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Leukemia Lymphocytic Chronic B-CellPhase 1NCT01732861

Safety Study of CC-292 and Lenalidomide in Subjects With Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma

A Phase 1 study testing CC-292 and Lenalidomide in people with Leukemia Lymphocytic Chronic B-Cell, run by Celgene at 11 sites in 2 countries.

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 dose finding study using a 3 + 3 dose escalation and expansion design to determine a Not Tolerated Dose (NTD), Optimal Biological Effect Dose (OBE) and / or Maximum Tolerated Dose (MTD). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia Lymphocytic Chronic B-Cell
What is being tested?
CC-292 and Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
11 sitesin 2 countries
Study dates
28 Dec 2012to 23 Jan 2019
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

  • Male and female subjects 18 years of age and older at the time of signing the informed consent document (ICD).
  • Body weight at least 50 kg.
  • Must have a documented diagnosis of CLL/SLL (International Workshop on Chronic Lymphocytic Leukemia IWCLL Guidelines - Hallek 2008) by investigator assessment.
  • Have failed at least 1 previous treatments for CLL/SLL, and have relapsed and/or refractory disease following last prior treatment defined as CLL/SLL that does not achieve at least a partial response (PR) to therapy or that progresses within 6 months of treatment.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 2 or less.
  • Life expectancy of at least 3 months from time of signing ICD.
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  • Females of childbearing potential (FCBP) must have a negative medically supervised pregnancy test prior to starting study therapy and agree to ongoing pregnancy testing during and after end of study therapy; commit to continued abstinence from heterosexual intercourse or agree to use, comply with two effective methods of contraception without interruption, 28 days prior to starting study drug, during study therapy, and for 28 days after discontinuation of study therapy.
  • Male subjects must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy, throughout study drug therapy and dose interruption, and for 28 days after end of study therapy; agree to not donate semen or sperm during study drug therapy and for 28 days after end of study drug therapy.
  • All subjects must understand that lenalidomide could have a potential teratogenic risk, agree to abstain from donating blood with taking lenalidomide therapy and following discontinuation of study drug therapy; have an echocardiogram (ECG) or multigated acquisition (MUGA) scan of the heart demonstrating left ventricular ejection fraction (LVEF) at least 50% or the institution's lower limit of normal; have recovered from adverse, toxic effects of prior therapies to equal to or less than 1 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4.03 except for alopecia and peripheral neuropathy.

Who cannot join

  • Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
  • Autologous stem cell transplant within 3 months prior to the time of signature on the ICD Informed Consent Document.
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection requiring parenteral antibiotics; uncontrolled diabetes mellitus; chronic symptomatic congestive heart failure; unstable angina pectoris, angioplasty, stenting, or myocardial infarctions within 6 months prior to the time of signature on the ICD; clinically significant cardiac arrhythmia that is symptomatic or requires treatment, or asymptomatic sustained ventricular tachycardia. Subjects with controlled atrial fibrillation that is asymptomatic are eligible.
  • Pregnant or lactating females.
  • Prior history of malignancies, unless the subject has been free of the disease for 5 years or more prior to the time of signature on the ICD. Exceptions to the 5 years or more time limit include history of basal cell carcinoma of the skin; squamous cell carcinoma of the skin; carcinoma in situ of the cervix; carcinoma in situ of the breast; carcinoma in situ of the bladder; incidental histologic finding of prostate cancer (Tumor/Nodes/Metastasis [TNM] stage of T1a or T1b).
  • Known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV).
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  • Known seropositivity for hepatitis C virus (HCV); hepatitis B virus (HBV).
  • Subjects who are at a high risk for a thromboembolic event and are not willing/able to take venous thromboembolic event (VTE) prophylaxis.
  • Any of the following laboratory abnormalities:
  • Absolute Neutrophil Count (ANC) ≤ 1,000 cells/mm3 (1.0 x 109/L)
  • Platelet count ≤ 50,000/mm3 (50 x 109/L) unless secondary to bone marrow involvement by recent bone marrow aspiration and bone marrow biopsy
  • Serum Aspartate Transaminase/Serum Glutamic-Oxaloacetic Transaminase (AST/SGOT) or Alanine Transaminase/Serum Glutamic-Pyruvic Transaminase (ALT/SGPT) > 3.0 x upper limit of normal (ULN) or > 5.0 x ULN in cases of documented liver involvement
  • Serum bilirubin > 1.5 x ULN or > 3.0 x ULN in cases of Gilbert's Syndrome and documented liver involvement by lymphoma;
  • Calculated creatinine clearance using the Cockcroft-Gault formula (Cockcroft,1976)
  • Corrected QT interval (QTc) prolongation (defined as a QTc > 450 msec for males and > 470 msec for females [Fridericia's correction]) or other clinically significant ECG abnormalities as assessed by the investigator.
  • Chemotherapy, radiotherapy, investigational anticancer therapy or major surgery within 28 days of Day 1 dosing.
  • Use of systemic corticosteroids in doses greater than prednisone equivalent to 20 mg/day within 3 weeks prior to study drug dosing.
  • Concomitant use of medicines known to cause QT prolongation or torsades de pointes.
  • Chronic use of H2 antagonists or proton pump inhibitors or their use within 7 days of first dose.
  • Gastrointestinal abnormalities including the inability to take oral medication, requiring intravenous alimentation, or prior surgical procedure affecting absorption.
  • Prior treatment with Btk (Bruton's tyrosine kinase) inhibitors.
  • Any live vaccinations within 3 weeks from first dose.
  • History of hypersensitivity to immunomodulatory drugs (IMiDs) (eg, lenalidomide, thalidomide, pomalidomide).
  • Disease transformation (ie, Richter's Syndrome [lymphomas] or prolymphocytic leukemia).
  • Patients with uncontrolled hyper or hypothyroidism.

Trial locations and contacts

11 sites in 2 countries.

11 sites in 2 countries

United States6 sites

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Clearview Cancer Institute Oncology Specialties, P.C

    Huntsville, Alabama, 35805

  • Horizon Oncology Center

    Lafayette, Indiana, 47905

  • The West Clinic

    Memphis, Tennessee, 38120

  • Mount Sinai School of Medicine

    New York, New York, 10029

Other trials in United States

Austria5 sites

  • Universitatsklinik fur Innere Medizin

    Innsbruck

  • AKh Linz

    Linz, 4021

  • Universitatsklinik der PMU

    Salzburg, 5020

  • Allgemeines Krankenhaus Wien

    Vienna, 1090

  • Medizinische Abteilung-Zentrum fur Onkologie und Hamatologie

    Vienna, 1100

Other trials in Austria

About this study

Official title: A MULTICENTER, PHASE 1B, OPEN-LABEL STUDY TO DETERMINE THE SAFETY AND ACTIVITY OF CC-292 IN COMBINATION WITH LENALIDOMIDE IN SUBJECTS WITH RELAPSED AND/OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA / SMALL LYMPHOCYTIC LYMPHOMA

This is a dose finding study using a 3 + 3 dose escalation and expansion design to determine a Not Tolerated Dose (NTD), Optimal Biological Effect Dose (OBE) and / or Maximum Tolerated Dose (MTD). These data will be used to establish a Recommended Phase 2 Dose (RP2D) for the combination of CC-292 and lenalidomide in subjects with Chronic Lymphocytic Leukemia (CLL).

Read the detailed description

This dose finding study uses a 3 + 3 dose escalation and expansion design to establish the recommended Phase 2 dose. The starting dose is CC-292 375 mg twice daily and Lenalidomide 10 mg once daily. After review of the data for dose limiting toxicities (DLTs), the second dose level will be enrolled. Doses for this second cohort are CC-292 500 mg twice daily and lenalidomide 10 mg once daily. Additional doses of lenalidomide in combination with CC-292 may be evaluated to accurately determine the maximum tolerated dose. Once the maximum tolerated dose and/or optimal biologic effect has been ascertained, an expansion cohort of 24 subjects may be enrolled.

Being tested
CC-292, Lenalidomide
Keywords
Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
Medical subject headings
Leukemia, B-Cell, Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

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

  • CC-292Drug

    CC-292-will be given twice daily on Days 8-28 of Cycle 1 and on Days 1-28 of the remaining 28-day cycles.

  • LenalidomideDrug

    Lenalidomde will be given once daily on Days 1-28 of 28-day cycles.

Study groups in NCT01732861
Study groupRoleWhat they receive
CC-292 + LenalidomideExperimentalNot described
Receives: Drug: CC-292; Drug: Lenalidomide

What is being measured

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

  1. Adverse Events

    Number of participants with adverse events

    Measured: Up to 5 years

Secondary outcomes (7)

  1. Percentage of Participants Who Have Received Some Form of Response

    Response rate is defined as the percentage of participants who have achieved some form of response including: a Complete Response (CR), a CR with incomplete bone marrow recovery, a Nodular Partial Response (PR), a Nodal PR or a PR with lymphoctyosis) based on the International Workshop for Chronic Lymphocytic Leukemia and lymphoma guidelines (IWCLL).

    Measured: Up to 2 years

  2. PK-Cmax

    Maximum observed plasma concentration

    Measured: Up to 15 days

  3. PK-Tmax

    Time to maximum observed plasma concentration

    Measured: Up to 15 days

  4. PK-λz

    Terminal phase rate constant, determined by linear regression of the terminal points of the log-linear plasma concentration-time curve. Visual assessment will be used to identify the terminal linear phase of the concentration

    Measured: Up to 15 days

  5. PK-t1/2

    Estimate of the terminal elimination half-life in plasma

    Measured: Up to 15 days

  6. PK-AUC (0-t)

    Area under the plasma concentration-time curve from time zero to time t, where t is the last measurable time point

    Measured: Up to 15 days

  7. PK-AUC0-∞

    Area under the plasma concentration time curve from time zero extrapolated to infinity.

    Measured: Up to 15 days

Timeline

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

  1. First posted26 Nov 2012 (estimated)
  2. Study start28 Dec 2012
  3. Primary completion23 Jan 2019
  4. Study completion23 Jan 2019

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01732861
Sponsor's protocol ID
CC-292-CLL-001
Other IDs
2012-003766-41
Status last verified
Dec 2019
First submitted
14 Nov 2012
Last updated
20 Dec 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CC-292 and Lenalidomide in people with Leukemia Lymphocytic Chronic B-Cell, run by Celgene at 11 sites in 2 countries.

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 9 inclusion and 25 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 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, Austria. 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 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?

Adverse Events (time frame: Up to 5 years). 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 NCT01732861.

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 20 Dec 2019.

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