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Phase I/II Trial of Lenalidomide in Combination With Vorinostat and Dexamethasone as Therapy in Relapsed or Refractory Patients With Peripheral T-Cell Non-Hodgkin's Lymphoma (PTCL)


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Peripheral T-Cell Non-Hodgkin's Lymphoma

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Trial Information

Phase I/II Trial of Lenalidomide in Combination With Vorinostat and Dexamethasone as Therapy in Relapsed or Refractory Patients With Peripheral T-Cell Non-Hodgkin's Lymphoma (PTCL)


Inclusion Criteria:



- Patients with relapsed PTCL according to WHO criteria who have received max. two
previous treatments for PTCL

- Age ≥ 18 years.

- Adequate bone marrow function i.e. absolute neutrophile count of > 1000/µl and
thrombocytes > 75,000/µl.

- Alkaline phosphatase and transaminases ≤ 2,5 x upper limit of normal (ULN)

- Total bilirubin ≤ 2,5 x ULN

- Creatinine clearance ≥ 50 ml/min

- Female subjects of childbearing potential† must: Understand that the study medication
could have an expected teratogenic risk and agree to use, and be able to comply with,
effective contraception and agree to have a medically supervised pregnancy test

- Male subjects must agree to use condoms and agree not to donate semen

Exclusion Criteria:

- Prior history of malignancies, other than PTCL, unless the subject has been free of
the disease for ≥ 3 years

- Prior allogeneic bone marrow transplant or plans to undergo autologous/ allogeneic
bone marrow transplant within 4 weeks of the initiation of vorinostat administration

- Prior treatment with a HDAC inhibitor

- Prior treatment with Lenalidomide (patients previously treated with Thalidomide may
be enrolled)

- Known history of Deep Vein Thrombosis (DVT) and/ or pulmonary embolism (PE)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary objective of this study is to determine the maximum tolerated dose (MTD) of a Lenalidomide, Vorinostat, and Dexamethasone combination regimen in terms of occurrence of dose-limiting toxicities (DLT) at any dose level.

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Georg Hopfinger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hanusch Krankenhaus Wien

Authority:

Austria: Federal Office for Safety in Health Care

Study ID:

AGMT_PTCL1

NCT ID:

NCT00972842

Start Date:

September 2009

Completion Date:

November 2012

Related Keywords:

  • Peripheral T-Cell Non-Hodgkin's Lymphoma
  • PTCL
  • Peripheral T-Cell Non-Hodgkin's Lymphoma
  • Vorinostat
  • Lenalidomid
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, T-Cell

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