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

NCT03339700 | Unknown Phase 2

• 1 other identifier: INCMNSZ REF 2235
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Lymphoblastic Leukemia, Adult

Outcome Measures

Primary Outcomes (1)

• Disease Free Survival

  Time between transplantation and relapse or last follow-up

  3 years

Secondary Outcomes (1)

• Overall Survival

  5 years

Study Arms (1)

Unique

EXPERIMENTAL

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; Drug: Busulfan; Drug: Cyclophosphamide; Procedure: Allogeneic Hematopoietic Stem Cell Transplantation

Interventions

Gemcitabine DRUG

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

Also known as: Gemzar

Unique

Busulfan DRUG

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

Also known as: Myleran

Unique

Cyclophosphamide DRUG

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

Also known as: Cytoxan

Unique

Allogeneic Hematopoietic Stem Cell Transplantation PROCEDURE

Bone Marrow HSC (allogeneic HSCT) transfusion, day 0

Also known as: Allogeneic Bone Marrow Transplantation

Unique

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

Study Sites (1)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, Mexico City, 14080, Mexico

RECRUITING

Related Publications (9)

• Nieto Y, Thall P, Valdez B, Andersson B, Popat U, Anderlini P, Shpall EJ, Bassett R, Alousi A, Hosing C, Kebriaei P, Qazilbash M, Frazier E, Gulbis A, Chancoco C, Bashir Q, Ciurea S, Khouri I, Parmar S, Shah N, Worth L, Rondon G, Champlin R, Jones RB. High-dose infusional gemcitabine combined with busulfan and melphalan with autologous stem-cell transplantation in patients with refractory lymphoid malignancies. Biol Blood Marrow Transplant. 2012 Nov;18(11):1677-86. doi: 10.1016/j.bbmt.2012.05.011. Epub 2012 May 27.

  PMID: 22643322 BACKGROUND

• Peters GJ, Ruiz van Haperen VW, Bergman AM, Veerman G, Smitskamp-Wilms E, van Moorsel CJ, Kuiper CM, Braakhuis BJ. Preclinical combination therapy with gemcitabine and mechanisms of resistance. Semin Oncol. 1996 Oct;23(5 Suppl 10):16-24.

  PMID: 8893877 BACKGROUND

• Wang E, Gulbis A, Hart JW, Nieto Y. The emerging role of gemcitabine in conditioning regimens for hematopoietic stem cell transplantation. Biol Blood Marrow Transplant. 2014 Sep;20(9):1382-9. doi: 10.1016/j.bbmt.2014.04.025. Epub 2014 May 9.

  PMID: 24816580 BACKGROUND

• Anderlini P, Saliba RM, Ledesma C, Chancoco C, Alousi AM, Shpall EJ, Popat UR, Hosing CM, Khouri IF, Nieto Y, Ciurea S, Younes A, Fanale MA, Acholonu S, Valverde R, Champlin RE. Gemcitabine, fludarabine and melphalan as a reduced-intensity conditioning regimen for allogeneic stem cell transplant in relapsed and refractory Hodgkin lymphoma: preliminary results. Leuk Lymphoma. 2012 Mar;53(3):499-502. doi: 10.3109/10428194.2011.615427. Epub 2011 Oct 24. No abstract available.

  PMID: 21859247 BACKGROUND

• Matsuda A, Sasaki T. Antitumor activity of sugar-modified cytosine nucleosides. Cancer Sci. 2004 Feb;95(2):105-11. doi: 10.1111/j.1349-7006.2004.tb03189.x.

  PMID: 14965358 BACKGROUND

• Spasokoukotskaja T, Arner ES, Brosjo O, Gunven P, Juliusson G, Liliemark J, Eriksson S. Expression of deoxycytidine kinase and phosphorylation of 2-chlorodeoxyadenosine in human normal and tumour cells and tissues. Eur J Cancer. 1995;31A(2):202-8. doi: 10.1016/0959-8049(94)00435-8.

  PMID: 7718326 BACKGROUND

• Braakhuis BJ, Ruiz van Haperen VW, Boven E, Veerman G, Peters GJ. Schedule-dependent antitumor effect of gemcitabine in in vivo model system. Semin Oncol. 1995 Aug;22(4 Suppl 11):42-6.

  PMID: 7481844 BACKGROUND

• Csoka K, Liliemark J, Larsson R, Nygren P. Evaluation of the cytotoxic activity of gemcitabine in primary cultures of tumor cells from patients with hematologic or solid tumors. Semin Oncol. 1995 Aug;22(4 Suppl 11):47-53.

  PMID: 7481845 BACKGROUND

• Plunkett W, Huang P, Searcy CE, Gandhi V. Gemcitabine: preclinical pharmacology and mechanisms of action. Semin Oncol. 1996 Oct;23(5 Suppl 10):3-15.

  PMID: 8893876 BACKGROUND

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Gemcitabine; Busulfan; Cyclophosphamide

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eucario Leon Rodriguez, M.D.

CONTACT

525554870900; eucarios@hotmail.com

Monica M Rivera Franco, M.D.,MSc

CONTACT

525554870900; monrif90d@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 13, 2017
• Study Start: September 15, 2018
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2021
• Last Updated: January 14, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)