CLINICAL TRIALS PROFILE FOR SPRYCEL

All Clinical Trials for Sprycel

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00036738 ↗	Fludarabine Phosphate and Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate, D	Completed	National Cancer Institute (NCI)	Phase 2	2001-07-13	This phase II trial is studying how well fludarabine phosphate and total-body irradiation followed by donor peripheral blood stem cell transplant work in treating patients with acute lymphoblastic leukemia or chronic myelogenous leukemia that has responded to previous treatment with imatinib mesylate, dasatinib, or nilotinib. Giving low doses of chemotherapy, such as fludarabine phosphate, and total-body irradiation (TBI) before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving mycophenolate mofetil and cyclosporine after the transplant may stop this from happening.
NCT00036738 ↗	Fludarabine Phosphate and Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate, D	Completed	Fred Hutchinson Cancer Research Center	Phase 2	2001-07-13	This phase II trial is studying how well fludarabine phosphate and total-body irradiation followed by donor peripheral blood stem cell transplant work in treating patients with acute lymphoblastic leukemia or chronic myelogenous leukemia that has responded to previous treatment with imatinib mesylate, dasatinib, or nilotinib. Giving low doses of chemotherapy, such as fludarabine phosphate, and total-body irradiation (TBI) before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving mycophenolate mofetil and cyclosporine after the transplant may stop this from happening.
NCT00070499 ↗	Imatinib Mesylate or Dasatinib in Treating Patients With Previously Untreated Chronic Phase Chronic Myelogenous Leukemia	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2004-08-15	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.
NCT00099606 ↗	Phase I (PH I) Mad Refractory Solid Tumor Study	Completed	Bristol-Myers Squibb	Phase 1	2004-07-01	The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, effect of food, and continue exploratory research of BMS-354825 in patients with solid tumors not responding to standard treatment, or for which no effective standard treatment exists.

Clinical Trial Conditions for Sprycel

Condition Name

Condition Name for Sprycel
Intervention	Trials
Leukemia	12
Chronic Myeloid Leukemia	10
Breast Cancer	9
Acute Lymphoblastic Leukemia	9

Condition MeSH

Condition MeSH for Sprycel
Intervention	Trials
Leukemia	81
Leukemia, Myeloid	56
Leukemia, Myelogenous, Chronic, BCR-ABL Positive	53
Leukemia, Lymphoid	34

Clinical Trial Locations for Sprycel

Trials by Country

Trials by Country for Sprycel
Location	Trials
United States	996
Canada	74
United Kingdom	59
Australia	43
Japan	33

Trials by US State

Trials by US State for Sprycel
Location	Trials
Texas	67
California	47
Illinois	40
New York	39
Pennsylvania	37

Clinical Trial Progress for Sprycel

Clinical Trial Phase

Clinical Trial Phase for Sprycel
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	11
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Sprycel
Clinical Trial Phase	Trials
Completed	83
Terminated	31
Recruiting	21

Clinical Trial Sponsors for Sprycel

Sponsor Name

Sponsor Name for Sprycel
Sponsor	Trials
Bristol-Myers Squibb	74
National Cancer Institute (NCI)	57
M.D. Anderson Cancer Center	24

Sponsor Type

Sponsor Type for Sprycel
Sponsor	Trials
Other	164
Industry	108
NIH	58

SPRYCEL (Dasatinib): Clinical Trials, Market Analysis, and Projections

Introduction to SPRYCEL

SPRYCEL, also known as dasatinib, is a second-generation tyrosine kinase inhibitor (TKI) used primarily to treat chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Study Design and Objectives

SPRYCEL was studied in a head-to-head clinical trial compared to imatinib, another TKI, in newly diagnosed adult patients with Ph+ CML in the chronic phase. The main goals of the trial were to evaluate the confirmed complete cytogenetic response (cCCyR) and major molecular response (MMR) at one year and over a five-year period[1][4].

Key Findings

• Confirmed Complete Cytogenetic Response (cCCyR): More patients who took SPRYCEL achieved cCCyR compared to those who took imatinib. By the end of the 5-year study, a higher percentage of SPRYCEL patients had achieved cCCyR[1][4].
• Major Molecular Response (MMR): SPRYCEL patients also achieved MMR at a higher rate than imatinib patients. The median time to MMR was 9.3 months for SPRYCEL patients versus 15 months for imatinib patients[4].
• Time to Response: The median time to achieve cCCyR was 3.1 months for SPRYCEL patients, significantly faster than the 5.8 months for imatinib patients[1].

Side Effects and Safety

While SPRYCEL has shown significant efficacy, it is not without side effects. Common side effects include diarrhea, cramping, and fatigue. Serious side effects such as thrombocytopenia, neutropenia, and anemia are more frequent in patients with advanced phase CML or Ph+ ALL. It is crucial for patients to report any side effects to their doctors promptly[1][4].

Market Analysis

Market Size and Growth

The global SPRYCEL market has been growing steadily. As of 2022, the market size was valued at approximately USD 5.47 billion and is projected to reach USD 8.52 billion by 2031, growing at a CAGR of 5.2% during the forecast period[2].

Another report estimates the global SPRYCEL market size to be around US$ 2.22 billion in 2023, expected to grow to US$ 2.69 billion by 2030 at a CAGR of 2.8%[3].

Market Segmentation

The SPRYCEL market is segmented based on demographics, psychographics, behavioral factors, and medical indications. The lifestyle segment is a major contributor due to changes in population lifestyles, especially in developing countries. The disease stage segment, particularly for Ph+ CML in the chronic phase, is also growing rapidly[2].

Key Players

Major players in the SPRYCEL market include Bristol-Myers Squibb (BMS), Novartis, Teva Pharmaceutical Industries, Mylan, Accord Healthcare, Sun Pharma, Dr Reddy's Laboratories, and Aurobindo Pharma[2].

Regional Market

The North American market holds a significant revenue share due to increased research on hereditary and rare disorders, the presence of key players, and government funding[2].

Market Projections

Future Growth

The SPRYCEL market is expected to continue growing driven by the increasing prevalence of CML and Ph+ ALL. According to the World Health Organization, CML is the most common type of leukemia, with an estimated 200,000 new cases diagnosed each year. This increasing demand, coupled with advancements in treatment options, will drive market growth[3].

Regional Expansion

The market is anticipated to expand in various regions, with North America maintaining its significant share. The growth in developing countries, particularly due to lifestyle changes and increasing income levels, will also contribute to the market's expansion[2].

Competitive Landscape

The competitive landscape is expected to remain dynamic with existing players continuing to innovate and new entrants potentially disrupting the market. Generic versions of SPRYCEL, once the patent expires, could also impact market dynamics[2].

Key Takeaways

• Clinical Efficacy: SPRYCEL has demonstrated superior efficacy in achieving cCCyR and MMR compared to imatinib in clinical trials.
• Market Growth: The global SPRYCEL market is projected to grow significantly, driven by increasing prevalence of CML and Ph+ ALL.
• Regional Dominance: North America is expected to maintain its significant market share, with growth also anticipated in other regions.
• Side Effects: While effective, SPRYCEL comes with notable side effects that require close monitoring.

FAQs

What is SPRYCEL used for?

SPRYCEL (dasatinib) is used to treat chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).

How does SPRYCEL compare to imatinib in clinical trials?

SPRYCEL has shown better outcomes in achieving confirmed complete cytogenetic response (cCCyR) and major molecular response (MMR) compared to imatinib in clinical trials.

What are the common side effects of SPRYCEL?

Common side effects include diarrhea, cramping, and fatigue. Serious side effects such as thrombocytopenia, neutropenia, and anemia can also occur.

What is the projected market size of SPRYCEL by 2031?

The global SPRYCEL market is projected to reach approximately USD 8.52 billion by 2031, growing at a CAGR of 5.2% during the forecast period.

Which region holds the largest market share for SPRYCEL?

The North American market holds the largest revenue share for SPRYCEL due to increased research, presence of key players, and government funding.

Sources

1. SPRYCEL® Ph+ CML Clinical Trial Results for Adults. SPRYCEL.
2. Sprycel Market Share, Size, Growth and Forecast to 2031. InsightAce Analytic.
3. Sprycel Market Size & Share Analysis - Industry Research Report. Coherent Market Insights.
4. Newly Diagnosed Patients | HCP - SPRYCEL® (dasatinib) Efficacy. SPRYCEL-HCP.
5. Sprycel - Market, Report Size, Worth, Revenue, Growth, Industry .... Valuates Reports.