CLINICAL TRIALS PROFILE FOR TREANDA

505(b)(2) Clinical Trials for TREANDA

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT00974233 ↗	Study of Bendamustine/Rituxan Induction Chemotherapy With Revlimid Maintenance for Relapsed/Refractory CLL and SLL	Completed	Celgene Corporation	Phase 2	2009-10-01	The purpose of this research is to evaluate a new combination of chemotherapy drugs for CLL/SLL using the drugs bendamustine (an intravenous chemotherapy drug), rituximab (an intravenous medication called a monoclonal antibody), and lenalidomide (an anti-cancer pill). The purpose of this study is to see if giving the chemotherapy pill lenalidomide after treatment with bendamustine and rituximab is able to prolong the period of time before the cancer starts growing again and causing symptoms.
New Combination	NCT00974233 ↗	Study of Bendamustine/Rituxan Induction Chemotherapy With Revlimid Maintenance for Relapsed/Refractory CLL and SLL	Completed	University of Wisconsin, Madison	Phase 2	2009-10-01	The purpose of this research is to evaluate a new combination of chemotherapy drugs for CLL/SLL using the drugs bendamustine (an intravenous chemotherapy drug), rituximab (an intravenous medication called a monoclonal antibody), and lenalidomide (an anti-cancer pill). The purpose of this study is to see if giving the chemotherapy pill lenalidomide after treatment with bendamustine and rituximab is able to prolong the period of time before the cancer starts growing again and causing symptoms.

All Clinical Trials for TREANDA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00139841 ↗	Safety and Efficacy of Treanda™ (Bendamustine HCl) in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Who Are Refractory to Rituximab	Completed	Cephalon	Phase 3	2005-10-01	SUMMARY: This is a multi-center open label study to evaluate the safety and effectiveness of Treanda™ (also known as bendamustine HCl or SDX-105) in patients who have indolent Non-Hodgkin's lymphoma and have relapsed within a defined timeframe after taking rituximab (Rituxan®). Treanda will be given via 60-minute intravenous infusion on days 1 and 2 of every 21-day treatment cycle. Patients will be treated for 6 cycles unless they develop progressive disease or unacceptable toxicity. Those who continue to receive clinical benefit at end of 6 cycles may receive an additional 2 cycles. Following the end of treatment, patients will be followed for up to 2 years until disease progression or start of another anti-cancer therapy.
NCT00547534 ↗	Pilot Study of Bortezomib, Bendamustine and Rituximab on Non-Hodgkin's Lymphoma	Completed	Cephalon	Phase 2	2007-10-01	The purpose of this study is to evaluate how non-Hodgkin's lymphoma that has not responded to, or that has returned after standard treatment, responds to bortezomib, rituximab and bendamustine, and also to see what effects this drug combination have on this cancer.
NCT00547534 ↗	Pilot Study of Bortezomib, Bendamustine and Rituximab on Non-Hodgkin's Lymphoma	Completed	Millennium Pharmaceuticals, Inc.	Phase 2	2007-10-01	The purpose of this study is to evaluate how non-Hodgkin's lymphoma that has not responded to, or that has returned after standard treatment, responds to bortezomib, rituximab and bendamustine, and also to see what effects this drug combination have on this cancer.
NCT00547534 ↗	Pilot Study of Bortezomib, Bendamustine and Rituximab on Non-Hodgkin's Lymphoma	Completed	University of Rochester	Phase 2	2007-10-01	The purpose of this study is to evaluate how non-Hodgkin's lymphoma that has not responded to, or that has returned after standard treatment, responds to bortezomib, rituximab and bendamustine, and also to see what effects this drug combination have on this cancer.
NCT00758693 ↗	Frontline Treatment With Bendamustine in Combination With Rituximab in Adults Age 65 or Older With Chronic Lymphocytic Leukemia (CLL)	Withdrawn	Cephalon	Phase 2	2008-10-01	Many chemotherapy combinations may be used to treat patients with chronic lymphocytic leukemia (CLL). Although there are many options, a single, best option is not agreed upon by most cancer specialists. Bendamustine, a medicine recently approved for use in the United States, has been used in combination with rituximab in previous studies to treat patients whose CLL has returned after previous standard treatments. The purpose of this study is to determine whether bendamustine with rituximab is effective for the initial treatment of CLL for patients aged 65 and older.
NCT00758693 ↗	Frontline Treatment With Bendamustine in Combination With Rituximab in Adults Age 65 or Older With Chronic Lymphocytic Leukemia (CLL)	Withdrawn	University of Kentucky	Phase 2	2008-10-01	Many chemotherapy combinations may be used to treat patients with chronic lymphocytic leukemia (CLL). Although there are many options, a single, best option is not agreed upon by most cancer specialists. Bendamustine, a medicine recently approved for use in the United States, has been used in combination with rituximab in previous studies to treat patients whose CLL has returned after previous standard treatments. The purpose of this study is to determine whether bendamustine with rituximab is effective for the initial treatment of CLL for patients aged 65 and older.
NCT00769522 ↗	FCR or BR in Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia	Completed	Mundipharma Pte Ltd.	Phase 3	2008-10-02	RATIONALE: Drugs used in chemotherapy, such as fludarabine, cyclophosphamide, and bendamustine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether giving fludarabine and cyclophosphamide together with rituximab is more effective than giving bendamustine together with rituximab in treating chronic lymphocytic leukemia. PURPOSE: This randomized phase III trial is studying fludarabine, cyclophosphamide, and rituximab to see how well they work compared with bendamustine and rituximab in treating patients with previously untreated B-cell chronic lymphocytic leukemia.

Clinical Trial Conditions for TREANDA

Condition Name

Condition Name for TREANDA
Intervention	Trials
Chronic Lymphocytic Leukemia	21
Multiple Myeloma	12
Mantle Cell Lymphoma	10
Lymphoma	10

Condition MeSH

Condition MeSH for TREANDA
Intervention	Trials
Lymphoma	66
Leukemia, Lymphocytic, Chronic, B-Cell	37
Leukemia, Lymphoid	32
Leukemia	30

Clinical Trial Locations for TREANDA

Trials by Country

Trials by Country for TREANDA
Location	Trials
United States	556
Canada	41
Australia	25
Italy	19
Poland	11

Trials by US State

Trials by US State for TREANDA
Location	Trials
Texas	30
New York	30
California	27
Ohio	20
Illinois	19

Clinical Trial Progress for TREANDA

Clinical Trial Phase

Clinical Trial Phase for TREANDA
Clinical Trial Phase	Trials
Phase 3	13
Phase 2/Phase 3	2
Phase 2	38

Clinical Trial Status

Clinical Trial Status for TREANDA
Clinical Trial Phase	Trials
Completed	47
Active, not recruiting	16
Recruiting	14

Clinical Trial Sponsors for TREANDA

Sponsor Name

Sponsor Name for TREANDA
Sponsor	Trials
National Cancer Institute (NCI)	24
Cephalon	19
M.D. Anderson Cancer Center	12

Sponsor Type

Sponsor Type for TREANDA
Sponsor	Trials
Other	103
Industry	83
NIH	24

TREANDA Market Analysis and Financial Projection

TREANDA (Bendamustine Hydrochloride): Clinical Trials, Market Analysis, and Projections

Introduction to TREANDA

TREANDA, or bendamustine hydrochloride, is an alkylating drug used in the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin’s lymphoma (NHL). Here, we will delve into the current state of clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Current Indications and Clinical Trials

TREANDA is approved for the treatment of CLL and indolent B-cell NHL that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen[2].

• CLL Trials: In randomized CLL clinical studies, TREANDA was administered at a dose of 100 mg/m² intravenously over 30 minutes on Days 1 and 2 of a 28-day cycle, up to 6 cycles. The trials showed that common non-hematologic adverse reactions included pyrexia, nausea, vomiting, asthenia, fatigue, and malaise. Hematologic adverse reactions were significant, with decreases in hemoglobin, platelets, leukocytes, lymphocytes, and neutrophils[1][2].

Ongoing and Future Trials

Several ongoing studies are exploring the efficacy of bendamustine in various combinations and indications:

• Combination Therapies: Studies are investigating bendamustine in combination with other agents such as bortezomib and prednisone, particularly for patients with renal compromise. Additionally, conditioning trials with bendamustine and melphalan for patients undergoing bone marrow transplants are underway[4].

• Solid Tumors: Ongoing trials are also examining the use of bendamustine in treating solid tumors, including non-small cell lung cancer, metastatic breast cancer, and sarcoma[4].

• Immunotherapies: While not specifically focused on bendamustine, the broader landscape of lymphoma treatment is seeing significant advancements with the combination of immunotherapies, targeted agents, and traditional chemotherapy. For example, trials involving checkpoint inhibitors like pembrolizumab are aiming to enhance immune responses against lymphoma cells[3].

Adverse Reactions and Safety Profile

Serious Adverse Reactions

TREANDA is associated with several serious adverse reactions:

• Myelosuppression: Significant decreases in blood cell counts, leading to anemia, thrombocytopenia, and neutropenia[1][2].

• Infections: Increased risk of infections due to myelosuppression[2].

• Infusion Reactions and Anaphylaxis: Hypersensitivity reactions, including anaphylaxis, have been reported[2].

• Tumor Lysis Syndrome: A potentially life-threatening condition that can occur, especially in the first treatment cycle, requiring vigorous hydration and close monitoring of blood chemistry[1][2].

• Skin Reactions: Fatal and serious skin reactions, including Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported[1][2].

Common Adverse Reactions

Common non-hematologic adverse reactions include pyrexia, nausea, vomiting, fatigue, and malaise. Hematologic adverse reactions are frequent, with significant decreases in various blood cell counts[1][2].

Market Analysis

Market Size and Growth

The bendamustine market is expected to register considerable growth during the forecast period, driven by factors such as the rising prevalence of CLL, NHL, and multiple myeloma. Growing awareness among the population and initiatives by governmental and non-governmental organizations to improve healthcare are also contributing to this growth[5].

Regional Analysis

Geographically, the market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. The Asia Pacific region is projected to expand at the highest CAGR due to an empowered healthcare industry and growing incidences of CLL and NHL. The Latin America and Middle East & Africa regions are expected to have slower growth rates but are still contributing to the overall market expansion due to improving healthcare sectors[5].

Market Drivers and Restraints

Key drivers include the increasing prevalence of CLL, NHL, and multiple myeloma, as well as growing awareness and healthcare improvements. However, the market is restrained by the side effects associated with the drug and limited awareness among the population about available treatments[5].

Market Projections

Forecast Period

The bendamustine market is forecasted to grow significantly from 2024 to 2034. This growth is anticipated due to the increasing demand for effective treatments for CLL, NHL, and other hematological malignancies[5].

Market Size

The market size is expected to reach substantial figures, driven by the growing need for bendamustine in various therapeutic settings. For instance, the diffuse large B-cell lymphoma market, which includes treatments like bendamustine, is projected to reach USD 5.2577 million by 2034[3].

Key Takeaways

• Clinical Trials: TREANDA is being explored in various clinical trials, including combination therapies and new indications such as solid tumors.
• Adverse Reactions: The drug has a significant safety profile with serious adverse reactions including myelosuppression, infections, infusion reactions, tumor lysis syndrome, and skin reactions.
• Market Growth: The bendamustine market is expected to grow substantially due to increasing prevalence of hematological malignancies and improving healthcare infrastructure.
• Regional Analysis: The Asia Pacific region is expected to show the highest CAGR, while Latin America and the Middle East & Africa will have slower but still significant growth.

FAQs

What are the approved indications for TREANDA?

TREANDA is approved for the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin’s lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen[2].

What are the common adverse reactions associated with TREANDA?

Common adverse reactions include pyrexia, nausea, vomiting, fatigue, and malaise, as well as significant decreases in various blood cell counts[1][2].

What are the serious adverse reactions associated with TREANDA?

Serious adverse reactions include myelosuppression, infections, infusion reactions and anaphylaxis, tumor lysis syndrome, and severe skin reactions[1][2].

What is the current state of clinical trials involving TREANDA?

Ongoing trials are exploring the efficacy of bendamustine in combination therapies, solid tumors, and as part of conditioning regimens for bone marrow transplants[4].

What are the key drivers and restraints of the bendamustine market?

Key drivers include the rising prevalence of CLL, NHL, and multiple myeloma, along with growing awareness and healthcare improvements. Restraints include the side effects associated with the drug and limited awareness among the population about available treatments[5].

What is the projected market growth for bendamustine?

The bendamustine market is expected to register considerable growth from 2024 to 2034, driven by increasing demand for effective treatments for hematological malignancies[5].