Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003747

Trial Description

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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)

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Trial Acronym

LENAMAINT

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00003747
  •   2012/05/04
  •   2008/07/17
  •   yes
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Secondary IDs

  •   NCT00720850  (ClinicalTrials.gov)
  •   TUD-LENAMA-022  (Dresden University of Technology)
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Health Condition or Problem studied

  •   Myelodysplastic Syndromes
  •   Acute Myelogenous Leukemia
  •   D46 -  Myelodysplastic syndromes
  •   C92.0 -  Acute myeloid leukaemia
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Interventions/Observational Groups

  •   Drug: lenalidomide
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
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Primary Outcome

- Cumulative incidence of relapse rate; time frame: 1 year post transplantation

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Secondary Outcome

- Overall survival, Incidence and severity of acute and chronic GVHD, Safety; time frame: 1 year post transplantation

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2008/04/30
  •   50
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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).

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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.

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Addresses

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    • Technische Universität Dresden
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    • Dresden University of Technology, Medizinische Klinik und Poliklinik 1
    • Uwe Platzbecker, PD Dr. med. 
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    • Dresden University of Technology, Medizinische Klinik und Poliklinik 1
    • Uwe Platzbecker, PD Dr. med. 
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    •   [---]*
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting stopped after recruiting started
  •   2011/01/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   121
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.