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 : November 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia, Adult||Drug: Gemcitabine Drug: Busulfan Drug: Cyclophosphamide Procedure: Allogeneic Hematopoietic Stem Cell Transplantation||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Addition of Gemcitabine to the Standard Reduced BUCY2 Pre Allogeneic Hematopoietic Stem Cell Transplantation Conditioning for Acute Lymphoblastic Leukemia|
|Actual Study Start Date :||September 15, 2017|
|Estimated Primary Completion Date :||September 30, 2018|
|Estimated Study Completion Date :||December 30, 2018|
U.S. FDA Resources
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.
4800mg/m2, intravenous, divided 4 days, 1200mg/m2/day, during days -5 to -2
Other Name: GemzarDrug: Busulfan
12mg/kg, ORAL, divided in 4 days, 3mg/kg/day ORAL, during days -7 to -4.
Other Name: MyleranDrug: Cyclophosphamide
80mg/kg, Intravenous (IV), divided in 2 days, 40mg/kg/day IV, during days -3 and -2.
Other Name: CytoxanProcedure: Allogeneic Hematopoietic Stem Cell Transplantation
Bone Marrow HSC (allogeneic HSCT) transfusion, day 0
Other Name: Allogeneic Bone Marrow Transplantation
- Disease Free Survival [ Time Frame: 3 years ]Time between transplantation and relapse or last follow-up
- Overall Survival [ Time Frame: 5 years ]Time between transplantation and dead or last follow-up
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
|Contact: Eucario M Leon Rodriguez, M.D.||525554870900 ext email@example.com|
|Contact: Monica M Rivera Franco, M.D.||525554870900 ext firstname.lastname@example.org|
|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 email@example.com|
|Contact: Monica M Rivera Franco, M.D. 525554870900 ext 2719 firstname.lastname@example.org|