Clinical trial · Interventional

Combination Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

ALLR3: An International Collaborative Trial for Relapsed and Refractory Acute Lymphoblastic Leukaemia (ALL)

NCT00967057CI-TRIAL-00011718completedPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known which combination chemotherapy regimen is more effective in treating young patients with acute lymphoblastic leukemia. PURPOSE: This partially randomized phase III trial is studying how well combination chemotherapy works in treating young patients with relapsed or refractory acute lymphoblastic leukemia.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Leukemia	Leukemia	ONTOLOGY_EXACT	0.90

Interventions

Interventions (7)

Intervention	Type	Mapped drug	Match
asparaginase	Drug	Asparaginase	ALIAS
dexamethasone	Drug	Dexamethasone	ALIAS
idarubicin	Drug	Idarubicin	ALIAS
methotrexate	Drug	Methotrexate	ALIAS
mitoxantrone hydrochloride	Drug	Mitoxantrone	ALIAS
pegaspargase	Drug	Pegaspargase	ALIAS
vincristine sulfate	Drug	Vincristine	ALIAS

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Arm I (induction therapy)
description
Patients receive idarubicin IV over 1 hour on days 1 and 2; oral dexamethasone twice daily on days 1-5 and 15-19; intrathecal (IT) methotrexate on days 1 and 8; vincristine sulfate IV on days 3, 10, 17, and 24; and pegaspargase intramuscularly (IM) on days 3 and 17 or asparaginase IM on days 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, and 25.
interventionNames
1. Drug: asparaginase
2. Drug: dexamethasone
3. Drug: idarubicin
4. Drug: methotrexate
5. Drug: pegaspargase
6. Drug: vincristine sulfate
type
EXPERIMENTAL
label
Arm II (induction therapy)
description
Patients receive mitoxantrone IV over 1 hour on days 1 and 2. Patients also receive dexamethasone, methotrexate, vincristine sulfate, and pegaspargase or asparaginase as in arm I.
interventionNames
1. Drug: asparaginase

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 1 Year
Maximum age: 18 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Diagnosis of acute lymphoblastic leukemia (ALL) meeting 1 of the following criteria:

  * In first relapse after treatment

    * Has not yet received chemotherapy or radiotherapy for the first relapse
  * Primary refractory disease
* No mature B-cell ALL
* Meets criteria for one of the following risk groups:

  * Standard-risk disease: non-T-cell or T-cell ALL with late isolated extramedullary relapse
  * Intermediate-risk disease: non-T-cell ALL with early isolated extramedullary relapse or combined marrow and extramedullary relapse; non-T-cell ALL with late combined marrow and extramedullary relapse or isolated marrow relapse; or T-cell ALL with early isolated extramedullary relapse
  * High-risk disease: non-T-cell ALL with very early isolated extramedullary relapse, combined marrow and extramedullary relapse, or isolated marrow relapse; non-T-cell ALL with early isolated marrow relapse; T-cell ALL with very early isolated extramedullary relapse, combined marrow and extramedullary relapse, or isolated marrow relapse; T-cell ALL with early combined marrow and extramedullary relapse or isolated marrow relapse; or T-cell ALL with late combined marrow and extramedullary relapse or isolated marrow relapse

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior bone marrow transplant

References

Publications (3)

RESULTParker C, Waters R, Leighton C, Hancock J, Sutton R, Moorman AV, Ancliff P, Morgan M, Masurekar A, Goulden N, Green N, Revesz T, Darbyshire P, Love S, Saha V. Effect of mitoxantrone on outcome of children with first relapse of acute lymphoblastic leukaemia (ALL R3): an open-label randomised trial. Lancet. 2010 Dec 11;376(9757):2009-17. doi: 10.1016/S0140-6736(10)62002-8. Epub 2010 Dec 3. PMID 21131038
DERIVEDEckert C, Parker C, Moorman AV, Irving JA, Kirschner-Schwabe R, Groeneveld-Krentz S, Revesz T, Hoogerbrugge P, Hancock J, Sutton R, Henze G, Chen-Santel C, Attarbaschi A, Bourquin JP, Sramkova L, Zimmermann M, Krishnan S, von Stackelberg A, Saha V. Risk factors and outcomes in children with high-risk B-cell precursor and T-cell relapsed acute lymphoblastic leukaemia: combined analysis of ALLR3 and ALL-REZ BFM 2002 clinical trials. Eur J Cancer. 2021 Jul;151:175-189. doi: 10.1016/j.ejca.2021.03.034. Epub 2021 May 16. PMID 34010787
DERIVEDParker C, Krishnan S, Hamadeh L, Irving JAE, Kuiper RP, Revesz T, Hoogerbrugge P, Hancock J, Sutton R, Moorman AV, Saha V. Outcomes of patients with childhood B-cell precursor acute lymphoblastic leukaemia with late bone marrow relapses: long-term follow-up of the ALLR3 open-label randomised trial. Lancet Haematol. 2019 Apr;6(4):e204-e216. doi: 10.1016/S2352-3026(19)30003-1. Epub 2019 Feb 27. PMID 30826273

Registry

Dates and enrollment

Start: Oct 1, 2002
Primary completion: Jan 1, 2010
Completion: Dec 1, 2011
First posted: Aug 27, 2009
Last update posted: Aug 12, 2013
Enrollment: 470 (estimated)
Lead sponsor: Children's Cancer and Leukaemia Group OTHER
Keywords: recurrent childhood acute lymphoblastic leukemia, T-cell childhood acute lymphoblastic leukemia

Data updated 22 days agoSource updated Aug 12, 2013source: clinicaltrials

Locations

Locations by country (6)

Country	Sites	Recruiting
United Kingdom	5	0
Australia	1	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.