A Phase Ib, Open-label, Multi-center Dose-finding Study of Oral Panobinostat (LBH589) in Combination With Ara-C and Mitoxantrone as Salvage Therapy for Refractory or Relapsed Acute Myeloid Leukemia

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01055483
• Collaborator: (none)
• Enrollment: 59
• Locations: 6
• Arm: 1
• Duration (Months): 29
• Patients Per Site: 9.8
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The study will determine the maximal tolerated dose (MTD) of panobinostat administered in combination with a fixed combination of cytarabine (ara-C) and mitoxantrone in adult patients with relapsed or refractory acute myeloid leukemia (AML).

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia	Drug: panobinostat/LBH589B	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 59 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase Ib, Open-label, Multi-center Dose-finding Study of Oral Panobinostat (LBH589) in Combination With Ara-C and Mitoxantrone as Salvage Therapy for Refractory or Relapsed Acute Myeloid Leukemia
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Feb 1, 2012
• Actual Study Completion Date: Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LBH589	Drug: panobinostat/LBH589B

Outcome Measures

Primary Outcome Measures

1. Incidence of dose limiting toxicity (DLT) [1 cycle (1 cycle = 28 days)]

Secondary Outcome Measures

1. Frequency, severity and duration of Adverse Events (AE) using CTCAE version 3.0 [During maximal three LBH589/chemotherapy cycles and subsequent optional single-agent LBH589 treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with cytopathologically confirmed diagnosis of AML according to WHO criteria, excluding acute promyelocytic leukemia.

• First relapsed AML

• Primary refractory AML defined as failure to respond to initial induction chemotherapy (no CR) or recurrence within 6 months of initial CR.

• Age more than 18 years

• ECOG performance status < 2

Exclusion Criteria:

• Prior treatment with deacetylase inhibitor

• Concurrent therapy with any other investigational agent

• Patients who have received cumulative doses (or its equivalent to other anthracyclines) of more than 360 mg/m2 of doxorubicin will be excluded from the study.

• Clinical symptoms suggesting CNS leukemia

• LVEF below 45% Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Paris Cedex 4		France	75181
2	Novartis Investigative Site	Paris		France	75475
3	Novartis Investigative Site	Dresden		Germany	01307
4	Novartis Investigative Site	Frankfurt		Germany	60590
5	Novartis Investigative Site	Hannover		Germany	30625
6	Novartis Investigative Site	Ulm		Germany	89081

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Results for LBH589B2116 can be found on the Novartis Clinical Trial Results Website

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01055483
• Other Study ID Numbers: CLBH589B2116; 2008-002986-30
• First Posted: Jan 25, 2010
• Last Update Posted: Dec 19, 2020
• Last Verified: Feb 1, 2013

• Keywords provided by Novartis Pharmaceuticals: Acute myeloid leukemia; AML; relapsed acute myeloid leukemia; refractory acute myeloid leukemia
• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Panobinostat

Study Results

No Results Posted as of Dec 19, 2020