Lenalidomide in HTLV-1 Adult T-Cell Leukemia

A Phase II Study of Lenalidomide in Patients With Relapsed or Refractory HTLV-1 Associated Adult T Cell Leukemia/Lymphoma

NCT01274533•Columbia University

View on ClinicalTrials.gov

Summary

This is a research study for subjects who have been diagnosed with Adult T cell Leukemia/Lymphoma, a rare and aggressive peripheral T cell neoplasm caused by the virus HTLV1. Currently, there is no accepted standard therapy for this disease. The purpose of this research study is to evaluate the use of the investigational drug lenalidomide in the treatment of Adult T cell Leukemia/Lymphoma. Lenalidomide is a drug that alters the immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. Lenalidomide is approved by the Food and Drug Administration (FDA) for the treatment of specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for patients with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM are cancers of the blood. It is currently being tested in a variety of cancer conditions. In this case it is considered experimental.

Detailed Description

The Primary Objective is to determine the efficacy of lenalidomide monotherapy in relapsed or refractory HTLV 1 associated Adult T Cell Leukemia/Lymphoma. Efficacy will be assessed by measuring the response rate, tumor control rate, duration of response, time to progression and progression free survival. The Secondary Objective is to evaluate the safety of lenalidomide monotherapy as treatment for subjects with relapsed or refractory HTLV 1 associated Adult T Cell Leukemia/Lymphoma.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥18 years at the time of signing the informed consent form.
•Able to adhere to the study visit schedule and other protocol requirements.
•Relapsed or refractory HTLV-1 associated Adult T-cell Leukemia/Lymphoma (Acute and lymphoma subtypes)
•All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study.
•ECOG performance status of ≤ 2 at study entry (see Appendix C).
•Laboratory test results within these ranges:
•* Absolute neutrophil count ≥ 1000/mm³
•* Platelet count ≥ 50,000 /mm³
•* Calculated creatinine clearance of ≥ 30 mL/min by Cockcroft-Gault formula (Appendix J). Patients with calculated creatinine clearance ≥ 30 mL/min and \< 60 mL/min will have a reduced starting dose of lenalidomide (see Section 5.4.2).
•* Total bilirubin ≤ 1.5 x ULN
+4 more criteria

Exclusion Criteria

•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.
•Evidence of laboratory TLS by Cairo-Bishop Definition of Tumor Lysis Syndrome (see Appendix H). Subjects may be enrolled upon correction of electrolyte abnormalities.
•Use of any other experimental drug or therapy within 28 days of baseline.
•Known hypersensitivity to thalidomide.
•The development of erythema nodosum 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 B or C.
+1 more criteria

Locations (1)

Columbia University Medical Center

New York, New York, United States

Key Dates

Start Date

December 1, 2010

Primary Completion Date

January 1, 2013

Completion Date

May 1, 2013

Last Updated

May 23, 2016

Enrollment

ACTUAL participants

Conditions

Adult T Cell Leukemia/Lymphoma

Interventions

Lenalidomide

DRUG