Follicular Lymphoma, Mantle Cell LymphomaPhase 1NCT02603445
Study of Safety and Efficacy of BCL201 and Idelalisib in Patients With FL and MCL
A Phase 1 study testing BCL201 and Idelalisib in people with Follicular Lymphoma, Mantle Cell Lymphoma, run by Novartis Pharmaceuticals at 7 sites in 4 countries.
Trial summary
This is a phase Ib multi-center, open-label study: escalation part followed by expansion part. The primary purpose of the Phase Ib CBCL201X2102C study is to characterize the safety and tolerability of BCL201 combined with idelalisib in patients with FL and MCL. Approximately 65 patients are to be enrolled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma, Mantle Cell Lymphoma
- What is being tested?
- BCL201 and Idelalisib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 16 Nov 2015to 10 Jul 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
- Histologically confirmed diagnosis of FL or MCL according to WHO 2008
- Relapsed or refractory with at least one (FL) or two (MCL), but not more than four, prior lines of antineoplastic regimens.
- Either FDG-avid on FDG-PET or measurable disease by CT on cross sectional imaging: > 1.5 cm for nodal lesion, > 1.0 cm for extra nodal lesion.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Who cannot join
- For dose escalation part: Patients with MCL at high risk for tumor lysis syndrome
- Prior treatment with PI3Kδ or Bcl-2 inhibitors.
- Any other malignant disease
- History of serious allergic reactions including anaphylaxis and toxic epidermal necrolysis
- Inadequate organ function
- Concomitant treatment with:
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- Strong CYP3A4/5 inducers or inhibitors
- Sensitive CYP3A4/5 substrates or CYP3A4/5 substrates with narrow therapeutic index (NTI)
- Sensitive CYP2D6 substrates or CYP2D6 substrates with NTI
- Selected dual substrates of CYP3A4/5 and CYP2C8
- Selected dual substrates of CYP3A4/5 and CYP2D6
- Selected dual substrates of OATP and CYP450
- Selected dual substrates of CYP3A4/5 and P-gp
- NTI P-gp substrates
- QT prolonging drugs with a known risk to induce TdP
- Proton pump inhibitors
- Treatment by warfarin or equivalent vitamin K antagonists.
- Other investigational therapies
- Herbal preparations/ medications
- Grapefruit, Seville oranges or products containing either juice
- Other protocol-defined inclusion/exclusion may apply.
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
United States2 sites
Novartis Investigative Site
Houston, Texas, 77030
Novartis Investigative Site
New York, New York, 10017
France2 sites
Novartis Investigative Site
Pierre-Bénite, 69495
Novartis Investigative Site
Toulouse, 31059
Germany2 sites
Novartis Investigative Site
Freiburg im Breisgau, 79106
Novartis Investigative Site
Mainz, 55131
About this study
Official title: A Phase Ib Dose Escalation Study of BCL201 in Combination With Idelalisib in Patients With Follicular Lymphoma (FL) and Mantle Cell Lymphoma (MCL)
This is a phase Ib multi-center, open-label study: escalation part followed by expansion part. The primary purpose of the Phase Ib CBCL201X2102C study is to characterize the safety and tolerability of BCL201 combined with idelalisib in patients with FL and MCL.
Approximately 65 patients are to be enrolled.
Read more
The primary endpoint for the Phase Ib is frequency, severity and seriousness of AEs, lab abnormalities and other safety parameters such as ECG changes. An adaptive Bayesian logistic regression model (BLRM) will guide the dose escalation to determine the MTD/RDE in phase Ib. In addition Bayesian regression models will be used to estimate the dose-exposure relationships for both BCL201 and idelalisib in order to guide the escalation steps. A Bayesian method for the expansion part will be used for the primary activity objective.
The study data will be analyzed and reported based on all patients' data of the escalation and expansion part.
- Being tested
- BCL201, Idelalisib
- Keywords
- BCL201, idelalisib, Follicular lymphoma, FL, mantle cell lymphoma, MCL
- Medical subject headings
- Lymphoma, Follicular, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCL201Drug
Also called S55746
IdelalisibDrug
Also called Idela
| Study group | Role | What they receive |
|---|---|---|
| Follicular lymphoma (FL) | Experimental | Not described Receives: Drug: BCL201; Drug: Idelalisib |
| Mantle cell lymphoma (MCL) | Experimental | Not described Receives: Drug: BCL201; Drug: Idelalisib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs)
Characterized by Frequency, severity and seriousness of AEs, lab abnormalities and other safety parameters such as electrocardiogram (ECG) changes
Measured: 24 months
Secondary outcomes (11)
Incidence rate of dose limiting toxicities (DLTs)
Measured: 24 months
Exposure to BCL201 and idelalisib as measured by AUC0-24h at C1D15
Measured: Cycle = 28 days
Plasma concentration of BCL201, idelalisib and GS-563117 (metabolite of idelalisib)
Measured: 24 Months
AUC pharmacokinetics (PK) parameter for BCL201, idelalisib and GS-563117
Measured: 24 months
Objective Response Rate (ORR)
Measured: 24 months
Best Overall Response (BOR)
Measured: 24 months
Duration of Response (DOR)
Measured: 24 months
Complete Response (CR)
Measured: 24 months
Partial Response (PR)
Measured: 24 months
Stable disease (SD)
Measured: 24 months
Cmax pharmacokinetics (PK) parameter for BCL201, idelalisib and GS-563117
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study start16 Nov 2015
- Primary completion10 Jul 2018
- Study completion10 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicular Lymphoma, Mantle Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02603445
- Sponsor's protocol ID
- CBCL201X2102C
- Status last verified
- Feb 2020
- First submitted
- 8 Oct 2015
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Dose Escalation Study of BCL201 in Combination With Idelalisib in Patients With Follicular Lymphoma (FL) and Mantle Cell Lymphoma (MCL)
- ClinicalTrials.gov ID
- NCT02603445
- Acronym / sponsor ID
- CBCL201X2102C
- Keywords
- BCL201, idelalisib, Follicular lymphoma, FL, mantle cell lymphoma, MCL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2015 (actual)
- Primary completion
- 10 Jul 2018 (actual)
- Study completion
- 10 Jul 2018 (actual)
- First posted
- 11 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase Ib multi-center, open-label study: escalation part followed by expansion part. The primary purpose of the Phase Ib CBCL201X2102C study is to characterize the safety and tolerability of BCL201 combined with idelalisib in patients with FL and MCL.
Approximately 65 patients are to be enrolled.
The primary endpoint for the Phase Ib is frequency, severity and seriousness of AEs, lab abnormalities and other safety parameters such as ECG changes. An adaptive Bayesian logistic regression model (BLRM) will guide the dose escalation to determine the MTD/RDE in phase Ib. In addition Bayesian regression models will be used to estimate the dose-exposure relationships for both BCL201 and idelalisib in order to guide the escalation steps. A Bayesian method for the expansion part will be used for the primary activity objective.
The study data will be analyzed and reported based on all patients' data of the escalation and expansion part.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Follicular lymphoma (FL) | Experimental | Drug: BCL201, Drug: Idelalisib |
| Mantle cell lymphoma (MCL) | Experimental | Drug: BCL201, Drug: Idelalisib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed diagnosis of FL or MCL according to WHO 2008
- Relapsed or refractory with at least one (FL) or two (MCL), but not more than four, prior lines of antineoplastic regimens.
- Either FDG-avid on FDG-PET or measurable disease by CT on cross sectional imaging: > 1.5 cm for nodal lesion, > 1.0 cm for extra nodal lesion.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Key exclusion criteria (21 listed)
- For dose escalation part: Patients with MCL at high risk for tumor lysis syndrome
- Prior treatment with PI3Kδ or Bcl-2 inhibitors.
- Any other malignant disease
- History of serious allergic reactions including anaphylaxis and toxic epidermal necrolysis
- Inadequate organ function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCL201Also: S55746 | Drug | Follicular lymphoma (FL), Mantle cell lymphoma (MCL) |
| IdelalisibAlso: Idela | Drug | Follicular lymphoma (FL), Mantle cell lymphoma (MCL) |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: 24 months
Characterized by Frequency, severity and seriousness of AEs, lab abnormalities and other safety parameters such as electrocardiogram (ECG) changes
11 secondary outcomes
Incidence rate of dose limiting toxicities (DLTs)
Time frame: 24 months
Exposure to BCL201 and idelalisib as measured by AUC0-24h at C1D15
Time frame: Cycle = 28 days
Plasma concentration of BCL201, idelalisib and GS-563117 (metabolite of idelalisib)
Time frame: 24 Months
AUC pharmacokinetics (PK) parameter for BCL201, idelalisib and GS-563117
Time frame: 24 months
Objective Response Rate (ORR)
Time frame: 24 months
Best Overall Response (BOR)
Time frame: 24 months
Duration of Response (DOR)
Time frame: 24 months
Complete Response (CR)
Time frame: 24 months
Partial Response (PR)
Time frame: 24 months
Stable disease (SD)
Time frame: 24 months
Cmax pharmacokinetics (PK) parameter for BCL201, idelalisib and GS-563117
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BCL201 and Idelalisib in people with Follicular Lymphoma, Mantle Cell Lymphoma, run by Novartis Pharmaceuticals at 7 sites in 4 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 4 inclusion and 21 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 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, France, Germany, 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?
Number of participants with adverse events (AEs) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2020.