Guadecitabine (SGI-110) vs Treatment Choice in Adults With MDS or CMML Previously Treated With HMAs
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02907359|
Recruitment Status : Recruiting
First Posted : September 20, 2016
Last Update Posted : April 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplastic Syndromes Leukemia, Myelomonocytic, Chronic||Drug: Guadecitabine Other: Treatment Choice||Phase 3|
Multicenter, randomized, open-label, parallel-group study of guadecitabine vs Treatment Choice (TC). Approximately 408 subjects will be randomly assigned 2:1 to either guadecitabine or TC.
- Guadecitabine: approximately 272 subjects.
- TC: approximately 136 subjects.
Before randomization, the investigator will assign each subject to one of the following TC options:
- Low dose cytarabine (LDAC).
- Standard Intensive Chemotherapy (IC) of a 7+3 regimen.
- Best Supportive Care (BSC) only. BSC will be provided to all subjects as per standard and institutional practice. Subjects randomized to TC will not be allowed to cross over to guadecitabine. Data will be reviewed by an independent Data Monitoring Committee at regular intervals, primarily to evaluate safety during study conduct. Randomization will be stratified by disease category (MDS vs CMML), bone marrow (BM) blasts (BM blasts >10% vs BM blasts ≤10%), TC option (LDAC vs IC vs BSC), and study center region.
Guadecitabine: 60 mg/m2 given SC daily on Days 1-5 in 28-day cycles (delayed as needed to allow blood count recovery). Treatment should be given for at least 6 total cycles in the absence of unacceptable toxicity or disease progression requiring alternative therapy. Beyond 6 cycles, treatment should continue as long as the subject continues to benefit. BSC should be given according to standard and institutional practice.
Treatment Choice (TC): Before randomization, the investigator will assign each subject to one of the following TC options:
- Low dose cytarabine (LDAC) given as 20 mg/m2 SC or IV once daily for 14 days in 28-day cycles (delayed as needed to allow blood count recovery). Treatment should be given for at least 4 cycles in the absence of disease progression or unacceptable toxicity.
- Standard Intensive Chemotherapy (IC) of a 7+3 regimen: given as cytarabine 100-200 mg/m2/day given as continuous infusion for 7 days and an anthracycline given as per institutional standard practice such as daunorubicin (45-60 mg/m2/day), or idarubicin (9-12 mg/m2/day), or mitoxantrone (8-12 mg/m2/day) by intravenous infusion for 3 days.
- Best Supportive Care (BSC) only: given according to standard and institutional practice. BSC includes, but is not limited to blood transfusions (RBCs or platelets), growth factors including erythropoiesis stimulating agents (ESA), granulocyte stimulating factors (GSFs), iron chelating therapy, and broad spectrum antibiotics and/or antifungals.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||408 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3, Multicenter, Randomized, Open-Label Study of Guadecitabine (SGI-110) Versus Treatment Choice in Adults With Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML) Previously Treated With Hypomethylating Agents|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Guadecitabine 60 mg/m2 given subcutaneously daily on Days 1-5 in 28-day cycles. The total amount (in mg) of guadecitabine to be administered is determined by body surface area.
Guadecitabine regimen is 60 mg/m2 given SC daily on Days 1-5 in 28-day cycles (delayed as needed to allow blood count recovery). Treatment should be given for at least 6 total cycles in absence of unacceptable toxicity or disease progression requiring alternative therapy.
Other Name: SGI-110
Active Comparator: Treatment Choice
Other: Treatment Choice
- Overall survival [ Time Frame: 18 Months ]
- Transfusion independence [ Time Frame: 18 months ]
- Marrow complete response [ Time Frame: 18 months ]
- Survival rate [ Time Frame: 18 months ]
- Leukemia-free survival [ Time Frame: 18 months ]As described in Time Frame.
- Number of days alive and out of the hospital (NDAOH). [ Time Frame: 18 months ]
- Disease response [ Time Frame: 18 months ]
- Duration of response [ Time Frame: 18 months ]
- Number of transfusions [ Time Frame: 18 months ]
- Health-related quality of life [ Time Frame: 18 months ]
- Incidence and severity of adverse events. [ Time Frame: 18 months ]
- 30-day and 60-day all-cause mortality [ Time Frame: 18 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02907359
|Contact: Harold Keer, MD, PhDfirstname.lastname@example.org|
Show 82 Study Locations
|Study Director:||Harold Keer, MD, PhD||Astex Pharmaceuticals, Inc.|