Imatinib or Dasatinib for Chronic Myeloid Leukemia

Recruiting at 376 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 5 years

406 Participants Needed

Trial Summary

What is the purpose of this trial?

This randomized phase IIB trial studies imatinib mesylate at two different doses and dasatinib to see how well they work in treating patients with previously untreated chronic phase chronic myelogenous leukemia. Imatinib mesylate or dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that you must not have received prior treatment for CML, except for hydroxyurea and/or anagrelide. It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug Dasatinib for treating chronic myeloid leukemia?

Research shows that Dasatinib is highly effective for treating chronic myeloid leukemia, especially in patients who are newly diagnosed or resistant to Imatinib. It provides better and faster responses compared to Imatinib and maintains its effectiveness over the long term. ^{1 2 3 4 5}

How do the drugs dasatinib and imatinib differ in treating chronic myeloid leukemia?

Dasatinib and imatinib are both used to treat chronic myeloid leukemia, but dasatinib tends to produce a faster and deeper response in reducing cancer cells compared to imatinib. However, dasatinib may also cause more blood-related side effects, like low platelet counts, than imatinib. ^{3 4 5 6 7}

Research Team

Brian J Druker

Principal Investigator

SWOG Cancer Research Network

Eligibility Criteria

This trial is for adults with newly diagnosed chronic phase chronic myelogenous leukemia who haven't had treatment except possibly hydroxyurea or anagrelide. They should be in good physical condition, not pregnant or breastfeeding, and willing to use birth control. Major surgery must not have been done recently, and they shouldn't have serious bleeding disorders or certain heart conditions.

Inclusion Criteria

At the time of patient registration, the treating institution's name and identification (ID) number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base

Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) or serum glutamate pyruvate transaminase (SGPT)/alanine transaminase (ALT) =< 2.0 x the IULN

All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines

Exclusion Criteria

Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method

I haven't had major surgery in the last 28 days and have recovered from past surgeries.

I have no cancer history except for certain skin cancers, early-stage cancers in remission, or any cancer I've been free from for 5 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive imatinib mesylate or dasatinib. Treatment repeats every 4 weeks for up to 5 years in the absence of disease progression or unacceptable toxicity.

5 years

Monthly visits for the first year, then every 6 months for years 2 and 3, and annually for years 4 and 5

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

15 years

Annually

Treatment Details

Interventions

• Dasatinib
• Imatinib Mesylate

Trial Overview The study compares the effectiveness of two drugs: Imatinib Mesylate at different doses and Dasatinib. These medications are designed to block enzymes that cancer cells need to grow. The trial randomly assigns patients to receive one of these treatments.

Participant Groups

Group I: Arm III (dasatinib) Experimental Treatment 2 Interventions

Patients receive dasatinib PO BID. Treatment repeats every 4 weeks for up to 5 years in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (BID imatinib mesylate) Experimental Treatment 2 Interventions

Patients receive imatinib mesylate PO BID. Treatment repeats every 4 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity.

Group III: Arm I (QD imatinib mesylate) Experimental Treatment 2 Interventions

Patients receive imatinib mesylate PO QD. Treatment repeats every 4 weeks for up to 5 years in the absence of disease progression or unacceptable toxicity.

Dasatinib is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Sprycel for:

• Chronic myeloid leukemia (CML)
• Acute lymphoblastic leukemia (ALL)

Approved in European Union as Sprycel for:

• Chronic myeloid leukemia (CML)
• Acute lymphoblastic leukemia (ALL)

Approved in Canada as Sprycel for:

• Chronic myeloid leukemia (CML)
• Acute lymphoblastic leukemia (ALL)

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Findings from Research

In a study of 117 patients with chronic myeloid leukemia, dasatinib showed higher adherence to treatment (91%) compared to nilotinib (82%) over two years.

Both dasatinib and nilotinib demonstrated similar efficacy in terms of progression-free survival (PFS) at 92%, indicating that while dasatinib may be better adhered to, both drugs are equally effective in preventing disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence, persistence and efficacy of dasatinib and nilotinib in the treatment of patients resistant or intolerant to imatinib with chronic myeloid leukemia in chronic phase: an Italian multicenter study over two years in real life. Santoleri, F., Ranucci, E., La Barba, G., et al.[2022]

Dasatinib demonstrated a higher rate of major molecular response (MMR) at 18 months compared to imatinib (76% vs 37%), indicating it may be more effective in achieving deeper responses in newly diagnosed chronic phase chronic myeloid leukemia (CML-CP) patients.

Both dasatinib and imatinib were well-tolerated with mostly mild side effects, but dasatinib was associated with specific adverse events like pleural effusion and thrombocytopenia, while imatinib had more cases of hypophosphatemia and neutropenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Preliminary comparison of efficacy and safety of dasatinib and imatinib in newly diagnosed chronic myeloid leukemia]. Zhou, L., Wang, JX., Huang, XJ., et al.[2022]

In a study of 519 patients with newly diagnosed chronic-phase CML, dasatinib resulted in a higher rate of complete cytogenetic response at 12 months compared to imatinib (77% vs. 66%), indicating its greater efficacy as a first-line treatment.

Dasatinib not only achieved higher response rates but also did so more quickly than imatinib, with a major molecular response rate of 46% compared to 28%, suggesting that dasatinib may lead to better long-term outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dasatinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia. Kantarjian, H., Shah, NP., Hochhaus, A., et al.[2023]

In a study of 253 patients with newly diagnosed chronic-phase chronic myeloid leukemia, dasatinib (DAS) showed a higher complete cytogenetic remission rate (84%) compared to imatinib (IM) (69%), indicating DAS may be more effective in achieving initial treatment goals.

While DAS resulted in more complete cytogenetic and deeper molecular responses after 12 months, both treatments had similar overall and progression-free survival rates, with DAS associated with higher rates of hematologic toxicities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of dasatinib 100 mg versus imatinib 400 mg in newly diagnosed chronic-phase chronic myeloid leukemia. Radich, JP., Kopecky, KJ., Appelbaum, FR., et al.[2022]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Dasatinib: a guide to its use in chronic myeloid leukemia in the EU. [2016]

2. England pubmed.ncbi.nlm.nih.gov

Adherence, persistence and efficacy of dasatinib and nilotinib in the treatment of patients resistant or intolerant to imatinib with chronic myeloid leukemia in chronic phase: an Italian multicenter study over two years in real life. [2022]

3. China pubmed.ncbi.nlm.nih.gov

[Preliminary comparison of efficacy and safety of dasatinib and imatinib in newly diagnosed chronic myeloid leukemia]. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Dasatinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Second-generation BCR-ABL inhibitors for frontline treatment of chronic myeloid leukemia in chronic phase. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

A randomized trial of dasatinib 100 mg versus imatinib 400 mg in newly diagnosed chronic-phase chronic myeloid leukemia. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Cost-utility analysis of dasatinib and nilotinib in patients with chronic myeloid leukemia refractory to first-line treatment with imatinib in Thailand. [2022]