NCT01036399

Brief Summary

Revlimid is a potent immunomodulatory analogue without the teratogenic effects, which has direct anti-tumor effects, anti-angiogenic and both anti-inflammatory and T-cell costimulatory properties. Both preclinical and clinical data indicate its efficacy solid tumor and multiple myeloma including advanced/refractory stages with its role in enhancing host antitumor immunity that provided the rationale to use in patients with PTCL.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2009

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
5 months until next milestone

First Posted

Study publicly available on registry

December 21, 2009

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

August 27, 2012

Status Verified

August 1, 2012

Enrollment Period

9 months

First QC Date

July 7, 2009

Last Update Submit

August 24, 2012

Conditions

Peripheral T-cell Lymphoma

Keywords

PTCL

Outcome Measures

Primary Outcomes (1)

  • To assess the feasibility of Revlimid as salvage treatment in PTCL

    12 months

Secondary Outcomes (1)

  • To assess the overall response rate (CR and PR) of PTCL receiving REVLIMID; To assess the Tumor Control Rate (TCR); To assess the duration of response; To assess the quality of life.

    12 months

Study Arms (1)

Revlimid

EXPERIMENTAL

Oral Revlimid is initiated on day 1 of cycle 1at the dose of 25 mg daily for 21 days with 7 days rest (28 day cycle) for a total of 4 cycles. After this induction phase, the CR, PR and SD will continue Revlimid with the same schedule for other 8 months.

Drug: Lenalidomide

Interventions

LenalidomideDRUG

Oral Lenalidomide is initiated on day 1 of cycle 1at the dose of 25 mg daily for 21 days with 7 days rest (28 day cycle) for a total of 4 cycles.

Also known as: Revlimid
Revlimid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with histologic diagnosis of PTCL according to the WHO-REAL classification;
  • Age \> 18 years;
  • Relapsed (³1) or refractory to conventional chemotherapy/radiotherapy;
  • Stage I-IV according to the Ann Arbor staging System;
  • Performance status \<2;
  • Adequate bone marrow reserve: platelets \>50 x 10(9)/L, absolute neutrophil count
  • (ANC) \> 1.0 x 10(9)/L, hemoglobin \>8 g/d;
  • Normal renal and hepatic functions;
  • Negative HIV, HCV, and HBV status;
  • Informed consent prior to registration on study

You may not qualify if:

  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  • Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
  • Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
  • Use of any other experimental drug or therapy within 28 days of baseline.
  • Known hypersensitivity to thalidomide.
  • The development of erythema if characterized by a desquamating rash while taking thalidomide or similar drugs.
  • Any prior use of lenalidomide.
  • Concurrent use of other anti-cancer agents or treatments.
  • Known positive for HIV or infectious hepatitis, type A, B or C.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute Of Hematology "Seràgnoli"

Bologna, 40138, Italy

Location

Related Publications (1)

  • Zinzani PL, Pellegrini C, Broccoli A, Stefoni V, Gandolfi L, Quirini F, Argnani L, Berti E, Derenzini E, Pileri S, Baccarani M. Lenalidomide monotherapy for relapsed/refractory peripheral T-cell lymphoma not otherwise specified. Leuk Lymphoma. 2011 Aug;52(8):1585-8. doi: 10.3109/10428194.2011.573031. Epub 2011 Apr 19. No abstract available.

    PMID: 21504290DERIVED

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 7, 2009

First Posted

December 21, 2009

Study Start

November 1, 2008

Primary Completion

August 1, 2009

Study Completion

August 1, 2011

Last Updated

August 27, 2012

Record last verified: 2012-08

Locations

IT(1)