Myelodysplastic Syndrome (MDS) Clinical Trial
Official title:
Phase 2 Study of Oral Ezatiostat Hydrochloride (Telintra®) in Patients With Lenalidomide (Revlimid®) Refractory or Resistant, Low to Intermediate-1 Risk, Deletion 5q Myelodysplastic Syndrome
Verified date | November 2013 |
Source | Telik |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
Study TLK199.2107 is a multicenter, single arm, open-label Phase 2 study of oral ezatiostat (Telintra®) in patients with lenalidomide (Revlimid®) refractory or resistant, red blood cell (RBC) transfusion-dependent, Low to Intermediate-1 IPSS risk, del5q Myelodysplastic Syndrome (MDS).
Status | Terminated |
Enrollment | 2 |
Est. completion date | February 2013 |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Primary or de Novo MDS - Low or Intermediate-1 IPSS risk MDS - Deletion of the 5q chromosome [del(5q) MDS] - Refractory or resistant to lenalidomide (Revlimid) - ECOG performance score of 0 or 1 - Documentation of significant anemia with or without additional cytopenia - Adequate kidney and liver function - Patients must have discontinued hematopoietic growth factors at least 3 weeks prior to study entry Exclusion Criteria: - Prior allogenic bone marrow transplant for MDS - Known sensitivity to ezatiostat (injection or oral tablets) - Prior treatment with hypomethylating agent (HMA) (e.g., azacitadine, decitabine) - History of MDS IPSS risk score of greater than 1.0 - Pregnant or lactating women - Any severe concurrent disease, infection or comorbidity that, in the judgement of the investigator, would make the patient inappropriate for study entry - Oral steroids greater than 10 mg per day. Exceptions: those prescribed for other conditions (such as new adrenal failure, asthma, arthritis) or brief steroid use (such as tapered dosing for an acute non-MDS condition) - History of hepatitis B or C, or HIV |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Center for Cancer and Blood Disorders | Bethesda | Maryland |
United States | Loyola University | Maywood | Illinois |
United States | Vanderbilt University | Nashville | Tennessee |
United States | Columbia University | New York | New York |
United States | SIU School of Medicine, Simmons Cancer Center | Springfield | Illinois |
Lead Sponsor | Collaborator |
---|---|
Telik |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hematologic Improvement-Erythroid (HI-E) rate | Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006) | At 8, 16, 24, and 32 weeks of treatment | No |
Secondary | RBC Transfusion independence (TI) rate | At 4, 8, 12, 16, 20, 24, 28 & 32 weeks of treatment | No | |
Secondary | Hematologic Improvement-Neutrophil (HI-N) rate | Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006) | At 8, 16, 24, & 32 weeks of treatment | No |
Secondary | Hematologic Improvement-Platelet (HI-P) rate | Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006) | At 8, 16, 24, & 32 weeks of treatment | No |
Secondary | Unilineage, bilineage, trilineage, and overall HI response rate | 2 years | No | |
Secondary | Cytogenetic response rate | 16 weeks, 48 weeks and at the time of first HI response | No | |
Secondary | Duration of response | 2 years | No | |
Secondary | Safety of ezatiostat in this MDS population | Recording and grading of AEs using NCI-CTCAE v4.03 | At 4, 8, 12, 16, 20, 24, 28 & 32 weeks of treatment | No |
Secondary | Evaluation of the relationship between HI-E response, gene expression profiling and response-related variables | 2 years | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02626715 -
Reduced-Intensity Conditioning (RIC) and Myeloablative Conditioning (MAC) for HSCT in AML/MDS
|
Phase 2 | |
Recruiting |
NCT02905552 -
Myelodysplasic Syndromes and Risk Factors for Infection
|
N/A | |
Completed |
NCT01772953 -
Treosulfan/Fludarabine/Low Dose TBI as a Preparative Regimen for Children With AML/MDS Undergoing Allo HCT
|
Phase 2 | |
Suspended |
NCT01211691 -
Study of KB004 in Subjects With Hematologic Malignancies (Myelodysplastic Syndrome, MDS, Myelofibrosis, MF)
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT06294275 -
A Study of Single and Multiple Dose Administration of LP-001 in Healthy Subjects
|
Phase 1 | |
Completed |
NCT00533416 -
Safety of ON 01910.Na in Patients With Myelodysplasia
|
Phase 1 | |
Active, not recruiting |
NCT04401748 -
Study Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Disease Activity In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome
|
Phase 3 | |
Recruiting |
NCT04608110 -
A Phase 1 Trial of ASTX030 in Patients With Myelodysplastic Syndrome
|
Phase 1 | |
Recruiting |
NCT03613532 -
Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN
|
Phase 1 | |
Withdrawn |
NCT03486353 -
A Study of FF-10501-01 in Combination With Azacitidine in Patients With Myelodysplastic Syndrome
|
Phase 2 | |
Terminated |
NCT02259348 -
Repeat Transplantation for Relapsed or Refractory Hematologic Malignancies Following Prior Transplantation
|
Phase 2 | |
Terminated |
NCT01459159 -
Study of (Telintra®) in Non-Del(5q) Myelodysplastic Syndrome
|
Phase 2 | |
Terminated |
NCT00542828 -
Rabbit Anti-thymocyte Globulin in the Treatment of Patients With Low to Intermediate-1 Risk Myelodysplastic Syndrome
|
Phase 2 | |
Completed |
NCT01685619 -
AML-MDS Novel Prognostic Tests Clinical Study
|
||
Recruiting |
NCT01861093 -
Safety Study of Cord Blood Units for Stem Cell Transplants
|
Phase 2 | |
Unknown status |
NCT01983761 -
Study of ASC-101 in Patients With Hematologic Malignancies Who Receive Dual-cord Umbilical Cord Blood Transplantation
|
Phase 1/Phase 2 | |
Recruiting |
NCT01758042 -
Bone Marrow and Kidney Transplant for Patients With Chronic Kidney Disease and Blood Disorders
|
N/A | |
Completed |
NCT01338337 -
Study of Vidaza (Azacitidine) Versus Support Treatment in Patients With Low Risk Myelodysplastic Syndrome (Low and Intermediate-1 IPSS) Without the 5q Deletion and Transfusion Dependent Anaemia
|
Phase 2 | |
Completed |
NCT01221857 -
Pilot Study Evaluating Safety & Efficacy of DCBT: NiCord® & UNM CBU to Patients With Hematological Malignancies
|
Phase 1/Phase 2 | |
Terminated |
NCT01034657 -
LBH589 Alone or in Combination With Erythropoietin Stimulating Agents (ESA) in Patients With Low or Int-1 Risk Myelodysplastic Syndromes (MDS)
|
Phase 2 |