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Completed

NCT Number: NCT00853008

Treatment of High Risk Adult Acute Lymphoblastic Leukemia

Current therapeutic protocols for adult ALL consider MRD together with the baseline risk factors (age, WBC count, immunophenotype, cytogenetics) and speed in response to therapy for treatment decisions. On the other hand, the systematic use of allogeneic SCT for all adult patients (pts) with Ph- HR-ALL is still a matter of debate. The aim of the prospective study ALL-AR-03 from the Spanish PETHEMA Group was to evaluate the response to a differentiated therapy (chemotherapy or allogeneic SCT) according to early bone marrow blast clearance and MRD levels (assessed by cytofluorometry at the end of induction and consolidation therapy) in HR Ph- adult ALL patients.

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Key information

Conditions

Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Juan Canalejo, A Coruña, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vincristine

Drug

Vincristine (VCR): 1.5 mg/m2 (max 2 mg) IV d 1, 8, 15, 22 in induction VCR 2 mg, IV, d 1,8 in consolidation (cycle 1, 2)

Daunorubicin

Drug

Daunorubicin (DNR): 60 mg/m2 IV d 1, 8, 15, 22

Prednisone

Drug

Prednisone (PDN): 60 mg/m2/d IV or PO, d 1-28

Mitoxantrone

Drug

Mitoxantrone:12 mg/m2, IV d 15-17 in induction 12 mg/m2, IV,d 5 in cycle 2 consolidation

Cytosine Arabinoside

Drug

ARA-C 2,000 mg/m2/12h IV, d18,19 (4 doses) in induction

Dexamethasone

Drug

Dexamethasone 20 mg/m2,IV, d 1-5,10 mg/m2,IV, d 6 and 5 mg/m2,IV, d 7 in Consolidation (3 cycles)

Methotrexate (MTX)

Drug

Methotrexate (MTX)3 g/m2,IV, d1 (24h)in consolidation, cycles 1 and 2 MTX (15 mg/m2/wk, IM)in maintenance MTX 15 mg, IT

Cytarabine

Drug

Cytarabine 2g/m2/12h, IV d5 in cycle 1 consolidation Cytarabine 2g/m2/12h, IV d 1,2 in cycle 3 consolidation Cytarabine 30 mg, intrathecal

ASP

Drug

ASP 25,000 IU/m2, IV, d5 in consolidation (cycle 1, 2, 3)

mercaptopurine

Drug

Mercaptopurine 100 mg/m2, PO, d 1-5 in consolidation

Teniposide

Drug

Teniposide 150 mg/m2, IV d 3,4 in consolidation cycle 3

Hydrocortisone

Drug

Hydrocortisone 20 mg, IT d 1, 28, 49, 77, 105, 175, 203, 231, 259,287, 311 intrathecal

Primary outcomes

  1. 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.

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

PETHEMA Foundation

Other

Registry information

Acronym: LAL-AR/2003

Important dates

Study start
2003
Primary completion
2012
Study completion
2012
First posted
Feb 27, 2009
Registry last updated
Apr 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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