PETHEMA LAL-RI/96: Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia

This study has been completed.
Sponsor:
Information provided by:
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT00494897
First received: June 29, 2007
Last updated: May 15, 2009
Last verified: May 2009
  Purpose

The objective of current protocol is try improve the results of chemotherapy treatment in patients with ALL wich is not indicated the peripheral stem cell transplant in first remission, with an intensive consolidation follow by re-inductions.


Condition Intervention Phase
Acute Lymphoblastic Leukemia
Drug: Asparaginase
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Daunorubicin
Drug: Mercaptopurine
Drug: Prednisone
Drug: Vincristine
Drug: Methotrexate
Procedure: Intrathecally treatment
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PETHEMA LAL-RI/96: Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia

Resource links provided by NLM:


Further study details as provided by PETHEMA Foundation:

Primary Outcome Measures:
  • Efficacy of treatment in adults with standard risk acute lymphoblastic leukemia [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Demonstrate that in this group of patients, the CNS relapse is not frequently and is not necessary cranial radiotherapy [ Time Frame: 2 years ]
  • To evaluate the treatment tolerance [ Time Frame: 1 year ]

Enrollment: 374
Study Start Date: June 1996
Study Completion Date: December 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Detailed Description:

Induction therapy:

Patients with standard risk receive vincristine (1,5 mg/m2)IV on days 1, 8, 15 and 22;daunorubicin (30 mg/m2)IV on days 1, 8, 15 and 22; oral or IV prednisone 60 mg/m2/day, days 1 to 27 and 30 mg/m2/day, days 28 to 35;asparaginase 10.000 UI/m2 IM or IV, days 10 to 12, 17 to 19 and 24 to 26;cyclophosphamide (500 mg/m2)IV days 1, 2 and 29; methotrexate, cytosine arabinoside and hydrocortisone, days 1 to 22.

Patients older than 55 years are not treated with asparaginase and cyclophosphamide.

Consolidation therapy (1):

Standard risk: Mercaptopurine 50 mg/m2, PO, days 1 to 7, 28-35 and 56-63; methotrexate (3g/m2)IV/24 hours, day 1, 28 and 56; VM-26 (150 mg/m2)/12 hours, IV, days 14 and 42; ARA-C (500 mg/m2)/12 hours, IV days 14-15 and 42-43; intrathecally treatment, days 1, 28 and 56.

Patients over 50 years: Mercaptopurine (50 mg/m2), PO, days 1 to 7, 28-35 and 56-63;methotrexate (1,5 g/m2) IV/24 hours, day 1, 28 and 56; VM-26 (150 mg/m2)/12 hours, IV days 14 and 42; ARA-C (500 mg/m2)/12 hours, IV days 14-15 and 42-43; intrathecally treatment, days 1, 28 and 56.

Consolidation therapy (2)/Reinduction: one cycle similar to induction. It starts one week after last dose of mercaptopurine.Dexamethasone 10 mg/m2/day,PO or IV, days 1-14 and 5 mg/m2/day, PO or IV days 15-21; VCR: 1,5 mg/m2 IV, days 1, 8 and 15; Daunorubicin 30 mg/m2 IV, days 1, 2, 8 and 9; cyclophosphamide 600 mg/m2/day IV, days 1 and 15; Asparaginase: 10.000 UI/m2 IM or IV, days 1-3 and 15-17;intrathecally treatment days 1 and 15

Maintenance therapy 1:administration of continuous chemotherapy (mercaptopurine and methotrexate) and reinductions until one year from diagnosis.

  • Continuous chemotherapy:

    • MP 50 mg/m2/day PO
    • MTX 20 mg/m2/week IM
  • Reinductions

    • VCR: 1,5 mg/m2 IV, day 1.
    • PDN: 60 mg/m2/day, IV or PO days 1 to 7
    • L-ASA: 20.000 UI/m2, IM or IV day 1.
    • Intrathecally day 1

Seven cycles, weeks 25, 29, 33, 37, 41, 45 and 49.

Maintenance therapy 2:administration of continuous chemotherapy (mercaptopurine and methotrexate) while second year from diagnosis (weeks 53 to 104).

  • MP 50 mg/m2/day, PO
  • MTX 20 mg/m2/week, IM.
  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults (over 15 years) with ALL standard risk no prior antiblastic chemotherapy

Exclusion Criteria:

  • Mature B-ALL (FABL3) or with cytogenetic ALL "Burkitt-like" alterations (t[8;14], t[2;8], t[8;22])
  • Mixed forms of ALL
  • Acute Leukemia no differentiate
  • Patients with coronary disorders, valvular or hypertensive cardiopathy
  • Patients with chronic liver disorders
  • Chronic pulmonary disorders
  • Renal insufficiency
  • Neurologic disfunctions
  • ECOG 3 and 4
  • No signed consent form
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00494897

  Show 87 Study Locations
Sponsors and Collaborators
PETHEMA Foundation
Investigators
Study Director: Ribera Josep Mª, Dr HOSPITAL GERMANS TRIAS I PUJOL
  More Information

Additional Information:
Publications:
Tomonaga M, Omine M, Morishima Y, Hirano M, Dogi H, Imai K, et al. . Individualized induction therapy followed by intensive consolidation and maintenance including asparaginase in adult ALL: JALSG-ALL87 study. Haematologica 1991; 76 (suppl 4): 68
Smedyr B, Simonsson B, Björkholm M, Carneskog J, Gahrton G, Grimfors G, et al. Treatment of adult acute lymphoblastic and undifferentiated (ALL/AUL) leukemia according to a national protocol in Sweden. Haematologica 1991; 76 (suppl 4): 107.
Dekker AW, van't Veer MB, Haak HL, van der Lelie J, Ossenkoppele G, Schouten HC, et al. Conventional induction remission followed by intensive consolidation without maintenance therapy in adult acute lymphoblastic leukemia. Results from a phase II in 130 patients. Blood 1994; 84 (suppl 1) 144a.
JM Ribera, JJ Ortega, A Oriol, M Fontanillas, J Maldonado, R Parody, C Rivas, JM Hernández-Rivas, MJ Terol, P Bastida, ME González-Valentín, E Feliu, J García-Conde, J Díaz-Mediavilla, JF san Miguel. Treatment of high-risk acute lymphoblastic leukemia (HRALL). Preliminary results of the protocol PETHEMA ALL-93. Acute Leukemias VII. Experimental Approaches and Novel Therapies. Ann Hematol 1997; 74 (suppl1): A41.
Ortega JJ, Olivé T, Diaz de Heredia C, et al. Allogeneic and autologous bone amrrow transplant in acute lymphoblastic leukaemia. Bone Marrow Transplant 1996; 17 (supl 1): 76
Barrett AJ. Bone marrow transplantation for acute lymphoblastic leukaemia. Bailliere's Clin Haematol 1994; 7: 377-402.
Metha J, Powles R, Horton C, Milan S, Trelaven J, Tait D, et al. Bone marrow transplantation for primary refractory acute lymphoblastic leukemia. Bone Marrow Transpl 1994; 14: 415-418.
Dicke KA, Hoelzer D, Gorin N, Löwenberg B, Gale RP. The role of bone marrow trnsplantation in adult acute lymphoblastic leukemia. Ann Oncol 1993; 4: 881-890.

Responsible Party: Pethema, pethema
ClinicalTrials.gov Identifier: NCT00494897     History of Changes
Other Study ID Numbers: LAL-RI/96
Study First Received: June 29, 2007
Last Updated: May 15, 2009
Health Authority: Spain: Ministry of Health

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
6-Mercaptopurine
Cytarabine
Methotrexate
Cyclophosphamide
Asparaginase
Daunorubicin
Prednisone
Vincristine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Antirheumatic Agents
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on April 16, 2014