Addition of Gemcitabine to Pre Allo-HSCT Conditioning for Acute Lymphoblastic Leukemia

• Status: Recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of the project is to evaluate the disease free survival and overall survival in patients diagnosed with acute lymphoblastic leukemia undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) adding gemcitabine to the standard institutional conditioning regimen based on two alkylating drugs, reduced busulfan and cyclophosphamide (reduced BUCY 2).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Treatments: Busulfan; Cyclophosphamide; Gemcitabine

Criteria

Inclusion Criteria:

• Diagnosis of acute lymphoblastic leukemia in 2nd complete remission or primary refractory disease, candidates to hematopoietic stem cell transplantation.

• Hemoglobin ≥ 10 g/dl, Absolute Neutrophil Count ≥ 1 x 103/mm3, and Platelets ≥ 100,000 /µL

• Eastern Cooperative Oncology Group status (ECOG) ≤2 oR Karnofsky ≥80%

• Signed Informed Consent

• Left ventricular ejection fraction (LVEF) >40%

• Normal liver function enzyme tests

• Preserved renal function

Exclusion Criteria:

• Patients not willing to participate or to sign the informed consent

• Patients who do not meet the inclusion criteria