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A Phase II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Single-Agent Lenalidomide (Revlimid®) in Subjects With Relapsed or Refractory T-Cell Non-Hodgkin's Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
T-cell Non-Hodgkin's Lymphoma

Thank you

Trial Information

A Phase II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Single-Agent Lenalidomide (Revlimid®) in Subjects With Relapsed or Refractory T-Cell Non-Hodgkin's Lymphoma


Study was terminated. Study data assessment revealed that study drug is active, but is not
likely to be sufficiently active as a single agent in this population for registration
purposes.


Inclusion Criteria:



- Must understand and voluntarily sign an informed consent form.

- Must be ≥ 18 years of age at the time of signing the informed consent form.

- Must be able to adhere to the study visit schedule and other protocol requirements.

- Biopsy-proven T-cell Non-Hodgkin's Lymphoma, either:

- Peripheral T-cell Lymphoma (PTCL) whatever the subtype, or

- Cutaneous T-cell Lymphoma (CTCL), but only the subtype mycosis fungoides.

- Relapsed or refractory to previous therapy for T-cell Non-Hodgkin's Lymphoma.

- Must have received at least one prior combination chemotherapy regimen. There is no
limit on the number of prior therapies.

Exclusion Criteria:

- Cutaneous T-cell Lymphoma of subtype Sézary Syndrome.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Participants Categorized by Best Response as Determined by Investigator

Outcome Description:

Participant response assessed by investigator; criteria by B. Cheson in Journal of Clinical Oncology, 1999 (see article for more detail): Complete Response(CR): Complete disappearance of all detectable disease Complete Response Unconfirmed(CRu): CR, but indeterminate bone marrow Partial Response(PR): >50% decrease in six largest nodes/nodal masses Stable Disease(SD): Less than PR, but not progressive disease Relapsed Disease: In CR/CRu Patients, new lesions seen or increased by >=50% in previous sites Progressive Disease(PD): >=50% increase from low in PR/Non-Responders

Outcome Time Frame:

Up to 24 months

Safety Issue:

No

Principal Investigator

Kenichi Takeshita, MD

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation

Authority:

United States: Food and Drug Administration

Study ID:

CC-5013-TCL-001

NCT ID:

NCT00655668

Start Date:

March 2008

Completion Date:

April 2010

Related Keywords:

  • T-cell Non-Hodgkin's Lymphoma
  • NHL, Non-Hodgkin's Lymphoma, T-cell Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, T-Cell

Name

Location
Western Pennsylvania Hospital Pittsburgh, Pennsylvania  15224
Hackensack University Medical Center Hackensack, New Jersey  07601
Tower Cancer Research Foundation Beverly Hills, California  90211
Cancer Center of Kansas Wichita, Kansas  67214