Ruxolitinib Phosphate and Decitabine in Treating Patients With Relapsed or Refractory or Post Myeloproliferative Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT02257138|
Recruitment Status : Recruiting
First Posted : October 6, 2014
Last Update Posted : November 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Blasts More Than 20 Percent of Bone Marrow Nucleated Cells Blasts More Than 20 Percent of Peripheral Blood White Cells Myelodysplastic/Myeloproliferative Neoplasm Recurrent Acute Myeloid Leukemia Refractory Acute Myeloid Leukemia||Drug: Decitabine Other: Laboratory Biomarker Analysis Drug: Ruxolitinib Phosphate||Phase 1 Phase 2|
I. To determine the tolerability of the combination of decitabine and ruxolitinib phosphate (ruxolitinib [DI]) in patients with leukemia. (Phase I) II. To determine the efficacy of ruxolitinib in increasing and prolonging response induced by decitabine alone in patients with post myeloproliferative neoplasm acute myeloid leukemia (AML) (post MPN-AML) alternatively referred to as (myeloproliferative neoplasm - blast phase; MPN-BP). (Compared to historical response rate with decitabine alone) (Phase II)
I. To compare whether there is a difference in response rate patients with post-MPN AML with janus kinase 2 (JAK2) mutations and patients without JAK2 mutations.
OUTLINE: This is a phase I, dose-escalation study of ruxolitinib phosphate followed by a phase II study.
Patients receive ruxolitinib phosphate orally (PO) twice daily (BID) on days 1-28 and decitabine intravenously (IV) over 1-2 hours on days 1-5. Treatment repeats every 4-6 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Ruxolitinib Plus Decitabine in Patients With Post Myeloproliferative Neoplasm - Acute Myeloid Leukemia (AML)|
|Actual Study Start Date :||February 12, 2015|
|Estimated Primary Completion Date :||February 1, 2019|
|Estimated Study Completion Date :||February 1, 2019|
Experimental: Treatment (ruxolitinib phosphate, decitabine)
Patients receive ruxolitinib phosphate PO BID on days 1-28 and decitabine IV on days 1-5. Treatment repeats every 4-6 weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Drug: Ruxolitinib Phosphate
- Maximum tolerated dose of ruxolitinib phosphate, defined as the dose at which 0 or 1 of 6 patients experience dose-limiting toxicity (Phase I) [ Time Frame: Up to 6 weeks ]Descriptive summaries will be provided for all patients for each safety parameter by course, grade, and relationship to treatment.
- Proportion of patients achieving overall response (complete response [CR] + CR with incomplete blood count recovery) as assessed by myeloproliferative neoplasm (MPN) criteria (Phase II) [ Time Frame: Up to 18 weeks (3 courses) ]Presented with 95% confidence intervals. The association between response and patient and disease characteristics will be examined by two-sample t-test (or Wilcoxon rank-sum test) or chi-square test.
- Proportion of patients with post-MPN acute myeloid leukemia (AML) with JAK2 mutations [ Time Frame: Baseline ]The association between response and patient and disease characteristics will be examined by two-sample t-test (or Wilcoxon rank-sum test) or chi-square test.
- Proportion of patients without JAK2 mutations and any difference in response rate [ Time Frame: Baseline ]The association between response and patient and disease characteristics will be examined by two-sample t-test (or Wilcoxon rank-sum test) or chi-square test.
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): NCT02257138
|Contact: Farhad Ravandi-Kashanifirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Farhad Ravandi-Kashani 713-745-0394|
|Principal Investigator: Farhad Ravandi-Kashani|
|Principal Investigator:||Farhad Ravandi-Kashani||M.D. Anderson Cancer Center|