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Relapsed/Refractory B-cell LymphomaPhase 1CLEARNCT01766583

A Phase IB Study Of The BTKi CC-292 Combined With Lenalidomide In Adults Patients With Relapsed/Refractory B-Cell Lymphoma

A Phase 1 study testing CC-292 + lenalidomide in people with Relapsed/Refractory B-cell Lymphoma, run by The Lymphoma Academic Research Organisation at 6 sites in France.

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 an open label, 3 + 3 dose escalation study, to determine the MTD, safety, efficacy and PK profiles for subjects with relapsed/refractory B-cell malignancies when using CC-292 and lenalidomide combination therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed/Refractory B-cell Lymphoma
What is being tested?
CC-292 + lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
6 sitesFrance
Study dates
Feb 2013to Jan 2018
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

  • Histology:
  • Patients with any type of B-cell Lymphoma except CLL, SLL and Waldenström disease will be eligible during the dose escalation phase
  • During the expansion phases, patients with DLBCL for cohort A, mantle cell lymphoma for cohort B and any other type of B-cell lymphoma except CLL, SLL and Waldenström disease for cohort C.
  • Other criteria:
  • Signed inform consent
  • Patients should be relapsed or refractory NHL after ≥1 prior Rituximab-containing regimen for which no other type of therapy is of higher priority
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  • Aged 18 years or more.
  • ECOG performance status 0-2.
  • Measurable disease defined by at least one single node or tumor lesion > 1.5 cm.
  • Life expectancy of ≥ 90 days (3 months).
  • Patients must be eligible and willing to undergo excisional biopsies of tumor sites with a lymph node of minimum 1 cm at baseline and after 21 days of treatment
  • Females of childbearing potential (FCBP)† must have two negative serum or urine pregnancy tests with a sensitivity of at least 25 mIU/mL before starting lenalidomide - the first test must be performed within 10-14 days before starting lenalidomide treatment and the second test must be performed within 24 hours before starting lenalidomide
  • FCBP must either commit to continued abstinence from heterosexual intercourse or begin two methods of birth control, at least 4 weeks before she starts taking lenalidomide. FCBP must also agree to monthly pregnancy testing and must be counseled at a minimum of every 4 weeks about pregnancy precautions and risks of fetal exposure.
  • Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential. Men must also be counseled at a minimum of every 4 weeks about pregnancy precautions and risks of fetal exposure.

Who cannot join

  • Previous treatment with lenalidomide or a BTK inhibitor. Central nervous system or meningeal involvement. Contraindication to any drug contained in this regimen Concomitant use of medicines known to cause QT prolongation or torsades de pointes HIV disease, active hepatitis B or C. Any serious active disease or co-morbid medical condition (according to investigator's decision);
  • Any of the following laboratory abnormalities :
  • Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L).
  • Platelet count < 80,000/mm3 (80 x 109/L)
  • Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN).
  • Serum total bilirubin > 1.5 ULN except in case of hemolytic anemia and Gilbert's syndrome.
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  • Calculated creatinine clearance (Cockcroft-Gault formula or MDRD) of < 50 mL /min Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast or Incidental histological finding of prostate cancer [TNM stage of T1a or T1b]) unless the subject has been free of the disease for ≥ 5 years Any serious medical condition, laboratory abnormality, or psychiatric illnessthat would prevent the subject from signing the informed consent form.
  • Pregnant or lactating females. Prior ≥ Grade 3 allergic reaction/hypersensitivity to thalidomide and/or pomalidomide.
  • Prior ≥ Grade 3 rash or any desquamating (blistering) rash while taking thalidomide and/or pomalidomide.
  • Subjects with ≥ Grade 2 neuropathy. Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation (Day 1) of study drug therapy.
  • Chronic use of proton pump inhibitors, H2 antagonists or antacids or their use in the last 7 days prior to the first CC-292 dose. Patients with chronic gastroesophageal reflux disease, dyspepsia, and peptic ulcer disease, should be carefully evaluated for their suitability for this treatment prior to enrollment in this study. These medications should be avoided throughout the study.
  • Patients taking corticosteroids during the 4 weeks prior to inclusion, unless administered at a dose equivalent of ≤ 10 mg/day prednisone (over these 4 weeks).

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

France6 sites

  • Hopital henri mondor

    Créteil, 94010

  • CHU de Lille

    Lille, 59037

  • Institut Paoli Calmette

    Marseille, 13273

  • CHU de Nantes

    Nantes, 44093

  • CHU Lyon Sud

    Pierre-Bénite, 69495

  • CHU de Toulouse

    Toulouse, 31059

Other trials in France

About this study

Official title: A PHASE IB STUDY OF THE BTKi CC-292 COMBINED WITH LENALIDOMIDE IN ADULTS PATIENTS WITH RELAPSED/REFRACTORY B-CELL LYMPHOMA

This is an open label, 3 + 3 dose escalation study, to determine the MTD, safety, efficacy and PK profiles for subjects with relapsed/refractory B-cell malignancies when using CC-292 and lenalidomide combination therapy. Subjects will be followed for disease progression and collection of second primary malignancy (SPM) events. This dose escalation will be followed by an exploratory expansion phase in 3 cohorts of 12 patients each.

Being tested
CC-292 + lenalidomide
Keywords
Open label, 3 + 3 dose escalation study followed by an expansion phase.
Medical subject headings
Lymphoma, B-Cell

What participants receive

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

  • CC-292 + lenalidomideDrug

    CC-292 + lenalidomide

Study groups in NCT01766583
Study groupRoleWhat they receive
CC-292 + lenalidomideExperimentalCombination of CC-292 + lenalidomide
Receives: Drug: CC-292 + lenalidomide

What is being measured

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

  1. Determination of the recommended dose of CC-292 and lenalidomide in patients with relapsed/refractory B-cell lymphoma

    The optimal CC-292 and lenalidomide combination will be determined based on the maximum tolerated dose (MTD), the dose limiting toxicities (DLT) and/or the analysis of adverse events, serious adverse events and toxicities observed during the study

    Measured: 28 days

Secondary outcomes (8)

  1. preliminary efficacy signals of the CC-292 + Lenalidomide combination

    Overall response rate and overall response rate, complete and partial response rates, progression free survival, response duration, time to next treatment and overall survival

    Measured: 6 months

  2. Observed maximum plasma concentration

    Measured: 0, 0.5, 1, 2, 4, 6, 8 hours post dose

  3. time to reach maximum observed plasma concentration (Tmax)

    Measured: 0, 0.5, 1, 2, 4, 6, 8 hours post dose

  4. Terminal phase rate constant (λz)

    Measured: 0, 0.5, 1, 2, 4, 6, 8 hours post dose

  5. plasma decay half-life (t1/2)

    Measured: 0, 0.5, 1, 2, 4, 6, 8 hours post dose

  6. Area under the curve from time zero to the last quantifiable concentration [AUC(0-t)]

    Area under the plasma concentration versus time curve from time zero (predose) to time of the last quantifiable concentration (0-t)

    Measured: 0, 0.5, 1, 2, 4, 6, 8 hours post dose

  7. Area under the curve from time zero to extrapolated infinity [AUC(0-∞)]

    Area under the plasma concentration versus time curve (AUC) from time zero (predose)to extrapolated infinity(0-∞)

    Measured: 0, 0.5, 1, 2, 4, 6, 8 hours post dose

  8. BTk receptor occupancy

    BTK receptor occupancy will be determined in the peripheral blood cells and tumor tissue

    Measured: 0 (predose) and 21 days post dose

Timeline

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

  1. First posted11 Jan 2013 (estimated)
  2. Study startFeb 2013
  3. Primary completionNov 2014
  4. Study completionJan 2018

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
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01766583
Sponsor's protocol ID
CLEAR
Acronym
CLEAR
Status last verified
Mar 2018
First submitted
29 Oct 2012
Last updated
7 Mar 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CC-292 + lenalidomide in people with Relapsed/Refractory B-cell Lymphoma, run by The Lymphoma Academic Research Organisation at 6 sites in France.

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 14 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 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France. 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?

Determination of the recommended dose of CC-292 and lenalidomide in patients with relapsed/refractory B-cell lymphoma (time frame: 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 NCT01766583.

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 7 Mar 2018; AzTrials last refreshed its copy on 7 Nov 2026.

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