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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 HospitalPittsburgh, Pennsylvania  15224
Hackensack University Medical CenterHackensack, New Jersey  07601
Tower Cancer Research FoundationBeverly Hills, California  90211
Cancer Center of KansasWichita, Kansas  67214