NCT01085617Completed
Standard Chemotherapy with or Without Nelarabine or Rituximab in Treating Patients with Newly Diagnosed Acute Lymphoblastic Leukemia
A Randomized Trial for Adults with Newly Diagnosed Acute Lymphoblastic Leukemia
Source: ClinicalTrials.gov · Last updated 30 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- First submitted
- 11 Mar 2010
- Start date
- Dec 2010
- Primary completion date
- 24 Feb 2025
- Lead sponsor
- University College, London
- Diseases
- Acute lymphoblastic leukaemia
- NCT number
- NCT01085617
- EudraCT number
- 2009-012717-22
What you commit to
- Study type: Interventional
- From Dec 2010 to the primary completion date, 24 Feb 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 25 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.