Ignite Creation Date:
2024-05-06 @ 4:04 AM
Last Modification Date:
2024-10-26 @ 11:43 AM
Study NCT ID:
NCT02441803
Status:
COMPLETED
Last Update Posted:
2024-02-22
First Post:
2015-05-05
Brief Title:
Allogeneic Hematopoietic Stem Cell Transplantation AlloSCT Initial Salvage Therapy for Induction Failure Acute Myeloid Leukemia AML
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Allogeneic Hematopoietic Stem Cell Transplantation as Initial Salvage Therapy for Patients With Primary Induction Failure Acute Myeloid Leukemia Refractory to High-Dose Cytarabine-Based Induction Chemotherapy
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objectives
Primary Objectives
1 To determine the safety and feasibility of allogeneic hematopoietic stem cell transplantation AHSCT as initial salvage treatment for patients with primary induction failure PIF acute myeloid leukemia AML
2 To determine efficacy of AHSCT following decitabine clofarabine idarubicin and cytarabine DCIA salvage chemotherapy evaluated by overall response rate RR defined as complete response CR or CR without platelet recovery CRp or CR with insufficient hematological recovery CRi
Secondary Objectives
1 To determine the percentage of patients with PIF AML eligible for AHSCT after up to 2 courses of induction chemotherapy
2 To determine the early treatment-related mortality TRM within first 4 weeks of first salvage chemotherapy regimen with DCIA and day 100 TRM after AHSCT
3 To determine the efficacy DCIA regimen as salvage chemotherapy for patients with PIF AML of patients who achieve 5 bone marrow blasts prior to AHSCT
4 To determine the TRM at 1 year relapse rate RR overall survival OS and event-free survival EFS for patients with PIF AML treated with DCIA followed by early AHSCT
Primary Objectives
1 To determine the safety and feasibility of allogeneic hematopoietic stem cell transplantation AHSCT as initial salvage treatment for patients with primary induction failure PIF acute myeloid leukemia AML
2 To determine efficacy of AHSCT following decitabine clofarabine idarubicin and cytarabine DCIA salvage chemotherapy evaluated by overall response rate RR defined as complete response CR or CR without platelet recovery CRp or CR with insufficient hematological recovery CRi
Secondary Objectives
1 To determine the percentage of patients with PIF AML eligible for AHSCT after up to 2 courses of induction chemotherapy
2 To determine the early treatment-related mortality TRM within first 4 weeks of first salvage chemotherapy regimen with DCIA and day 100 TRM after AHSCT
3 To determine the efficacy DCIA regimen as salvage chemotherapy for patients with PIF AML of patients who achieve 5 bone marrow blasts prior to AHSCT
4 To determine the TRM at 1 year relapse rate RR overall survival OS and event-free survival EFS for patients with PIF AML treated with DCIA followed by early AHSCT
Detailed Description:
Salvage Chemotherapy Before Transplant
Study Drug Administration
On Days 1-5 you will receive decitabine 1 time each day by vein over about 1-3 hours
On Days 6-10
You will receive cytarabine 1 time a day by vein over about 1-3 hours
On Days 6-8 only you will receive idarubicin 1 time a day by vein over about 30 minutes
On Days 6-9 only you will receive clofarabine 1 time a day by vein over about 1-2 hours
Study Visits
After your last study drug dose
Blood about 2 teaspoons will be drawn to check your kidney and liver function
You will have an echocardiogram ECHO or multigated acquisition MUGA scan to check your heart function
You will have a lung function test
On Day 21 - 7 days you will have a bone marrow biopsyaspirate to check the status of the disease To collect a bone marrow biopsyaspirate an area of the hip is numbed with anesthetic and a small amount of bone and bone marrow is withdrawn through a large needle
If the results of your bone marrow biopsyaspirate blood tests and heart and lung function tests show that you are eligible to receive an allogeneic stem cell transplant you will be asked to sign a separate informed consent for the transplant
If the results of your bone marrow aspiratebiopsy blood tests and heart and lung function tests show that you are not eligible to receive an allogeneic stem cell transplant you will not receive it The study staff will call you and ask how you are feeling and about any other drugs you may be taking every 3 months for 2 years after your last study drug dose These calls should last about 5 minutes each
If you are found to NOT be eligible to receive an allogeneic stem cell transplant your doctor will discuss other treatment options with you
Stem Cell Transplant
Study Drug Administration Pharmacokinetic PK Testing and Stem Cell Transplant
For a stem cell transplant the days before you receive your stem cells are called minus days The day you receive the stem cells is called Day 0 The days after you receive the stem cells are called plus days
You will receive a dose of busulfan by vein over about 45 minutes to 1 hour as an outpatient or as an inpatient on Day -8 With the first busulfan infusion blood about 1 teaspoon each time will be drawn for pharmacokinetic PK testing about 11 times over 11 hours before and after you receive your first dose of busulfan PK testing measures the amount of study drug in the body at different time points The study staff will tell you the blood testing schedule Test doses are used to study how your body breaks down busulfan and decide the dose of busulfan that you will receive on Days -6 through -3
A heparin lock line will be placed in your vein before the PK testing to lower the number of needle sticks needed for these draws If for any reason it is not possible for the PK tests to be performed you will receive the standard dose of busulfan
On Day -7 you will rest
On Days -6 through -3 you will receive fludarabine by vein over 1 hour clofarabine by vein over 1 hour and then busulfan by vein over 3 hours
On Days -3 and -2 if you will receive stem cells from a matched unrelated donor you will receive ATG by vein over 4 hours each day
On Day -2 if you will receive stem cells from a haploidentical donor you will receive total body irradiation TBI one time TBI involves the delivery of high doses of radiation designed to destroy cancer cells andor lower the immune system in order to lower the risk of the body rejecting the new stem cells
On Day -2 you will receive tacrolimus by vein over 24 hours every day until you are able to take it by mouth Tacrolimus is designed to weaken the immune system and lower the risk of graft-versus-host-disease GVHD - a reaction of the donors immune cells against your body After you are able to take tacrolimus by mouth you will take it every day for about 6 months or until the doctor thinks it is safe to stop
On Day -1 you will rest If you will receive stem cells from a matched sibling donor you will rest on Days -2 and -1
On Day 0 you will receive the donors stem cells by vein The infusion will last anywhere from about 30 minutes to several hours
If you will receive stem cells from a haploidentical donor
After the stem cell infusion you will receive tacrolimus to help lower the risk of GVHD Tacrolimus will be given by vein non-stop for about 2 weeks After the 2 weeks of taking tacrolimus by vein you will take tacrolimus by mouth as a pill for at least 4 months after the transplant
On Days 3 and 4 you will receive cyclophosphamide by vein over 3 hours Cyclophosphamide is given to lower the immune system in order to lower the risk of GVHD
If you receive stem cells from a matched sibling or matched unrelated donor
On Days 1 3 6 and 11 you will receive methotrexate by vein over 30 minutes Methotrexate is given to help prevent GVHD
Study Testing
Before you are sent home from the hospital andor clinic you will receive additional written instructions These instructions will include how often you will come to the hospitalclinic which standard drugs you will take at home and what side effects you may have and what to do for them
After finishing the chemotherapy and transplant your follow-up care will be routine standard of care follow-up that all patients receiving allogeneic stem cell transplantation receive At each visit you will have a physical exam You will be asked about any side effects you may have had Blood about 1 tablespoon will be drawn for routine tests If the doctor thinks it is needed you will have a bone marrow aspiration to check the status of the disease To collect a bone marrow aspirate an area of the hip or other site is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle
Length of Treatment
After 2 years your participation in this study will be over You may be taken off study early if the disease gets worse if your transplant does not take graft failure if you are unable to follow study directions if your doctor thinks it is in your best interest if the study is stopped or if you choose to leave the study early
If for any reason you want to leave the study early you must talk to the study doctor It may be life-threatening to leave the study after you have started to receive the study drugs but before you receive the stem cell transplant because your blood cell counts will be dangerously low
Study Drug Administration
On Days 1-5 you will receive decitabine 1 time each day by vein over about 1-3 hours
On Days 6-10
You will receive cytarabine 1 time a day by vein over about 1-3 hours
On Days 6-8 only you will receive idarubicin 1 time a day by vein over about 30 minutes
On Days 6-9 only you will receive clofarabine 1 time a day by vein over about 1-2 hours
Study Visits
After your last study drug dose
Blood about 2 teaspoons will be drawn to check your kidney and liver function
You will have an echocardiogram ECHO or multigated acquisition MUGA scan to check your heart function
You will have a lung function test
On Day 21 - 7 days you will have a bone marrow biopsyaspirate to check the status of the disease To collect a bone marrow biopsyaspirate an area of the hip is numbed with anesthetic and a small amount of bone and bone marrow is withdrawn through a large needle
If the results of your bone marrow biopsyaspirate blood tests and heart and lung function tests show that you are eligible to receive an allogeneic stem cell transplant you will be asked to sign a separate informed consent for the transplant
If the results of your bone marrow aspiratebiopsy blood tests and heart and lung function tests show that you are not eligible to receive an allogeneic stem cell transplant you will not receive it The study staff will call you and ask how you are feeling and about any other drugs you may be taking every 3 months for 2 years after your last study drug dose These calls should last about 5 minutes each
If you are found to NOT be eligible to receive an allogeneic stem cell transplant your doctor will discuss other treatment options with you
Stem Cell Transplant
Study Drug Administration Pharmacokinetic PK Testing and Stem Cell Transplant
For a stem cell transplant the days before you receive your stem cells are called minus days The day you receive the stem cells is called Day 0 The days after you receive the stem cells are called plus days
You will receive a dose of busulfan by vein over about 45 minutes to 1 hour as an outpatient or as an inpatient on Day -8 With the first busulfan infusion blood about 1 teaspoon each time will be drawn for pharmacokinetic PK testing about 11 times over 11 hours before and after you receive your first dose of busulfan PK testing measures the amount of study drug in the body at different time points The study staff will tell you the blood testing schedule Test doses are used to study how your body breaks down busulfan and decide the dose of busulfan that you will receive on Days -6 through -3
A heparin lock line will be placed in your vein before the PK testing to lower the number of needle sticks needed for these draws If for any reason it is not possible for the PK tests to be performed you will receive the standard dose of busulfan
On Day -7 you will rest
On Days -6 through -3 you will receive fludarabine by vein over 1 hour clofarabine by vein over 1 hour and then busulfan by vein over 3 hours
On Days -3 and -2 if you will receive stem cells from a matched unrelated donor you will receive ATG by vein over 4 hours each day
On Day -2 if you will receive stem cells from a haploidentical donor you will receive total body irradiation TBI one time TBI involves the delivery of high doses of radiation designed to destroy cancer cells andor lower the immune system in order to lower the risk of the body rejecting the new stem cells
On Day -2 you will receive tacrolimus by vein over 24 hours every day until you are able to take it by mouth Tacrolimus is designed to weaken the immune system and lower the risk of graft-versus-host-disease GVHD - a reaction of the donors immune cells against your body After you are able to take tacrolimus by mouth you will take it every day for about 6 months or until the doctor thinks it is safe to stop
On Day -1 you will rest If you will receive stem cells from a matched sibling donor you will rest on Days -2 and -1
On Day 0 you will receive the donors stem cells by vein The infusion will last anywhere from about 30 minutes to several hours
If you will receive stem cells from a haploidentical donor
After the stem cell infusion you will receive tacrolimus to help lower the risk of GVHD Tacrolimus will be given by vein non-stop for about 2 weeks After the 2 weeks of taking tacrolimus by vein you will take tacrolimus by mouth as a pill for at least 4 months after the transplant
On Days 3 and 4 you will receive cyclophosphamide by vein over 3 hours Cyclophosphamide is given to lower the immune system in order to lower the risk of GVHD
If you receive stem cells from a matched sibling or matched unrelated donor
On Days 1 3 6 and 11 you will receive methotrexate by vein over 30 minutes Methotrexate is given to help prevent GVHD
Study Testing
Before you are sent home from the hospital andor clinic you will receive additional written instructions These instructions will include how often you will come to the hospitalclinic which standard drugs you will take at home and what side effects you may have and what to do for them
After finishing the chemotherapy and transplant your follow-up care will be routine standard of care follow-up that all patients receiving allogeneic stem cell transplantation receive At each visit you will have a physical exam You will be asked about any side effects you may have had Blood about 1 tablespoon will be drawn for routine tests If the doctor thinks it is needed you will have a bone marrow aspiration to check the status of the disease To collect a bone marrow aspirate an area of the hip or other site is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle
Length of Treatment
After 2 years your participation in this study will be over You may be taken off study early if the disease gets worse if your transplant does not take graft failure if you are unable to follow study directions if your doctor thinks it is in your best interest if the study is stopped or if you choose to leave the study early
If for any reason you want to leave the study early you must talk to the study doctor It may be life-threatening to leave the study after you have started to receive the study drugs but before you receive the stem cell transplant because your blood cell counts will be dangerously low
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2015-00849 | REGISTRY | NCI CTRP | None |