Trial of High Dose Lenalidomide in Patients With MDS and AML With Trilineage Dysplasia

NCT00867308 | Terminated Phase 2 Results

• 3 other identifiers: J0882RV- MDS-PI-295NA_00019818
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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 lenalidomide. Patients who respond may given additional cycles of lenalidomide until disease progression.

Conditions

Myelodysplastic Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Response Rate

  Number of participants with a complete or partial response according to International Working Group 2006 criteria.

  15 weeks

Secondary Outcomes (1)

• Grade 3-4 Toxicity

  Up to 8 months

Study Arms (2)

Lenalidomide 15 mg

EXPERIMENTAL

Patients diagnosed with high risk Myelodysplastic syndrome (MDS), regardless of 5q deletion status, will receive lenalidomide 15 mg per 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.

Drug: Lenalidomide 15 mg

Lenalidomide 50 mg

EXPERIMENTAL

Patients diagnosed with high risk Myelodysplastic syndrome (MDS), regardless of 5q deletion status, will receive lenalidomide 50 mg per 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.

Drug: Lenalidomide 50 mg

Interventions

Lenalidomide 50 mg DRUG

Also known as: Revlimid

Lenalidomide 50 mg

Lenalidomide 15 mg DRUG

Also known as: Revlimid

Lenalidomide 15 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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 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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

• Zeidan AM, Smith BD, Carraway HE, Gojo I, DeZern A, Gore SD. A phase 2 trial of high dose lenalidomide in patients with relapsed/refractory higher-risk myelodysplastic syndromes and acute myeloid leukaemia with trilineage dysplasia. Br J Haematol. 2017 Jan;176(2):241-247. doi: 10.1111/bjh.14407. Epub 2016 Oct 28.

  PMID: 27790720 RESULT

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Amy DeZern, MD
• Organization: Johns Hopkins University

adezern1@jhmi.edu

4105027208

Study Officials

• Amy DeZern, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2009
• First Posted: March 23, 2009
• Study Start: July 1, 2009
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: October 17, 2018
• Results First Posted: October 17, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)