Overview

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

Status:
Recruiting
Trial end date:
2023-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University College London Hospitals
University College, London
Treatments:
6-Mercaptopurine
Cyclophosphamide
Cytarabine
Daunorubicin
Etoposide
Fludarabine
Fludarabine phosphate
Imatinib Mesylate
Melphalan
Mercaptopurine
Methotrexate
Pegaspargase
Rituximab
Vincristine
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