LymphomaPhase 1/2NCT00621244

A Study of Oral LBH589 in Adult Patients With Advanced Hematological Malignancies

A Phase 1/2 study testing LBH589 in people with Lymphoma and Leukemia, run by Novartis Pharmaceuticals at 7 sites in 3 countries.

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 study evaluated safety, tolerability, pharmacokinetics and preliminary anti-leukemic or anti-tumor activity of LBH589B in adult patients with advanced hematological malignancies Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lymphoma, Leukemia, Multiple Myeloma
What is being tested?: LBH589
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 175 participants
Where: 7 sitesin 3 countries
Study dates: 1 Mar 2003to 3 Dec 2009
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Adult patients (≥18 years old) with advanced hematological malignancies who relapsed after or are refractory to standard therapy, or for which no standard therapy existed; or, were considered inappropriate candidates for standard therapy
World Health Organization (WHO) performance status ≤ 2
Patients who met protocol-specified hematologic and non-hematologic laboratory values
Patients with adequate liver and renal function

Who cannot join

Concurrent brain metastases or leukemic infiltration of the cerebrospinal fluid
Peripheral neuropathy ≥ CTCAE grade 2
Unresolved diarrhea ≥ CTCAE grade 2
Concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study, including impaired heart function or clinically significant heart disease, and impaired gastrointestinal function or disease that significantly altered aborption of LBH589
Female patients who were pregnant or breast feeding
Patients who were unwilling to use an effective method of birth control
Patients who took medications specified by the protocol as prohibited for administration in combination with LBH589
Patients with another primary malignancy that required active intervention or were clinically significant

Trial locations and contacts

7 sites in 3 countries.

Country

City, postcode or hospital

7 sites in 3 countries

United States3 sites

Georgia Health Sciences University Dept.ofMedicalCollegeOfGeorgia
Augusta, Georgia, 30912
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
MD Anderson Cancer Center/University of Texas
Houston, Texas, 77030

Other trials in United States

Australia2 sites

Novartis Investigative Site
Parkville, Victoria, 3002
Novartis Investigative Site
Prahran, Victoria, 3181

Other trials in Australia

Germany2 sites

Novartis Investigative Site
Frankfurt/M, 60590
Novartis Investigative Site
Mainz, 55131

Other trials in Germany

About this study

Official title: A Phase IA/II, Two-arm, Multi-center, Open-label, Dose-escalation Study of LBH589 Administered Orally Via Different Dosing Schedules in Adult Patients With Advanced Hematological Malignancies

This study evaluated safety, tolerability, pharmacokinetics and preliminary anti-leukemic or anti-tumor activity of LBH589B in adult patients with advanced hematological malignancies

Conditions: Lymphoma, Leukemia, Multiple Myeloma
Being tested: LBH589
Keywords: HDAC inhibitor, Oral, LBH589, Lymphoma, Leukemia, Multiple myeloma
Medical subject headings: Lymphoma, Leukemia, Multiple Myeloma

What participants receive

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

LBH589Drug

Study groups in NCT00621244
Study group	Role	What they receive
Arm 1, Group X	Experimental	Not described Receives: Drug: LBH589
Arm 1, Group Y	Experimental	Not described Receives: Drug: LBH589
Arm 2, Group X	Experimental	Not described Receives: Drug: LBH589
Arm 2, Group Y	Experimental	Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication. Receives: Drug: LBH589

What is being measured

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

Number of Participants DLT in Arm 1 in Dose Escalation Phase
Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) for consecutive dosing schedule (MWF weekly). A 3-parameter version of a Bayesian logistic regression model with overdose control (Babb, Rogatko, and Zacks 1998) was used during the dose escalation phase for dose level selection and determination of the MTD.
Measured: Cycle 1 (28-day treatment cycle)
Number of Participants DLT in Arm 2 in Dose Escalation Phase
Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) for intermittent dosing schedule (MWF weekly).
A 3-parameter version of a Bayesian logistic regression model with overdose control (Babb, Rogatko, and Zacks 1998) was used during the dose escalation phase for dose level selection and determination of the MTD.
Measured: Cycle 1 (28-day treamtent cycle)

Secondary outcomes (15)

Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML)
Response as per investigator assessment for patients include complete response, progressive disease/failure, stable disease.
Measured: 3.5 years
Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) in Expansion Phase
Stage 2 did not open for enrollment.
Measured: 1.2 years
Response as Per Investigator Assessment for Patients With Hodgkin's Lymphoma (HD)
Response as per investigator assessment for patients include complete response, partial remission, stable disease, progressive disease (PD)/failure.
Measured: 3.5 years
Response as Per Investigator Assessment for Patients With Myelodysplastic Syndromes (MDS)
Response as per investigator assessment for patients include complete response, stable disease, progressive disease/failure, partial remission.
Measured: 3.5 years
Maximum Plasma Concentration of Panobinostat After the First Dose in Arms 1 and 2
Measured: Day 1
Half Life of Panobinostat After the First Dose in Arms 1 and 2
Measured: Day 1
Maximum Plasma Concentration of Panobinostat After Multiple Doses in Arm 1 on Day 15
From day 15 by dose with schedule: MWF every week
Measured: Day 15
Half Life of Panobinostat After Multiple Doses in Arm 1 on Day 15
Measured: Day 15
Geometric Mean Ratio (GMR) Comparing Treatment Days in Arm 1
MWF Every week schedule n = number of subjects with non-missing values.
Measured: Day 15/day 1
Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X
Reporting the number of patients with a reading at the timepoint in the dose group.
Measured: Days 1, 5, 8, 10, 15
Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group Y
Measured: Days 5, 8, end of study (up to 3.5 years)
Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X
Measured: Days 5, 8, 10, 12, 15, End of study, Unscheduled (up to 3.5 years)
Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y
Measured: Days 5, 8, 10, 12, 15, End of study (up to 3.5 years)
Highest Percent Change in Fetal Hemoglobin From Baseline in Arm 1 (MWF Every Week)
All blood samples were drawn immediately prior to each administration of LBH589 dose and at the end of treatment (≤ 7 days post last dose (preferably ≥ 4 days [96 hours]))
Measured: Post dose to pre-dose (up to 3.5 years)
Highest Percent Change of Fetal Hemoglobin From Baseline in Arm 2 (MWF Every Other Week)
All blood samples were drawn immediately prior to each administration of LBH589 dose and at the end of treatment (≤ 7 days post last dose (preferably ≥ 4 days [96 hours]))
Measured: Post dose to pre-dose (up to 3.5 years)

Timeline

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

1 Mar 20033 Dec 2009

First posted22 Feb 2008 (estimated)
Study start1 Mar 2003
Primary completion3 Dec 2009
Study completion3 Dec 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for 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 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 175 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00621244
Sponsor's protocol ID: CLBH589B2102
Other IDs: 2005-003670-26, 2005
Status last verified: Jul 2017
First submitted: 12 Feb 2008
Last updated: 5 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Lymphoma trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IA/II, Two-arm, Multi-center, Open-label, Dose-escalation Study of LBH589 Administered Orally Via Different Dosing Schedules in Adult Patients With Advanced Hematological Malignancies
ClinicalTrials.gov ID: NCT00621244
Acronym / sponsor ID: CLBH589B2102
Conditions: Lymphoma, Leukemia, Multiple Myeloma
Keywords: HDAC inhibitor, Oral, LBH589, Lymphoma, Leukemia, Multiple myeloma
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 175 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 1 Mar 2003 (actual)
Primary completion: 3 Dec 2009 (actual)
Study completion: 3 Dec 2009 (actual)
First posted: 22 Feb 2008 (estimated)
Results: Posted 17 Aug 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study evaluated safety, tolerability, pharmacokinetics and preliminary anti-leukemic or anti-tumor activity of LBH589B in adult patients with advanced hematological malignancies

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Arm 1, Group X	Experimental	Drug: LBH589
Arm 1, Group Y	Experimental	Drug: LBH589
Arm 2, Group X	Experimental	Drug: LBH589
Arm 2, Group Y	Experimental	Drug: LBH589Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Adult patients (≥18 years old) with advanced hematological malignancies who relapsed after or are refractory to standard therapy, or for which no standard therapy existed; or, were considered inappropriate candidates for standard therapy
World Health Organization (WHO) performance status ≤ 2
Patients who met protocol-specified hematologic and non-hematologic laboratory values
Patients with adequate liver and renal function

Key exclusion criteria (8 listed)

Concurrent brain metastases or leukemic infiltration of the cerebrospinal fluid
Peripheral neuropathy ≥ CTCAE grade 2
Unresolved diarrhea ≥ CTCAE grade 2
Concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study, including impaired heart function or clinically significant heart disease, and impaired gastrointestinal function or disease that significantly altered aborption of LBH589
Female patients who were pregnant or breast feeding

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
LBH589	Drug	Arm 1, Group X, Arm 1, Group Y, Arm 2, Group X, Arm 2, Group Y

Primary outcome

Number of Participants DLT in Arm 1 in Dose Escalation Phase
Time frame: Cycle 1 (28-day treatment cycle)
Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) for consecutive dosing schedule (MWF weekly). A 3-parameter version of a Bayesian logistic regression model with overdose control (Babb, Rogatko, and Zacks 1998) was used during the dose escalation phase for dose level selection and determination of the MTD.
Number of Participants DLT in Arm 2 in Dose Escalation Phase
Time frame: Cycle 1 (28-day treamtent cycle)
Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) for intermittent dosing schedule (MWF weekly). A 3-parameter version of a Bayesian logistic regression model with overdose control (Babb, Rogatko, and Zacks 1998) was used during the dose escalation phase for dose level selection and determination of the MTD.

15 secondary outcomes

Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML)
Time frame: 3.5 years
Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) in Expansion Phase
Time frame: 1.2 years
Response as Per Investigator Assessment for Patients With Hodgkin's Lymphoma (HD)
Time frame: 3.5 years
Response as Per Investigator Assessment for Patients With Myelodysplastic Syndromes (MDS)
Time frame: 3.5 years
Maximum Plasma Concentration of Panobinostat After the First Dose in Arms 1 and 2
Time frame: Day 1
Half Life of Panobinostat After the First Dose in Arms 1 and 2
Time frame: Day 1
Maximum Plasma Concentration of Panobinostat After Multiple Doses in Arm 1 on Day 15
Time frame: Day 15
Half Life of Panobinostat After Multiple Doses in Arm 1 on Day 15
Time frame: Day 15
Geometric Mean Ratio (GMR) Comparing Treatment Days in Arm 1
Time frame: Day 15/day 1
Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X
Time frame: Days 1, 5, 8, 10, 15
Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group Y
Time frame: Days 5, 8, end of study (up to 3.5 years)
Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X
Time frame: Days 5, 8, 10, 12, 15, End of study, Unscheduled (up to 3.5 years)
Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y
Time frame: Days 5, 8, 10, 12, 15, End of study (up to 3.5 years)
Highest Percent Change in Fetal Hemoglobin From Baseline in Arm 1 (MWF Every Week)
Time frame: Post dose to pre-dose (up to 3.5 years)
Highest Percent Change of Fetal Hemoglobin From Baseline in Arm 2 (MWF Every Other Week)
Time frame: Post dose to pre-dose (up to 3.5 years)

Results and safety

Results posted to the registry on 17 Aug 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1, Group X	86	0
Arm 1, Group Y	34	0
Arm 2, Group X	33	0
Arm 2, Group Y	23	0

Primary outcome: Number of Participants DLT in Arm 1 in Dose Escalation Phase

Time frame: Cycle 1 (28-day treatment cycle). Number. Unit: Participants

Measure	Arm 1, Group X (20 mg) n = 7	Arm 1, Group X (30 mg) n = 6	Arm 1, Group X (40 mg) n = 8	Arm 1, Group X (60 mg) - MTD n = 12	Arm 1, Group X (80 mg) n = 6	Arm 1, Group Y (20 mg) n = 1	Arm 1, Group Y (30 mg) n = 3	Arm 1, Group Y (40 mg) - MTD n = 15	Arm 1, Group Y (60 mg) n = 4
Value	0	0	2	1	4	0	0	5	4

Population analysed: MTD-determining set: Patients in the safety set who were in the dose escalation phase, and who received panobinostat for ≥ 9 full doses in arm 1 in cycle 1 and completed all needed safety evaluations; or who received panobinostat for ≥ 5 full doses in arm 2 in cycle 1 and completed all required safety evaluations; or who experienced DLT in cycle 1.

Primary outcome: Number of Participants DLT in Arm 2 in Dose Escalation Phase

Time frame: Cycle 1 (28-day treamtent cycle). Number. Unit: Participants

Measure	Arm 2, Group X (30 mg) n = 6	Arm 2, Group X (45 mg) n = 7	Arm 2, Group X (60 mg) n = 7	Arm 2, Group X (80 mg) n = 8	Arm 2, Group Y (30 mg) n = 1	Arm 2, Group Y (45 mg) n = 6	Arm 2, Group Y (60 mg) - MTD n = 13
Value	0	0	0	4	0	0	3

Population analysed: MTD-determining population: All patients from the safety population who were in the dose escalation phase of the study, and who received panobinostat for ≥ 9 full doses in arm 1 during cycle 1 and completed all required safety evaluations; or who received panobinostat.

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs were collected for at least 4 weeks following last dose of treatment (3.5 years). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm1, Group X (20 mg)	8 of 8 (100%)	8 of 8 (100%)	Not reported
Arm1, Group X (30 mg)	5 of 8 (62.5%)	8 of 8 (100%)	Not reported
Arm1, Group X (40 mg)	9 of 10 (90%)	10 of 10 (100%)	Not reported
Arm1 GroupX 60 mg	34 of 49 (69.4%)	49 of 49 (100%)	Not reported
Arm1 GroupX 80 mg	10 of 11 (90.9%)	11 of 11 (100%)	Not reported
Arm1 GroupY 20 mg	0 of 1 (0%)	1 of 1 (100%)	Not reported
Arm1 GroupY 30 mg	3 of 4 (75%)	4 of 4 (100%)	Not reported
Arm1 GroupY 40 mg	10 of 24 (41.7%)	24 of 24 (100%)	Not reported
Arm1 GroupY 60 mg	2 of 5 (40%)	5 of 5 (100%)	Not reported
Arm2 GroupX 30 mg	5 of 6 (83.3%)	6 of 6 (100%)	Not reported
Arm2 GroupX 45 mg	8 of 9 (88.9%)	9 of 9 (100%)	Not reported
Arm2 GroupX 60 mg	7 of 9 (77.8%)	9 of 9 (100%)	Not reported
Arm2 GroupX 80 mg	8 of 9 (88.9%)	9 of 9 (100%)	Not reported
Arm2 GroupY 30 mg	0 of 1 (0%)	1 of 1 (100%)	Not reported
Arm2 GroupY 45 mg	3 of 7 (42.9%)	7 of 7 (100%)	Not reported
Arm2 GroupY 60 mg	11 of 15 (73.3%)	15 of 15 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results for CLBH589B2102 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.

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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 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing LBH589 in people with Lymphoma and Leukemia, run by Novartis Pharmaceuticals at 7 sites in 3 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 8 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 5 Jan 2021. 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, Australia, Germany. 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 combined 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.

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?

Yes. Results are posted in the registry (first posted 17 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 DLT in Arm 1 in Dose Escalation Phase (time frame: Cycle 1 (28-day treatment cycle)). The study lists 2 primary outcomes in all. 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 NCT00621244.

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 5 Jan 2021.