search
Back to results

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

Primary Purpose

Myelodysplastic Syndrome

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lenalidomide 50 mg
Lenalidomide 15 mg
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Syndrome focused on measuring IPSS Int-2, high risk myelodysplastic syndrome, MDS), 5q31.1 deletions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 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.

Sites / Locations

  • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Lenalidomide 15 mg

Lenalidomide 50 mg

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Grade 3-4 Toxicity
Number of participants who experienced at least one grade 3-4 non-hematological toxicity by CTCAE 3.0 that was attributed to lenalidomide.

Full Information

First Posted
March 19, 2009
Last Updated
September 21, 2018
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
search

1. Study Identification

Unique Protocol Identification Number
NCT00867308
Brief Title
Trial of High Dose Lenalidomide in Patients With MDS and AML With Trilineage Dysplasia
Official Title
Phase II Trial of High Dose Lenalidomide in Patients With MDS and AML With Trilineage Dysplasia (AML-TLD)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Terminated
Why Stopped
Lack of efficacy
Study Start Date
July 2009 (Actual)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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 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 15 mg daily lenalidomide (later amended to 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndrome
Keywords
IPSS Int-2, high risk myelodysplastic syndrome, MDS), 5q31.1 deletions

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lenalidomide 15 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Lenalidomide 50 mg
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lenalidomide 50 mg
Other Intervention Name(s)
Revlimid
Intervention Type
Drug
Intervention Name(s)
Lenalidomide 15 mg
Other Intervention Name(s)
Revlimid
Primary Outcome Measure Information:
Title
Response Rate
Description
Number of participants with a complete or partial response according to International Working Group 2006 criteria.
Time Frame
15 weeks
Secondary Outcome Measure Information:
Title
Grade 3-4 Toxicity
Description
Number of participants who experienced at least one grade 3-4 non-hematological toxicity by CTCAE 3.0 that was attributed to lenalidomide.
Time Frame
Up to 8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy DeZern, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27790720
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs