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Diffuse Large B Cell LymphomaPhase 2NCT01238692

A Phase II Study of Oral Panobinostat (LBH589) and Rituximab to Treat Diffuse Large B Cell Lymphoma (DLBCL)

A Phase 2 study testing LBH589 and Rituximab in people with Diffuse Large B Cell Lymphoma, run by Sarit Assouline at 4 sites 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

The purpose of the study is to examine both efficacy of LBH589 in treating relapsed and refractory DLBCL, and added benefit of combining rituximab with LBH589 in this setting. Tissue samples from accessible lymph nodes will be collected and banked before the start of the study treatment and after 15 days. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diffuse Large B Cell Lymphoma
What is being tested?
LBH589 and Rituximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
4 sitesCanada
Study dates
Nov 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

  • Pathological confirmation of any stage of DLBCL. Patients with transformation to DLBCL will be permitted on study.
  • Patients must have received at least 1 prior line of treatment if not eligible for an autologous stem cell transplant (ASCT) or 2 prior therapies, one of which must have been an ASCT, if eligible for such therapy.
  • Patients must have received prior rituximab therapy and the last treatment administered with rituximab must have been given at least 6 months prior to study registration on this trial. Exception may be granted to patients treated with rituximab or other anti-CD20 monoclonal antibody 3-6 months prior to study registration upon discussion with the Sponsor.
  • Patients must have at least one site of bi-dimensionally measurable lesion (> 1.5 cm in its largest dimension by CT scan).
  • ECOG performance status of 0 or 1.
  • Age 18 years or older.
  • Baseline MUGA or ECHO must demonstrate LVEF ≥ the lower limit of the institutional normal (results 3 months prior to study registration is acceptable).
  • Provide written consent after the investigational nature, study design, risks and benefits of the study have been explained.

Who cannot join

  • Prior use of any anti-CD20 monoclonal antibody within 6 months of study start (refer to inclusion #3 for exception).
  • History of serious infusion-related reaction to rituximab or other monoclonal antibodies.
  • Central nervous system lymphoma.
  • Prior treatment with HDAC, DAC, HSP90 inhibitors or valproic acid for the treatment of cancer.
  • Evidence of significant, uncontrolled concomitant disease which could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm).
  • Impaired cardiac function
Show all 18Show fewer
  • Uncontrolled hypertension.
  • Concomitant use of CYP3A4/5 inhibitors.
  • Concomitant use of drugs with a risk of causing "torsades de pointes".
  • Patients with unresolved diarrhea ≥ CTCAE grade 1.
  • Impairment of gastrointestinal function or GI disease that may significantly alter the absorption of oral LBH589.
  • Patients who have received treatment for DLBCL ≤ 3 weeks prior to starting the study treatment or who have not recovered from side effects of such therapy.
  • Women who are pregnant of breast feeding or women of childbearing potential (WOCBP) not willing to use a double barrier method of contraception during the study and 3 months after the end of treatment. One of these methods of contraception must be a barrier method. WOCBP are defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (ie. who has had menses any time preceding 12 consecutive months). WOCBP must have a negative serum pregnancy test at baseline.
  • Male patients whose sexual partners are WOCBP not using double method of contraception during the study and 3 months after the end of treatment. One of these methods must be a condom.
  • Patients with a history of another primary malignancy within 5 years other than curatively treated CIS of the cervix, completely excised melanoma-in-situ, or basal or squamous cell carcinoma of the skin.
  • Patients with a known positivity for HIV or hepatitis C; baseline testing for HIV and hepatitis C is not required.
  • Patients with hepatitis B sAg positivity will be excluded. However, exceptions may be granted but only after discussion between the Sponsor and the site. Patients with hepatitis B core antibody positivity only must also be discussed with the Sponsor prior to entry on study (results 6 months prior to study registration is acceptable).
  • Patients who cannot stop ingestion of grapefruits, starfruit, or Seville oranges

Trial locations and contacts

4 sites in 1 country.

Canada4 sites

  • Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia, H3T 1E2

  • Jewish General Hospital

    Montreal, Quebec, H3T1E2

  • Sacré-Cœur Hospital

    Montreal, Quebec, H4J 1C5

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: A Randomized Phase II Study of Oral Panobinostat (LBH589) With or Without Rituximab to Treat Relapsed or Refractory Diffuse Large B Cell Lymphoma

The purpose of the study is to examine both efficacy of LBH589 in treating relapsed and refractory DLBCL, and added benefit of combining rituximab with LBH589 in this setting. Tissue samples from accessible lymph nodes will be collected and banked before the start of the study treatment and after 15 days. Additionally, blood samples will be drawn and stored in the tissue biobank.

Read the detailed description

This is a randomized Phase II, multi-center study of LBH589 given alone (Arm A) or in combination with rituximab (Arm B).

The objectives of this study are:

  • To investigate the efficacy of LBH589 alone and in addition to rituximab in patients with relapsed or refractory DLBCL.
  • To investigate the safety and tolerability of single agent LBH589 therapy and combination therapy of LBH589 with rituximab.
  • To identify potential biological factors that might correlate with efficacy.

LBH589 will be given at a dose of 30mg orally every Monday, Wednesday and Friday, as in other studies of this agent. Rituximab will be given as a single 375mg/m2 dose intravenously on day 1 of each cycle. Treatment may be administered up to 6 cycles. Treatment beyond 6 cycles will be discussed with the Sponsor. Each cycle will last 21 days.

A Phase I, dose-escalation component to the study, to determine the recommended phase II dose of rituximab in combination with LBH589, is not considered necessary as the respective toxicity profiles of these two drugs do not predict for overlapping toxicity. Dose de-escalation of LBH589 will be performed for toxicity. No dose escalations will be permitted. If patients experience grade 2 or more toxicity not returning to grade < 1 within 4 weeks after stopping therapy, they will not be allowed to continue on therapy. If more than two dose interruptions are required for toxicity, this will also be a reason to be removed from the study.

An interim analysis for safety and futility will be performed after a total of 10 patients in each arm have been enrolled.

Being tested
LBH589, Rituximab
Keywords
Diffuse large B cell lymphoma, DLBCL, Relapsed B-cell lymphoma, Refractory B-cell lymphoma, B-cell Lymphoma, Panobinostat, LBH589, Rituximab, Histone Deacetylase Inhibitors
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Lymphoma, B-Cell

What participants receive

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

  • LBH589Drug

    Also called Panabinostat

    Patients randomized to both arms will receive oral LBH589, once-a-day, at a dose of 30 mg/day, on a three times-a-week (Monday, Wednesday and Friday) schedule as part of a 3 week (21 day) treatment cycle. Day one of each cycle will be on a Monday.

  • RituximabDrug

    Also called MabThera IV

    Patients randomized to Arm B will receive IV rituximab at a dose of 375 mg/m2 in combination with oral LBH589. Rituximab should be administered on the same day as LBH589, after the patient has taken their LBH589 dose. The appropriate amount of solution should be withdrawn from the vial for the following calculation:

    Volume (mL) = BSA (m2) × dose (375 mg/m2) / concentration of reconstituted solution ml/mL (100 mg/10 mL and/or 500 mg/50 mL).

Study groups in NCT01238692
Study groupRoleWhat they receive
LBH589ExperimentalNot described
Receives: Drug: LBH589
LBH589 plus RituximabExperimentalNot described
Receives: Drug: LBH589; Drug: Rituximab

What is being measured

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

  1. Efficacy of LBH589 alone and when given in combination with rituximab

    Measured: 2 years

Secondary outcomes (2)

  1. Safety and tolerability of single agent LBH589 therapy and combination therapy of LBH589 with rituximab

    Measured: 2 years

  2. Identify potential biological factors that might correlate with efficacy

    Measured: 2 years

Timeline

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

  1. First posted11 Nov 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionJan 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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01238692
Sponsor's protocol ID
Q-CROC-02
Status last verified
Mar 2023
First submitted
10 Nov 2010
Last updated
24 Mar 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • Assouline SE, Nielsen TH, Yu S, Alcaide M, Chong L, MacDonald D, Tosikyan A, Kukreti V, Kezouh A, Petrogiannis-Haliotis T, Albuquerque M, Fornika D, Alamouti S, Froment R, Greenwood CM, Oros KK, Camglioglu E, Sharma A, Christodoulopoulos R, Rousseau C, Johnson N, Crump M, Morin RD, Mann KK. Phase 2 study of panobinostat with or without rituximab in relapsed diffuse large B-cell lymphoma. Blood. 2016 Jul 14;128(2):185-94. doi: 10.1182/blood-2016-02-699520. Epub 2016 May 10.

    PubMed 27166360

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LBH589 and Rituximab in people with Diffuse Large B Cell Lymphoma, run by Sarit Assouline at 4 sites 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 8 inclusion and 18 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 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

Efficacy of LBH589 alone and when given in combination with rituximab (time frame: 2 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 NCT01238692, 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 24 Mar 2023; AzTrials last refreshed its copy on 8 Nov 2026.

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