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Myelodysplastic SyndromesPhase 2LENAMAINTNCT00720850

Lenalidomide Maintenance Therapy in Patients With Myelodysplastic Syndromes (MDS) or Acute Myelogenous Leukemia (AML)

A Phase 2 study testing lenalidomide in people with Myelodysplastic Syndromes and Acute Myelogenous Leukemia, run by Technische Universität Dresden at 7 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
7 sitesGermany
Study dates
Apr 2008to Jan 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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).

Who cannot join

  • 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)
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  • 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.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Germany7 sites

  • Dresden University of Technology, Medizinische Klinik und Poliklinik 1

    Dresden, Saxony, 01307

  • Universitätsklinikum Düsseldorf, Medizinische Klinik und Poliklinik, Klinik für Hämatologie, Onkologie und klinische Immunologie

    Düsseldorf, 40225

  • Universitätsklinikum Essen, Klinik für Knochenmarktransplantation

    Essen, 45122

  • Universitätsklinikum Hamburg-Eppendorf, Onkologisches Zentrum

    Hamburg, 20246

  • Medizinische Hochschule Hannover, Zentrum Innere Medizin, Hämatologie

    Hanover, 30625

  • Universitätsklinikum Ulm, Klinik für Innere Medizin III

    Ulm, 89081

  • Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik II

    Würzburg, 97080

Other trials in Germany

About this 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)

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.

Read the 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.

Being tested
lenalidomide
Keywords
MDS, AML, Lenalidomide, monosomy 5, monosomy del5q
Medical subject headings
Myelodysplastic Syndromes, Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lenalidomideDrug

    Also called Revlimid

    p.o. 10 mg/d for 21 days every 4 weeks for 1 year (12 cycles) after HSCT

Study groups in NCT00720850
Study groupRoleWhat they receive
lenalidomideExperimentallenalidomide therapy p.o. 10 mg/d for 21 days every 4 weeks for 1 year (12 cycles) after HSCT
Receives: Drug: lenalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative incidence of relapse rate

    Measured: 1 year post transplantation

Secondary outcomes (1)

  1. Overall survival, Incidence and severity of acute and chronic GVHD, Safety

    Measured: 1 year post transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionJan 2011
  4. Study completionJan 2011

Why it stopped: Low recruitment, scientific rationale not applicable anymore to all patients and possible induction of GvHD by the study drug

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00720850
Sponsor's protocol ID
TUD-LENAMA-022
Acronym
LENAMAINT
Status last verified
Sep 2013
First submitted
17 Jul 2008
Last updated
27 Sep 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing lenalidomide in people with Myelodysplastic Syndromes and Acute Myelogenous Leukemia, run by Technische Universität Dresden at 7 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Low recruitment, scientific rationale not applicable anymore to all patients and possible induction of GvHD by the study drug). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative incidence of relapse rate (time frame: 1 year post transplantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00720850.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2013.

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