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Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

NCT01256398 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2023-04-04

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Alemtuzumab

Given IV

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo peripheral blood allogeneic HCT

PROCEDURE

Autologous Hematopoietic Stem Cell Transplantation

Undergo peripheral blood autologous HCT

DRUG

Cyclophosphamide

Given IV

DRUG

Cytarabine

Given IV

DRUG

Dasatinib

Given PO

DRUG

Daunorubicin Hydrochloride

Given IV

DRUG

Dexamethasone

Given PO or IV

DRUG

Etoposide Phosphate

Given IV

BIOLOGICAL

Filgrastim

Given SC

DRUG

Fludarabine Phosphate

Given IV

PROCEDURE

In Vitro-Treated Peripheral Blood Stem Cell Transplantation

Undergo peripheral blood autologous or allogeneic HCT

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Leucovorin Calcium

Given IV or PO

DRUG

Melphalan

Given IV

DRUG

Mercaptopurine

Given PO

DRUG

Methotrexate

Given IT, IV, or PO

BIOLOGICAL

Pegfilgrastim

Given SC

OTHER

Pharmacological Study

Correlative studies

DRUG

Tacrolimus

Given IV or PO

DRUG

Vincristine Sulfate

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Matthew J Wieduwilt · Alliance for Clinical Trials in Oncology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-14
Primary Completion
2017-11-14
Completion
2021-11-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01256398 on ClinicalTrials.gov