Comparing two conditioning regimens for treating acute B-cell leukemia

Shanghai General Hospital, Shanghai, Jiao Tong University School of Medicine

This study is testing if a new treatment plan using fludarabine can help younger adults with acute B-cell leukemia live longer and stay healthier after a stem cell transplant compared to a standard treatment plan.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 142 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine (Academic / other)
• Drugs / interventions: CART, chemotherapy, CAR T, cyclophosphamide, fludarabine
• Locations: 1 site (Shanghai)
• Trial ID: NCT05379569 on ClinicalTrials.gov

What this trial studies

This clinical trial compares the efficacy and safety of a fludarabine-containing conditioning regimen (BFC) against a traditional busulfan-cyclophosphamide regimen (BuCy) in patients with acute B-cell lymphoblastic leukemia undergoing allogeneic hematopoietic stem cell transplantation. A total of 142 eligible patients aged 18-55 are randomly assigned to either the experimental or control group, with follow-up extending up to one year post-transplantation. The primary goal is to evaluate whether the BFC regimen can improve disease-free survival and overall survival rates compared to the BuCy regimen.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-55 diagnosed with acute B-lymphoblastic leukemia in remission.

Not a fit: Patients outside the age range of 18-55 or those with significant organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved survival rates for patients with acute B-cell leukemia undergoing stem cell transplantation.

How similar studies have performed: While there have been studies on conditioning regimens for leukemia, this specific comparison of BFC versus BuCy is novel.

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.

Where this trial is running

Shanghai

• Shanghai General Hospital — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Xianmin Song, MD — Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Study coordinator: Yu Cai, MD

Conditions Acute B Lymphoblastic Leukemia; Allogeneic Hematopoietic Stem Cell Transplantation