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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01310010
Other study ID # DASA-TRAS
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date April 2010
Est. completion date July 2016

Study information

Verified date March 2022
Source Grupo Espanol de trasplantes hematopoyeticos y terapia celular
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Study hypothesis: Treatment with dasatinib 100 mg QD is safe and efficacious when given to patients with Ph+ ALL in the post SCT setting.


Description:

Participants - inclusion criteria 1. Adult patients ≥ 18 years. 2. Diagnostic confirmation of de novo Ph+ ALL. 3. Patients in first/second CR (assessed by cytology, karyotyping and/or FISH) at transplantation. 4. Patients with sustained hematologic and cytogenetic CR at the time of study entry. 5. Any modality of allogeneic SCT. 6. Patients are in days between 120 until 180 after allogeneic SCT with stable graft. 7. Ability to understand and voluntarily sign the informed consent form. 8. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy and have a negative pregnancy test, a maximum of 48 hours prior to study drug start. Participants - exclusion criteria: 1. Patients with ECOG 3-4 at study entry 2. Any of the following laboratory abnormalities: - Absolute neutrophil count < 1.5 x 109/l or platelets < 75 x 109/l - Serum creatinine > 2.0 mg/dl (177 mmol/l). - Serum glutamic oxalacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) > 5,0 x upper limit of normal (ULN). - Total bilirubin > 3 mg/dl. 3. Known HIV infection or any other uncontrolled infection at study entry 4. Known pleural effusion of any grade at study entry. 5. Morphologic or cytogenetic or molecular relapse at study entry 6. Evidence of digestive dysfunction that could prevent administration of study therapy 7. Prior therapy with dasatinib during >21 days 8. Other concurrent malignancy at study entry 9. Uncontrolled or significant cardiovascular disease, including myocardial infarction within 6 months, uncontrolled angina within 3 months, prolonged QT interval, congestive heart failure within 3 months and clinically significant ventricular arrhythmias 10. Any psychiatric condition that could prevent patient from signing the informed consent o could put the patient at an unacceptable risk in case of participating in the trial 11. Subjects enrolled in another clinical trial at study entry. If patients have received other investigational agent, a minimum of 30 days wash-out period must have elapsed. Primary Outcome measures The primary objective of this study is to assess the efficacy of dasatinib maintenance in terms of Disease Free Survival at 2 years in patients with Ph+ ALL who receive maintenance with dasatinib after allogeneic SCT. Secondary Outcome measures .To assess the efficacy of maintenance with dasatinib in terms of duration of hematologic, cytogenetic and molecular remission, Relapse rate at 2 years, survival at 2 years, overall DFS, and Overall Survival (OS). ·To assess the safety and tolerability of dasatinib maintenance regimen after allogeneic SCT Regarding the secondary objective "To assess the safety and tolerability of dasatinib maintenance regimen after allogeneic SCT", such safety analysis includes the frequency of all adverse events and laboratory abnormalities as well as frequency of dose interruptions, dose reductions and treatment discontinuation for drug-related toxicity. Frequency tables will be reported using the "All treated subjects" dataset. Safety will be reported for all treated patients and assessed by baseline findings, AEs and SAEs (definition, pattern, seriousness and intensity according to NCI CTCAE v3.0, relationship with dasatinib and outcome). Hematologic toxicity will be analyzed separately.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date July 2016
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Adult patients = 18 years 2. Diagnostic confirmation of de novo Ph+ ALL 3. Patients in first/second CR (assessed by cytology, karyotyping and/or FISH) at transplantation 4. Patients with sustained hematologic and cytogenetic CR at the time of study entry 5. Any modality of allogeneic SCT 6. Patients are in days between 120 until 180 after allogeneic SCT with stable graft. 7. Ability to understand and voluntarily sign the informed consent form 8. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy and have a negative pregnancy test, a maximum of 48 hours prior to study drug start Exclusion Criteria: 1. Patients with ECOG 3-4 at study entry 2. Any of the following laboratory abnormalities: - Absolute neutrophil count < 1.5 x 109/l or platelets < 75 x 109/l - Serum creatinine > 2.0 mg/dl (177 mmol/l). - Serum glutamic oxalacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) > 5,0 x upper limit of normal (ULN). - Total bilirubin > 3 mg/dl. 3. Known HIV infection or any other uncontrolled infection at study entry 4. Known pleural effusion of any grade at study entry. 5. Morphologic or cytogenetic or molecular relapse at study entry 6. Evidence of digestive dysfunction that could prevent administration of study therapy 7. Prior therapy with dasatinib during >21 days 8. Other concurrent malignancy at study entry 9. Uncontrolled or significant cardiovascular disease, including myocardial infarction within 6 months, uncontrolled angina within 3 months, prolonged QT interval, congestive heart failure within 3 months and clinically significant ventricular arrhythmias 10. Any psychiatric condition that could prevent patient from signing the informed consent o could put the patient at an unacceptable risk in case of participating in the trial 11. Subjects enrolled in another clinical trial at study entry. If patients have received other investigational agent, a minimum of 30 days wash-out period must have elapsed.

Study Design


Related Conditions & MeSH terms

  • Leukemia
  • Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
dasatinib
Treatment with 100 mg QD of dasatinib (Sprycel®) administered orally as continuous daily dosing (CDD).

Locations

Country Name City State
Spain Hospital La Fe Valencia

Sponsors (1)

Lead Sponsor Collaborator
Grupo Espanol de trasplantes hematopoyeticos y terapia celular

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary The efficacy of dasatinib The primary objective of this study is to assess the efficacy of dasatinib maintenance in terms of Disease Free Survival at 2 years in patients with Ph+ ALL who receive maintenance with dasatinib after allogeneic SCT. at 2 years
Secondary To assess the efficacy of maintenance with dasatinib in terms of duration of hematologic, cytogenetic and molecular remission To assess the efficacy of maintenance with dasatinib in terms of duration of hematologic, cytogenetic and molecular remission, Relapse rate at 2 years, survival at 2 years, overall DFS, and Overall Survival (OS). at 2 years
Secondary To assess the safety and tolerability of dasatinib maintenance regimen after allogeneic SCT To assess the safety and tolerability of dasatinib maintenance regimen after allogeneic SCT at 2 years
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Completed NCT00103701 - BMS-354825 in Patients With Chronic Accelerated, or Blast Phase Chronic Myelogenous Leukemia or Philadelphia Positive Acute Lymphoblastic Leukemia Phase 1
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Terminated NCT00464113 - Study of XL228 in Subjects With Chronic Myeloid Leukemia or Philadelphia-Chromosome-Positive Acute Lymphocytic Leukemia Phase 1
Completed NCT00123487 - Advanced Chronic Myelogenous Leukemia (CML) - Follow On: Study of BMS-354825 in Subjects With CML Phase 3
Terminated NCT00907517 - Study of SCH 900776 (MK-8776) With and Without Cytarabine in Participants With Acute Leukemias (P05247) Phase 1
Terminated NCT01761682 - Acute Lymphoblastic Leukemia Registry at Asan Medical Center
Completed NCT00101595 - Dasatinib (BMS-354825) in Subjects With Lymphoid Blast Phase Chronic Myeloid Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Phase 2