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Mantle Cell LymphomaPhase 1BUS48TNCT01504776

Phase I Study of Panobinostat + Bortezomib for Relapsed and/or Refractory Mantle Cell Lymphoma (MCL)

A Phase 1 study testing Panobinostat and Bortezomib in people with Mantle Cell Lymphoma, run by Anand Jillella at 1 site in United States.

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 this study is to determine the safety and clinical efficacy of the combination of panobinostat plus bortezomib. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mantle Cell Lymphoma
What is being tested?
Panobinostat and Bortezomib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited States
Study dates
Apr 2011to Sep 2014
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 or female patients aged ≥ 18 years old
  • Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
  • Patients must have adequate hematology/chemistry lab values
  • Echocardiogram (ECHO) must demonstrate Left Ventricular Ejection Fraction (LVEF) ≥ 50%.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
  • Patients with previously diagnosed MCL based on standard criteria and with at least one and a maximum of 4 lines of therapy and currently requiring further treatment
  • Prior therapy with autologous and allogeneic stem cell transplant is permissible. Patients who have undergone an allogeneic transplant should have no evidence of graft-versus-host disease (GVHD) and should not be on any immunosuppressive therapy. Autologous and allogeneic transplant will be counted as one prior therapy.
  • Patients previously treated with bortezomib will be included in the study

Who cannot join

  • Prior HDAC, DAC, HSP90 inhibitors or valproic acid for the treatment of cancer
  • Patients who will need valproic acid for any medical condition during the study or within 5 days prior to first LBH589 (Panobinostat) treatment
  • Peripheral neuropathy ≥ Common Toxicity Criteria for Adverse Effects (CTCAE) grade 2 on clinical examination within 14 days of randomization
  • Impaired cardiac function or clinically significant cardiac diseases
  • Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of LBH589
  • Patients with diarrhea > CTCAE grade 2.
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  • Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes or active or uncontrolled infection) including abnormal laboratory values, that could cause unacceptable safety risks or compromise compliance with the protocol
  • Patients using medications that have a relative risk of prolonging the QT interval or inducing torsade de pointes if treatment cannot be discontinued or switched to a different medication prior to starting study drug
  • Patients who have received targeted agents within 2 weeks or within 5 half-lives of the agent and active metabolites (whichever is longer) and who have not recovered from side effects of those therapies.
  • Patients who have received either immunotherapy within < 8 weeks; chemotherapy within < 4 weeks; or radiation therapy to > 30% of marrow-bearing bone within < 2 weeks prior to starting study treatment; or who have not yet recovered from side effects of such therapies.
  • Patients who have undergone major surgery ≤ 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy
  • Women who are pregnant or breast feeding or women of childbearing potential (WOCBP) not using an effective method of birth control. 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 (i.e., who has had menses any time in the preceding 12 consecutive months). Women of childbearing potential must have a negative serum pregnancy test within 24hrs of receiving the first dose of study medication.
  • Male patients whose sexual partners are WOCBP not using effective birth control
  • Patients with a prior malignancy within the last 5 years (except for basal or squamous cell carcinoma, or in situ cancer of the cervix)
  • Patients with known positivity for human immunodeficiency virus (HIV) ) or hepatitis C; baseline testing for HIV and hepatitis C is not required
  • Patients with any significant history of non-compliance to medical regimens or unwilling or unable to comply with the instructions given to him/her by the study staff.
  • Allergic reaction to bortezomib

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Georgia Regents University

    Augusta, Georgia, 30912

Other trials in United States

About this study

Official title: A Phase I Study of Panobinostat in Combination With Bortezomib in the Treatment of Relapsed and/or Refractory Mantle Cell Lymphoma

The purpose of this study is to determine the safety and clinical efficacy of the combination of panobinostat plus bortezomib.

Read the detailed description

This is a phase I single arm, open label, multi-center (3 participating sites) dose escalation study of oral panobinostat administered Monday-Wednesday-Friday (MWF) weekly x 4 weeks, utilizing 3+3 dosing scheme (15, 20, 25 mg) in combination with a fixed dose of bortezomib 1.3 mg/m2 administered as a short intravenous (IV) infusion of 3-5 seconds every week x 4 weeks, representing one cycle. Each week, bortezomib will be administered IV prior to the oral dose of panobinostat. There will be sub-investigators participating in this study who will enroll at sub-sites.

Being tested
Panobinostat, Bortezomib
Keywords
MCL, Lymphoma, Panobinostat
Medical subject headings
Lymphoma, Mantle-Cell, Lymphoma

What participants receive

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

  • PanobinostatDrug

    Also called LBH589

    Dose escalation study of oral panobinostat administered Monday-Wednesday-Friday (MWF) weekly x 4 weeks, utilizing 3+3 dosing scheme (15, 20, 25 mg) in combination with a fixed dose of bortezomib 1.3 mg/m2 administered as a short intravenous (IV)infusion of 3-5 seconds every week x 4 weeks, representing one cycle. Each week, bortezomib will be administered IV prior to the oral dose of panobinostat

  • BortezomibDrug

Study groups in NCT01504776
Study groupRoleWhat they receive
Open Label Drug TherapyExperimentalSingle arm
Receives: Drug: Panobinostat; Drug: Bortezomib

What is being measured

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

  1. Dose-Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD)

    To determine the DLTs and MTD of panobinostat given in combination with bortezomib.

    Measured: 3 years

Secondary outcomes (1)

  1. Observe the activity of the combination against Mantle Cell Lymphoma (MCL) in patients treated in this Phase I study.

    Pre-treatment primary MCL cells derived from the bone marrow and/or peripheral blood of patients enrolled in this clinical trial will be isolated and treated ex vivo with panobinostat and/or bortezomib. IC50 values for each agent, as well as the combination indices values for the two agents will be determined and correlated with clinical response.

    Pre-treatment and 24 hour post-treatment primary MCL cells from patients who have circulating MCL cells in the peripheral blood will be isolated, as above.

    Measured: 3 years

Timeline

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

  1. First posted5 Jan 2012 (estimated)
  2. Study startApr 2011
  3. Primary completionSep 2014
  4. Study completionSep 2014

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
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01504776
Sponsor's protocol ID
CLBH589BUS48T
Acronym
BUS48T
Status last verified
Jan 2012
First submitted
8 Aug 2011
Last updated
19 Sep 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Panobinostat and Bortezomib in people with Mantle Cell Lymphoma, run by Anand Jillella at 1 site in United States.

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 17 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 19 Sep 2014. 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 United States. 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?

Dose-Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) (time frame: 3 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 NCT01504776.

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 19 Sep 2014.

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