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Treatment of High Risk Adult Acute Lymphoblastic Leukemia (LAL-AR/2003)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT00853008
First received: February 25, 2009
Last updated: May 16, 2016
Last verified: May 2016
History of Changes

February 25, 2009
May 16, 2016
January 2003
December 2016   (final data collection date for primary 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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00853008 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Treatment of High Risk Adult Acute Lymphoblastic Leukemia
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.
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.
Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Lymphoblastic Leukemia
  • Drug: Vincristine
    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)
  • Drug: Daunorubicin
    Daunorubicin (DNR): 60 mg/m2 IV d 1, 8, 15, 22
  • Drug: Prednisone
    Prednisone (PDN): 60 mg/m2/d IV or PO, d 1-28
  • Drug: Mitoxantrone
    Mitoxantrone:12 mg/m2, IV d 15-17 in induction 12 mg/m2, IV,d 5 in cycle 2 consolidation
  • Drug: Cytosine Arabinoside
    ARA-C 2,000 mg/m2/12h IV, d18,19 (4 doses) in induction
  • Drug: Dexamethasone
    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)
  • Drug: Methotrexate (MTX)
    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
  • Drug: Cytarabine
    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
  • Drug: ASP
    ASP 25,000 IU/m2, IV, d5 in consolidation (cycle 1, 2, 3)
  • Drug: Mercaptopurine
    Mercaptopurine 100 mg/m2, PO, d 1-5 in consolidation
  • Drug: Teniposide
    Teniposide 150 mg/m2, IV d 3,4 in consolidation cycle 3
  • Drug: Hydrocortisone
    Hydrocortisone 20 mg, IT d 1, 28, 49, 77, 105, 175, 203, 231, 259,287, 311 intrathecal
Not Provided
Ribera JM, Oriol A, Morgades M, Montesinos P, Sarrà J, González-Campos J, Brunet S, Tormo M, Fernández-Abellán P, Guàrdia R, Bernal MT, Esteve J, Barba P, Moreno MJ, Bermúdez A, Cladera A, Escoda L, García-Boyero R, Del Potro E, Bergua J, Amigo ML, Grande C, Rabuñal MJ, Hernández-Rivas JM, Feliu E. Treatment of high-risk Philadelphia chromosome-negative acute lymphoblastic leukemia in adolescents and adults according to early cytologic response and minimal residual disease after consolidation assessed by flow cytometry: final results of the PETHEMA ALL-AR-03 trial. J Clin Oncol. 2014 May 20;32(15):1595-604. doi: 10.1200/JCO.2013.52.2425. Epub 2014 Apr 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
January 2017
December 2016   (final data collection date for primary outcome measure)

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.
Both
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00853008
LAL-AR/2003
Yes
Not Provided
Not Provided
PETHEMA Foundation
PETHEMA Foundation
Not Provided
Study Chair: Ribera Josep Mª, Dr PETHEMA Foundation
PETHEMA Foundation
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP