A Phase II randomized multicenter study to assess the efficacy of lenalidomide with or without erythropoietin and granulocyte-colony stimulating factor in patients with low and intermediate-1 risk myelodysplastic syndrome.
- Conditions
- myelodysplastic syndromeMedDRA version: 21.1Level: PTClassification code 10028533Term: Myelodysplastic syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2008-002195-10-NL
- Lead Sponsor
- HOVON Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 170
- Patients with MDS classified as
- RA, RARS and RAEB (with <10% myeloid blasts), CMML (with <10% myeloid
blasts), according to FAB or
- RA, RARS, RCMD, RCMD-RS, RAEB-1, MDS-U according to WHO or
- patients with MPD/MDS (CMML-1 according to WHO) with a WBC = 12x109/l
with an IPSS = 1.0
- Hb = 6.2 mmol/l (10.0 g/dl)
or Hb = 7.2 mmol/l and ANC = 1.0x109/l
or red blood cell transfusion dependent
- Age = 18 years
- WHO performance status 0-2
- Patient not previously treated with Epo/G-CSF, or
failure of response or relapse after hematological improvement or disease
progression to maximal RAEB-1 after previous therapy with Epo/G-CSF
- Serum creatinin < 150 µmol/l
- Serum billirubin < 25 µmol/l and ASAT, ALAT and Alkaline phosphatase < 2.5 times
the upper limit of normal, except if related to disease
- The patient must give written informed consent
- Negative pregnancy test within 7 days prior to start of study drug, if applicable.
- Patient (all men, pre-menopausal women) agrees to use adequate contraceptive
methods.
- Serum erythropoietin level
> 200 U/l or
= 200 U/l if failure of response or loss of hematological improvement or disease
progression to maximal RAEB-1 after prior standard therapy with Epo/G-CSF;
Epo/G-CSF should be stopped at least 1 month before randomization.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150
- Severe cardiac, pulmonary, neurologic, metabolic or psychiatric diseases or active malignancies.
- Anemia due to other causes than MDS including iron, B12 and folate deficiencies, auto-immune hemolysis and/or paroxysmal noctural hemoglobinuria (PNH)
- Hypoplastic MDS
- High predictive score (score 0 or 1) to respond on standard treatment with Epo/G-CSF according to guidelines
- Active uncontrolled infection
- Absolute neutrophil count (ANC) < 0.5x109/l
- Patients dependent on platelet transfusions or with platelet counts < 25x109/l or patients with active bleeding
- Patients treated with biological response modifiers (i.e. growth factors, immunosuppressive agents and/or chemotherapy) within 1 month prior to randomization
- Lactating women
- Prior treatment with lenalidomide
- Prior CTCAE = grade 3 allergic reaction/hypersensitivity to thalidomide
- Prior CTCAE = grade 3 rash/blistering while taking thalidomide
- Prior CTCAE = grade 3 allergic/hypersensitivity to Epo and/or G-CSF
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method