Status:
UNKNOWN
Addition of Gemcitabine to Pre Allo-HSCT Conditioning for Acute Lymphoblastic Leukemia
Lead Sponsor:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Conditions:
Acute Lymphoblastic Leukemia, Adult
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief 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 tran...
Detailed Description
In the last decade, hematopoietic stem cell transplantation (HSCT) has become an efficient strategy for the treatment of high risk acute lymphoblastic leukemias. Lymphoid acute leukemias (ALL) are con...
Eligibility Criteria
Inclusion
- 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
- Patients not willing to participate or to sign the informed consent
- Patients who do not meet the inclusion criteria
Key Trial Info
Start Date :
September 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03339700
Start Date
September 15 2018
End Date
September 1 2021
Last Update
January 14 2020
Active Locations (1)
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1
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico City, Mexico, 14080