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

NCT00720850 | Terminated Phase 2

• 1 other identifier: TUD-LENAMA-022
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 7

Brief 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. 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.

Conditions

Myelodysplastic Syndromes; Acute Myelogenous Leukemia

Keywords

MDS; AML; Lenalidomide; monosomy 5; monosomy del5q

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence of relapse rate

  1 year post transplantation

Secondary Outcomes (1)

• Overall survival, Incidence and severity of acute and chronic GVHD, Safety

  1 year post transplantation

Study Arms (1)

lenalidomide

EXPERIMENTAL

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

Drug: lenalidomide

Interventions

lenalidomide DRUG

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

Also known as: Revlimid

lenalidomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Technische Universität Dresden: lead
• Celgene Corporation: collaborator

Study Sites (7)

Dresden University of Technology, Medizinische Klinik und Poliklinik 1

Dresden, Saxony, 01307, Germany

Location

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

Düsseldorf, 40225, Germany

Location

Universitätsklinikum Essen, Klinik für Knochenmarktransplantation

Essen, 45122, Germany

Location

Universitätsklinikum Hamburg-Eppendorf, Onkologisches Zentrum

Hamburg, 20246, Germany

Location

Medizinische Hochschule Hannover, Zentrum Innere Medizin, Hämatologie

Hanover, 30625, Germany

Location

Universitätsklinikum Ulm, Klinik für Innere Medizin III

Ulm, 89081, Germany

Location

Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik II

Würzburg, 97080, Germany

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes; Leukemia, Myeloid, Acute

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Uwe Platzbecker, PD Dr. med.

  Dresden University of Technology, Medizinische Klinik und Poliklinik 1

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2008
• First Posted: July 23, 2008
• Study Start: April 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: September 27, 2013

Record last verified: 2013-09

Locations

DE (7)