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Treatment of High Risk Adult Acute Lymphoblastic Leukemia

Phase 4
16 Years
Open (Enrolling)
Acute Lymphoblastic Leukemia

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Trial Information

Treatment of High Risk Adult Acute Lymphoblastic Leukemia

HR ALL included one or more of the following baseline parameters: age 30-60 yr, WBC count
>25x109/L and 11q23 or MLL rearrangements. Induction therapy included vincristine,
prednisone and daunorubicin for 4 weeks. In pts with slow cytologic response to therapy
(≥10% blasts in bone marrow assessed on d14) intensified induction with high dose ARA-C and
mitoxantrone was administered. Early consolidation therapy included 3 cycles with rotating
cytotoxic drugs including high-dose methotrexate, high-dose ARA-C and high-dose
asparaginase. Pts. with slow cytologic response on d14 or MRD level >0.05% after
consolidation were assigned to allogeneic SCT (related or unrelated) and those with standard
cytologic response on d14 and MRD level <0.05% after consolidation received 3 additional
cycles of delayed consolidation (identical to those of early consolidation) followed by
maintenance therapy up to 2yr in CR.

Inclusion Criteria:

- High risk ALL adult patients (age> 15 years)no treated previously

- High-risk ALL:

- One or more of the following:

- Age 30-60 yr.

- WBC count >25x109/L

- 11q23 or ALL1/AF4

- Very high-risk ALL:

- HR ALL and one or the following:

- Slow cytologic response (>10% blasts in BM on d14 of induction therapy).

- MRD>0.05% (by flow cytometry) at the end of consolidation

Exclusion Criteria:

- L3 ALL or B mature(sIg +) or t(8;14), t(2;8), t(8;22).

- ALL Ph (BCR/ABL) positive.

- Bifenotipics ALL as EGIL criteria.

- Indifferentiated ALL.

- Patients with cardiac pathology

- Patients with chronic liver disease in activity fase

- Pulmonary disease

- Renal insufficiency not due to ALL

- Neurological disorders not due to ALL

- PS (grades 3 and 4) not due to ALL.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the response to a differentiated therapy (chemotherapy or allogeneic SCT) according to early bone marrow blast clearance and MRD levels in HR Ph- adult ALL patients.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Ribera Josep Mª, Dr

Investigator Role:

Study Chair

Investigator Affiliation:

PETHEMA Foundation


Spain: Ministry of Health

Study ID:




Start Date:

January 2003

Completion Date:

January 2014

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • Acute Lymphoblastic Leukemia
  • High-Risk (HR)
  • Philadelphia Chromosome-Negative
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma