Addition of Gemcitabine to Pre Allo-HSCT Conditioning for Acute Lymphoblastic Leukemia
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| ClinicalTrials.gov Identifier: NCT03339700 |
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Recruitment Status : Unknown
Verified January 2020 by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran.
Recruitment status was: Recruiting
First Posted : November 13, 2017
Last Update Posted : January 14, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Lymphoblastic Leukemia, Adult | Drug: Gemcitabine Drug: Busulfan Drug: Cyclophosphamide Procedure: Allogeneic Hematopoietic Stem Cell Transplantation | Phase 2 |
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.
| 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 |
|---|---|
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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.
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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 |
- 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
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| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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 Leon Rodriguez, M.D. | 525554870900 ext 2255 | eucarios@hotmail.com | |
| Contact: Monica M Rivera Franco, M.D.,MSc | 525554870900 ext 2719 | monrif90d@gmail.com |
| 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 | |
| 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 |
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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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 |