Status:
TERMINATED
Trial of High Dose Lenalidomide in Patients With MDS and AML With Trilineage Dysplasia
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Conditions:
Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a phase II study of lenalidomide in patients with myelodysplastic syndrome (MDS) and with acute myeloid leukemia (AML) with trilineage dysplasia. Patients will receive two cycles of lenalidomi...
Detailed Description
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 lenalidomid...
Eligibility Criteria
Inclusion
- Age greater than 18 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
- 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.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00867308
Start Date
July 1 2009
End Date
May 1 2014
Last Update
October 17 2018
Active Locations (1)
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1
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21205