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A Phase III Randomized Trial of the Reduction of Chemotherapy in Philadelphia Chromosome-positive ALL of Young Adults

NCT02611492 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 265

Last updated 2019-10-21

No results posted yet for this study

Summary

The Primary objective is to assess the non-inferiority of the experimental arm (arm B) compared to the control arm (arm A) in terms of Major Molecular Response (MMolR) after the 4th cycle (MRD4) in patients aged 18-59 years old with de novo Philadelphia positive (Ph+) acute lymphoblastic leukemia (ALL)

Conditions

  • Philadelphia Chromosome Positive Adult Acute Lymphoblastic Leukemia

Interventions

DRUG

Nilotinib

400 mg/12h per os D1 to D28 cycles 1-4 300 mg/12h per os D1-D14 interphase

DRUG

Methotrexate

1 g/m2 continuous Intravenous Infusion (CIV) D1 cycles 2 and 4 25 mg/m2 per os D1, D8 interphase

DRUG

Aracytine (Ara C)

Age\<45 years: 3 mg/m2/12h D2, D3 cycles 2 and 4 Age\>=45 years: 1.5 mg/m2/12h D2, D3 cycles 2 and 4

DRUG

Granulocyte Colony-Stimulating Factor (G-CSF)

5µg/kg/d (SC) D6 until neutrophils \> 1 G/L D15 cycles 1 and 3; D6 cycles 2 and 4

DRUG

Depomedrol

40 mg + methotrexate 15 mg + Aracytine (AraC) 40mg IT cycle 1: D1, D8, D15 IT cycles 2 and 4: D9 IT cycle 3: D1

DRUG

Dexamethasone

40 mg per os, D1-D2, D8-D9, D15-D16, D22-D23, cycles 1 and 3

DRUG

Vincristine

2 mg total dose IV, D1 D8 D15 D22 cycles 1 and 3

DRUG

Imatinib

300 mg/12h per os in post-SCT maintenance therapy for during at least 2 years

DRUG

6 Mercaptopurine (6MP)

60 mg/m2 per os, D1 to D14, interphase

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2020-12-31
Completion
2025-12-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02611492 on ClinicalTrials.gov