This trial is active, not recruiting.

Condition myelodysplastic syndrome
Treatment lenalidomide
Phase phase 2
Sponsor Sidney Kimmel Comprehensive Cancer Center
Start date March 2009
End date December 2015
Trial size 48 participants
Trial identifier NCT00867308, J0882, NA_00019818, RV- MDS-PI-295


This is a single center open label phase II study of lenalidomide in IPSS Int-1 with increased blasts or hematologic needs with 5q31.1 deletions who have failed to respond to standard dose lenalidomide., IPSS Int-1 with increased blasts or hematologic needs without 5q31.1 deletions, and Int-2 and high risk myelodysplastic syndrome (MDS) patients with or without 5q31.1 deletions, regardless of whether they have received lenalidomide previously or not. Patients will receive two cycles of 50 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Patients diagnosed with high risk Myelodysplastic syndrome (MDS), regardless of 5q deletion status, will receive lenalidomide, 50mg/day orally, on days 1-28 of a 42 day cycle for 2 cycles. At this point, patients meeting protocol specified response criteria will proceed to Continuing Therapy on a reduced dose of lenalidomide until progression. Patients not achieving response will receive 2 additional cycles of treatment, whereupon response will again be assessed. Patients achieving response at this point will proceed to Continuing Therapy as described. Patients without evidence of response after 4 cycles will be taken off-study.
Lenalidomide 50 mg PO daily on days 1 - 28 out of a 42 day cycle for 4 cycles.

Primary Outcomes

The primary endpoint is hematologic response rate (defined by IWG 2006 response criteria) following administration of 2 - 4 cycles of lenalidomide 50 mg. Response will be assessed following administration of two 42 day treatment cycles.
time frame: End of cycle (42 day treatment)

Secondary Outcomes

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)

Eligibility Criteria

Male or female participants at least 18 years old.

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 REMS® 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.

Additional Information

Official title Protocol Title: Phase II Trial of High Dose Lenalidomide in Patients With MDS and AML With Trilineage Dysplasia (AML-TLD)
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center.