Myelodysplastic Syndromes Clinical Trial
Official title:
Thalidomide for the Treatment of Cytopenias of Patients With Low Risk Myelodysplastic Syndromes
The GFM previously conducted a dose-escalating phase II trial of thalidomide in MDS with a
minimum dose of 200mg/d and a maximum dose 800mg/d. Responses were evaluated according to
IWG criteria at week 16 and thalidomide continued up to week 56 in responders. 82% patients
received at least 8 weeks of treatment and were evaluable. 59% had hematological
improvement, mainly on the erythroid lineage (Increase of Hemoglobin). Most responses were
observed at low doses and between 4 and 8 weeks.
The objectives of this trial (Thal-SMD-20) are to evaluate the efficacy and tolerance of
lower doses thalidomide in low risk MDS patients with transfusion-dependant anemia.
Thalidomide:
First part of the trial: 82 patients at 200mg/day given at bedtime x 12 weeks, decreased to
100mg/day if grade 1 or 2 side. Stopped temporally for 1 week if grade 3 or 4 side effects.
Then reintroduced at the same dose. If side effects again, definitively stopped.
Responses evaluated at 12 weeks according to IWG criteria for the erythroid lineage
At week 12:
- If no Hematological improvement (HI): increased to 300mg/day for 8 weeks and then
eventually to 400mg/day for 8 weeks more, if no HI.
- If Hematological improvement (HI): continued at the same dose.
Second part of the trial: 30 patients treated at 50mg/day x 12 weeks. Responses evaluated at
12 weeks according to IWG criteria for the erythroid lineage
At week 12:
- If no Hematological improvement (HI): increased to 100mg/day for 8 weeks and then
eventually to 200mg/day for 8 weeks more, if no HI.
- If Hematological improvement (HI): continued at the same dose.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05400122 -
Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer
|
Phase 1 | |
| Terminated |
NCT04313881 -
Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS)
|
Phase 3 | |
| Recruiting |
NCT05088356 -
Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft
|
Phase 1 | |
| Recruiting |
NCT04003220 -
Idiopathic Chronic Thrombocytopenia of Undetermined Significance : Pathogenesis and Biomarker
|
||
| Completed |
NCT02916979 -
Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators' Expression in Allogeneic SCT Using FluBuATG
|
Phase 1 | |
| Active, not recruiting |
NCT03755414 -
Study of Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation
|
Phase 1 | |
| Completed |
NCT00003270 -
Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer
|
Phase 2 | |
| Recruiting |
NCT04904588 -
HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide
|
Phase 2 | |
| Terminated |
NCT04866056 -
Jaktinib and Azacitidine In Treating Patients With MDS With MF or MDS/MPN With MF.
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04701229 -
Haploinsufficiency of the RBM22 and SLU7 Genes in Del(5q) Myelodysplastic Syndromes
|
||
| Suspended |
NCT04485065 -
Safety and Efficacy of IBI188 With Azacitidine in Subjects With Newly Diagnosed Higher Risk MDS
|
Phase 1 | |
| Recruiting |
NCT04174547 -
An European Platform for Translational Research in Myelodysplastic Syndromes
|
||
| Enrolling by invitation |
NCT04093570 -
A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose), With a Food Effect Substudy at Select Study Centers
|
Phase 2 | |
| Completed |
NCT02508870 -
A Study of Atezolizumab Administered Alone or in Combination With Azacitidine in Participants With Myelodysplastic Syndromes
|
Phase 1 | |
| Completed |
NCT04543305 -
A Study of PRT1419 in Patients With Relapsed/Refractory Hematologic Malignancies
|
Phase 1 | |
| Recruiting |
NCT05384691 -
Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions
|
Phase 2 | |
| Recruiting |
NCT05365035 -
A Phase II Study of Cladribine and Low Dose Cytarabine in Combination With Venetoclax, Alternating With Azacitidine and Venetoclax, in Patients With Higher-risk Myeloproliferative Chronic Myelomonocytic Leukemia or Higher-risk Myelodysplastic Syndromes With Excess Blasts
|
Phase 2 | |
| Recruiting |
NCT06008405 -
Clinical Trial Evaluating the Safety of the TQB2928 Injection Combination Therapy
|
Phase 1 | |
| Not yet recruiting |
NCT05969821 -
Clonal Hematopoiesis of Immunological Significance
|
||
| Withdrawn |
NCT05170828 -
Cryopreserved MMUD BM With PTCy for Hematologic Malignancies
|
Phase 1 |