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Lenalidomide Maintenance Therapy in Patients With Myelodysplastic Syndromes (MDS) or Acute Myelogenous Leukemia (AML) (LENAMAINT)
This study is currently recruiting participants.
Verified by Dresden University of Technology, September 2008
First Received: July 17, 2008   Last Updated: September 4, 2008   History of Changes
Sponsors and Collaborators: Dresden University of Technology
Celgene Corporation
Information provided by: Dresden University of Technology
ClinicalTrials.gov Identifier: NCT00720850
  Purpose

The hypothesis of this study is that lenalidomide can be an effective drug in preventing relapse of MDS and AML patients with chromosomal abnormalities involving monosomy 5 or del5q after allogeneic HSCT. Due to its immunomodulatory action it might also be able to enhance a T - or NK cell mediated graft versus leukemia (GVL) effects. Nevertheless, one has to keep in mind a possible, yet unknown influence on modulation of clinical GVHD.


Condition Intervention Phase
Myelodysplastic Syndromes
Acute Myelogenous Leukemia
Drug: lenalidomide
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Lenalidomide Maintenance Therapy in Patients With MDS or AML With Cytogenetic Abnormalities Involving Monosomy 5 or del5q After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Resource links provided by NLM:


Further study details as provided by Dresden University of Technology:

Primary Outcome Measures:
  • Cumulative incidence of relapse rate [ Time Frame: 1 year post transplantation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival, Incidence and severity of acute and chronic GVHD, Safety [ Time Frame: 1 year post transplantation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: April 2008
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
lenalidomide therapy
Drug: lenalidomide
p.o. 10 mg/d for 21 days every 4 weeks for 1 year (12 cycles) after HSCT

Detailed Description:

Cytogenetics are main predictors of outcome in patients with MDS and AML. In fact, a monosomy 5 (-5) or del5q (excluding typical 5q-syndrome) are mostly poor prognostic markers also because being frequently part of a complex karyotype. Together, these patients often do not respond to conventional chemotherapy and can only be cured by allogeneic HSCT. Nevertheless, even after transplantation the relapse rate is considerably high and in the majority of patient's relapses occur within the first year after HSCT. Lenalidomide has been successfully used in MDS patients with del5q, irrespective of additional cytogenetic abnormalities. Furthermore, in vitro studies have demonstrated also impressive anti-proliferative effects of the compound in cell lines harbouring a monosomy 5. Therefore, it seems to be a promising compound in preventing relapse of high-risk MDS or AML patients with chromosomal abnormalities involving del5q or -5 after allogeneic HSCT. Due to its immunomodulatory action it might also be able to enhance T - or NK cell mediated graft versus leukemia effects. Nevertheless, it is unknown whether lenalidomide could modulate or enhance clinical graft versus host disease.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Understand and voluntarily sign an informed consent form.
  • Age >=18 years at the time of signing the informed consent form.
  • Able to adhere to the study visit schedule and other protocol requirements.
  • AML (>/= 20% blasts) including secondary (s)AML (after radio-chemotherapy) with karyotype abnormalities involving monosomy 5 or del5q or MDS and sMDS RAEB-1 and RAEB-2 with karyotype abnormalities involving monosomy 5 or del5q or MDS and sMDS type RA(+/-RS) or RCMD(+/-RS) only with complex karyotype abnormalities involving monosomy 5 or del5q
  • in complete hematological remission documented by bone marrow aspiration within 8-12 weeks after allogeneic HSCT
  • All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study.
  • ECOG performance status of </= 2 at study entry.
  • Laboratory test results within these ranges:

    • Absolute neutrophil count >= 1.0 x 10 9/L
    • Platelet count >= 100 x 10 9/L
    • Serum creatinine <= 2.0 mg/dL
    • Total bilirubin <= 1.5 mg/dL
    • AST (SGOT) and ALT (SGPT) <= 5 x ULN
  • Females of childbearing potential (FCBP)† must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study. The two methods of reliable contraception must include one highly effective method (i.e. intrauterine device (IUD), hormonal [birth control pills, injections, or implants], tubal ligation, partner's vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap). FCBP must be referred to a qualified provider of contraceptive methods if needed.
  • Disease free of prior malignancies for >= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast
  • Able to take aspirin (ASA) 100mg daily as prophylactic anticoagulation in case of concomitant steroid treatment (patients intolerant to ASA may use low molecular weight heparin).

Exclusion Criteria:

  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  • active uncontrolled acute GVHD overall grade 3-4
  • Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
  • History of arterial or venous embolism or stroke
  • 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 to treat MDS or AML within 28 days of baseline (patients within a clinical trial evaluating new conditioning regimens are allowed to participate in the LENAMAINT study)
  • Known hypersensitivity to thalidomide or lenalidomide.
  • history of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
  • Known positive for HIV or infectious hepatitis, type A, B or C.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00720850

Contacts
Contact: Uwe Platzbecker, PD Dr. med. +49 (0)351 458-4577 Uwe.Platzbecker@uniklinikum-dresden.de

Locations
Germany
Universitätsklinikum Essen, Klinik für Knochenmarktransplantation Active, not recruiting
Essen, Germany, 45122
Universitätsklinikum Ulm, Klinik für Innere Medizin III Active, not recruiting
Ulm, Germany, 89081
Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik II Not yet recruiting
Würzburg, Germany, 97080
Contact: H. Einsele, Prof. Dr.     +49 (0)931 / 201-70010     Einsele_H@medizin.uni-wuerzburg.de    
Principal Investigator: H. Einsele, Prof. Dr.            
Medizinische Hochschule Hannover, Zentrum Innere Medizin, Hämatologie Active, not recruiting
Hannover, Germany, 30625
Universitätsklinikum Düsseldorf, Medizinische Klinik und Poliklinik, Klinik für Hämatologie, Onkologie und klinische Immunologie Active, not recruiting
Düsseldorf, Germany, 40225
Universitätsklinikum Hamburg-Eppendorf, Onkologisches Zentrum Active, not recruiting
Hamburg, Germany, 20246
Germany, Saxony
Dresden University of Technology, Medizinische Klinik und Poliklinik 1 Recruiting
Dresden, Saxony, Germany, 01307
Contact: Uwe Platzbecker, PD Dr. med.     +49 (0)351 458-4577     Uwe.Platzbecker@uniklinikum-dresden.de    
Principal Investigator: Uwe Platzbecker, PD Dr. med.            
Sponsors and Collaborators
Dresden University of Technology
Celgene Corporation
Investigators
Study Chair: Uwe Platzbecker, PD Dr. med. Dresden University of Technology, Medizinische Klinik und Poliklinik 1
  More Information

Additional Information:
No publications provided

Responsible Party: Dresden University of Technology, Medizinische Klinik und Poliklinik 1 ( PD Dr. med. Uwe Platzbecker )
Study ID Numbers: TUD-LENAMA-022
Study First Received: July 17, 2008
Last Updated: September 4, 2008
ClinicalTrials.gov Identifier: NCT00720850     History of Changes
Health Authority: Germany: Ethics Commission;   Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dresden University of Technology:
MDS
AML
Lenalidomide
monosomy 5
monosomy del5q

Study placed in the following topic categories:
Monosomy
Precancerous Conditions
Hematologic Diseases
Myelodysplastic Syndromes
Lenalidomide
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Preleukemia
Acute Myelocytic Leukemia
Acute Myeloid Leukemia, Adult
Chromosome Aberrations
Congenital Abnormalities
Bone Marrow Diseases

Additional relevant MeSH terms:
Disease
Neoplasms by Histologic Type
Precancerous Conditions
Antineoplastic Agents
Hematologic Diseases
Myelodysplastic Syndromes
Lenalidomide
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Pharmacologic Actions
Leukemia
Preleukemia
Neoplasms
Pathologic Processes
Therapeutic Uses
Syndrome
Chromosome Aberrations
Bone Marrow Diseases

ClinicalTrials.gov processed this record on September 09, 2009