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

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.
 
ClinicalTrials.gov Identifier: NCT03339700
Recruitment Status : Recruiting
First Posted : November 13, 2017
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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 transplantation (allo-HSCT) adding gemcitabine to the standard institutional conditioning regimen based on two alkylating drugs, reduced busulfan and cyclophosphamide (reduced BUCY 2).

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia, Adult Drug: Gemcitabine Drug: Busulfan Drug: Cyclophosphamide Procedure: Allogeneic Hematopoietic Stem Cell Transplantation Phase 2

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 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. The hypothesis is that adding gemcitabine to the standard institutional conditioning regimen (reduced BUCY 2) in patients with ALL undergoing an allo-HSCT, the relapse free survival as well as the overall survival will improve, 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Addition of Gemcitabine to the Standard Reduced Busulfan and Cyclophosphamide (BUCY2) Pre Allogeneic Hematopoietic Stem Cell Transplantation Conditioning for Acute Lymphoblastic Leukemia
Actual Study Start Date : September 15, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2021


Arm Intervention/treatment
Experimental: Unique
Patients will receive reduced Busulfan and Cyclophosphamide (BUCY 2) conditioning regimen, consisting in the administration of two medications: Busulfan and Cyclophosphamide Plus: Gemcitabine. Then patients will undergo an Allogeneic Hematopoietic Stem Cell Transplantation.
Drug: Gemcitabine
4800mg/m2, intravenous (IV), 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




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


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



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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 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

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

Locations
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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
Investigators
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Principal Investigator: Eucario Leon Rodriguez, M.D. Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Principal Investigator: Monica M Rivera Franco, M.D.,MSc Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Publications:

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Responsible Party: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT03339700    
Other Study ID Numbers: INCMNSZ REF 2235
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gemcitabine
Cyclophosphamide
Busulfan
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors