL, who either have Rai stage III/IV disease or require treatment for Rai stage I/II disease as defined by criteria based on the NCI 1996 guidelines (Appendix VII and IX).
  • Relapsed and/or refractory disease to a purine nucleoside analogue (pentostatin, fludarabine, or cladribine). Relapse is defined as a patient who has previously achieved the clinicopathologic criteria for a CR or PR, but after a period of ≥ 6 months demonstrates evidence of disease progression. Refractory is defined as a patient progressing on therapy or who cannot maintain at least a PR for ≥ 6 months (Appendix IV). The patient may have had therapy subsequent to receiving a purine nucleoside analogue, but must also have relapsed or been refractory to this most recent therapy (Appendix IV).
  • ECOG performance status of ≤ 2 at study entry (see Appendix X).
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  • Laboratory test results within these ranges:
  • Absolute neutrophil count ≥ 1,000/mm3
  • Platelet count ≥ 50,000/mm³
  • Serum creatinine ≤ 1.5 mg/dL. Subjects with serum creatinine > 1.5 mg/dL may be eligible if they have creatinine clearance of ≥ 60 mL/min by Cockroft-Gault formula.
  • Total bilirubin ≤ 1.5 mg/dL
  • AST (SGOT) and ALT (SGPT) ≤ 2 x ULN or ≤ 5 x ULN if hepatic metastases are present.
  • 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. Patients with low- and intermediate-risk prostate cancer who have had either local therapy (radiation or surgery) or are actively receiving hormonal therapy will also be allowed. Patients being observed with "watchful waiting" will be excluded. Low- and intermediate-risk prostate cancer will be defined as PSA ≤ 20, Gleason score ≤ 7, and AJCC clinical stage of ≤ T2b.
  • 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 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 I: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods, AND also Appendix II: Education and Counseling Guidance Document.
  • Ability to take oral medication (dasatinib and lenalidomide must be swallowed whole).
  • Concomitant Medications
  • Patient agrees to discontinue St. Johns Wort while receiving dasatinib therapy (discontinue St. Johns Wort at least 5 days before starting dasatinib)
  • Bisphosphonate use will be restricted

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 and/or dasatinib)
  • 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.
  • Use of any other experimental drug or therapy within 28 days of baseline.
  • Known hypersensitivity to thalidomide
  • The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
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  • Any prior use of lenalidomide or dasatinib
  • Known positive for HIV or infectious hepatitis, type A, B or C.
  • Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness
  • Women who:
  • are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study drug, or
  • have a positive pregnancy test at baseline, or
  • are pregnant or breastfeeding
  • Concomitant Medications, any of the following should be considered for exclusion:
  • Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Patients must discontinue drug 7 days prior to starting dasatinib)
  • quinidine, procainamide, disopyramide
  • amiodarone, sotalol, ibutilide, dofetilide
  • erythromycin, clarithromycin
  • chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide
  • cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine
  • History of significant bleeding disorder unrelated to cancer, including:
  • Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)
  • Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)
  • Ongoing or recent (≤ 3 months) significant bleeding from any cause
  • Cardiac Symptoms; any of the following should be considered for exclusion:
  • Uncontrolled angina, congestive heart failure or MI within (6 months)
  • Diagnosed congenital long QT syndrome
  • Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)
  • Prolonged QTc interval on pre-entry electrocardiogram (> 450 msec)
  • Subjects with hypokalemia or hypomagnesemia if it cannot be corrected prior to dasatinib administration
  • Concurrent medical condition which may increase the risk of toxicity, including:
  • Pleural or pericardial effusion of any grade
  • Evidence of laboratory TLS by Cairo-Bishop criteria (Appendix XIII) (subjects may be enrolled upon correction of electrolyte abnormalities)
  • Patients with an increased risk for thromboembolic events at baseline, including patients with a history of prior thrombosis

About this study

Official title: A Phase I/II Study of Combination Dasatinib and Lenalidomide in Purine Analogue-Failed Chronic Lymphocytic Leukemia

Dasatinib and lenalidomide are both prescribed for use in patients with different cancers of the blood. This study is experimental because neither drug has been approved by the Food and Drug Administration for the treatment of chronic lymphocytic leukemia. There are few standard treatments when fludarabine is no longer effective in patients with CLL. Some patients have received additional combination therapy with fludarabine, Campath, bone marrow transplants or supportive care. Dasatinib and lenalidomide have been effective in high-risk CLL patients in other pilot mono therapy studies. The combination of dasatinib and lenalidomide has not been studied in humans before and this study is designed to test whether this combination is safe to use.

Read the detailed description

CLL is an incurable disease with current therapies. Modern chemoimmunotherapies, including combinations of rituximab and purine nucleoside analogues (fludarabine, cladribine, and pentostatin), offer the possibility for improved survival, but all patients will eventually relapse. Patients with relapsed or refractory disease will only experience diminishing benefits with additional lines of therapy. In addition, patients with high-risk CLL have poor responses to even first-line therapies. Lenalidomide and dasatinib have non-overlapping proposed mechanisms of action. Single agent phase II studies with lenalidomide and dasatinib have demonstrated responses in heavily pretreated and high-risk patients. For these reasons, we propose to treat patients with relapsed and/or refractory CLL to purine nucleoside analogue therapy with combination lenalidomide and dasatinib.

Being tested
dasatinib and lenalidomide
Keywords
CLL, dasatinib, lenalidomide, sprycel, revlimid, CLL relapsed or refractory to fludarabine
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.

  • dasatinib and lenalidomideDrug

    Also called spyrcel and revlimid

    dasatinib will be started at 70mg/day po and lenalidomide will be started at 2.5mg/day po

Study groups in NCT00829647
Study groupRoleWhat they receive
combination dasatinib plus lenalidomideExperimentaldasatinib 70 mg po daily plus lenalidomide 2.5 md po daily
Receives: Drug: dasatinib and lenalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and maximum tolerated dose (phase I) and overall response rate (phase II)

    Measured: 6 months

Secondary outcomes (1)

  1. Assess responses in subgroups of high-risk patients, including 17p- and 11q- deletion, and CD38 and ZAP-70 positive expression

    Measured: 16 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2009 (estimated)
  2. Study startJan 2009
  3. Primary completionDec 2009
  4. Study completion1 Mar 2016

Why it stopped: Unable to enroll

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00829647
Sponsor's protocol ID
SCLL084993
Status last verified
Apr 2019
First submitted
23 Jan 2009
Last updated
11 Apr 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No: There is no data to share.

Publications

  • Chanan-Khan A, Miller KC, Musial L, Lawrence D, Padmanabhan S, Takeshita K, Porter CW, Goodrich DW, Bernstein ZP, Wallace P, Spaner D, Mohr A, Byrne C, Hernandez-Ilizaliturri F, Chrystal C, Starostik P, Czuczman MS. Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia: results of a phase II study. J Clin Oncol. 2006 Dec 1;24(34):5343-9. doi: 10.1200/JCO.2005.05.0401. Epub 2006 Nov 6.

    PubMed 17088571

  • Ferrajoli A, Lee BN, Schlette EJ, O'Brien SM, Gao H, Wen S, Wierda WG, Estrov Z, Faderl S, Cohen EN, Li C, Reuben JM, Keating MJ. Lenalidomide induces complete and partial remissions in patients with relapsed and refractory chronic lymphocytic leukemia. Blood. 2008 Jun 1;111(11):5291-7. doi: 10.1182/blood-2007-12-130120. Epub 2008 Mar 11.

    PubMed 18334676

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing dasatinib and lenalidomide in people with Chronic Lymphocytic Leukemia and Leukemia, run by Scripps Health.

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 18 inclusion and 34 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: withdrawn, as of the sponsor's last update on 11 Apr 2019. 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 combined 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.

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?

Safety and maximum tolerated dose (phase I) and overall response rate (phase II) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00829647, which also lists 2 linked publications.

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 11 Apr 2019.

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