CLINICAL TRIALS PROFILE FOR HYDELTRA-TBA

All Clinical Trials for Hydeltra-tba

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00900445 ↗	Studying Body Mass Index in Younger Patients Who Are Receiving Treatment for High-Risk Acute Lymphoblastic Leukemia	Withdrawn	National Cancer Institute (NCI)		2008-03-24	This clinical trial is studying body mass index in younger patients receiving prednisone/prednisolone, vincristine, daunorubicin, and pegaspargase for high-risk acute lymphoblastic leukemia. Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about the affect of body mass index on the way anticancer drugs work in the body. It may also help doctors predict how patients will respond to treatment
NCT00900445 ↗	Studying Body Mass Index in Younger Patients Who Are Receiving Treatment for High-Risk Acute Lymphoblastic Leukemia	Withdrawn	Children's Oncology Group		2008-03-24	This clinical trial is studying body mass index in younger patients receiving prednisone/prednisolone, vincristine, daunorubicin, and pegaspargase for high-risk acute lymphoblastic leukemia. Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about the affect of body mass index on the way anticancer drugs work in the body. It may also help doctors predict how patients will respond to treatment
NCT02828358 ↗	Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2017-03-27	This pilot phase II trial studies the side effects of azacitidine and combination chemotherapy in infants with acute lymphoblastic leukemia and KMT2A gene rearrangement. Drugs used in chemotherapy, such as methotrexate, prednisolone, daunorubicin hydrochloride, cytarabine, dexamethasone, vincristine sulfate, pegaspargase, hydrocortisone sodium succinate, azacitidine, cyclophosphamide, mercaptopurine, leucovorin calcium, and thioguanine work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug may kill more cancer cells.
NCT03007147 ↗	Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia	Recruiting	EsPhALL network I-BFM Study Group	Phase 3	2017-07-28	This randomized phase III trial studies how well imatinib mesylate and combination chemotherapy work in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving imatinib mesylate and combination chemotherapy may work better in treating patients with Philadelphia chromosome positive acute lymphoblastic leukemia.
NCT03007147 ↗	Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia	Recruiting	National Cancer Institute (NCI)	Phase 3	2017-07-28	This randomized phase III trial studies how well imatinib mesylate and combination chemotherapy work in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving imatinib mesylate and combination chemotherapy may work better in treating patients with Philadelphia chromosome positive acute lymphoblastic leukemia.
NCT03007147 ↗	Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia	Recruiting	Children's Oncology Group	Phase 3	2017-07-28	This randomized phase III trial studies how well imatinib mesylate and combination chemotherapy work in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving imatinib mesylate and combination chemotherapy may work better in treating patients with Philadelphia chromosome positive acute lymphoblastic leukemia.

Clinical Trial Conditions for Hydeltra-tba

Condition Name

Condition Name for Hydeltra-tba
Intervention	Trials
B Acute Lymphoblastic Leukemia	5
Mixed Phenotype Acute Leukemia	3
Recurrent Mixed Phenotype Acute Leukemia	2
Untreated Childhood Acute Lymphoblastic Leukemia	2

Condition MeSH

Condition MeSH for Hydeltra-tba
Intervention	Trials
Precursor Cell Lymphoblastic Leukemia-Lymphoma	8
Leukemia, Lymphoid	8
Leukemia	8
Acute Disease	4

Clinical Trial Locations for Hydeltra-tba

Trials by Country

Trials by Country for Hydeltra-tba
Location	Trials
United States	233
Canada	30
Australia	15
New Zealand	6
Puerto Rico	4

Trials by US State

Trials by US State for Hydeltra-tba
Location	Trials
Texas	6
Tennessee	6
South Carolina	6
Pennsylvania	6
Oklahoma	6

Clinical Trial Progress for Hydeltra-tba

Clinical Trial Phase

Clinical Trial Phase for Hydeltra-tba
Clinical Trial Phase	Trials
Phase 3	6
Phase 2	2
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for Hydeltra-tba
Clinical Trial Phase	Trials
Not yet recruiting	4
Recruiting	4
Withdrawn	1

Clinical Trial Sponsors for Hydeltra-tba

Sponsor Name

Sponsor Name for Hydeltra-tba
Sponsor	Trials
National Cancer Institute (NCI)	9
Children's Oncology Group	5
EsPhALL network I-BFM Study Group	1

Sponsor Type

Sponsor Type for Hydeltra-tba
Sponsor	Trials
NIH	9
Other	6

Clinical Trials Update, Market Analysis, and Projections for HYDELTRA and Similar Drugs

Introduction

Clinical trials are the cornerstone of drug development, ensuring the safety and efficacy of new treatments before they reach the market. This article will focus on the current state of clinical trials, particularly in the context of drugs like HYDELTRA, and provide a market analysis and projections for the U.S. clinical trials market.

What are Clinical Trials?

Clinical trials are research studies performed on people to evaluate the safety and efficacy of new drugs, devices, or medical procedures. These trials are rigorously regulated by the Food and Drug Administration (FDA) to ensure patient safety and data integrity[3][4].

The Role of ClinicalTrials.gov

ClinicalTrials.gov is a public database that contains information about federally and privately supported clinical trials. It is mandatory for trial sponsors to submit results information to this database within 12 months after the primary completion date of the trial, with possible delays for trials involving unapproved products or new uses[1].

Market Size and Growth of the U.S. Clinical Trials Market

The U.S. clinical trials market was valued at USD 25.81 billion in 2023 and is projected to grow to USD 41.57 billion by 2033. This growth is driven by the increasing demand for innovative healthcare solutions and ongoing research efforts[3].

Phase Distribution in Clinical Trials

• Phase I Trials: These trials mark the initial step in human testing for new drugs, focusing on determining the optimal dosage and assessing safety. Phase I trials are expected to register the fastest CAGR growth of 7.2% during the forecast period[3].
• Phase III Trials: These trials held the largest share of 55% in 2023, as they are crucial for demonstrating the efficacy and safety of drugs before FDA approval[3].

Study Design and Segments

• Interventional Study Design: This segment accounted for the largest market share of 48.9% in 2023 and is anticipated to register the second-fastest growth during the forecast period[3].
• Expanded Access Trials: These trials are projected to grow at a CAGR of 5.7% during the forecasted period[3].

Therapeutic Areas

• Oncology: This segment accounted for the maximum revenue share of 27% in 2023 and is expected to register the fastest CAGR over the forecast period. Cancer immunotherapy clinical trials are particularly significant in this area[3].
• Autoimmune Diseases: The autoimmune segment is expected to be the second most lucrative segment with a CAGR of 5.6%[3].

Regulatory Framework

The FDA plays a critical role in shaping the parameters of clinical trials through various guidance documents. These documents cover aspects such as good clinical practice (GCP), informed consent, and the design and conduct of externally controlled trials[4].

Challenges in Clinical Trials

Despite the growth, the U.S. clinical trials market faces several challenges, including high costs, complex regulatory requirements, and ethical considerations. Ensuring patient safety and data integrity while navigating these challenges is paramount[3].

Market Drivers

• Pharmaceutical Companies: Clinical trials are essential for pharmaceutical companies to demonstrate the safety and efficacy of new drugs, driving innovation in medical product development. Significant investments in clinical research by the U.S. government also propel market growth[3].

Example: Recent Approvals and Collaborations

In April 2024, Alvotech and Teva announced the FDA approval of SELARSDI, a biosimilar to Stelara. This approval highlights the ongoing innovation in the pharmaceutical industry. Additionally, collaborations like the one between Exelixis and Arcus Biosciences on a clinical trial for Zanzalintinib in combination with AB521 for patients with advanced renal cell carcinoma demonstrate the active research landscape[3].

Projections for HYDELTRA and Similar Drugs

Given the growth trends in the U.S. clinical trials market, drugs like HYDELTRA, which are undergoing clinical trials, can expect a favorable environment for development and approval. Here are some key projections:

• Increased Focus on Oncology and Autoimmune Diseases: As these segments are expected to grow significantly, drugs targeting these areas will likely see increased investment and research activity.
• Advancements in Trial Design: The use of adaptive design clinical trials and decentralized clinical trials will continue to streamline the drug development process, potentially reducing costs and increasing efficiency[4].
• Regulatory Support: The FDA's ongoing guidance and support for innovative trial designs and data submission requirements will facilitate the approval process for new drugs.

Key Takeaways

• The U.S. clinical trials market is poised for significant growth, driven by the demand for innovative healthcare solutions.
• Phase I trials are expected to grow rapidly, while Phase III trials continue to hold a significant share.
• Oncology and autoimmune disease segments will remain key areas of focus.
• Regulatory frameworks and advancements in trial design will continue to shape the market.

FAQs

Q: What is the primary purpose of clinical trials? A: The primary purpose of clinical trials is to evaluate the safety and efficacy of new drugs, devices, or medical procedures.

Q: How is the U.S. clinical trials market expected to grow? A: The U.S. clinical trials market is expected to grow from USD 27.07 billion in 2024 to USD 41.57 billion by 2033.

Q: Which therapeutic area is expected to grow the fastest in clinical trials? A: The oncology segment is expected to register the fastest CAGR over the forecast period.

Q: What role does the FDA play in clinical trials? A: The FDA regulates clinical trials through various guidance documents to ensure patient safety and data integrity.

Q: What are some of the challenges faced by the U.S. clinical trials market? A: High costs, complex regulatory requirements, and ethical considerations are some of the key challenges faced by the U.S. clinical trials market.

Sources

1. ClinicalTrials.gov - Human Subjects Office - The University of Iowa
2. Specified Pool and TBA Trading in the Mortgage Backed ... - SMU
3. U.S. Clinical Trials Market Size Industry Analysis Report, 2033 - BioSpace
4. Clinical Trials Guidance Documents - FDA