Clofarabine or High-Dose Cytarabine and Pegaspargase in Children with ALL

Summary

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. Giving more than once drug (combination chemotherapy) may kill more cancer cells. Radiation therapy uses high-energy x-rays to kill cancer cells. It is not yet known whether giving clofarabine or high-dose cytarabine, pegaspargase, and combination chemotherapy followed by daunorubicin hydrochloride or doxorubicin hydrochloride is more effective in treating young patients with acute lymphoblastic leukemia.

PURPOSE: This randomized phase II/III trial is studying the side effects of giving clofarabine compared with giving high-dose cytarabine, pegaspargase, and combination chemotherapy followed by daunorubicin hydrochloride or doxorubicin hydrochloride and to see how well it works in treating young patients with T-cell acute lymphoblastic leukemia or precursor B-cell acute lymphoblastic leukemia.

Conditions

• Leukemia

Interventions

DRUG

Amsacrine

one block amsacrine together with etoposide and methylprednisolone for very high risk patients

DRUG

Clofarabine

one block clofarabine with Asparaginase for MRD positive patients after induction

DRUG

Cyclophosphamide

together wit MTX and ASP in consolidation and together with cytarabine and 6-TG in reinduction

DRUG

Cytarabine

part of different chemotherapy blocks in consolidation and reinduction

DRUG

Daunorubicin hydrochloride

part of induction and reinduction therapy

DRUG

Dexamethasone

part of reinduction therapy

DRUG

Doxorubicin hydrochloride

part of reinduction therapy

DRUG

Etoposide phosphate

part of different chemotherapy blocks

DRUG

Mercaptopurine

part of different chemotherapy blocks

DRUG

Methotrexate

part of different chemotherapy blocks

DRUG

Methylprednisolone

part of different chemotherapy blocks

DRUG

Pegaspargase

part of different chemotherapy blocks

DRUG

Thioguanine

part of different chemotherapy blocks

DRUG

Vincristine sulfate

part of intravenous chemotherapy

RADIATION

Whole-brain radiation therapy

patients with initial cns involvement receive cranial irradiation

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf

  lead OTHER

Principal Investigators

• Martin Horstmann, MD · Universitätsklinikum Hamburg-Eppendorf

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-10-31

Primary Completion

2019-12-31

Completion

2024-11-20

Countries

• Germany

Study Locations