Copanlisib in Combination With Romidepsin in Patients With Relapsed or Refractory Mature T-cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT04233697|
Recruitment Status : Withdrawn (Investigator left institution)
First Posted : January 18, 2020
Last Update Posted : August 13, 2020
This is an open label, Phase IB dose-escalation study of the PI3K inhibitor copanlisib in combination with romidepsin in patients with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HL).
The primary objective of the phase I study is to determine the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), and dose limiting toxicities (DLTs) of the combination of copanlisib and romidepsin in patients with R/R, NHL or HL.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, T-Cell||Drug: Copanlisib Drug: Romidepsin||Phase 1|
The non-Hodgkin lymphomas (NHL) represent 4-5% of all new cancer cases, and is the seventh leading cause of cancer death. In 2015, there were an estimated 71,850 cases in the United States, and approximately 19,790 deaths. An evaluation of the distribution of NHL sub-types was performed on 114,548 cases of lymphoid neoplasms diagnosed between 1992-2001 and reported to the Surveillance Epidemiology and End Results (SEER) registry. Of all NHL, 87,666 were B-cell lymphoid neoplasms, and 6,228 were considered T/Natural Killer (NK) cell neoplasms.
The peripheral T-cell lymphomas (PTCL) are a heterogeneous group of aggressive lymphoid neoplasms and account for 10-15% of all newly diagnosed cases of NHL. The current prevalence of PTCL in the United States is estimated to be approximately 9,500 patients. PTCL-Not Otherwise Specified (NOS), a nodal subtype, is the most common T-cell lymphoma in the United States and Europe. PTCL is associated with a significantly worse prognosis compared to its B-cell counterparts. Treatment options for patients with relapsed/refractory (R/R) PTCL have been limited. The addition of novel drugs to conventional chemotherapy has largely proven unsuccessful. Since 2009, new drugs have entered the therapeutic field for patients with R/R PTCL.
Pralatrexate was the first drug approved for patients with R/R PTCL. Other drugs approved for patients with R/R PTCL include romidepsin and belinostat. These agents appear to exhibit lineage-specific activity in PTCL. Over the past few years, the investigators have focused on exploring rational combinations of these T-cell active agents in an effort to develop novel treatment platforms. Early clinical studies of these combinations have shown very promising activity.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1B Study of the PI3K Inhibitor Copanlisib in Combination With Romidepsin in the Treatment of Patients With Relapsed or Refractory Mature T-cell Lymphoma|
|Estimated Study Start Date :||February 2020|
|Estimated Primary Completion Date :||July 30, 2022|
|Estimated Study Completion Date :||July 30, 2023|
Experimental: Copanlisib and Romidepsin
Copanlisib and romidepsin will be both administered via IV (through a vein in arm) on days 1, 8, and 15 every 28 days, also called a "cycle".
Novel, pan-class phosphatidylinositol 3-kinase (PI3K) inhibitor with potent activity against both the δ and α isoforms9. Copanlisib has been evaluated for the treatment of a wide variety of malignancies, including lymphoma, either as a single agent or in combination with other investigational agents.
Indicated for treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.
Other Name: Istodax
- Maximum tolerated dose (MTD) [ Time Frame: 2 years ]The estimated MTD would be the highest dose at which 0 out of 3 or 1 out of 6 subjects experience a dose-limiting toxicity (DLT), i.e. dose with an observed DLT rate of less than 0.33.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04233697
|Principal Investigator:||Changchun Deng, MD, PhD||Columbia University|