Acute Myelogenous Leukemia Clinical Trial
Official title:
Phase II, Open, Randomized Comparative Trial of Two Different Schedules of Palonosetron Versus Ondansetron for the Prevention of Nausea and Vomiting in Patients With Hematologic Malignancies Receiving Regimens Containing High-dose Cytarabine
The goal of this clinical research study is to compare the effectiveness of 3 drug schedules in preventing chemotherapy-related nausea and/or vomiting in patients with acute myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (MDS).
Chemotherapy-related nausea and vomiting is a frequent problem among patients with leukemia
that can lead to further medical problems, such as malnutrition, dehydration, electrolyte
imbalance, and a lower quality of life. Cytarabine, one of the drugs that is used to treat
AML and high-risk MDS, is known to cause nausea and/or vomiting, so all patients that
receive chemotherapy with cytarabine also need to receive medication to prevent these side
effects.
One standard-of-care drug to treat chemotherapy-related nausea and vomiting is called
Ondansetron. Palonosetron is a new drug similar to Ondansetron that is designed to stay
longer in the bloodstream. Researchers want to find out if palonosetron can prevent nausea
and vomiting better than ondansetron.
Women who are able to have children must have a negative blood or urine pregnancy test
before starting treatment.
If you are still eligible to take part in this study, you will be randomly assigned (as in
the roll of the dice) to one of 3 treatment groups. Participants in the first group will be
given Ondansetron as an intravenous (IV--through a needle in your vein) continuous infusion,
from 30 minutes before your chemotherapy treatment until 12 hours after chemotherapy ends.
This is considered the standard of care.
Participants assigned to the second treatment group will be given palonosetron once a day by
IV injection for 5 days. Each dose will be given over a period of 30 seconds, 30 minutes
before your chemotherapy treatment.
Participants assigned to the third treatment group will be given palonosetron once a day by
IV injection, on Days 1, 3, and 5 of chemotherapy treatment. Each dose will be given over a
period of 30 seconds, 30 minutes before your chemotherapy treatment.
No matter what group you are assigned to, you will receive extra medication for nausea
and/or vomiting as needed.
You will be asked to fill out a study diary daily for 7 days, and it should take you no
longer than 10 minutes to complete. The diary will be used to record the number of episodes
of nausea and/or vomiting you experience during this study, as well as to record any need
for extra medications, and to help researchers learn which of the 2 drugs helps the best to
improve participants' quality of life (such as sleep, daily activities, and your ability to
think and reason).
You will be taken off study if intolerable side effects occur.
This is an investigational study. The Food and Drug Administration (FDA) has approved
palonosetron and Ondansetron for the prevention of chemotherapy-related nausea and vomiting,
and both drugs are commercially available. Up to 150 participants will take part in this
study. All will be enrolled at UT MD Anderson Cancer Center.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01200355 -
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
|
Phase 4 | |
Active, not recruiting |
NCT03755414 -
Study of Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation
|
Phase 1 | |
Recruiting |
NCT04904588 -
HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide
|
Phase 2 | |
Active, not recruiting |
NCT04188678 -
Resiliency in Older Adults Undergoing Bone Marrow Transplant
|
N/A | |
Completed |
NCT02543879 -
Study of a Novel BET Inhibitor FT-1101 in Patients With Relapsed or Refractory Hematologic Malignancies
|
Phase 1 | |
Completed |
NCT01681537 -
Lenalidomide Plus Chemotherapy for AML
|
Phase 1 | |
Completed |
NCT01385423 -
Haploidentical Donor Natural Killer Cell Infusion With IL-15 in Acute Myelogenous Leukemia (AML)
|
Phase 1 | |
Terminated |
NCT01193400 -
Clofarabine and Low-dose Cytarabine Followed by Consolidation Therapy in AML Patients Age Greater Than or Equal to 60 Years
|
Phase 2 | |
Completed |
NCT00981240 -
Dose Escalation, Safety and Pharmacokinetic Study of SAR103168 in Patients Refractory/ Relapsed Acute Leukemias or High-risk Myelodysplastic Syndromes
|
Phase 1 | |
Completed |
NCT00975975 -
Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent Graft-Versus_Host Disease (GVHD) After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer
|
Phase 2 | |
Completed |
NCT00995332 -
Disease Stabilization in AML by Treatment With ATRA, Valproic Acid and Low-dose Cytarabine
|
Phase 1/Phase 2 | |
Completed |
NCT00726934 -
The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients
|
N/A | |
Completed |
NCT00378534 -
Methods to Enhance the Safety and Effectiveness of Stem Cell Transplants
|
Phase 2 | |
Completed |
NCT00789256 -
Low Dose Melphalan and Bortezomib for AML and High-Risk MDS
|
N/A | |
Completed |
NCT00098033 -
Investigation of Clofarabine in Acute Leukemias
|
Phase 2 | |
Completed |
NCT01020539 -
Allogeneic Stem Cell Transplantation Followed By Targeted Immune Therapy In Average Risk Leukemia
|
Phase 1 | |
Not yet recruiting |
NCT04709458 -
Safety and Early Efficacy Study of TBX-2400 in Patients With AML or Myelofibrosis
|
Phase 1 | |
Recruiting |
NCT04024241 -
Medium Dose of Cytarabine and Mitoxantrone
|
||
Terminated |
NCT02203773 -
Study of ABT-199 (GDC-0199) in Combination With Azacitidine or Decitabine (Chemo Combo) in Subjects With Acute Myelogenous Leukemia (AML)
|
Phase 1 | |
Terminated |
NCT04023071 -
FT516 in Subjects With Advanced Hematologic Malignancies
|
Phase 1 |