Back to resultsTotal Body Irradiation and Cladribine Before Allogeneic Hematopoietic Cell Transplantation in Patients With AML (Acute Myeloid Leukemia) and Myelodysplastic Syndromes (CLARA)
Primary Purpose
Acute Myeloid Leukemia Myelodysplastic Syndromes
Status
Not yet recruiting
Phase
Phase 2
Locations
Poland
Study Type
Interventional
Intervention
Cladribine
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia Myelodysplastic Syndromes
Eligibility Criteria
Inclusion Criteria:
- Age between 18 and 60 years (inclusive).
- Patient is a candidate for allogeneic hematopoietic cell transplantation due to acute myeloid leukemia(intermediate or high risk acute myeloid leukemia in complete remission, low risk with positive Minimal residual disease) or high risk myelodysplastic syndrome.
- Demonstration of chemosensitivity in the case of treatment regimens with cladribine in induction therapy.
- Patient signed informed consent form prior to any study related screening procedures are performed.
- Patient has Eastern Cooperative Oncology Group performance status score of 0 or 1.
- Patient is a candidate for allogeneic hematopoietic cell transplantation from sibling or unrelated donor (full matched or 9/10 mismatched) or from haploidentical donor.
Exclusion Criteria:
- Has received more than 1 allogeneic hematopoietic cell transplantation.
- Presence of active uncontrolled infection (i.e. sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection).
- Known active human immunodeficiency virus, hepatitis B virus or hepatitis C virus infection (positive polymerase chain reaction test) or risk of hepatitis B virus reactivation (Hepatitis B surface antigen positive).
- Presence of active disease in acute myeloid leukemia patients.
- History or current diagnosis for uncontrolled or significant cardiac or pulmonary disease.
- Presence of severe renal or liver dysfunction (creatinine, alanine aminotransferase,aspartate aminotransferase or bilirubin concentration > 3.0 upper limit of normal
- Currently pregnancy or breast feeding.
- Treatment of any other investigational agent in the same time as this study.
- Known allergies, hypersensitivity, or intolerance to cladribine or similar compounds.
- Women of childbearing potential who do not agree to use two effective methods of contraception.
Sites / Locations
- Klinika Transplantacji Szpiku i Onkohematologii Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy, Oddział w Gliwicach
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cladribine
Arm Description
Outcomes
Primary Outcome Measures
The probability of progression-free survival in 24 month follow up
Secondary Outcome Measures
Frequency of adverse events
24-month overall survival probability
Disease recurrence probability.
Mortality unrelated with disease recurrence
Likelihood of acute and chronic graft-versus-host disease
Time of neutrophil and platelet implantation
Full Information
NCT ID
NCT04861207
First Posted
April 25, 2021
Last Updated
May 3, 2021
Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
Collaborators
KCRI
1. Study Identification
Unique Protocol Identification Number
NCT04861207
Brief Title
Total Body Irradiation and Cladribine Before Allogeneic Hematopoietic Cell Transplantation in Patients With AML (Acute Myeloid Leukemia) and Myelodysplastic Syndromes
Acronym
CLARA
Official Title
Assessment of Tolerance and Effectiveness of Total Body Irradiation and Cladribine Before Allogeneic Hematopoietic Cell Transplantation in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 30, 2021 (Anticipated)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
Collaborators
KCRI
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A single center, prospective, one arm clinical study to assess the tolerance and effectiveness of total body irradiation and cladribine in adult patients diagnosed with AML( acute myeloid leukemia) and myelodysplastic syndromes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia Myelodysplastic Syndromes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cladribine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cladribine
Intervention Description
The conditioning regimen used will be cladribine-based at a dose of 5 mg / m2 for 5 days (iv.) and total body irradiation at a total dose of 12 Gy in three fractions.
Primary Outcome Measure Information:
Title
The probability of progression-free survival in 24 month follow up
Time Frame
24 month follow up
Secondary Outcome Measure Information:
Title
Frequency of adverse events
Time Frame
24 month follow up
Title
24-month overall survival probability
Time Frame
24 month follow up
Title
Disease recurrence probability.
Time Frame
24 month follow up
Title
Mortality unrelated with disease recurrence
Time Frame
24 month follow up
Title
Likelihood of acute and chronic graft-versus-host disease
Time Frame
24 month follow up
Title
Time of neutrophil and platelet implantation
Time Frame
24 month follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 18 and 60 years (inclusive).
Patient is a candidate for allogeneic hematopoietic cell transplantation due to acute myeloid leukemia(intermediate or high risk acute myeloid leukemia in complete remission, low risk with positive Minimal residual disease) or high risk myelodysplastic syndrome.
Demonstration of chemosensitivity in the case of treatment regimens with cladribine in induction therapy.
Patient signed informed consent form prior to any study related screening procedures are performed.
Patient has Eastern Cooperative Oncology Group performance status score of 0 or 1.
Patient is a candidate for allogeneic hematopoietic cell transplantation from sibling or unrelated donor (full matched or 9/10 mismatched) or from haploidentical donor.
Exclusion Criteria:
Has received more than 1 allogeneic hematopoietic cell transplantation.
Presence of active uncontrolled infection (i.e. sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection).
Known active human immunodeficiency virus, hepatitis B virus or hepatitis C virus infection (positive polymerase chain reaction test) or risk of hepatitis B virus reactivation (Hepatitis B surface antigen positive).
Presence of active disease in acute myeloid leukemia patients.
History or current diagnosis for uncontrolled or significant cardiac or pulmonary disease.
Presence of severe renal or liver dysfunction (creatinine, alanine aminotransferase,aspartate aminotransferase or bilirubin concentration > 3.0 upper limit of normal
Currently pregnancy or breast feeding.
Treatment of any other investigational agent in the same time as this study.
Known allergies, hypersensitivity, or intolerance to cladribine or similar compounds.
Women of childbearing potential who do not agree to use two effective methods of contraception.
Facility Information:
Facility Name
Klinika Transplantacji Szpiku i Onkohematologii Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy, Oddział w Gliwicach
City
Gliwice
ZIP/Postal Code
44-101
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastian Giebel, prof. n.med.
Phone
32 278 85 23
Email
Sebastian.Giebel@io.gliwice.pl
First Name & Middle Initial & Last Name & Degree
Martyna Palich
Phone
32 278 85 23
Email
Martyna.Palich@io.gliwice.pl
12. IPD Sharing Statement
Learn more about this trial
Total Body Irradiation and Cladribine Before Allogeneic Hematopoietic Cell Transplantation in Patients With AML (Acute Myeloid Leukemia) and Myelodysplastic Syndromes
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