Anti T-lymphocyte Immunoglobulin With Post Transplant Cyclophosphamide to Prevent GVHD Post Allogeneic Transplantation

Launched by SHEBA MEDICAL CENTER · Nov 28, 2017

Keywords

ClinConnect Summary

This clinical trial is studying a combination of two treatments, Anti T-lymphocyte Immunoglobulin (ATLG) and Post Transplant Cyclophosphamide (PTCy), to help prevent a condition called Graft Versus Host Disease (GVHD) after patients receive a stem cell transplant. GVHD can occur when the new cells from a donor attack the patient's body, and this trial aims to see if the combination of these two treatments can lower the chances of getting GVHD. The hope is that this approach will also allow doctors to reduce the length of time patients need to take other immunosuppressive medications.

To be eligible for this trial, participants should be at least 18 years old and have a diagnosis of either Myelodysplastic Syndromes (MDS) or Acute Myeloid Leukemia (AML). They should be undergoing a specific type of stem cell transplant with a well-matched donor. Participants will need to sign a consent form and must meet certain health criteria, like having a good heart function. Those who join the study can expect close monitoring during and after their treatment, as the research team will be looking at how well this combination therapy works and its safety. If you're considering participation, it's important to discuss this with your doctor to see if you meet the criteria and if this trial aligns with your treatment goals.

Gender

ALL

Eligibility criteria

• 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.