Chemo Sensitization Before Hematopoietic Stem Cell Transplantation in Patients With Acute Leukemia in Complete Remission

• Status: Recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the disease free survival and the overall survival in patients with acute leukemia in first or second complete remission after administrating a CXCR4 antagonist, as a chemo sensitization strategy, plus chemotherapy as the conditioning regimen for autologous or allogeneic hematopoietic stem cell transplantation (HSCT).

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

Details

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

Criteria

Inclusion Criteria:

• Diagnosis of Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL), candidates to HSCT

• Allogeneic HSCT: High risk AML in first complete remission (CR), AML in second CR, and ALL in first or second CR with a matched or half-matched (haploidentical) related or unrelated donor

• Autologous HSCT: Intermediate risk AML in first CR, ALL in first or second CR without a donor

• Normal liver function enzyme tests

• Preserved renal function

• Eastern Cooperative Oncology Group score ≤2 or Karnofsky ≥80%

• Left ventricle ejection fraction (LVEF) >40%

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

• Signed Informed Consent

Exclusion Criteria:

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

• Patients who do not meet the inclusion criteria