CLINICAL TRIALS PROFILE FOR DEPOCYT

All Clinical Trials for Depocyt

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002524 ↗	Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma	Completed	National Cancer Institute (NCI)	Phase 2	1993-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with AIDS-related lymphoma.
NCT00002524 ↗	Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma	Completed	M.D. Anderson Cancer Center	Phase 2	1993-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with AIDS-related lymphoma.
NCT00002833 ↗	Peripheral Stem Cell Transplantation Plus Filgrastim in Treating Patients With Acute or Chronic Myelogenous Leukemia	Completed	National Cancer Institute (NCI)	Phase 2	1994-10-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Colony stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation plus filgrastim in treating patients who have acute or chronic myelogenous leukemia.
NCT00002833 ↗	Peripheral Stem Cell Transplantation Plus Filgrastim in Treating Patients With Acute or Chronic Myelogenous Leukemia	Completed	M.D. Anderson Cancer Center	Phase 2	1994-10-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Colony stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation plus filgrastim in treating patients who have acute or chronic myelogenous leukemia.
NCT00004263 ↗	Cytarabine and UCN-01 in Treating Patients With Refractory or Relapsed Acute Myelogenous Leukemia or Myelodysplastic Syndrome	Completed	National Cancer Institute (NCI)	Phase 1	1999-12-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. UCN-01 may make cancer cells more sensitive to cytarabine. PURPOSE: Phase I trial to study the effectiveness of cytarabine and UCN-01 in treating patients who have refractory or relapsed acute myelogenous leukemia or myelodysplastic syndrome.
NCT00004263 ↗	Cytarabine and UCN-01 in Treating Patients With Refractory or Relapsed Acute Myelogenous Leukemia or Myelodysplastic Syndrome	Completed	M.D. Anderson Cancer Center	Phase 1	1999-12-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. UCN-01 may make cancer cells more sensitive to cytarabine. PURPOSE: Phase I trial to study the effectiveness of cytarabine and UCN-01 in treating patients who have refractory or relapsed acute myelogenous leukemia or myelodysplastic syndrome.

Clinical Trial Conditions for Depocyt

Condition Name

Condition Name for Depocyt
Intervention	Trials
Leukemia	25
Lymphoma	16
Acute Lymphoblastic Leukemia	9
Acute Myeloid Leukemia	9

Condition MeSH

Condition MeSH for Depocyt
Intervention	Trials
Leukemia	48
Leukemia, Myeloid	29
Leukemia, Myeloid, Acute	25
Lymphoma	24

Clinical Trial Locations for Depocyt

Trials by Country

Trials by Country for Depocyt
Location	Trials
United States	130
Italy	16
Spain	7
United Kingdom	7
Germany	4

Trials by US State

Trials by US State for Depocyt
Location	Trials
Texas	49
California	7
Massachusetts	7
Florida	6
Ohio	5

Clinical Trial Progress for Depocyt

Clinical Trial Phase

Clinical Trial Phase for Depocyt
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Depocyt
Clinical Trial Phase	Trials
Completed	44
Recruiting	10
Terminated	9

Clinical Trial Sponsors for Depocyt

Sponsor Name

Sponsor Name for Depocyt
Sponsor	Trials
M.D. Anderson Cancer Center	47
National Cancer Institute (NCI)	17
Massachusetts General Hospital	3

Sponsor Type

Sponsor Type for Depocyt
Sponsor	Trials
Other	84
Industry	48
NIH	18

DEPOCYT: A Comprehensive Review of Clinical Trials, Market Analysis, and Projections

Introduction

DEPOCYT, a sustained-release liposomal formulation of the chemotherapeutic agent cytarabine, has been a significant treatment option for lymphomatous meningitis since its introduction in 1999. Here, we delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials and Efficacy

DEPOCYT was studied in several clinical trials to assess its efficacy and safety in treating lymphomatous meningitis. Here are some key findings:

• Induction and Consolidation Therapy: Patients were treated with DEPOCYT 50 mg every 2 weeks for 1 month of induction therapy, followed by consolidation therapy for an additional 3 months. The treatment was administered via either lumbar puncture (LP) or intraventricular (IVT) injection[1][4].
• Response Rates: In one study, 70 out of 76 patients with positive CSF cytology were evaluable for response. Of these, 19 (27%) attained the criteria for response, which included cytologic response in the absence of neurologic progression[1].
• Adverse Events: Common adverse events included headache and arachnoiditis. These were largely low-grade, transient, and reversible. Grade 3 headache occurred in 4% of cycles, and grade 3 or 4 arachnoiditis occurred in 6% of cycles[1][4].

Manufacturing and Production Issues

Despite its clinical efficacy, DEPOCYT faced significant manufacturing challenges:

• Technical Issues: Pacira Pharmaceuticals, the manufacturer of DEPOCYT, discontinued production in 2017 due to persistent technical issues specific to the manufacturing process. This decision did not affect treatments already distributed or administered to patients[2][5].
• Previous Manufacturing Halt: In 2012, Pacira temporarily ceased manufacturing DEPOCYT for the EU market to address issues identified by the U.K.'s Medicines & Healthcare products Regulatory Agency (MHRA). Production resumed in January 2013 after the issues were resolved[2][5].

Market Analysis

Revenue and Sales

• Revenue Impact: The discontinuation of DEPOCYT resulted in a $5 million charge for Pacira in the second quarter of 2017, including asset write-offs, lease costs, and employee severance[2][5].
• Sales Performance: DEPOCYT accounted for 2.5% of Pacira's total revenues in the year preceding its discontinuation. Sales of DEPOCYT and other related products totaled $724,000 in the first three months of 2017, down 3% from the same period the previous year[2].

Market Share and Distribution

• Distribution Partners: DEPOCYT was marketed by Leadiant Biosciences (formerly Sigma-Tau Pharmaceuticals) in the U.S. and by Mundipharma International in the EU and other European countries[5].
• Global Presence: Despite its limited market share, DEPOCYT was an important treatment option in regions where it was available, particularly for patients with lymphomatous meningitis who had limited alternative treatments[5].

Projections and Future Outlook

Impact of Discontinuation

• Treatment Alternatives: The discontinuation of DEPOCYT has left a gap in the treatment options for lymphomatous meningitis. Patients now rely more heavily on other chemotherapy agents like methotrexate, which, while effective, may not offer the same sustained-release benefits as DEPOCYT[5].

Market Trends

• Clinical Trials Market: The global clinical trials market is expected to grow significantly, driven by the increasing demand for treatments for chronic diseases. However, this growth does not directly benefit DEPOCYT due to its discontinued production[3].
• Cancer Treatment Market: The market for cancer treatments, including intrathecal chemotherapy, continues to evolve with new technologies and drugs. The absence of DEPOCYT in this market may lead to increased competition among other treatment options[3].

Key Takeaways

• Clinical Efficacy: DEPOCYT demonstrated efficacy in treating lymphomatous meningitis with a sustained-release formulation of cytarabine.
• Manufacturing Challenges: Persistent technical issues led to the discontinuation of DEPOCYT production.
• Market Impact: The discontinuation affected a niche but critical market segment, leaving patients with limited alternative treatments.
• Future Outlook: The global clinical trials and cancer treatment markets continue to grow, but DEPOCYT is no longer a part of these markets.

FAQs

What is DEPOCYT used for?

DEPOCYT is used for the intrathecal treatment of lymphomatous meningitis, a life-threatening complication of lymphoma[4].

Why was DEPOCYT production discontinued?

Production of DEPOCYT was discontinued due to persistent technical issues specific to the manufacturing process[2][5].

What are the common adverse events associated with DEPOCYT?

Common adverse events include headache and arachnoiditis, which are largely low-grade, transient, and reversible[1][4].

How does DEPOCYT compare to other intrathecal chemotherapy agents?

DEPOCYT offers a sustained-release formulation, providing cytotoxic concentrations of cytarabine in the CSF for over 14 days, which is comparable to but less frequent than conventional schedules of other agents like methotrexate[1].

What are the implications of DEPOCYT's discontinuation for patients?

The discontinuation of DEPOCYT leaves patients with limited alternative treatments for lymphomatous meningitis, potentially increasing reliance on other chemotherapy agents like methotrexate[5].

Sources

1. An open label trial of sustained-release cytarabine (DepoCyt) for the treatment of neoplastic meningitis. PubMed.
2. Pacira halts production of DepoCyt. BioPharma Dive.
3. Clinical Trials Market SIZE, SHARE | GROWTH REPORT [2032]. Fortune Business Insights.
4. DEPOCYT (cytarabine liposome injection) Label. FDA.
5. Pacira Ends Production of DepoCyt. Genetic Engineering & Biotechnology News.