Back to resultsSafety Study of Oral Azacitidine (CC-486) as Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in Participants With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS).
Primary Purpose
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CC-486
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia, Myeloid, Acute focused on measuring Acute myeloid leukemia,, myelodysplastic syndromes,, CC-486, oral Azacitidine,, transplantation,, allogeneic,, HSCT.
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed Myelodysplastic Syndromes or Acute Myeloid Leukemia undergoing allogeneic hematopoietic stem cell transplantation with either peripheral blood or bone marrow as the source of hematopoietic stem cells
At the time of allogeneic HSCT:
- No prior allogeneic HSCT; and
- No more than 1 antigen mismatch at Human Leukocyte Antigen (HLA)-A, -B, -C, -DRB1 or -DQB1 locus for either related or unrelated donor; and
- Bone marrow blast < 20% if MDS or ≤ 10% if AML; and
- Peripheral blood blast ≤ 5%
Be able to start study drug between 42 to 84 days following allogeneic HSCT
Post transplant bone marrow blast count ≤ 5% confirmed within 21 days prior to starting study therapy
Adequate engraftment within 14 days prior to starting study therapy:
- Absolute Neutrophil count (ANC) ≥ 1.0 x 10^9/L without daily use of myeloid growth factor; and
- Platelet count 75 x 10^9/L without platelet transfusion within one week.
Adequate organ function:
- Serum aspartate transaminase (AST) and alanine transaminase (ALT) < 3 x upper limit of normal (ULN)
- Serum bilirubin < 2 x ULN
- Serum creatinine < 2 x ULN
Adequate coagulation (Prothrombin time [PT] ≤ 15 seconds, Partial thromboplastin time (PTT) ≤ 40 seconds, and/or International normalized ratio [INR] ≤ 1.5)
Have a negative serum pregnancy test (sensitivity of at least 25 mIU/mL at screening).
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Must agree to follow protocol-specified pregnancy precautions
Exclusion Criteria:
Use of any of the following after transplantation and prior to starting oral azacitidine:
- Chemotherapeutic agents for chemotherapy
- Investigational agents/therapies
- Azacitidine, decitabine or other demethylating agents
- Lenalidomide, thalidomide and pomalidomide
Active Graft-versus-host disease (GVHD) grade II or higher
Any evidence of gastrointestinal (GI) GVHD
Concurrent use of corticosteroids equivalent of prednisone at a dose > 0.5 mg/kg
Known active viral infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV)
Active uncontrolled systemic fungal, bacterial or viral infection
Presence of malignancies, other than MDS or AML, within the previous 12 months
Significant active cardiac disease within the previous 6 months
Sites / Locations
- Memorial Sloan-Kettering Cancer Center.
- University Hospitals Cleveland Medical Center
- MD Anderson Cancer Center The University of Texas
- Fred Hutchinson Cancer Research Center
- Queen Elizabeth Hospital UHB NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CC-486
Arm Description
Dose of 150 mg, 200 mg, or 300 mg once daily (QD) for the first 7, 10, or 14 days of each 28-day cycle, starting 42-84 days after transplantation.
Outcomes
Primary Outcome Measures
The Number of Participants With Dose Limiting Toxicities (DLT)
A DLT included events that started within 28 days of the first dose of CC-486 in a 28-day cycle, constituted a change from baseline irrespective of outcome, as decided by the investigator to be related to CC-486 including:
≥ Grade (GR) 3 nausea, diarrhea, or vomiting despite the use of medical support
Other significant nonhematologic toxicity of ≥ GR 3 considered not related to the disease or intercurrent illness • Absolute neutrophil count (ANC) < 0.5 x 10^9/L for > 1 week despite growth factor support
Platelets < 25 x 10^9/L for > 1 week despite transfusion support
Failure of recovery to an ANC ≥ 1.0 x 10^9/L and/or platelets ≥ 50 x 10^9/L with a hypocellular marrow by 56 days after the start of a cycle of CC-486 not due to relapse or progressive disease.
The maximum tolerated dose is defined as the cohort delivering the highest dose in which no more than 33% of the evaluable subjects had a DLT The safety population included subjects who received ≥ 1 dose of CC-486
Number of Participants With Treatment Emergent Adverse Events (TEAE)
A TEAE was defined as any AE with an onset date on or after the first dose of IP or any event already present that worsened in severity or increased in frequency after exposure to IP up to 28 days after the last dose. In addition, an AE that occurred beyond the timeframe and was assessed by the doctor as possibly related to IP was considered to be treatment-emergent. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for AEs (NCI CTCAE) version 4.0, where 1= Mild; 2= Moderate; 3= Severe; 4= Life-threatening; 5= Death related to AE. Serious AEs resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in a medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes above.
Secondary Outcome Measures
Percentage of Participants With Graft Versus Host Disease During the Entire Course of the Study
Acute graft versus host disease generally occurs after allogeneic hematopoietic stem cell transplantation. It is a reaction of donor immune cells against host tissues. The 3 main tissues that acute GVHD affects are the skin, liver, and gastrointestinal tract. Chronic GVHD is scored per the National Institute of Health consensus conference grading system. Clinical manifestations of chronic GVHD include skin involvement resembling lichen planus or the cutaneous manifestations of scleroderma; dry oral mucosa with ulcerations and sclerosis of the gastrointestinal tract; and a rising serum bilirubin concentration.
Kaplan Meier Estimate of Time to Discontinuation From Treatment
The time to discontinuation from treatment was assessed as an estimate of treatment tolerability and was defined as the interval from the date of the first IP dose to the date of discontinuation from IP as indicated on the discontinuation from treatment Case Report Form page. Time to discontinuation from study treatment was analyzed using the Kaplan-Meier method where participants who did not discontinue were censored at the date of last visit.
Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration Of CC-486 (AUC-t)
Area under the plasma concentration-time curve from Time 0 to the time of the last quantifiable concentration, calculated by linear trapezoidal method when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing.
Area Under the Plasma Concentration-Time Curve From Time 0 to Extrapolated to Infinity (AUC-inf; AUC0-∞) Of CC-486
Area under the plasma concentration-time curve from time 0 extrapolated to infinity, calculated as [AUCt + Ct/ λz]. Ct is the last quantifiable concentration. No AUC extrapolation was performed with unreliable λz. If AUC %Extrap was ≥25%, AUC inf was not reported.
Maximum Observed Concentration (Cmax) Of CC-486
Maximum observed plasma concentration, obtained directly from the observed concentration versus time data.
Time to Reach Maximum Concentration (Tmax) of CC-486
Time to Cmax, obtained directly from the observed concentration versus time data.
Terminal Half-Life (T1/2) of CC-486
Terminal phase half-life in plasma, calculated as [(ln 2)/λz]. t1/2 will only be calculated when a reliable estimate for λz can be obtained.
Apparent Total Clearance (CL/F) of CC-486
Apparent total clearance, calculated as [Dose/AUCinf].
Apparent Volume of Distribution (Vz/F) of CC-486
Apparent volume of distribution, calculated as [(CL/F)/λz].Apparent volume of distribution, calculated as [(CL/F)/λz].
Percentage of Participants With Disease Relapse or Progression
Disease relapse was defined as the reappearance of > 5% blasts in the bone marrow that persists for at least 4 weeks. Disease progression was defined as the reappearance of > 10% of blasts in the bone marrow that persisted for at least 4 weeks.
Time to Disease Recurrence/Progression
Time to disease relapse/progression was defined as the interval from the date of allogeneic HSCT to the date of treatment discontinuation or study discontinuation where reason for discontinuation is disease relapse or disease progression, or the date of disease progression recorded on the survival electronic Case Report Form page, whichever occurred first. Time to disease relapse/progression was analyzed using competing risk methods where death without documented relapse/progression was treated as a competing risk for relapse/progression. relapse/progression.
Overall Survival
Overall Survival was defined as the time from the date of allogeneic hematopoietic stem cell transplantation to death from any cause.
Kaplan Meier Estimate of Relapse-Free Survival (RFS)
Relapse-free survival was defined as the interval from the date of allogeneic HSCT to the date of first documented > 5% blasts in the bone marrow or death from any cause, whichever occurs first. Participants who were still alive and continued to have less than or equal to 5% blasts in the bone marrow or who were lost to follow-up were censored at the date of their last response assessment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01835587
Brief Title
Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in Participants With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS).
Official Title
A Phase 1/2 Dose and Schedule Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Oral Azacitidine (CC-486) in Subjects With Acute Myelogenous Leukemia and Myelodysplastic Syndromes After Allogeneic Hematopoietic Stem Cell Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 25, 2013 (Actual)
Primary Completion Date
November 13, 2016 (Actual)
Study Completion Date
May 26, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to determine the maximal tolerated dose and schedule of CC-486, known as oral azacitidine, in patients with AML or MDS after allogeneic hematopoetic stem cell transplant (HSCT). HSCT is more frequently used in AML or MDS as a potential curative therapy. However, disease recurrence/relapse and graft-versus-host disease (GVHD) remain the principal causes of fatal complications after transplantation. Oral azacitidine has significant activity in MDS and AML. Oral azacitidine has also demonstrated immunomodulatory activity in AML patients after allogeneic HSCT. An oral formulation of oral azacitidine provides a convenient route of administration and an opportunity to deliver the drug over a prolonged schedule.
Detailed Description
This is an open-label, multicenter study of oral azacitidine in MDS or AML patients who have undergone allogeneic HSCT. The study consists of three phases: Screening, Treatment and Follow-up. During the Screening phase, the study doctor will do tests to see if the patient is suitable for this study. The patients meeting protocol-specified entry criteria will enter the treatment phase and be assigned to receive one of the oral azacitidine cohorts. The dosing group of 200 mg QD on Days 1 to 7 will be evaluated first (ie, Cohort 1). In the event that unacceptable toxicity occurs in Cohort 1, then oral azacitidine may be evaluated at lower dose levels (eg, 150 mg). If the dosing regimen is confirmed to be safe in Cohort 1, other cohorts will be evaluated sequentially. During the treatment phase, patients will be monitored closely for safety and tolerability. Dosing interruption or delay, dose or schedule reduction, intra-subject dose/schedule escalation or re-escalation may occur on the basis of protocol-specified dosing adjustment guidelines. Safety will be monitored throughout the study at predetermined intervals and as clinically indicated by vital signs, physical examination, performance status, laboratory tests and evaluation of adverse events. The patient can continue to receive the study treatment for up to 12 months provided that they benefit from the study treatment and all protocol-specified criteria are met. However, the patient may receive the study treatment for less than 12 months due to adverse event, disease recurrence or progression. When the study treatment is discontinued, all patients who have received at least one dose of oral azacitidine will be asked to see the study doctor for the treatment discontinuation visit. Thereafter, all patients discontinued from the study treatment will enter the Follow-up phase for safety and survival follow up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
Keywords
Acute myeloid leukemia,, myelodysplastic syndromes,, CC-486, oral Azacitidine,, transplantation,, allogeneic,, HSCT.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CC-486
Arm Type
Experimental
Arm Description
Dose of 150 mg, 200 mg, or 300 mg once daily (QD) for the first 7, 10, or 14 days of each 28-day cycle, starting 42-84 days after transplantation.
Intervention Type
Drug
Intervention Name(s)
CC-486
Other Intervention Name(s)
Oral Azacitdine
Intervention Description
Cohorts of 3 to 6 subjects will be treated at escalating or de-escalating sequential dose levels until a preliminary Maximum Tolerated Dose (MTD) is identified.
Primary Outcome Measure Information:
Title
The Number of Participants With Dose Limiting Toxicities (DLT)
Description
A DLT included events that started within 28 days of the first dose of CC-486 in a 28-day cycle, constituted a change from baseline irrespective of outcome, as decided by the investigator to be related to CC-486 including:
≥ Grade (GR) 3 nausea, diarrhea, or vomiting despite the use of medical support
Other significant nonhematologic toxicity of ≥ GR 3 considered not related to the disease or intercurrent illness • Absolute neutrophil count (ANC) < 0.5 x 10^9/L for > 1 week despite growth factor support
Platelets < 25 x 10^9/L for > 1 week despite transfusion support
Failure of recovery to an ANC ≥ 1.0 x 10^9/L and/or platelets ≥ 50 x 10^9/L with a hypocellular marrow by 56 days after the start of a cycle of CC-486 not due to relapse or progressive disease.
The maximum tolerated dose is defined as the cohort delivering the highest dose in which no more than 33% of the evaluable subjects had a DLT The safety population included subjects who received ≥ 1 dose of CC-486
Time Frame
2 months (Cycles 1 and 2)
Title
Number of Participants With Treatment Emergent Adverse Events (TEAE)
Description
A TEAE was defined as any AE with an onset date on or after the first dose of IP or any event already present that worsened in severity or increased in frequency after exposure to IP up to 28 days after the last dose. In addition, an AE that occurred beyond the timeframe and was assessed by the doctor as possibly related to IP was considered to be treatment-emergent. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for AEs (NCI CTCAE) version 4.0, where 1= Mild; 2= Moderate; 3= Severe; 4= Life-threatening; 5= Death related to AE. Serious AEs resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in a medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes above.
Time Frame
From the first dose of investigational product (IP) up to 28 days after the last dose of IP. The median duration of exposure was 252.5 days overall; up to the final data cut off date of 14 July 2017
Secondary Outcome Measure Information:
Title
Percentage of Participants With Graft Versus Host Disease During the Entire Course of the Study
Description
Acute graft versus host disease generally occurs after allogeneic hematopoietic stem cell transplantation. It is a reaction of donor immune cells against host tissues. The 3 main tissues that acute GVHD affects are the skin, liver, and gastrointestinal tract. Chronic GVHD is scored per the National Institute of Health consensus conference grading system. Clinical manifestations of chronic GVHD include skin involvement resembling lichen planus or the cutaneous manifestations of scleroderma; dry oral mucosa with ulcerations and sclerosis of the gastrointestinal tract; and a rising serum bilirubin concentration.
Time Frame
From the first dose of CC-486 up to study discontinuation or death. Up to final data cut off date of 14 July 2017; up to 186 weeks and 4 days
Title
Kaplan Meier Estimate of Time to Discontinuation From Treatment
Description
The time to discontinuation from treatment was assessed as an estimate of treatment tolerability and was defined as the interval from the date of the first IP dose to the date of discontinuation from IP as indicated on the discontinuation from treatment Case Report Form page. Time to discontinuation from study treatment was analyzed using the Kaplan-Meier method where participants who did not discontinue were censored at the date of last visit.
Time Frame
From the first dose of IP dose to the date of discontinuation from IP; the overall median time to discontinuation of IP was 283.5 days
Title
Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration Of CC-486 (AUC-t)
Description
Area under the plasma concentration-time curve from Time 0 to the time of the last quantifiable concentration, calculated by linear trapezoidal method when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing.
Time Frame
On Day 1, pharmacokinetic (PK) samples were collected at predose and over a 6-hour period following drug administration on the following schedule: 0.5, 1, 1.5, 2, 2.5, 3, 4, and 6 hours post-dose; Cycle 1 or 2 until 6 hours after CC-486 administration.
Title
Area Under the Plasma Concentration-Time Curve From Time 0 to Extrapolated to Infinity (AUC-inf; AUC0-∞) Of CC-486
Description
Area under the plasma concentration-time curve from time 0 extrapolated to infinity, calculated as [AUCt + Ct/ λz]. Ct is the last quantifiable concentration. No AUC extrapolation was performed with unreliable λz. If AUC %Extrap was ≥25%, AUC inf was not reported.
Time Frame
On Day 1, PK samples were collected at predose and over the 6-hour period following CC-486 administration on the following schedule: 0.5, 1, 1.5, 2, 2.5, 3, 4, and 6 hours post-dose at Cycle 1 or 2 until 6 hours after CC-486 administration.
Title
Maximum Observed Concentration (Cmax) Of CC-486
Description
Maximum observed plasma concentration, obtained directly from the observed concentration versus time data.
Time Frame
On Day 1, PK samples were collected at predose and over the 6-hour period following CC-486 administration on the following schedule: 0.5, 1, 1.5, 2, 2.5, 3, 4, and 6 hours post-dose at Cycle 1 or 2 until 6 hours after CC-486 administration.
Title
Time to Reach Maximum Concentration (Tmax) of CC-486
Description
Time to Cmax, obtained directly from the observed concentration versus time data.
Time Frame
On Day 1, PK samples were collected at predose and over the 6-hour period following CC-486 administration on the following schedule: 0.5, 1, 1.5, 2, 2.5, 3, 4, and 6 hours post-dose at Cycle 1 or 2 until 6 hours after CC-486 administration.
Title
Terminal Half-Life (T1/2) of CC-486
Description
Terminal phase half-life in plasma, calculated as [(ln 2)/λz]. t1/2 will only be calculated when a reliable estimate for λz can be obtained.
Time Frame
On Day 1, PK samples were collected at predose and over the 6-hour period following CC-486 administration on the following schedule: 0.5, 1, 1.5, 2, 2.5, 3, 4, and 6 hours post-dose at Cycle 1 or 2 until 6 hours after CC-486 administration.
Title
Apparent Total Clearance (CL/F) of CC-486
Description
Apparent total clearance, calculated as [Dose/AUCinf].
Time Frame
On Day 1, PK samples were collected at predose and over the 6-hour period following CC-486 administration on the following schedule: 0.5, 1, 1.5, 2, 2.5, 3, 4, and 6 hours post-dose at Cycle 1 or 2 until 6 hours after CC-486 administration.
Title
Apparent Volume of Distribution (Vz/F) of CC-486
Description
Apparent volume of distribution, calculated as [(CL/F)/λz].Apparent volume of distribution, calculated as [(CL/F)/λz].
Time Frame
On Day 1, PK samples were collected at predose and over the 6-hour period following CC-486 administration on the following schedule: 0.5, 1, 1.5, 2, 2.5, 3, 4, and 6 hours post-dose at Cycle 1 or 2 until 6 hours after CC-486 administration.
Title
Percentage of Participants With Disease Relapse or Progression
Description
Disease relapse was defined as the reappearance of > 5% blasts in the bone marrow that persists for at least 4 weeks. Disease progression was defined as the reappearance of > 10% of blasts in the bone marrow that persisted for at least 4 weeks.
Time Frame
Date of first dose of IP to disease relapse or progression; up to data cut-off date of 14 July 2017; median number of days assessed was 963.0 days for Cohort 1, 743.5 days for Cohort 2, 675.5 days for Cohort 3A and 559.0 days for Cohort 3.
Title
Time to Disease Recurrence/Progression
Description
Time to disease relapse/progression was defined as the interval from the date of allogeneic HSCT to the date of treatment discontinuation or study discontinuation where reason for discontinuation is disease relapse or disease progression, or the date of disease progression recorded on the survival electronic Case Report Form page, whichever occurred first. Time to disease relapse/progression was analyzed using competing risk methods where death without documented relapse/progression was treated as a competing risk for relapse/progression. relapse/progression.
Time Frame
Date of allogenic HSCT to disease progression or relaopse; up to data cut-off date of 14 July 2017; median number of days assessed was 963.0 days for Cohort 1, 743.5 days for Cohort 2, 675.5 days for Cohort 3A and 559.0 days for Cohort 3.
Title
Overall Survival
Description
Overall Survival was defined as the time from the date of allogeneic hematopoietic stem cell transplantation to death from any cause.
Time Frame
Date of the allogeneic HSCT to death from any cause. Median number of days participants were assessed from first dose to last contact was 963.0 days for Cohort 1, 743.5 days for Cohort 2, 675.5 days for Cohort 3A and 559.0 days for Cohort 3.
Title
Kaplan Meier Estimate of Relapse-Free Survival (RFS)
Description
Relapse-free survival was defined as the interval from the date of allogeneic HSCT to the date of first documented > 5% blasts in the bone marrow or death from any cause, whichever occurs first. Participants who were still alive and continued to have less than or equal to 5% blasts in the bone marrow or who were lost to follow-up were censored at the date of their last response assessment.
Time Frame
Date of allogenic HSCT to date of progression or death from any cause; Median number of days participants were assessed from first dose to last contact was 963 days for Cohort 1, 674.8 days for Cohort 2, 577.5 days for Cohort 3A and 553 days for Cohort 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed Myelodysplastic Syndromes or Acute Myeloid Leukemia undergoing allogeneic hematopoietic stem cell transplantation with either peripheral blood or bone marrow as the source of hematopoietic stem cells
At the time of allogeneic HSCT:
No prior allogeneic HSCT; and
No more than 1 antigen mismatch at Human Leukocyte Antigen (HLA)-A, -B, -C, -DRB1 or -DQB1 locus for either related or unrelated donor; and
Bone marrow blast < 20% if MDS or ≤ 10% if AML; and
Peripheral blood blast ≤ 5%
Be able to start study drug between 42 to 84 days following allogeneic HSCT
Post transplant bone marrow blast count ≤ 5% confirmed within 21 days prior to starting study therapy
Adequate engraftment within 14 days prior to starting study therapy:
Absolute Neutrophil count (ANC) ≥ 1.0 x 10^9/L without daily use of myeloid growth factor; and
Platelet count 75 x 10^9/L without platelet transfusion within one week.
Adequate organ function:
Serum aspartate transaminase (AST) and alanine transaminase (ALT) < 3 x upper limit of normal (ULN)
Serum bilirubin < 2 x ULN
Serum creatinine < 2 x ULN
Adequate coagulation (Prothrombin time [PT] ≤ 15 seconds, Partial thromboplastin time (PTT) ≤ 40 seconds, and/or International normalized ratio [INR] ≤ 1.5)
Have a negative serum pregnancy test (sensitivity of at least 25 mIU/mL at screening).
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Must agree to follow protocol-specified pregnancy precautions
Exclusion Criteria:
Use of any of the following after transplantation and prior to starting oral azacitidine:
Chemotherapeutic agents for chemotherapy
Investigational agents/therapies
Azacitidine, decitabine or other demethylating agents
Lenalidomide, thalidomide and pomalidomide
Active Graft-versus-host disease (GVHD) grade II or higher
Any evidence of gastrointestinal (GI) GVHD
Concurrent use of corticosteroids equivalent of prednisone at a dose > 0.5 mg/kg
Known active viral infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV)
Active uncontrolled systemic fungal, bacterial or viral infection
Presence of malignancies, other than MDS or AML, within the previous 12 months
Significant active cardiac disease within the previous 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry Skikne, M.D., FACP; FCP (SA)
Organizational Affiliation
Celgene Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center.
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
MD Anderson Cancer Center The University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-4417
Country
United States
Facility Name
Queen Elizabeth Hospital UHB NHS Foundation Trust
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
29933073
Citation
de Lima M, Oran B, Champlin RE, Papadopoulos EB, Giralt SA, Scott BL, William BM, Hetzer J, Laille E, Hubbell B, Skikne BS, Craddock C. CC-486 Maintenance after Stem Cell Transplantation in Patients with Acute Myeloid Leukemia or Myelodysplastic Syndromes. Biol Blood Marrow Transplant. 2018 Oct;24(10):2017-2024. doi: 10.1016/j.bbmt.2018.06.016. Epub 2018 Jun 20.
Results Reference
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Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in Participants With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS).
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