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Lenalidomide Maintenance Therapy in Patients With MDS or AML With Cytogenetic Abnormalities Involving Monosomy 5 or del5q After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Phase 2
18 Years
Open (Enrolling)
Myelodysplastic Syndromes, Acute Myelogenous Leukemia

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Trial Information

Lenalidomide Maintenance Therapy in Patients With MDS or AML With Cytogenetic Abnormalities Involving Monosomy 5 or del5q After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

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.

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
- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Cumulative incidence of relapse rate

Outcome Time Frame:

1 year post transplantation

Safety Issue:


Principal Investigator

Uwe Platzbecker, PD Dr. med.

Investigator Role:

Study Chair

Investigator Affiliation:

Dresden University of Technology, Medizinische Klinik und Poliklinik 1


Germany: Ethics Commission

Study ID:




Start Date:

April 2008

Completion Date:

September 2011

Related Keywords:

  • Myelodysplastic Syndromes
  • Acute Myelogenous Leukemia
  • MDS
  • AML
  • Lenalidomide
  • monosomy 5
  • monosomy del5q
  • Chromosome Aberrations
  • Chromosome Disorders
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Monosomy
  • Myelodysplastic Syndromes
  • Preleukemia