Anti T-lymphocyte Immunoglobulin With Post Transplant Cyclophosphamide to Prevent GVHD Post Allogeneic Transplantation
NCT ID: NCT03357159
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2018-09-06
2024-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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cyclophosphamide and ATLG
The study will include 2 phases. In the first phase escalated doses of post-transplant cyclophosphamide up to a maximal dose of 50 mg/kg administered on day +3 and +4 (target dose) will be added to a standard GVHD prophylaxis consisting of anti-human T-lymphocyte immunoglobulin (ATLG, Grafalon®, formerly ATG-Fresenius S, Neovii Pharmaceuticals) 15mg/kg total (5mg/kg day) on days -3 to -1 pre transplantation in order to find the maximally tolerated dose (MTD) of post-transplant cyclophosphamide (PTCy) in combination with pre-transplant immunosuppression by ATLG. The second phase will use the MTD cyclophosphamide dose identified in the first phase.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Sheba Medical Center
OTHER_GOV
Responsible Party
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Prof Arnon Nagler
M.D., M.Sc, Professor of Medicine Tel Aviv University, Director Hematology Division, Chair Israeli BMT Association,Chair of the ALWP of the EBMT, Co-Chair Scientific Council of the EBMT Chaim Sheba Medical Center
Principal Investigators
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Arnon Nagler, MD
Role: PRINCIPAL_INVESTIGATOR
Sheba Medical Center
Locations
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Chaim Sheba Medical Center
Ramat Gan, , Israel
Countries
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Central Contacts
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Facility Contacts
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Arnon Nagler, M.D.
Role: primary
M.D.
Role: backup
Other Identifiers
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SHEBA-17-4055-AN-CTIL
Identifier Type: -
Identifier Source: org_study_id