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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03357159
Other study ID # SHEBA-17-4055-AN-CTIL
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date September 6, 2018
Est. completion date December 1, 2024

Study information

Verified date November 2023
Source Sheba Medical Center
Contact Arnon Nagler, MD
Phone 972-3-530-58-30
Email Arnon.Nagler@sheba.health.gov.il
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Investigators hypothesize that combination of ATLG with PTCy in matched or mismatched unrelated hematopoietic stem cell transplantation will reduce acute and chronic GVHD incidence. Furthermore it will allow shortening of the length of post-transplantation immunosuppression with calcineurin inhibitor (CNI) administration (currently administrated in addition to ATG as GVHD prophylaxis in daily common practice)


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 1, 2024
Est. primary completion date December 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Patients with MDS/AML 2. 18 years or older and willing and able to comply with the protocol requirements. 3. LVEF = 40%. 2-D transthoracic echocardiogram (ECHO) is the preferred method of evaluation. Multigated Acquisition Scan (MUGA) is acceptable if ECHO is not available. 4. Patients undergoing 8-10/10 HLA matched unrelated and unmanipulated PBSC transplantation 5. Patients conditioned with reduced intensity or reduced toxicity conditioning of fludarabine with reduced dose (2 days) or myeloabalative doses (4 days) of busulfan or with treosulfan. 6. Patients must sign written informed consent. 7. Adequate birth control in fertile patients. Exclusion Criteria: 1. Patients undergoing other type of transplantation or with other type of basic disease other than AML or MDS. 2. Patients with respiratory failure (DLCO < 30%). 3. Active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. 4. Psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate 5. Bilirubin > 3.0 mg/dl, transaminases > 3 times upper normal limit 6. Creatinine > 2.0 mg/dl 7. ECOG-Performance status > 2 8. Uncontrolled infection 9. Pregnancy or lactation 10. CNS disease involvement 11. Pleural effusion or ascites > 1 liter.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Cyclophosphamide
In the first phase escalated doses of post-transplant cyclophosphamide up to a maximal dose of 50 mg/kg , the second phase will use the MTD cyclophosphamide dose identified in the first phase.
anti-human T-lymphocyte immunoglobulin (ATLG)
15mg/kg total (5mg/kg day) on days -3 to -1 pre transplantation

Locations

Country Name City State
Israel Chaim Sheba Medical Center Ramat Gan

Sponsors (1)

Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overal survival Overall survival will be calculated from the day of SCT until death or last follow-up. OS will be determined using Kaplan-Meyer product limit method. 24 months
Primary Disease-free survival Disease-free survival will be calculated from the day of SCT until relapse, death of any cause, or last follow-up. DFS will be determined using Kaplan-Meyer product limit method. 24 months
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