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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2011 by National Cancer Institute (NCI)
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01085617
First received: March 11, 2010
Last updated: August 23, 2013
Last verified: June 2011
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial for Adults With Newly Diagnosed Acute Lymphoblastic Leukemia

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Event-free survival [ Designated as safety issue: No ]
  • Toxicity related to pegaspargase [ Designated as safety issue: Yes ]
  • Mucositis score in patients treated with palifermin [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Anti-asparaginase antibodies in patients treated with monoclonal antibody therapy [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Complete remission (CR) rate [ Designated as safety issue: No ]
  • Minimal-residual disease quantification after first phase of induction and post-transplantation [ Designated as safety issue: No ]
  • Relapse rate (including bone marrow and CNS relapse) [ Designated as safety issue: No ]
  • Death in CR [ Designated as safety issue: No ]

Estimated Enrollment: 720
Study Start Date: January 2010
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01085617

Locations
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
Investigators
Principal Investigator: Adele K. Fielding University College London (UCL) Cancer Institute
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01085617     History of Changes
Other Study ID Numbers: CDR0000667211, UCL-08-0167, EU-21009, EUDRACT-2009-012717-22, UCL-UKALL14, MREC-09-H0711-90, NCRI-UCL-08-0167, CRUK-C27995-A9609
Study First Received: March 11, 2010
Last Updated: August 23, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
oral complications
mucositis
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:
Leukemia
Leukemia, Lymphoid
Mucositis
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Mouth Diseases
Neoplasms
Neoplasms by Histologic Type
Stomatognathic Diseases
Cyclophosphamide
Daunorubicin
Fludarabine
Fludarabine phosphate
Imatinib
Methotrexate
Pegaspargase
Rituximab
Vincristine
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Alkylating Agents
Antibiotics, Antineoplastic
Antimetabolites
Antimetabolites, Antineoplastic

ClinicalTrials.gov processed this record on November 24, 2014