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

Sponsor

Maria Sklodowska-Curie National Research Institute of Oncology (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04861207

Collaborator

KCRI (Other)

Enrollment

Location

Arm

43.1

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

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

Anticipated 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

Anticipated Study Start Date :

Jun 30, 2021

Anticipated Primary Completion Date :

Jan 31, 2025

Anticipated Study Completion Date :

Jan 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.

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

The probability of progression-free survival in 24 month follow up [24 month follow up]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinika Transplantacji Szpiku i Onkohematologii Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy, Oddział w Gliwicach	Gliwice		Poland	44-101