No registrations found.
ID
Source
Brief title
Health condition
Myelodysplastic syndrome (MDS)
Sponsors and support
Intervention
Outcome measures
Primary outcome
Hematological improvement (HI) according to IWG 2006 criteria.
Secondary outcome
1. Adverse events of CTCAE >= grade 2;
2. Time-to-HI and duration-of-HI;
3. Number of given treatment cycles per patient, and especially for arm B the number of patients receiving Epo and/or G-CSF;
4. Response rate (in terms of CR, PR, including cytogenetic response according to the modified response criteria of the IWG for MDS).
5. Progression-free-survival;
6. Leukemic evolution. The risk of leukemic evolution will be calculated with competing risk death without previous evolution
7. Number of transfusions of red blood cells and duration of RBC transfusion independence.
Background summary
Study phase: Phase II.
Study objective:
To evaluate the efficacy of lenalidomide (Revlimid) in low/intermediate-1 risk MDS with or without treatment with Epo (NeoRecormon)/G-CSF (Neupogen).
To evaluate the safety and tolerability of lenalidomide (Revlimid) in low/intermediate-1 risk MDS with or without Epo (NeoRecormon)/G-CSF (Neupogen).
Patient population: Patients with low/intermediate-1 risk myelodysplastic syndrome.
Study design: Prospective, multicenter, open label, randomized.
Duration of treatment: Minimum of 6 months for arm A and 12 months for arm B or until relapse or disease progression; continuation thereafter if responsive. All patients will be followed until 5 years after registration.
Study objective
The hypothesis to be tested is that the outcome in arm B is better than in arm A.
Study design
1. At entry;
2. After each induction cycle;
3. After each maintenance cycle;
4. During follow up: every 6 months.
Intervention
Arm A: 12 cycles of lenalidomide, followed by lenalidomide maintenance cycles.
Arm B: 4 cycles of lenalidomide, followed by 4 cycles of lenalidomide +/- Epo; followed by 4 cycles of lenalidomide +/- Epo +/- G-CSF, followed by lenalidomide +/- Epo +/- G-CSF maintenance cycles.
A.A. Loosdrecht, van de
Amsterdam 1081 HV
The Netherlands
00-31-20-4442604
a.vandeloosdrecht@vumc.nl
A.A. Loosdrecht, van de
Amsterdam 1081 HV
The Netherlands
00-31-20-4442604
a.vandeloosdrecht@vumc.nl
Inclusion criteria
1. 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 <= 12x10^9/l, with an IPSS <= 1.0.
2. Hb <= 6.2 mmol/l (10.0 g/dl) or Hb <= 7.2 mmol/l and ANC <= 1.0x10^9/l or red blood cell transfusion dependent;
3. Age >= 18 years;
4. WHO performance status 0-2;
5. 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;
6. Serum creatinin < 150 µmol/l;
7. Serum billirubin < 25 µmol/l and ASAT, ALAT and Alkaline phosphatase < 2.5 times the upper limit of normal, except if related to disease;
8. The patient must give written informed consent;
9. Negative pregnancy test within 7 days prior to start of study drug, if applicable;
10. Patient (all men, pre-menopausal women) agrees to use adequate contraceptive methods;
11. 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.
Exclusion criteria
1. Severe cardiac, pulmonary, neurologic, metabolic or psychiatric diseases or active malignancies;
2. Anemia due to other causes than MDS including iron, B12 and folate deficiencies, auto-immune hemolysis and/or paroxysmal noctural hemoglobinuria (PNH);
3. Hypoplastic MDS;
4. High predictive score (score 0 or 1) to respond on standard treatment with Epo/G-CSF according to guidelines;
5. Active uncontrolled infection;
6. Absolute neutrophil count (ANC) < 0.5x10^9/l;
7. Patients dependent on platelet transfusions or with platelet counts < 25x10^9/l or patients with active bleeding;
10. Patients treated with biological response modifiers (i.e. growth factors, immunosuppressive agents and/or chemotherapy) within 1 month prior to randomization;
11. Lactating women;
12. Prior treatment with lenalidomide;
13. Prior CTCAE >= grade 3 allergic reaction/hypersensitivity to thalidomide;
14. Prior CTCAE >= grade 3 rash/blistering while taking thalidomide
15. Prior CTCAE >= grade 3 allergic/hypersensitivity to Epo and/or G-CSF
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1715 |
| NTR-old | NTR1825 |
| Other | EudraCT number : 2008-002195-10 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |