Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia

Summary

This phase II trial is studying the side effects of giving combination chemotherapy together with or without donor stem cell transplant and to see how well it works in treating patients with acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect).

Conditions

• Acute Lymphoblastic Leukemia
• Adult B Acute Lymphoblastic Leukemia
• Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
• Adult L1 Acute Lymphoblastic Leukemia
• Adult L2 Acute Lymphoblastic Leukemia
• Adult T Acute Lymphoblastic Leukemia
• Recurrent Adult Acute Lymphoblastic Leukemia

Interventions

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo allogeneic stem cell transplant

DRUG

Cyclophosphamide

Given IV

DRUG

Cytarabine

Given IT

DRUG

Dasatinib

Given PO

DRUG

Dexamethasone

Given IV or PO

DRUG

Doxorubicin Hydrochloride

Given IV

DRUG

Etoposide

Given IV

BIOLOGICAL

Filgrastim

Given SC

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Leucovorin Calcium

Given IV

DRUG

Methotrexate

Given IV or IT

DRUG

Methylprednisolone

Given IV

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Undergo allogeneic stem cell transplant

DRUG

Prednisone

Given PO

DRUG

Sirolimus

Given PO

DRUG

Tacrolimus

Given IV

RADIATION

Total-Body Irradiation

Undergo TBI

DRUG

Vincristine Sulfate

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Farhad Ravandi-Kashani · SWOG Cancer Research Network

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-09-01

Primary Completion

2016-06-01

Completion

2027-01-06

Countries

• United States

Study Locations