Nodal LymphomaPhase 2VEG VCA1NCT01658241
Panobinostat Biological Correlates Study
A Phase 2 study testing panobinostat in people with Nodal Lymphoma and Lymphoma With Cutaneous Involvement, run by Peter MacCallum Cancer Centre, Australia at 1 site in Australia.
Trial summary
This study is looking at the effects of Panobinostat, an investigational treatment, on cancer cells in patients who have Hodgkin lymphoma (a cancer of the immune system with specific Hodgkin/Reed Sternberg Cells), T-cell lymphoma (a cancer of the immune system with too many T lymphocytes), chronic lymphocytic leukemia… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nodal Lymphoma, Lymphoma With Cutaneous Involvement, Lymphoma in Leukemic Phase
- What is being tested?
- panobinostat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- 16 Jul 2012to 18 Mar 2015
- 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
- Histologically proven lymphoproliferative neoplasm belonging to one of the following disease categories that has relapsed or has an incomplete response to conventional therapy, or where the patient is considered intolerant to conventional chemotherapy or where no other conventional therapy is considered appropriate.
- Hodgkin lymphoma
- Multiple myeloma (patient must have been exposed to or otherwise unable to tolerate lenalidomide and bortezomib).
- Peripheral T-cell lymphoma (including angioimmunoblastic lym-phoma and PTCL Not otherwise specified)
- Cutaneous T-Cell lymphoma [Mycosis fungoides, Sézary syndrome, Primary cutaneous gamma-delta T cell lymphoma, Lymphomatoid papulosis, Subcutaneous panniculitis-like T cell lymphoma Alpha/Beta or lambda/delta type and CD30+ Anaplastic large cell lymphoma]
- Cutaneous B-cell lymphoma [Extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue (MALT) lymphoma of the skin, Primary cutaneous follicle cell lymphoma, Primary cutaneous DLBCL, leg type]
Show all 29Show fewer
- Chronic lymphocytic leukaemia
- Lymphoplasmacytic lymphoma
- B-prolymphocytic leukaemia (or CLL in prolymphocytic transfor-mation)
- T-prolymphocytic leukaemia
- The lymphoma needs to be accessible, convenient and safe (< 5% risk of bleeding or serious event) for biopsy in at least one of the following sample types on multiple occasions as stipulated by the study protocol:
- Peripheral blood samples (absolute peripheral circulating lymphoma cells > 2x109/L).
- Bone marrow biopsy (> 30% marrow involvement by lymphoma).
- Clinically apparent cutaneous lymphoma amenable to skin biopsy (patients with cutaneous involvement and blood stream involvement must agree to biopsies of the skin in addition to peripheral blood samples).
- Clinically accessible lymph node or extranodal disease amenable to core biopsy.
- Age ≥ 18 years
- ECOG performance status score 0-2 at screening.
- Life expectancy of ≥12 weeks
- Patient has the following laboratory values within 3 weeks of starting study drug (labs may be repeated, if needed, to obtain acceptable values before failure at screening is concluded)
- ANC ≥ 1.5x109 /L
- Platelet count ≥ 100 x 109 /L (unless due to marrow involvement)
- AST/SGOT and ALT/SGPT ≤ 2.5 x ULN
- Serum total bilirubin ≤ 1.5 x ULN (except gilbert's syndrome, in which case ≤ 3 x ULN is required)
- Serum creatinine ≤ 1.5 x ULN
- Serum potassium, magnesium, phosphorus, sodium, total calcium (corrected for serum albumin) or ionized calcium within normal limits
- Patient has the ability to swallow capsules.
- Sexually active patient (men and women of child bearing potential) agrees to use double barrier method of contraception during the course of the study treatment period (13 cycles) and for 3 months after completing study treatment. WOCBP are defined as sexually mature women who have not undergone a hysterectomy or who are not postmenapausal (no menses) for at least 12 consecutive months.
- Males with a female partner of childbearing potential must agree to use a medically reliable method of preventing conception throughout the study and for 30 days following the date of last dose.
- Mentally competent and is able to understand the information given and provide informed consent to both the clinical aspects of the study as well as the demands of the correlative studies and associated tumour biopsies.
Who cannot join
- Concomitant use (within 28 days of first biopsy) of any anti-cancer therapy including radiation therapy
- Exposure to a histone deacetylase inhibitor within the preceding 4 weeks.
- Patient has received chemotherapy or any investigational drug or undergone major surgery ≤ 2 weeks prior to starting study drug or whose side effects of such therapy have not resolved to ≤ grade 1 (except for grade 2 neuropathy).
- Current involvement (medication delivered within 28 days of first biopsy)in a study of an alternative investigational agent.
- Impaired cardiac function including any one of the following:
- LVEF < the lower limit of institutional normal, as determined by ECHO or MUGA
Show all 37Show fewer
- Obligate use of a permanent cardiac pacemaker
- Congenital long QT syndrome
- History or presence of ventricular tachy-arrhythmias
- Resting bradycardia defined as < 50 beats per minute
- QTcF > 450 msec on screening ECG
- Complete left bundle branch block, bifasicular block
- Any clinically significant ST segment and/or T-wave abnormalities
- Presence of unstable atrial fibrillation (ventricular rate > 100 bpm). Patient with stable atrial fibrillation is allowed in the study provided the other cardiac exclusion criteria are satisfied.
- Myocardial infarction or unstable angina pectoris ≤ 6 months prior to starting study drug
- Congestive heart failure (New York Heart Association class III-IV)
- Other clinically significant heart disease and vascular disease (e.g. uncontrolled hypertension)
- Patient is taking medications with relative risk of prolonging the QT interval or inducing torsade de pointes, if such treatment cannot be discontinued or switched to a different medication prior to starting study drug
- Patient has impairment of GI function or GI disease that may significantly alter the absorption of panobinostat, such as:
- Active ulcerative disease
- uncontrolled nausea or vomiting
- diarrhea CTCAE grade ≥ 2 (despite antidiarrheal medications)
- malabsorption syndrome
- obstruction
- stomach and/or small bowel resection
- Known HIV, hepatitis B or hepatitis C (a screening test is not required)
- Female patients who are pregnant or breast feeding
- Other concurrent severe and/or uncontrolled medical conditions such as (but not limited to)
- uncontrolled diabetes
- active or uncontrolled infection
- chronic obstructive or chronic restrictive pulmonary disease including dyspnea at rest from any cause
- uncontrolled thyroid dysfunction
- recent, acute or active bleeding
- Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. This condition must be discussed with the patient prior to signing consent and registration in the trial.
- Prior diagnosis of cancer that was:
- more than 3 years prior to current diagnosis with subsequent evidence of disease recurrence or estimated clinical expectation of recurrence is greater than 10% within next 2 years
- within 3 years of current diagnosis with the exception of successfully treated basal cell or squamous cell skin carcinoma, carcinoma in situ of the cervix or localised cancer treated curatively with local therapy only.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study to Investigate Biological Correlates of Clinical Response to Panobinostat in Haematological Malignancy
This study is looking at the effects of Panobinostat, an investigational treatment, on cancer cells in patients who have Hodgkin lymphoma (a cancer of the immune system with specific Hodgkin/Reed Sternberg Cells), T-cell lymphoma (a cancer of the immune system with too many T lymphocytes), chronic lymphocytic leukemia or prolymphocytic leukaemia (immune system with too many lymphocytes in the blood stream), lymphoplasmacytic lymphoma (immune system with too many plasma cells or B lymphocytes) or myeloma (a cancer of plasma cells).
Panobinostat is a new drug which has led to disease improvement in some patients with Hodgkin lymphoma, certain types of T-cell lymphoma, myeloma and some B cell lymphomas. Not all patients benefit from panobinostat.
Read more
The researchers wish to look at the effects of panobinostat on cancer cells. The aim of this project is find out which patients or diseases are likely to respond to treatment with panobinostat in the future and to see if there are particular features of the patient or of the cancer that affects the likelihood of the way individuals respond to panobinostat.
Panobinostat is an oral medication (taken by mouth) that effects the way cancer cells and in normal cells make proteins. Panobinostat has been used in several clinical trials around the world. The largest trials generally have fewer than 200 patients and are in Hodgkin lymphoma, cutaneous T-cell lymphoma, and myeloma where between one in five and one in three patients have significant improvement in their disease.
Researchers will look at samples of tumour before treatment and during treatment. This will be one of the first studies to look at how cancer cells change following treatment with this drug. It is unusual because it requires repeated biopsies of the participant's tumour. Panobinostat is considered an experimental (or investigational) drug and not approved by any regulatory authority (such as the Food and Drug Administration, FDA in the USA or by the Therapeutics Goods and Administration, TGA, in Australia) to treat any type of cancer. Therefore, Panobinostat is not approved to treat patients who have been diagnosed with refractory or relapsed cancer.
A total of 30 patients with one of the diseases listed above will be enrolled at Peter MacCallum Cancer Centre.
It is expected it will take about 2 to 3 years to recruit 30 patients and that on average patients will take part for six to eighteen months. This time could be shorter or longer depending on how well the treatment works in each individual. While the trial will take up to 4 years to complete, the science studies may take longer.
- Conditions
- Nodal Lymphoma, Lymphoma With Cutaneous Involvement, Lymphoma in Leukemic Phase, Marrow Involvement With Lymphoma, Multiple Myeloma
- Being tested
- panobinostat
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
panobinostatDrug
Also called LBH589
40mg, three times a week, oral pill over 12 cycles, 4 weeks per cycle
| Study group | Role | What they receive |
|---|---|---|
| Single Arm Main population | Experimental | Not described Receives: Drug: panobinostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gene expression profile of tumor samples taken before and after treatement with panobinostat
Measured: Up to two years from trial entry
Secondary outcomes (7)
Overall response (OR): this is a composite clinical endpoint including those who have achieved a complete remission (CR) or partial remission (PR) by conventional disease-appropriate criteria. (i.e. OR=CR+PR)
Measured: Up to two years from trial entry
Clinical benefit: a composite endpoint including those with complete remission, partial remission, marginal response and those with otherwise stable disease that has been maintained for at least 2 cycles of therapy
Measured: Up to two years from trial entry
Time to response: the time from first drug dose to best confirmed response
Measured: Up to two years from trial entry
Time to progression: the time from initial observation of response to confirmed disease progression, or the time from first drug dose to confirmed disease progression
Measured: Up to two years from trial entry
Progression-free survival: time from trial registration to disease progression or death from any cause
Measured: Up to two years from trial entry
Disease-specific biological improvement - as defined in the protocol
Measured: Up to two years from trial entry
Sustained disease-specific biological improvement - as defined in the protocol
Measured: Up to two years from trial entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study start16 Jul 2012
- Primary completion18 Mar 2015
- Study completion18 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nodal LymphomaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter MacCallum Cancer Centre, Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Dickinson, Principal investigator, Peter MacCallum Cancer Centre, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01658241
- Sponsor's protocol ID
- 12/18
- Acronym
- VEG VCA1
- Status last verified
- May 2022
- First submitted
- 20 Jul 2012
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Investigate Biological Correlates of Clinical Response to Panobinostat in Haematological Malignancy
- ClinicalTrials.gov ID
- NCT01658241
- Acronym / sponsor ID
- VEG VCA1 / 12/18
- Conditions
- Nodal Lymphoma, Lymphoma With Cutaneous Involvement, Lymphoma in Leukemic Phase, Marrow Involvement With Lymphoma, Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Peter MacCallum Cancer Centre, AustraliaUniversity, hospital or other
- Study start
- 16 Jul 2012 (actual)
- Primary completion
- 18 Mar 2015 (actual)
- Study completion
- 18 Mar 2015 (actual)
- First posted
- 6 Aug 2012 (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 study is looking at the effects of Panobinostat, an investigational treatment, on cancer cells in patients who have Hodgkin lymphoma (a cancer of the immune system with specific Hodgkin/Reed Sternberg Cells), T-cell lymphoma (a cancer of the immune system with too many T lymphocytes), chronic lymphocytic leukemia or prolymphocytic leukaemia (immune system with too many lymphocytes in the blood stream), lymphoplasmacytic lymphoma (immune system with too many plasma cells or B lymphocytes) or myeloma (a cancer of plasma cells).
Panobinostat is a new drug which has led to disease improvement in some patients with Hodgkin lymphoma, certain types of T-cell lymphoma, myeloma and some B cell lymphomas. Not all patients benefit from panobinostat.
The researchers wish to look at the effects of panobinostat on cancer cells. The aim of this project is find out which patients or diseases are likely to respond to treatment with panobinostat in the future and to see if there are particular features of the patient or of the cancer that affects the likelihood of the way individuals respond to panobinostat.
Panobinostat is an oral medication (taken by mouth) that effects the way cancer cells and in normal cells make proteins. Panobinostat has been used in several clinical trials around the world. The largest trials generally have fewer than 200 patients and are in Hodgkin lymphoma, cutaneous T-cell lymphoma, and myeloma where between one in five and one in three patients have significant improvement in their disease.
Researchers will look at samples of tumour before treatment and during treatment. This will be one of the first studies to look at how cancer cells change following treatment with this drug. It is unusual because it requires repeated biopsies of the participant's tumour. Panobinostat is considered an experimental (or investigational) drug and not approved by any regulatory authority (such as the Food and Drug Administration, FDA in the USA or by the Therapeutics Goods and Administration, TGA, in Australia) to treat any type of cancer. Therefore, Panobinostat is not approved to treat patients who have been diagnosed with refractory or relapsed cancer.
A total of 30 patients with one of the diseases listed above will be enrolled at Peter MacCallum Cancer Centre.
It is expected it will take about 2 to 3 years to recruit 30 patients and that on average patients will take part for six to eighteen months. This time could be shorter or longer depending on how well the treatment works in each individual. While the trial will take up to 4 years to complete, the science studies may take longer.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm Main population | Experimental | Drug: panobinostat |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Histologically proven lymphoproliferative neoplasm belonging to one of the following disease categories that has relapsed or has an incomplete response to conventional therapy, or where the patient is considered intolerant to conventional chemotherapy or where no other conventional therapy is considered appropriate.
- The lymphoma needs to be accessible, convenient and safe (< 5% risk of bleeding or serious event) for biopsy in at least one of the following sample types on multiple occasions as stipulated by the study protocol:
- Age ≥ 18 years
- ECOG performance status score 0-2 at screening.
- Life expectancy of ≥12 weeks
Key exclusion criteria (37 listed)
- Concomitant use (within 28 days of first biopsy) of any anti-cancer therapy including radiation therapy
- Exposure to a histone deacetylase inhibitor within the preceding 4 weeks.
- Patient has received chemotherapy or any investigational drug or undergone major surgery ≤ 2 weeks prior to starting study drug or whose side effects of such therapy have not resolved to ≤ grade 1 (except for grade 2 neuropathy).
- Current involvement (medication delivered within 28 days of first biopsy)in a study of an alternative investigational agent.
- Impaired cardiac function including any one of the following:
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 |
|---|---|---|
| panobinostatAlso: LBH58940mg, three times a week, oral pill over 12 cycles, 4 weeks per cycle | Drug | Single Arm Main population |
Primary outcome
Change in gene expression profile of tumor samples taken before and after treatement with panobinostat
Time frame: Up to two years from trial entry
7 secondary outcomes
Overall response (OR): this is a composite clinical endpoint including those who have achieved a complete remission (CR) or partial remission (PR) by conventional disease-appropriate criteria. (i.e. OR=CR+PR)
Time frame: Up to two years from trial entry
Clinical benefit: a composite endpoint including those with complete remission, partial remission, marginal response and those with otherwise stable disease that has been maintained for at least 2 cycles of therapy
Time frame: Up to two years from trial entry
Time to response: the time from first drug dose to best confirmed response
Time frame: Up to two years from trial entry
Time to progression: the time from initial observation of response to confirmed disease progression, or the time from first drug dose to confirmed disease progression
Time frame: Up to two years from trial entry
Progression-free survival: time from trial registration to disease progression or death from any cause
Time frame: Up to two years from trial entry
Disease-specific biological improvement - as defined in the protocol
Time frame: Up to two years from trial entry
Sustained disease-specific biological improvement - as defined in the protocol
Time frame: Up to two years from trial entry
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 6 May 2022.
Related trials for Nodal Lymphoma
RecruitingPhase 2
Testing the Addition of Duvelisib or CC-486 to the Usual Treatment for Peripheral T-Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma, Enteropathy-Associated T-Cell Lymphoma
Not yet recruitingPhase 2
Zilovertamab Vedotin and Lenalidomide (ZiVLen) Therapy for Relapsed/Refractory Peripheral T-Cell Lymphoma
Peripheral T-Cell Lymphoma Refractory
RecruitingPhase 2
Non-covalent BTK Inhibitor Nemtabrutinib in Combination With the CD20 Monoclonal Antibody Rituximab for the Treatment of Marginal Zone Lymphoma
Conjunctival Mucosa-Associated Lymphoid Tissue Lymphoma, Gastric Mucosa-Associated Lymphoid Tissue Lymphoma
Active, not recruitingPhase 1/2
Pembrolizumab and Pralatrexate in Treating Patients With Relapsed or Refractory Peripheral T-Cell Lymphomas
Anaplastic Large Cell Lymphoma, Nodal Peripheral T-Cell Lymphoma With TFH Phenotype
RecruitingObservational study
Tissue, Blood, and Body Fluid Sample Collection From Patients With Hematologic Cancer
Chronic Myeloproliferative Disorders, Leukemia
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.
Michael Dickinson principal investigator
Peter MacCallum Cancer Centre, Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing panobinostat in people with Nodal Lymphoma and Lymphoma With Cutaneous Involvement, run by Peter MacCallum Cancer Centre, Australia at 1 site in Australia.
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 29 inclusion and 37 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 6 May 2022. 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 Australia. 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?
Change in gene expression profile of tumor samples taken before and after treatement with panobinostat (time frame: Up to two years from trial entry). 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 6 May 2022.