Total Body Irradiation and Cladribine Before Allogeneic Hematopoietic Cell Transplantation in Patients With AML (Acute Myeloid Leukemia) and Myelodysplastic Syndromes (CLARA)

• ClinicalTrials.gov Identifier: NCT04861207
• Recruitment Status: Not yet recruiting
• First Posted: April 27, 2021
• Last Update Posted: May 6, 2021
• Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
• Collaborator: KCRI
• Information provided by (Responsible Party): Maria Sklodowska-Curie National Research Institute of Oncology

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.

Condition or disease	Intervention/treatment	Phase
Acute Myeloid Leukemia Myelodysplastic Syndromes	Drug: Cladribine	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Estimated Study Start Date: June 30, 2021
• Estimated Primary Completion Date: January 31, 2025
• Estimated Study Completion Date: January 31, 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cladribine	Drug: Cladribine; 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.

Outcome Measures

Primary Outcome Measures :

1. The probability of progression-free survival in 24 month follow up [ Time Frame: 24 month follow up ]

Secondary Outcome Measures :

1. Frequency of adverse events [ Time Frame: 24 month follow up ]
2. 24-month overall survival probability [ Time Frame: 24 month follow up ]
3. Disease recurrence probability. [ Time Frame: 24 month follow up ]
4. Mortality unrelated with disease recurrence [ Time Frame: 24 month follow up ]
5. Likelihood of acute and chronic graft-versus-host disease [ Time Frame: 24 month follow up ]
6. Time of neutrophil and platelet implantation [ Time Frame: 24 month follow up ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Age between 18 and 60 years (inclusive).
2. 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.
3. Demonstration of chemosensitivity in the case of treatment regimens with cladribine in induction therapy.
4. Patient signed informed consent form prior to any study related screening procedures are performed.
5. Patient has Eastern Cooperative Oncology Group performance status score of 0 or 1.
6. 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:

1. Has received more than 1 allogeneic hematopoietic cell transplantation.
2. Presence of active uncontrolled infection (i.e. sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection).
3. 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).
4. Presence of active disease in acute myeloid leukemia patients.
5. History or current diagnosis for uncontrolled or significant cardiac or pulmonary disease.
6. Presence of severe renal or liver dysfunction (creatinine, alanine aminotransferase,aspartate aminotransferase or bilirubin concentration > 3.0 upper limit of normal
7. Currently pregnancy or breast feeding.
8. Treatment of any other investigational agent in the same time as this study.
9. Known allergies, hypersensitivity, or intolerance to cladribine or similar compounds.
10. Women of childbearing potential who do not agree to use two effective methods of contraception.

Contacts and Locations

Locations

Poland

Klinika Transplantacji Szpiku i Onkohematologii Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy, Oddział w Gliwicach

Gliwice, Poland, 44-101

Contact: Sebastian Giebel, prof. n.med. 32 278 85 23 Sebastian.Giebel@io.gliwice.pl

Contact: Martyna Palich 32 278 85 23 Martyna.Palich@io.gliwice.pl

Sponsors and Collaborators

Maria Sklodowska-Curie National Research Institute of Oncology

KCRI

More Information

• Responsible Party: Maria Sklodowska-Curie National Research Institute of Oncology
• ClinicalTrials.gov Identifier: NCT04861207
• Other Study ID Numbers: 20-NIO-0001
• First Posted: April 27, 2021
• Last Update Posted: May 6, 2021
• Last Verified: March 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Myelodysplastic Syndromes; Syndrome; Disease; Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Precancerous Conditions; Cladribine; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs