A Study of REduction And DIscontinuation Treatment of TKI (Imatinib, Nilotinib, Dasatinib and Bosutinib)

NCT04578847 | Unknown Phase 2 DMC

• 1 other identifier: READIT-2020
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The main goal of this study is to evaluate the stability of molecular response (major and deep molecular response( MMR and DMR)) in patients with chronic myeloid leukemia (CML) with stable DMR after two-stage dose reduction phase and discontinuation treatment TKI: imatinib, nilotinib, dasatinib and bosutinib.

Conditions

Chronic Myeloid Leukemia; Chronic Myeloid Leukemia in Remission; BCR-ABL Positive Chronic Myelogenous Leukemia

Keywords

chronic myeloid leukimea; tyrosine kinase inhibitors; the TKI dose reduction; discontinuation treatment TKI; imatinib; nilotinib; dasatinib; bosutinib

Outcome Measures

Primary Outcomes (1)

• Overall survival, survival without molecular relapse

  37 months

Secondary Outcomes (9)

• The proportion of patients with molecular relapse who achieved MMR and DMR after the resumption TKI therapy in standard doses

  37 months

• The proportion of patients who resolved the adverse events after TKI dose reduction and discontinuation of TKI therapy

  37 months

• The proportion of patients who have TKI withdrawal syndrome after TKI dose reduction and discontinuation of TKI therapy.

  37 months

• Clinical factors, that affect the preservation of MMR after TKI dose reduction and discontinuation of therapy TKI.

  37 months

• Clinical factor, that affect the preservation of MMR after TKI dose reduction and discontinuation of therapy TKI.

  37 months

Study Arms (1)

The TKI dose reduction

EXPERIMENTAL

Imatinib, nilotinib, dasatinib or bosutinib; the two stage of TKI dose reduction phase for 12 months (6 months and 6 months, respectively).

Drug: Imatinib; Drug: Nilotinib; Drug: Dasatinib; Drug: Bosutinib

Interventions

Imatinib DRUG

Initial dose - 400 mg daily. If on imatinib, the dose should be decreased to 300 mg daily on the first stage, to 200 mg daily - on the second stage.

The TKI dose reduction

Nilotinib DRUG

Initial dose - 300 or 400 mg twice daily. If on nilotinib to 400mg daily on the first stage, to 200 mg daily - on the second stage.

The TKI dose reduction

Dasatinib DRUG

Initial dose 100 or 140 mg daily. If on dasatinib then to 50 mg daily on the first stage, to 25 mg daily - on the second stage.

The TKI dose reduction

Bosutinib DRUG

Initial dose 500 mg daily. If on bosutinib, the dose should be reduced to 300 mg daily on the first stage, to 200 mg daily on the second stage.

The TKI dose reduction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CML in chronic phase.
• TKI treatment for at least 3 years.
• DMR (BCR-ABL≤0.01%) for at least 1 year, MMR (BCR-ABL≤0.1%) for at least 2 years
• At least 3 molecular results over the preceding 24 months, which confirm the presence of MMR and DMR
• Written Informed Consent
• CML patients with DMR for at least 1 years and MMR for at least 2 years after STOP TKI in anamnesis.
• \. The duration of therapy at reduced doses of TKI phase I is at least 6 months.
• DMR (BCR-ABL≤0.01%) for at least 2 years
• The duration of therapy at reduced doses of TKI phase 1 is for at least 6 months, the total duration of therapy at reduced doses is for at least 12 months.

You may not qualify if:

• Age under 18
• ECOG \>2
• CML in accelerated phase or blast crisis at any time
• Lack of Written Informed Consent
• Pregnant or lactating women
• Incapacity

Sponsors & Collaborators

• National Research Center for Hematology, Russia: lead

Study Sites (1)

National Research Center for Hematology

Moscow, Russia

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Imatinib Mesylate; nilotinib; Dasatinib; bosutinib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Thiazoles; Sulfur Compounds; Azoles

Study Officials

• Anna Turkina, Professor

  National Research Center for Hematology

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: October 8, 2020
• Study Start: January 15, 2020
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: October 8, 2020

Record last verified: 2020-10

Locations

RU (1)