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

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ClinicalTrials.gov Identifier: NCT00853008
Recruitment Status : Completed
First Posted : February 27, 2009
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
PETHEMA Foundation

Tracking Information
First Submitted Date  ICMJE February 25, 2009
First Posted Date  ICMJE February 27, 2009
Last Update Posted Date April 7, 2020
Study Start Date  ICMJE January 2003
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of High Risk Adult Acute Lymphoblastic Leukemia
Official Title  ICMJE Treatment of High Risk Adult Acute Lymphoblastic Leukemia
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Lymphoblastic Leukemia
Intervention  ICMJE
  • 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
Study Arms  ICMJE Not Provided
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: February 26, 2009)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00853008
Other Study ID Numbers  ICMJE LAL-AR/2003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party PETHEMA Foundation
Study Sponsor  ICMJE PETHEMA Foundation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Ribera Josep Mª, Dr PETHEMA Foundation
PRS Account PETHEMA Foundation
Verification Date April 2020

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