A phase I/II feasibility study of panobinostat alone and the combination of panobinostat and decitabine prior to donor lymphocyte infusion in recipients of allogeneic stem cell transplantation with poor and very poor risk AML

A phase I/II feasibility study of panobinostat alone and the combination of panobinostat and decitabine prior to donor lymphocyte infusion in recipients of allogeneic stem cell transplantation with poor and very poor risk AML - HOVON 116 AML

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50408

Enrollment

115

Registered

2013-09-19

Start date

2014-01-17

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute myeloid leukemia (AML) myelodysplastic syndrome

Interventions

During part I of the trial the combination of panobinostart en decitabine will be tested at 4 dose levels, the first being panobinstat alone. In part II, patients will be treated with T cell replete

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Patients with poor-risk or very poor-risk AML or RAEB with IPSS >= 1.5 , -Eligibility for continuation with intensive induction/consolidation chemotherapy -Eligible for allogeneic donor search (related/unrelated) -18-70 years, inclusive -Written informed consent

Exclusion criteria

Exclusion criteria: - History of active malignancy during the past 2 years with the exception of basal carcinoma of the skin or carcinoma *in situ* of the cervix or breast - Known HIV-positivity - Pregnant or breast-feeding female patients

Design outcomes

Primary

Measure	Time frame
Part I • Feasibility of protocol treatment as defined by the number of DLTs during the first cycle PNB/DAC Part II • Feasibility of protocol treatment as defined by percentage of patients actually receiving treatment according to protocol up to eligibility for the first DLI within 115 days. Part III • Feasibility of protocol treatment as defined by percentage of patients actually receiving treatment according to protocol up to eligibility for the first DLI within 115 days.	—

Measure

Time frame

Part I • Feasibility of protocol treatment as defined by the number of DLTs during the first cycle PNB/DAC Part II • Feasibility of protocol treatment as defined by percentage of patients actually receiving treatment according to protocol up to eligibility for the first DLI within 115 days. Part III • Feasibility of protocol treatment as defined by percentage of patients actually receiving treatment according to protocol up to eligibility for the first DLI within 115 days.

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Secondary

Measure	Time frame
• Response to first cycle PNB/DAC • Response to second cycle PNB/DAC • Percentage of successful donor searches • Percentage of patients who received alloHSCT • Best response on protocol • Engraftment after alloHSCT • Incidence and severity of acute and chronic GvHD • (Serious) adverse events • Overall survival (OS) from registration and start of protocol treatment • PFS from registration and from start of protocol treatment	—

Measure

Time frame

• Response to first cycle PNB/DAC • Response to second cycle PNB/DAC • Percentage of successful donor searches • Percentage of patients who received alloHSCT • Best response on protocol • Engraftment after alloHSCT • Incidence and severity of acute and chronic GvHD • (Serious) adverse events • Overall survival (OS) from registration and start of protocol treatment • PFS from registration and from start of protocol treatment

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)