Brief Summary

The aim of this study is to investigate the efficacy of lenalidomide in high risk MDS or AML with chromosome 5 aberrations.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started Oct 2007

Geographic Reach

3 countries

18 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.2 years study duration

Study Start

First participant enrolled

October 1, 2007

Completed

12 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2008

Completed

3 days until next milestone

First Posted

Study publicly available on registry

September 29, 2008

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed

Last Updated

April 27, 2012

Status Verified

January 1, 2010

Enrollment Period

2.2 years

First QC Date

September 26, 2008

Last Update Submit

April 26, 2012

Conditions

MDS AML

Keywords

MDSAMLLenalidomidemonosomy 5del5q

Outcome Measures

Primary Outcomes (1)

Major cytogenetic response (50% or more reduction of the del5(q) or monosomy 5 FISH positive clone in the bone marrow using the LSI EGR1/D5S23,D5S721 FISH probe) after 16 weeks of lenalidomide treatment
16 weeks

Secondary Outcomes (6)

Minor and complete cytogenetic (FISH) response after 8 and 16 weeks
16 weeks
Red blood cell transfusion independence
16 weeks
Erythroid response
16 weeks
Bone marrow response (morphology)
16 weeks
Modification of gene expression profiling during treatment
16 weeks
+1 more secondary outcomes

Study Arms (1)

1

EXPERIMENTAL

1\. lenalidomide

Drug: lenalidomide

Interventions

lenalidomideDRUG

Initial dose is oral lenalidomide 10 mg daily continuously. The dose should be increased to 20 mg day 1 in week 6 and to 30 mg day 1 in week 10. This dose should be kept for seven weeks. Thus, the total study period is 16 weeks.

Also known as: Revlimid

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Must be \>18 years of age at the time of signing the informed consent form
MDS at IPSS Int-2 or High with a karyotype including del(5q) or monosomy 5 confirmed with FISH (using the LSI EGR1/D5S23,D5S721 FISH probe)
Acute myeloid leukemia with a karyotype including del(5q) or monosomy 5 confirmed with FISH (using the LSI EGR1/D5S23,D5S721 FISH probe)
Patients could be included if:
At diagnosis and not considered eligible for induction chemotherapy
Refractory to induction therapy
Relapse after induction chemotherapy leading to CR and considered not eligible for reinduction
Relapse after allogeneic stem cell transplantation and not considered suitable for reinduction chemotherapy or other conventional relapse therapy.
Subject has signed the informed consent document.
Women of childbearing potential, WCBP, must agree to practice complete abstinence from heterosexual intercourse or to use two methods of contraception beginning 4 weeks prior to the start of the study medication, while on study medication and 4 weeks after the last dose of study medication. WCBP must have two negative serum or urine pregnancy tests prior to starting study drug. WCBP must agree to have pregnancy tests weekly for the first 4 weeks and then every 4 weeks while on study medication and 4 weeks after the last dose of study medication.
Males (including those who have had a vasectomy) must use barrier contraception (latex condoms) when engaging in reproductive sexual activity with WCBP while on study medication and 4 weeks after the last dose of study medication.

You may not qualify if:

Pregnant or lactating females.
Prior therapy with lenalidomide
Patients who are eligible for curative treatment
Expected survival less than two months.
Acute promyelocytic leukemia (APL)
Absolute peripheral blast count \>30,000/mm3
Central nervous system leukemia
Serum biochemical values as follows
Serum creatinine \>2.0 mg/dL (177 micromol/L)
Serum aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) \>3.0 x upper limit of normal (ULN)
Serum total bilirubin \>1.5 mg/dL (26 micromol/L)
Prior allergic reaction to thalidomide
Uncontrolled systemic infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Nordic MDS Grouplead

Study Sites (18)

Department of Hematology, Aalborg Hospital

Aalborg, 9000, Denmark

Location

Department of Hematology, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Department of Hematology, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Department of Hematology, Herlev Hospital

Herlev, 2730, Denmark

Location

Department of Hematology, Odense University Hospital

Odense, 5000, Denmark

Location

Department of Hematology, Vejle Hospital

Vejle, 7100, Denmark

Location

Department of Hematology, Rikshospitalet University Hospital

Oslo, 0027, Norway

Location

Department of Medicine, Ullevål Hospital

Oslo, 0407, Norway

Location

Department of Hematology, Trondheim University Hospital

Trondheim, 7006, Norway

Location

Department of Hematology and Coagulation, Sahlgrenska University hospital

Gothenburg, 413 45, Sweden

Location

Department of Hematology, Lund University Hospital

Lund, 221 85, Sweden

Location

Department of Hematology, Malmö University Hospital

Malmo, 205 02, Sweden

Location

Department of Medicine, Örebro University Hospital

Örebro, 701 85, Sweden

Location

Hematology Center, Karolinska University Hospital Huddinge

Stockholm, 141 86, Sweden

Location

Hematology Center, Karolinska University Hospital Solna

Stockholm, 171 76, Sweden

Location

Department of Medicine, Sundsvall Hospital

Sundsvall, 851 86, Sweden

Location

Department of Medicine, Umeå University Hospital

Umeå, 901 85, Sweden

Location

Department of Hematology, Akademiska University Hospital

Uppsala, 751 85, Sweden

Location

Related Publications (1)

Mollgard L, Saft L, Treppendahl MB, Dybedal I, Norgaard JM, Astermark J, Ejerblad E, Garelius H, Dufva IH, Jansson M, Jadersten M, Kjeldsen L, Linder O, Nilsson L, Vestergaard H, Porwit A, Gronbaek K, Hellstrom-Lindberg E. Clinical effect of increasing doses of lenalidomide in high-risk myelodysplastic syndrome and acute myeloid leukemia with chromosome 5 abnormalities. Haematologica. 2011 Jul;96(7):963-71. doi: 10.3324/haematol.2010.039669.
PMID: 21719884DERIVED

MeSH Terms

Interventions

Lenalidomide

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

Eva Hellström-Lindberg, MD, PhD
Nordic MDS Group
PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 26, 2008

First Posted

September 29, 2008

Study Start

October 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

April 27, 2012

Record last verified: 2010-01

Locations

NO(3)SE(9)DK(6)

Lenalidomide in High-risk MDS and AML With Del(5q) or Monosomy 5

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

1

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (18)

Related Publications (1)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

1

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (18)

Related Publications (1)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations