Comparative Study of BFC and BuCy Conditioning Regimen for Allo-PBSCT in Acute B-cell ALL

Launched by SHANGHAI GENERAL HOSPITAL, SHANGHAI JIAO TONG UNIVERSITY SCHOOL OF MEDICINE · May 13, 2022

Keywords

ClinConnect Summary

This clinical trial is comparing two different treatment plans before a stem cell transplant for patients with acute B-cell lymphoblastic leukemia (B-ALL). The study aims to find out if a new treatment regimen, called BFC, which includes a combination of medications, is more effective and safer than the traditional BuCy regimen. Both treatments are designed to prepare patients for an allogeneic hematopoietic stem cell transplantation, which is a procedure that can help treat B-ALL by replacing the diseased bone marrow with healthy stem cells from a donor.

To participate in this trial, patients should be between the ages of 18 and 55 and have been diagnosed with acute B-ALL that is currently in remission. They should also have a suitable donor for the stem cell transplant. Participants can expect to receive the assigned treatment regimen and be closely monitored for their health and response to the therapy. This trial is important as it seeks to improve survival rates for adult patients with B-ALL by optimizing the treatment they receive before their transplant.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Ages 18-55.
• • 2. The patient was diagnosed as acute B-lymphoblastic leukemia, which was confirmed by bone marrow cell morphology, cytochemistry, immunotyping and chromosome examination, including acute chronic myelocytic leukemia, Ph-acute B-lymphoblastic leukemia, and acute B-lymphoblastic leukemia after CART treatment.
• • 3. The diagnostic criteria for b-blastic leukemia in remission were: complete hematologic response (CR) with negative minimal residual lesions (MRD) after regular induction of remission chemotherapy, or complete hematologic response with negative MRD after CART treatment.
• • 4. ECOG physical fitness status score ≤2.
• 5. All organs function normally and meet the following inspection standards:
• • A) Liver function ALT, AST and TBIL≤2 times the upper limit of normal value B) BUN and Cr of renal function ≤1.25 times the upper limit of normal value.
• • 6. Have the following cardiac function conditions: ecg examination did not indicate any acute myocardial infarction, arrhythmia or atrioventricular block of degree I or above; Centerless incomplete function; No active rheumatic heart disease; There was no indication of cardiac enlargement on chest radiograph or physical examination.
• • (7) The patient had a qualified allogeneic hematopoietic stem cell transplantation donor, including haploid, myeloma and sibling.
• • 8) The patient and its legal client have the desire and requirement for hematopoietic stem cell transplantation, and sign the informed consent, and are willing to and abide by the treatment plan, follow-up plan, laboratory examination, etc.
• • 9) The donor meets the donation requirements-
• Exclusion Criteria:
• • 1. There are any contraindications for allogeneic hematopoietic stem cell transplantation.
• • 2. Ph+ acute lymphoblastic leukemia
• • 3. Serious damage of important organ functions, such as respiratory failure, heart failure, decompensated liver insufficiency, renal insufficiency, etc.
• • 4. Pregnant or lactating women.
• • 5. Those who are undergoing clinical trials of other drugs.
• • 6. Patients suffering from other serious acute or chronic physical or mental diseases, or abnormal laboratory examination, which may affect the administration of study drugs and the researchers' judgment of the condition and interpretation of the test results, are not suitable to participate in the clinical trial.
• • 7. The donor does not fit the conditions of the donor.