Pethema LAL-RI/2008: Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia

NCT02036489 | Completed Phase 4 DMC

• 1 other identifier: LAL-RI/2008
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

Understand the dynamics of elimination of MRD in adult patients with standard-risk LAL treated with a pediatric protocol.

Conditions

Acute Lymphobkastic Leukemia

Outcome Measures

Primary Outcomes (1)

• Efficacy of treatment in adulta with standard risk acute lymphoblastic leukemia

  2 years

Study Arms (1)

Induction and consolidation treatment

EXPERIMENTAL

Drug: Vincristine; Drug: Daunorubicin; Drug: Prednisone; Drug: L-asparaginase; Drug: Ciclophosphamide; Drug: Metotrexate; Drug: ARA-C; Drug: Hidrocortisone; Drug: Mercaptopurine; Drug: VP-16; Drug: Dexametasone

Interventions

Vincristine DRUG

Induction and consolidation treatment

Daunorubicin DRUG

Induction and consolidation treatment

Prednisone DRUG

Induction and consolidation treatment

L-asparaginase DRUG

Induction and consolidation treatment

Ciclophosphamide DRUG

Induction and consolidation treatment

Metotrexate DRUG

Induction and consolidation treatment

ARA-C DRUG

Induction and consolidation treatment

Hidrocortisone DRUG

Induction and consolidation treatment

Mercaptopurine DRUG

Induction and consolidation treatment

VP-16 DRUG

Induction and consolidation treatment

Dexametasone DRUG

Induction and consolidation treatment

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (age\> 15 years) with ALL standard risk previously untreated. The LAL standard risk is defined by all of the following criteria:
• Age less than 30 years
• WBC \<25x109 / L
• Absence of cytogenetic alterations that misbehave forecast or t (9, 22) or demonstration of BCR-ABL rearrangement or alterations in 11q23, or demonstration ALL1-AF4 rearrangement (MLL)

You may not qualify if:

• LAL L3 type mature phenotype B (sIg +) or with cytogenetic abnormalities characteristic of Burkitt LAL (t \[8, 14\], t \[2, 8\], t \[8, 22\]). For these patients have the BURKIMAB study.
• LAL Ph (BCR-ABL) positive. These patients should be treated with imatinib associated with chemotherapy.
• Biphenotypic acute leukemias and bilinear. For these patients treatment is recommended LAM own guidelines.
• Acute undifferentiated leukemias. For these patients treatment is recommended LAM own guidelines.
• Patients with a history of coronary artery disease, valvular or hypertensive heart disease.
• Patients with chronic liver disease.
• Patients with chronic respiratory failure.
• Renal failure not due to the LAL.
• Severe neurological disorders, not due to the LAL.
• General State concerned (grades 3 and 4 WHO scale), not attributable to the LAL.

Sponsors & Collaborators

• PETHEMA Foundation: lead

Study Sites (1)

Hospital Germans Trias i Pujol

Barcelona, Spain

Location

MeSH Terms

Interventions

Vincristine; Daunorubicin; Prednisone; Asparaginase; Cytarabine; Mercaptopurine; Etoposide

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Sulfhydryl Compounds; Sulfur Compounds; Purines; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2014
• First Posted: January 15, 2014
• Study Start: January 1, 2008
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 5, 2020

Record last verified: 2020-03

Locations

ES (1)