Standard Chemotherapy with or Without Nelarabine or Rituximab in Treating Patients with Newly Diagnosed Acute Lymphoblastic Leukemia

Summary

RATIONALE: 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. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known which regimen of combination chemotherapy given together with or without monoclonal antibodies is more effective in treating patients with newly diagnosed acute lymphoblastic leukemia.

PURPOSE: This randomized phase III trial is studying standard chemotherapy to see how well it works when given together with or without rituximab, and with or without nelarabine in treating patients with newly diagnosed acute lymphoblastic leukemia.

Conditions

• Leukemia
• Mucositis
• Oral Complications

Interventions

BIOLOGICAL

palifermin

BIOLOGICAL

rituximab

DRUG

cyclophosphamide

DRUG

cytarabine

DRUG

daunorubicin hydrochloride

DRUG

etoposide

DRUG

fludarabine phosphate

DRUG

imatinib mesylate

DRUG

melphalan

DRUG

mercaptopurine

DRUG

methotrexate

DRUG

nelarabine

DRUG

pegaspargase

DRUG

vincristine sulfate

PROCEDURE

allogeneic hematopoietic stem cell transplantation

RADIATION

total-body irradiation

Sponsors & Collaborators

• University College, London

  lead OTHER

Principal Investigators

• Adele K. Fielding · University of York

Eligibility

Min Age

25 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-12-31

Primary Completion

2025-02-24

Completion

2025-02-24