Canakinumab and Azacitidine for the Treatment of Low or Intermediate Risk Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia
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|ClinicalTrials.gov Identifier: NCT04239157|
Recruitment Status : Not yet recruiting
First Posted : January 23, 2020
Last Update Posted : January 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myelomonocytic Leukemia Myelodysplastic Syndrome Recurrent Chronic Myelomonocytic Leukemia Recurrent Myelodysplastic Syndrome Refractory Chronic Myelomonocytic Leukemia Refractory Myelodysplastic Syndrome||Drug: Azacitidine Biological: Canakinumab||Phase 2|
I. To assess the clinical activity, hematological improvement (HI) of canakinumab in patients with low or intermediate-1 myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML).
I. To study the safety profile of canakinumab in patients with low or intermediate-1 MDS or CMML.
II. To assess the safety and tolerability of canakinumab including:
IIa. Adverse events with particular emphasis on occurrence and type of infections.
IIb. Hospitalizations. IIc. Therapy discontinuation. III. Transfusion independence. IV. Duration of response. V. Progression-free survival (PFS), leukemia-free survival (LFS) and overall survival (OS).
I. Correlative studies (pharmacodynamic [PD] parameters of canakinumab).
Patients receive canakinumab subcutaneously (SC) on day 1. Patients not responding to canakinumab after 4 cycles, may receive azacitidine SC or intravenously (IV) on days 1-3. If azacitidine is added after cycle 4, patients receive canakinumab SC on day 4. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then every 6 months thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2, Open-Label, Study of Subcutaneous Canakinumab, an Anti-IL-1B Human Monoclonal Antibody, for Patients With Low or Int-1 Risk IPSS/IPSS-R Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia|
|Estimated Study Start Date :||June 1, 2020|
|Estimated Primary Completion Date :||January 31, 2022|
|Estimated Study Completion Date :||January 31, 2022|
Experimental: Treatment (canakinumab, azacitidine)
Patients receive canakinumab SC on day 1. Patients not responding to canakinumab after 4 cycles, may receive azacitidine SC or IV on days 1-3. If azacitidine is added after cycle 4, patients receive canakinumab SC on day 4. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Given SC or IV
- Hematological improvement (HI) [ Time Frame: After 2 cycles (each cycle is 28 days) ]Will be monitored simultaneously using the Bayesian approach of Thall, Simon, Estey. Will estimate the HI rate for canakinumab, along with the 95% credible intervals. The association between HI rate and patient's clinical characteristics will be examined by Wilcoxon's rank sum test or Fisher's exact test.
- Incidence of adverse events [ Time Frame: Up to 4 weeks ]Will be monitored simultaneously using the Bayesian approach of Thall, Simon, Estey. Safety data of the patients will be summarized using descriptive statistics such as mean, standard deviation, median and range. Toxicity type, severity and attribution will be summarized for each patient using frequency tables.
- Duration of Response [ Time Frame: up to 2 years ]Response date to loss of response or last follow up
- Progression-Free Survival [ Time Frame: Up to 3 cycles (each cycles is 28 days) ]The time from start of treatment to first documentation of disease progression or death due to any cause, whichever occurred first
- Overall Survival [ Time Frame: up to 2 years ]Time from date of treatment start until date of death due to any cause or last Follow-up
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): NCT04239157
|Contact: Guillermo Garcia-Maneroemail@example.com|
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Contact: Guillermo Garcia-Manero 713-794-3604|
|Principal Investigator: Guillermo Garcia-Manero|
|Principal Investigator:||Guillermo Garcia-Manero||M.D. Anderson Cancer Center|