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

NCT ID: NCT00761449

Last Updated: 2012-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2009-12-31

Brief Summary

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

Detailed Description

Previous studies have shown that the immunomodulatory drug lenalidomide is effective in the treatment of low risk MDS with del(5q). Treatment of this subgroup of MDS patients resulted in 67% major erythroid responses and 45% complete cytogenetic responses. We therefore intend to test the efficacy of lenalidomide in a group of high-risk patients who are ineligible for conventional chemotherapy and who have a dismal prognosis. The patients must have a karyotype including del(5q) but patients with a karyotype including monosomy 5 are also eligible. We hypothesize that hight risk MDS or AML patients with other chromosomal aberrations than del(5q) can be affected by the lenalidomide effect.

Conditions

MDS; AML

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

1\. lenalidomide

Group Type: EXPERIMENTAL

lenalidomide

Intervention Type: DRUG

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.

Interventions

lenalidomide

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.

Intervention Type: DRUG

Other Intervention Names

Revlimid

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nordic MDS Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eva Hellström-Lindberg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Nordic MDS Group

Locations

Department of Hematology, Aalborg Hospital

Aalborg, , Denmark

Department of Hematology, Aarhus University Hospital

Aarhus, , Denmark

Department of Hematology, Rigshospitalet

Copenhagen, , Denmark

Department of Hematology, Herlev Hospital

Herlev, , Denmark

Department of Hematology, Odense University Hospital

Odense, , Denmark

Department of Hematology, Vejle Hospital

Vejle, , Denmark

Department of Hematology, Rikshospitalet University Hospital

Oslo, , Norway

Department of Medicine, Ullevål Hospital

Oslo, , Norway

Department of Hematology, Trondheim University Hospital

Trondheim, , Norway

Department of Hematology and Coagulation, Sahlgrenska University hospital

Gothenburg, , Sweden

Department of Hematology, Lund University Hospital

Lund, , Sweden

Department of Hematology, Malmö University Hospital

Malmo, , Sweden

Department of Medicine, Örebro University Hospital

Örebro, , Sweden

Hematology Center, Karolinska University Hospital Huddinge

Stockholm, , Sweden

Hematology Center, Karolinska University Hospital Solna

Stockholm, , Sweden

Department of Medicine, Sundsvall Hospital

Sundsvall, , Sweden

Department of Medicine, Umeå University Hospital

Umeå, , Sweden

Department of Hematology, Akademiska University Hospital

Uppsala, , Sweden

Countries

Denmark; Norway; Sweden

References

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.

Reference Type: DERIVED

PMID: 21719884 (View on PubMed)

Related Links

http://www.nmds.org

Nordic MDS Group website

Other Identifiers

EudraCT no: 2007-000450-31

Identifier Type: -

Identifier Source: secondary_id

NMDSG07A

Identifier Type: -

Identifier Source: org_study_id