M-2018-334 in Hematological Malignancies

Launched by MILTENYI BIOMEDICINE GMBH · Jan 15, 2024

Keywords

ClinConnect Summary

This clinical trial, titled M-2018-334, is exploring a new treatment approach for adults with serious blood cancers, known as hematological malignancies. The study will involve using special stem cell grafts from partially matched donors (called haploidentical donors) to help patients who need a type of stem cell transplant but don’t have a fully matched donor available. The trial aims to enroll 12 to 18 participants aged between 18 and 75 years who are facing high-risk situations that require this transplant.

To take part in this trial, patients must meet certain criteria, such as needing the transplant and not having a matched donor. However, some individuals may not be eligible if they have specific health conditions, like serious heart or liver problems, active infections, or if they’ve recently had another type of transplant. Participants in the study can expect to receive the new treatment and will be carefully monitored throughout the process. It's important to note that this trial is not yet recruiting participants, so interested individuals will need to wait for it to begin.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients, between 18 years to 75 years of age, with high-risk hematological malignancy requiring an allogeneic hematopoietic stem cell transplantation (AlloHCT), but do not have an HLA-matched donor available
• Exclusion Criteria:
• • \<3 months after preceding autologous transplantation or prior AlloHCT
• • History of neurological impairment (active seizures, severe peripheral neuropathy, signs of leukoencephalopathy, active CNS infection)
• • Active fungal infections with radiological and clinical progression
• • Liver function abnormalities with bilirubin \>2 mg/dL and elevation of transaminases higher than 400 U/L
• • Chronic active viral hepatitis
• • Cardiac dysfunction: adult patients ejection fraction \<50% on echocardiography
• • Patients with uncontrolled, \>grade II hypertension (per Common Toxicity Criteria, CTC)
• • Creatinine clearance \<60 mL/min/1.73m2
• • Respiratory failure necessitating supplemental oxygen
• • HIV infection
• • Positive anti-donor HLA antibody
• • Treatment with checkpoint inhibitors in the period between 3 months prior to and 3 months after transplantation
• • Female patients who are pregnant or breast feeding, or adults of reproductive potential not willing to use an effective method of birth control during study treatment and for at least 12 months thereafter. Note: Women of childbearing potential must have a negative serum pregnancy test at study entry
• • Concurrent severe or uncontrolled medical disease (e.g., uncontrolled diabetes, myocardial infarction within 6 months prior to the study) which by assessment of the treating physician could compromise participation in the study
• • Patients with a history of psychiatric illness or a condition which could interfere with their ability to understand the requirements of the study (this includes alcoholism/drug addiction).
• • Patients unwilling or unable to comply with the protocol or unable to give informed consent
• • Treatment with any investigational product within 4 weeks prior to study treatment