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

Sponsor
University College, London
Study ID
NCT01085617
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
25 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • palifermin — BIOLOGICAL
  • rituximab — BIOLOGICAL
  • 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 — DRUG
  • allogeneic hematopoietic stem cell transplantation — PROCEDURE
  • total-body irradiation — RADIATION

Study Details

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.

Key Dates

Start date
Dec 31, 2010
Status verified
Mar 2025
Primary completion
Feb 24, 2025
Completion
Feb 24, 2025

Arms

  • Active Comparator: B1 - Standard therapy
    Standard chemotherapy for precursor B-cell ALL
  • Experimental: B2 - Rituximab
    Standard chemotherapy for precursor B-cell ALL plus weekly rituximab infusions during phase 1 induction
  • Active Comparator: T1 - Standard therapy
    Standard chemotherapy for T-cell ALL
  • Experimental: T2 - Nelarabine
    Standard chemotherapy for T-cell ALL plus an additional course of treatment with nelarabine following phase 2 induction
  • Active Comparator: P1 - standard palifermin
    6 doses of palifermin before/after myeloablative stem cell transplant (randomisation closed due to lack of clinical relevance in 2016)
  • Experimental: P2 - collapsed palifermin
    1 x large dose of palifermin before myeloablative stem cell transplant and 3 low doses after transplant (randomisation closed due to lack of clinical relevance in 2016)

Primary Outcome Measure

Event-free survival [ Time Frame: 3 years ]

Related Studies