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

NCT03339700 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-01-14

No results posted yet for this study

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).

Conditions

  • Acute Lymphoblastic Leukemia, Adult

Interventions

DRUG

Gemcitabine

4800mg/m2, intravenous (IV), divided 4 days, 1200mg/m2/day, during days -5 to -2

DRUG

Busulfan

12mg/kg, Oral, divided in 4 days, 3mg/kg/day Oral, during days -7 to -4.

DRUG

Cyclophosphamide

80mg/kg, intravenous (IV), divided in 2 days, 40mg/kg/day IV, during days -3 and -2.

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Bone Marrow HSC (allogeneic HSCT) transfusion, day 0

Sponsors & Collaborators

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    lead OTHER

Principal Investigators

  • Eucario Leon Rodriguez, M.D. · Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  • Monica M Rivera Franco, M.D.,MSc · Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-15
Primary Completion
2020-09-30
Completion
2021-09-30

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03339700 on ClinicalTrials.gov