CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 66 enrolled
Drug / intervention
Alemtuzumab +20 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01256398
NCT01256398Phase 2Completed

A Phase II Study of Dasatinib (Sprycel®) (NSC #732517) as Primary Therapy Followed by Transplantation for Adults >/= 18 Years With Newly Diagnosed Ph+ Acute Lymphoblastic Leukemia by CALGB, ECOG and SWOG

National Cancer Institute (NCI)·interventional·Posted Dec 8, 2010·Updated Apr 4, 2023

In Brief

A Phase 2 clinical trial evaluating Alemtuzumab, Allogeneic Hematopoietic Stem Cell Transplantation, and 19 other interventions for Acute Lymphoblastic Leukemia and Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1. Completed, enrolled 66 participants across 101 sites.

Detailed Summary

This phase II clinical trial studies how well dasatinib followed by stem cell transplant works in treating older patients with newly diagnosed acute lymphoblastic leukemia. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Monoclonal antibodies, such as alemtuzumab, may interfere with the ability of cancer cells to grow and spread. Giving more than one drug (combination chemotherapy) and giving dasatinib together with chemotherapy may kill more cancer cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 8, 2010
Enrollment StartDec 14, 2010
Primary CompletionNov 14, 2017
Study CompletionNov 15, 2021
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 15.6 years ago

Interventions

Alemtuzumabbiological

Given IV

Allogeneic Hematopoietic Stem Cell Transplantationprocedure

Undergo peripheral blood allogeneic HCT

Autologous Hematopoietic Stem Cell Transplantationprocedure

Undergo peripheral blood autologous HCT

Cyclophosphamidedrug

Given IV

Cytarabinedrug

Given IV

Dasatinibdrug

Given PO

Daunorubicin Hydrochloridedrug

Given IV

Dexamethasonedrug

Given PO or IV

Etoposide Phosphatedrug

Given IV

Filgrastimbiological

Given SC

Fludarabine Phosphatedrug

Given IV

In Vitro-Treated Peripheral Blood Stem Cell Transplantationprocedure

Undergo peripheral blood autologous or allogeneic HCT

Laboratory Biomarker Analysisother

Correlative studies

Leucovorin Calciumdrug

Given IV or PO

Melphalandrug

Given IV

Mercaptopurinedrug

Given PO

Methotrexatedrug

Given IT, IV, or PO

Pegfilgrastimbiological

Given SC

Pharmacological Studyother

Correlative studies

Tacrolimusdrug

Given IV or PO

Vincristine Sulfatedrug

Given IV