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Chronic Lymphocytic LeukemiaPhase 2NCT01133743

Open-Label Study of Lenalidomide in Combination With Oral Dexamethasone in the Treatment of Previously Untreated, Symptomatic Patients With Chronic Lymphocytic Leukemia

A Phase 2 study testing Lenalidomide and Dexamethasone in people with Chronic Lymphocytic Leukemia, run by University Health Network, Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a phase II, non-randomized, single institution study in symptomatic, previously untreated CLL patients. All patients will receive the study drug, lenalidomide, given PO daily continuously on a 28 day cycle at the starting dose level of either 2.5 mgs or 5 mgs with dose escalations to a target dose of 25mg… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
Lenalidomide and Dexamethasone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteCanada
Study dates
May 2010to Dec 2016
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

  • 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.
  • A confirmed diagnosis of B-cell CLL by IWCLL 2008 criteria
  • No prior systemic therapy for CLL. Steroid therapy alone for autoimmune cytopenias (anemia or thrombocytopenia) is NOT considered a prior systemic therapy.
  • Radiation: Patients may have received prior radiation therapy restricted to </= 25% of functioning bone marrow. Patients must be >/= 4 weeks since last treatment with radiation therapy.
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  • Surgery: previous surgery is permissible. Patient must be >/= 4 weeks since any major surgery.
  • Patients must have symptomatic disease requiring therapy as per the IWCLL 2008 criteria. One or more of the following must be present to be eligible:
  • Massive (>10cm diameter), progressive or symptomatic lymphadenopathy
  • Massive (>6 cm below costal margin) or progressive or symptomatic splenomegaly
  • Anemia (Hb <110 g/L)
  • Thrombocytopenia (platelets <100 x 109/L)
  • Constitutional symptoms (one of the following):
  • Weight loss >10% or more over previous 6 months
  • Significant fatigue
  • Fevers >38 degrees Celsius for 2 or more weeks without infection
  • Night sweats > 1 month without evidence of infection
  • Other constitutional symptoms felt to require treatment as per treating physician discretion
  • Persistent rise in lymphocyte count with doubling time of < 6 months
  • Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroids or other standard therapy
  • ECOG performance status of </= 2 at study entry
  • Laboratory Requirements: (must be done within 7 days prior to first study drug dose) Hematology: Absolute granulocytes (AGC)>/= 1000/mm³ Platelets >/= 50,000/mm³ Chemistry: Creatinine clearance>/= 30ml/min (by Cockcroft-Gault calculation, see Appendix 9) Bilirubin </= 1.5 x UNL AST (or ALT if AST not available) </= 2.5 x UNL
  • 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.
  • 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
  • Able to take aspirin 81 mg daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).

Who cannot join

  • Patients who fulfill any of the following criteria are not eligible for admission to the study:
  • 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 TLS by Cairo-Bishop Definition of Tumor Lysis Syndrome. Subjects may be enrolled upon correction of electrolyte abnormalities.
  • Use of any other experimental drug or therapy within 28 days of baseline.
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  • Known hypersensitivity to thalidomide.
  • 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 B or C.
  • Known intolerance to steroids (i.e. poorly controllable hyperglycemia or hypertension, significant mood disturbances, steroid-related myopathy, etc.)

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University Health Network - Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: An Open-Label Phase 2 Study of Lenalidomide (Revlimid) in Combination With Oral Dexamethasone in the Treatment of Previously Untreated, Symptomatic Patients With Chronic Lymphocytic Leukemia (CLL)

This is a phase II, non-randomized, single institution study in symptomatic, previously untreated CLL patients. All patients will receive the study drug, lenalidomide, given PO daily continuously on a 28 day cycle at the starting dose level of either 2.5 mgs or 5 mgs with dose escalations to a target dose of 25mg daily. Oral dexamethasone at 12 mg PO daily will be administered on days 1-7, 14 and 21 of each cycle. Patients will be treated with lenalidomide and dexamethasone to 2 cycles past CR or to a maximum of 18 cycles, each cycle of 28 days duration. Primary endpoint is response.

Being tested
Lenalidomide and Dexamethasone
Keywords
Lenalidomide, Dexamethasone, Immunomodulatory Drugs(IMiD™), Thalidomide analogues
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lenalidomide and DexamethasoneDrug

    Also called Lenalidomide, Immunomodulatory drug(IMiD™), Thalidomide analogues

    Starting Lenalidomide dose 2.5 mgs or 5 mgs (based on baseline calculated creatinine clearance)PO daily on a 28 day cycle. Dose escalations will take place at the start of subsequent cycles as frequently as tolerated but not more frequently than at the start of each cycle to a target dose of 25mg daily. Oral dexamethasone at 12 mg PO daily will be administered on days 1-7, 14 and 21 of each cycle

Study groups in NCT01133743
Study groupRoleWhat they receive
Lenalidomide and DexamethasoneExperimentalLenalidomide target dose of 25 mg PO OD continuously (28-day cycle) using an initial dose escalation period. Oral dexamethasone 12 mg daily on days 1-7, 14 and 21 of each cycle.
Receives: Drug: Lenalidomide and Dexamethasone

What is being measured

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

  1. Response rate

    Measured: 18 cycles (each cycle is of 28 days)

Secondary outcomes (1)

  1. Time to progression

    Measured: Participants will be followed until death

Timeline

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

  1. First posted31 May 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionDec 2016
  4. Study completionDec 2016

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01133743
Sponsor's protocol ID
RV-CLL-PI-0411
Status last verified
May 2017
First submitted
19 May 2010
Last updated
3 May 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Chen CI, Paul H, Snitzler S, Kakar S, Le LW, Wei EN, Lau A, Johnston JB, Gibson SB, Queau M, Spaner D, Croucher D, Sherry B, Trudel S. A phase 2 study of lenalidomide and dexamethasone in previously untreated patients with chronic lymphocytic leukemia (CLL). Leuk Lymphoma. 2019 Apr;60(4):980-989. doi: 10.1080/10428194.2018.1508669. Epub 2018 Oct 2.

    PubMed 30277089

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lenalidomide and Dexamethasone in people with Chronic Lymphocytic Leukemia, run by University Health Network, Toronto at 1 site in Canada.

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 25 inclusion and 12 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: finished, as of the sponsor's last update on 3 May 2017. 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 Canada. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Response rate (time frame: 18 cycles (each cycle is of 28 days)). 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 NCT01133743, which also lists 1 linked publication.

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 May 2017.

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