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

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ClinicalTrials.gov Identifier: NCT01085617
Recruitment Status : Unknown
Verified June 2011 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : March 12, 2010
Last Update Posted : August 26, 2013
Information provided by:
National Cancer Institute (NCI)

Brief 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.

Condition or disease Intervention/treatment Phase
Leukemia Mucositis Oral Complications 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 Procedure: assessment of therapy complications Radiation: total-body irradiation Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 720 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial for Adults With Newly Diagnosed Acute Lymphoblastic Leukemia
Study Start Date : January 2010
Estimated Primary Completion Date : January 2016

Primary Outcome Measures :
  1. Event-free survival
  2. Toxicity related to pegaspargase
  3. Mucositis score in patients treated with palifermin

Secondary Outcome Measures :
  1. Anti-asparaginase antibodies in patients treated with monoclonal antibody therapy
  2. Overall survival
  3. Complete remission (CR) rate
  4. Minimal-residual disease quantification after first phase of induction and post-transplantation
  5. Relapse rate (including bone marrow and CNS relapse)
  6. Death in CR

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Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Newly diagnosed, previously untreated acute lymphoblastic leukemia

    • A pre-phase steroid treatment of 5-7 days is required and can be started prior to registration
  • Philadelphia chromosome-negative or -positive patients are eligible
  • No blast transformation of chronic myeloid leukemia
  • No mature B-cell leukemia [i.e., Burkitt disease t(8,14)(q24 ;q32)] or variant c-myc translocations [e.g., t(2;8)(p12;q24), t(8;22)(q24;q11)]
  • Patients who undergo study transplantation must have HLA-compatible sibling or unrelated donor

    • 8/8 molecular match at -A, -B, -C, and -DR (DQ mismatch is permitted)
  • Patients meeting ≥ 1 the following criteria are considered high-risk:

    • Over 40 years old
    • WBC ≥ 30 x 10^9/L (precursor-B) OR ≥ 100 x 10^9/L (T-lineage)
    • Any 1 or more of the following cytogenetic abnormalities:

      • t(4;11)(q21;q23)/MLL-AF4
      • Low hypodiploidy/near triploidy (30-39 chromosomes/60-78 chromosomes)
      • Complex karyotype (≥ 5 chromosomal abnormalities)
      • Philadelphia chromosome t(9;22) (q34;q11)/BCR-ABL1 (detected by cytogenetic or molecular methods)
    • High-risk minimal-residual disease after completion of part 2 standard induction therapy


  • No known HIV infection
  • Not pregnant or nursing (no nursing during and for 12 months after completion of study therapy)
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for up to 12 months after completion of study therapy


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01085617

United Kingdom
UCL Cancer Institute Recruiting
London, England, United Kingdom, WC1E 6DD
Contact: Contact Person    44-207-830-2833      
Sponsors and Collaborators
University College London Hospitals
Principal Investigator: Adele K. Fielding University College London (UCL) Cancer Institute

ClinicalTrials.gov Identifier: NCT01085617     History of Changes
Other Study ID Numbers: CDR0000667211
First Posted: March 12, 2010    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: June 2011

Keywords provided by National Cancer Institute (NCI):
oral complications
untreated adult acute lymphoblastic leukemia
B-cell adult acute lymphoblastic leukemia
T-cell adult acute lymphoblastic leukemia
Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Fludarabine phosphate
Imatinib Mesylate
Immunosuppressive Agents
Immunologic Factors