NCT01665001

Brief Summary

The primary goal of this study by The Polish Adult Leukemia Group (PALG) is to verify if individual therapeutic approach taking into account biological and phenotypic differences as well as response at the level of minimal residual disease is associated with improved outcome of adults with precursor lymphoid neoplasms

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2012

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 15, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 17, 2012

Status Verified

August 1, 2012

Enrollment Period

4 years

First QC Date

August 11, 2012

Last Update Submit

August 16, 2012

Conditions

Precursor Lymphoid Neoplasms

Keywords

Acute lymphoblastic leukemiaInductionConsolidationMinimal residual diseaseHematopoietic stem cell transplantation

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    three years

Secondary Outcomes (1)

  • Leukemia-free survival

    three years

Other Outcomes (1)

  • Remission duration

    three years

Study Arms (1)

Multiagent induction-consolidation

EXPERIMENTAL

Induction, consolidation, HSCT, maintenance for adults with newly diagnosed precursor lymphoid neoplasms

Other: Treatment strategy: induction, consolidation, HSCT, maintenance

Interventions

Treatment strategy: induction, consolidation, HSCT, maintenanceOTHER

Patients \<55 years Ph-neg.: induction (daunorubicin, prednisone, vincristin, PEG-asparaginase), 2nd induction (if non-remission or MRD\>0.1%; FLAM, MiniFLAM or FLAM-CAMP dependent on age and phenotype), consolidation (methotrexate, etoposide, cytarabine, cyclophosphamide, PEG-asparaginase). If MRD \<0.01%: autoHSCT + maintenance (mercaptopurine, methotrexate) or multiagent maintenance (additionally daunorubicin, vincristin, prednisone); remaining patients: alloHSCT. Prophylaxis of leptomeningeal involvement: liposomal cytarabine intrathecally. Patients \>55 years, Ph-neg.: as above, reduced doses. AlloHSCT with reduced conditioning. Patients Ph-pos.: as above, reduced doses in combination with continues imatinib. All intended for alloHSCT.

Multiagent induction-consolidation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • New diagnosis of PLN according to WHO 2008 classification
  • Age ≥18 years
  • Biological status allowing administration of induction therapy
  • Informed patient consent form signed

You may not qualify if:

  • Pregnancy
  • Psychiatric diseases
  • History of other malignancies
  • HIV infection
  • Active hepatitis
  • Hypersensitivity to drugs used in induction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch

Gliwice, 44-101, Poland

Location

Related Publications (1)

  • Holowiecki J, Krawczyk-Kulis M, Giebel S, Jagoda K, Stella-Holowiecka B, Piatkowska-Jakubas B, Paluszewska M, Seferynska I, Lewandowski K, Kielbinski M, Czyz A, Balana-Nowak A, Krol M, Skotnicki AB, Jedrzejczak WW, Warzocha K, Lange A, Hellmann A. Status of minimal residual disease after induction predicts outcome in both standard and high-risk Ph-negative adult acute lymphoblastic leukaemia. The Polish Adult Leukemia Group ALL 4-2002 MRD Study. Br J Haematol. 2008 Jun;142(2):227-37. doi: 10.1111/j.1365-2141.2008.07185.x. Epub 2008 May 19.

    PMID: 18492099BACKGROUND

Related Links

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaNeoplasm, Residual

Interventions

Maintenance

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Study Officials

  • Sebastian Giebel, MD

    Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastian Giebel, MD

CONTACT

0048322788523sgiebel@io.gliwice.pl

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2012

First Posted

August 15, 2012

Study Start

August 1, 2012

Primary Completion

August 1, 2016

Study Completion

August 1, 2018

Last Updated

August 17, 2012

Record last verified: 2012-08

Locations

PL(1)