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

This study is currently recruiting participants.
Verified November 2017 by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor:
ClinicalTrials.gov Identifier:
NCT03339700
First Posted: November 10, 2017
Last Update Posted: November 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  Purpose
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 our standard conditioning regimen based on two alkylating drugs (reduced BUCY 2).

Condition Intervention Phase
Acute Lymphoblastic Leukemia, Adult Drug: Gemcitabine Drug: Busulfan Drug: Cyclophosphamide Procedure: Allogeneic Hematopoietic Stem Cell Transplantation Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Addition of Gemcitabine to the Standard Reduced BUCY2 Pre Allogeneic Hematopoietic Stem Cell Transplantation Conditioning for Acute Lymphoblastic Leukemia

Resource links provided by NLM:


Further study details as provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:

Primary Outcome Measures:
  • Disease Free Survival [ Time Frame: 3 years ]
    Time between transplantation and relapse or last follow-up


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 5 years ]
    Time between transplantation and dead or last follow-up


Estimated Enrollment: 15
Actual Study Start Date: September 15, 2017
Estimated Study Completion Date: December 30, 2018
Estimated Primary Completion Date: September 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Unique
Patients will receive reduced BUCY 2 conditioning regimen, consisting in the administration of two medications: Busulfan and Cyclophosphamide Plus: Gemcitabine. Then they will undergo an Allogeneic Hematopoietic Stem Cell Transplantation.
Drug: Gemcitabine
4800mg/m2, intravenous, divided 4 days, 1200mg/m2/day, during days -5 to -2
Other Name: Gemzar
Drug: Busulfan
12mg/kg, ORAL, divided in 4 days, 3mg/kg/day ORAL, during days -7 to -4.
Other Name: Myleran
Drug: Cyclophosphamide
80mg/kg, Intravenous (IV), divided in 2 days, 40mg/kg/day IV, during days -3 and -2.
Other Name: Cytoxan
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Bone Marrow HSC (allogeneic HSCT) transfusion, day 0
Other Name: Allogeneic Bone Marrow Transplantation

Detailed Description:

In the last decade, HSCT has become an efficient strategy for the treatment of high risk acute lymphoblastic leukemias. Lymphoid acute leukemias (ALL) are considered malignant clonal diseases of the hematopoietic stem cells, and represent a therapeutic challenge due to the high relapse rate and mortality using conventional chemotherapy regimens. Many studies have shown a decrease in relapse and an increase in overall survival with allogeneic HSCT, however, despite the fact that results in ALL have improved in the past years, achieving complete remission (CR) in approximately 75% of the patients, the relapse rate remains high and long term survival is lower than 50% depending on age and disease characteristics. On the other hand, it has been stated that relapse is higher when an allo-HSCT is performed in second CR, obtaining poorer results compared to performing HSCT in first CR, although better than chemotherapy alone (87% probability of relapse).

It is necessary to implement strategies that increase efficiency of pre transplant conditioning regimens in patients diagnosed with ALL undergoing an allo-HSCT in order to reduce relapse and increase overall survival. Our hypothesis is that adding gemcitabine to our standard reduced BUCY 2 conditioning regimen in patients with ALL undergoing an allo-HSCT will have an improved relapse free survival as well as better overall survival, because it has been demonstrated in other malignant hematological diseases that gemcitabine plus two alkylating agents, facilitates synergism with busulfan and melphalan, inhibiting the DNA damage repair and causing a higher cytotoxic effect.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of ALL in 1st or 2nd complete remission, candidates to HSCT
  • Hb ≥ 10 g/dl, Absolute Neutrophil Count ≥ 1 x 103/mm3, and Platelets ≥ 100,000 /µL
  • ECOG ≤2 oR Karnofsky ≥80%
  • Signed Informed Consent
  • FEVI >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
  • ALL in 3rd complete remission
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03339700


Contacts
Contact: Eucario M Leon Rodriguez, M.D. 525554870900 ext 2255 eucarios@hotmail.com
Contact: Monica M Rivera Franco, M.D. 525554870900 ext 2719 monrif90d@gmail.com

Locations
Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Recruiting
Mexico City, Distrito Federal, Mexico, 14080
Contact: Eucario Leon Rodriguez, M.D.    525554870900 ext 2255    eucarios@hotmail.com   
Contact: Monica M Rivera Franco, M.D.    525554870900 ext 2719    monrif90d@gmail.com   
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  More Information

Publications:

Responsible Party: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT03339700     History of Changes
Other Study ID Numbers: INCMNSZ REF 2235
First Submitted: November 8, 2017
First Posted: November 10, 2017
Last Update Posted: November 10, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gemcitabine
Cyclophosphamide
Busulfan
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists