Myelodysplastic Syndrome Clinical Trial
Official title:
A Randomized Open-Label Trial of Posaconazole Versus Micafungin for Prophylaxis Against Invasive Fungal Infections During Neutropenia in Patients Undergoing Chemotherapy for Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia or Myelodysplastic Syndrome
Verified date | April 2018 |
Source | Memorial Sloan Kettering Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare the effects, good and/or bad, of posaconazole and
micafungin in preventing fungal infections after chemotherapy for acute leukemia or
myelodysplastic syndrome. When people take chemotherapy, they are more likely to get
infections. Posaconazole has been approved for the prevention of fungal infections in
patients who receive induction chemotherapy for acute leukemia and myelodysplastic syndrome.
Posaconazole is available only as an oral suspension and has to be given with food. After
chemotherapy, many patients are not able to tolerate food or oral medication because of
severe mucositis. Patients unable to tolerate food and oral medications cannot take
posaconazole.
Micafungin is an antifungal medication that is given only intravenously. Micafungin is
approved for the treatment of certain fungal infections and for preventing fungal infections
in patients who receive bone marrow transplant. The investigators know that micafungin is
safe. Micafungin has not been tested for the prevention of fungal infections in patients
receiving chemotherapy for acute leukemia and myelodysplastic syndrome. Because micafungin is
given by vein, it can be given even in patients who cannot take food or medications by mouth
after chemotherapy. In this study the investigators want to compare micafungin to
posaconazole when given for the prevention of fungal infections in leukemia and
myelodysplastic syndrome patients.
Status | Completed |
Enrollment | 113 |
Est. completion date | April 3, 2018 |
Est. primary completion date | April 20, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Subjects of greater than or equal to 18 years of age of either sex and of any race. Disease definition: - Anticipated or documented prolonged neutropenia (ANC<500/mm3 [0.5x109/L]) at baseline or likely to develop within 3 to 5 days and lasting for at least 7 days due to: - Intensive induction chemotherapy for new diagnosis of acute myelogenous leukemia, acute lymphocytic leukemia or myelodysplastic syndrome receiving standard anthracycline based chemotherapy - Re-induction of acute myelogenous or lymphocytic leukemia after primary relapse - Myelodysplastic syndromes requiring induction (myelosuppressive) chemotherapy - Female subjects of childbearing potential must have a negative serum pregnancy test as per MSKCC guidelines. - Able to swallow oral medications Exclusion Criteria: - Subjects with history of presumed or proven invasive fungal infection within 30 days of randomization. - Subjects who are taking the following: Drugs known to interact with posaconazole and that may lead to life-threatening side effects (terfenadine, cisapride, and ebastine at entry or within 24 hours before entry, or astemizole at entry or within 10 days before entry); b. Drugs known to lower the serum concentration/efficacy of posaconazole: cimetidine, rifampin, carbamazepine, phenytoin, rifabutin, barbiturates, and isoniazid at entry or within 24 hours before entry; c. Subjects who are planned to receive > 2mg flat dose of vinca alkaloids. - Subjects with a history of hypersensitivity or idiosyncratic reactions to azole agents. - Subjects with renal insufficiency (estimated creatinine clearance less than 20 mL/minute at baseline or likely to require dialysis during the study). - Subjects having an electrocardiogram with a prolonged QTc interval by manual reading: QTc greater than 490 msec. - Subjects with moderate or severe liver dysfunction at baseline, defined as aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase levels greater than 5 times the upper limit of normal (ULN), or a total bilirubin level greater than 3 times the ULN. - Subjects who are undergoing re-induction chemotherapy and have participated in this study during their first induction chemotherapy. - Subjects who will be receiving dasatinib. |
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center | Astellas Pharma US, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to Failure | Clinical failure is defined as: 1) need for systemic antifungal therapy (AmBisome) for > 3 consecutive days for presumptive fungal infection, toxicity or intolerance of study medication or 2) death. | 2 years | |
Secondary | To Compare the Number of Days on Study Drug Between Patients Who Receive Posaconazole and Patients Who Receive Micafungin. | 2 years | ||
Secondary | To Compare the Incidence of Possible, Probable or Proven Invasive Fungal Infections Between Patients Who Receive Posaconazole and Those Who Receive Micafungin During Treatment Phase | 2 years | ||
Secondary | Prophylaxis Failure of Study Medication for Any Reason Between Patients Who Receive Posaconazole and Those Who Receive Micafungin. | 2 years | ||
Secondary | To Compare Overall Survival Rates at 6 Weeks | 6 weeks from randomization between the two treatment arms. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04022785 -
PLX51107 and Azacitidine in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
|
Phase 1 | |
Active, not recruiting |
NCT02530463 -
Nivolumab and/or Ipilimumab With or Without Azacitidine in Treating Patients With Myelodysplastic Syndrome
|
Phase 2 | |
Completed |
NCT02057185 -
Occupational Status and Hematological Disease
|
||
Completed |
NCT01682226 -
Cord Blood With T-Cell Depleted Haplo-identical Peripheral Blood Stem Cell Transplantation for Hematological Malignancies
|
Phase 2 | |
Completed |
NCT02485535 -
Selinexor in Treating Patients With Intermediate- and High-Risk Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome After Transplant
|
Phase 1 | |
Completed |
NCT03941769 -
2018-0674 - IL-7 for T-Cell Recovery Post Haplo and CB Transplant - Phase I/II
|
Phase 1/Phase 2 | |
Completed |
NCT00001637 -
Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults
|
Phase 2 | |
Recruiting |
NCT06195891 -
Orca-T Following Chemotherapy and Total Marrow and Lymphoid Irradiation for the Treatment of Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia or Myelodysplastic Syndrome
|
Phase 1 | |
Active, not recruiting |
NCT04188678 -
Resiliency in Older Adults Undergoing Bone Marrow Transplant
|
N/A | |
Completed |
NCT00987480 -
Hematopoietic Stem Cell Transplantation for the Treatment of Patients With Fanconi Anemia Lacking a Genotypically Identical Donor, Using a Chemotherapy Only Cytoreduction With Busulfan, Cyclophosphamide and Fludarabine
|
Phase 2 | |
Recruiting |
NCT02356159 -
Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation
|
Phase 1/Phase 2 | |
Completed |
NCT04666025 -
SARS-CoV-2 Donor-Recipient Immunity Transfer
|
||
Completed |
NCT02756572 -
Early Allogeneic Hematopoietic Cell Transplantation in Treating Patients With Relapsed or Refractory High-Grade Myeloid Neoplasms
|
Phase 2 | |
Terminated |
NCT02877082 -
Tacrolimus, Bortezomib, & Thymoglobulin in Preventing Low Toxicity GVHD in Donor Blood Stem Cell Transplant Patients
|
Phase 2 | |
Completed |
NCT02543879 -
Study of a Novel BET Inhibitor FT-1101 in Patients With Relapsed or Refractory Hematologic Malignancies
|
Phase 1 | |
Completed |
NCT02262312 -
Iron Overload and Transient Elastography in Patients With Myelodysplastic Syndrome
|
Phase 0 | |
Completed |
NCT02188290 -
Transplant-Related Mortality in Patients Undergoing a Peripheral Blood Stem Cell Transplantation or an Umbilical Cord Blood Transplantation
|
N/A | |
Recruiting |
NCT02330692 -
Cohort Study of New Prognostic Factors With Peripheral Blood and Bone Marrow Evaluation at the Time of Diagnosis and Relapse in Myelodysplastic Syndrome
|
||
Completed |
NCT01684150 -
A Phase 1, Open-Label, Dose-Escalation & Expanded Cohort, Continuous IV Infusion, Multi-center Study of the Safety, Tolerability,PK & PD of EPZ-5676 in Treatment Relapsed/Refractory Patients With Leukemias Involving
|
Phase 1 | |
Completed |
NCT01462578 -
Treatment of Patients With Myelodysplastic Syndrome or Acute Myelocytic Leukemia With an Impending Hematological Relapse With Azacitidine (Vidaza)
|
Phase 2 |