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: January 11, 2017

Last verified: January 2017

History of Changes

Tracking Information

First Received Date ^ICMJE

February 25, 2009

Last Updated Date

January 11, 2017

Start Date ^ICMJE

January 2003

Estimated Primary Completion Date

December 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Complete list of historical versions of study NCT00853008 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 4

Study Design ^ICMJE

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

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

Active, not recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

January 2018

Estimated Primary Completion Date

December 2017 (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

Sexes Eligible for Study:

All

Ages

16 Years and older (Child, Adult, Senior)

Accepts Healthy Volunteers

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

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

January 2017

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

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