Trial of High Dose Lenalidomide in Patients With Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) With Trilineage Dysplasia (AML-TLD)

This study is currently recruiting participants.

Verified by Sidney Kimmel Comprehensive Cancer Center, March 2009

First Received: March 19, 2009 Last Updated: March 20, 2009 History of Changes

Sponsored by:	Sidney Kimmel Comprehensive Cancer Center
Information provided by:	Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00867308

Purpose

This is a single center open label phase II study of lenalidomide in IPSS Int-2 and high risk myelodysplastic syndrome (MDS) patients without 5q31.1 deletions and those with 5q31.1 deletions who have failed to respond to standard dose lenalidomide. Patients will receive two cycles of 15 mg daily lenalidomide given on days 1-28 out of a 42 day cycle. Within each of the two cycles of lenalidomide, patients will be given up to three weeks with no drug treatment to recover. Patients who fail to respond after two cycles of treatment may receive two additional cycles if stable. Patients who develop clinical response may continue to receive drug until disease progression.

Condition	Intervention	Phase
Myelodysplastic Syndrome	Drug: Lenalidomide	Phase II

Drug Information available for: Lenalidomide CC 5013

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Protocol Title: Phase II Trial of High Dose Lenalidomide in Patients With MDS and AML With Trilineage Dysplasia (AML-TLD)

Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:

The primary endpoint is hematologic response rate (defined by IWG 2006 response criteria) following administration of 2 - 4 cycles of lenalidomide 15 mg. Response will be assessed following administration of two 42 day treatment cycles. [ Time Frame: End of cycle (42 day treatment) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine and describe toxicity of higher doses of lenalidomide in patients with MDS and AML-TLD who do not harbor the 5q31.1.deletion and those who have such a deletion but have failed to respond to standard dose lenalidomide [ Time Frame: End of cycle (42 day treatment) ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	48
Study Start Date:	March 2009
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Intervention Details:

Lenalidomide 15 mg PO daily on days 1 - 28 out of a 42 day cycle for 4 cycles.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age greater than18 years at the time of signing the informed consent form.
Able to adhere to the study visit schedule and other protocol requirements.
MDS or MDS/AML
Patients must not have received any other treatment for their disease, including hematopoietic growth factors, within three weeks of beginning the trial
ECOG performance status of 0, 1, or 2 at study entry
All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
Patients must have no clinical evidence of CNS or pulmonary leukostasis, disseminated intravascular coagulation, or CNS leukemia.
Subjects must agree to use appropriate contraception.

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.
Use of any other experimental drug or therapy within 21 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 except for MDS patients with del 5q31.1 abnormalities..
Concurrent use of other anti-cancer agents or treatments.
Patients may not have received prior AML induction chemotherapy or stem cell transplant. However, patients with secondary MDS who have received a stem cell transplant for other indications (eg lymphoma, multiple myeloma) will be eligible.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00867308

Contacts

Contact: Steven Gore, MD

(410) 955-8781

Locations

United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Recruiting
Baltimore, Maryland, United States, 21205
Contact: Steven Gore, MD 410-955-8781
Principal Investigator: Steven Gore, MD

Sponsors and Collaborators

Sidney Kimmel Comprehensive Cancer Center

More Information

No publications provided

Responsible Party:	The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Steven Gore, MD/Principal Investigator )
Study ID Numbers:	J0882, RV- MDS-PI-295
Study First Received:	March 19, 2009
Last Updated:	March 20, 2009
ClinicalTrials.gov Identifier:	NCT00867308 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:

IPSS Int-2
high risk myelodysplastic syndrome
MDS)
5q31.1 deletions
5q31.1 deletions

Study placed in the following topic categories:

Leukemia
Acute Myelocytic Leukemia
Preleukemia
Precancerous Conditions
Hematologic Diseases

Myelodysplastic Syndromes
Lenalidomide
Leukemia, Myeloid
Bone Marrow Diseases
Leukemia, Myeloid, Acute

Additional relevant MeSH terms:

Disease
Precancerous Conditions
Hematologic Diseases
Antineoplastic Agents
Myelodysplastic Syndromes
Lenalidomide
Pharmacologic Actions

Preleukemia
Neoplasms
Pathologic Processes
Syndrome
Therapeutic Uses
Bone Marrow Diseases

ClinicalTrials.gov processed this record on May 07, 2009