Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation

Launched by UNIVERSITY OF CALIFORNIA, IRVINE · Aug 31, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new way to prepare patients for an allogeneic hematopoietic stem cell transplantation (AHSCT), which is a treatment for certain blood cancers like leukemia and lymphoma. The researchers want to see if using different doses of medications and total body radiation, based on each patient's risk and condition, can improve outcomes. The trial is currently looking for participants aged 18 to 70 who have been diagnosed with specific types of blood cancers and have a suitable stem cell donor.

To be eligible, participants need to have a good level of health and organ function, meaning they can carry out daily activities without significant limitation. They should not be pregnant or have certain infections or active diseases. If you join this trial, you will receive the AHSCT treatment and be monitored closely by the medical team to ensure your safety and the effectiveness of this new approach. This study is important because it aims to personalize treatment based on individual risk, which could lead to better results for patients facing these serious conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female aged 18-70 years
• • 2. Diagnosis of AML, ALL, MDS, CML, NHL, HD, CLL requiring AHSCT
• • 3. Has an HLA-matched related (MRD), HLA-matched unrelated (MUD), haploidentical (HAPLO) or 1-Ag mismatched unrelated donor (MMUD)
• • 4. Karnofsky performance \>70%
• 5. Adequate major organ system function as demonstrated by:
• • 1. Serum creatinine clearance equal or more than 50 ml/min (calculated with Cockroft-Gault formula).
• • 2. Bilirubin equal or less than 1.5 mg/dl except for Gilbert's disease. ALT or AST equal or less than 200 IU/ml for adults. Conjugated (direct) bilirubin less than 2x upper limit of normal.
• • 3. Left ventricular ejection fraction equal or greater than 40%.
• • 4. Diffusing capacity for carbon monoxide (DLCO) equal or greater than 50% predicted corrected for hemoglobin.
• • 6. Ability to understand and the willingness to sign a written informed consent. a. Both men and women and members of all races and ethnic groups are eligible for this trial. Non-English speaking, deaf, hard of hearing and illiterate individuals are eligible for this trial.
• Exclusion Criteria:
• • 1. Inability to comply with medical recommendations or follow-up
• • 2. Pregnancy
• • 3. Active/uncontrolled bacterial or viral infection (PI is the final arbiter of this criterion.)
• • 4. Has active CNS or ocular disease involvement within 3 months
• • 5. Patients with primary CNS lymphoma
• • 6. Patients who require modifications of the conditional regimen