NCT01998035

Romidepsin Plus Oral 5-Azacitidine in Relapsed/Refractory Lymphoid Malignancies

Phase I/IIa Study of the Oral 5-Azacitidine in Combination With the Histone Deacetylase Inhibitor Romidepsin for the Treatment of Patients With Relapsed and Refractory Lymphoid Malignancies

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, phase I/IIa, 3 x 3 dose escalation study with an initial phase I followed by a disease focused phase II. The primary objective of the phase I is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of the combinations of oral 5-azacitidine and romidepsin in patients with lymphoma. The safety and toxicity of this combination will be evaluated throughout the entire study. If the combination of oral 5-azacitidine and romidepsin is found to be feasible and an MTD is established, the phase II part of the study will be initiated. Phase II will consist of a 2 stage design of the combination of oral 5-azacitidine and romidepsin for patients with relapsed or refractory T-cell lymphomas.

Detailed description

Subjects will receive oral 5-azacitidine and romidepsin, administered as follows: oral 5-azacitidine from Days 1-14 (Dose cohorts -1 to 5) or Days 1-21 (Dose cohort 6); and romidepsin administered intravenously on Days 8 (Dose cohorts 1-4) of a 28 day cycle, and Day 22 (Dose cohorts 5 and 6) of a 35 day cycle. Cohorts of 3 patients will be enrolled sequentially as outlined in the dose escalation scheme. Once the MTD is reached the Phase II part of the protocol will be initiated in patients with T-Cell Lymphoma.

Conditions

• Lymphoid Malignancies
• Lymphoma
• Hodgkin Lymphoma
• Non-hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	RomiDEPsin 10 MG/M2	Romidepsin is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. Romidepsin is classified as a "Histone Deacetylase Inhibitor". Dose escalation (10 mg/m2)
DRUG	Oral 5-Azacitidine 100 MG	A pyrimidine nucleoside analogue of cytidine with antineoplastic activity. Dose escalation (100 mg)
DRUG	Romidepsin 14 MG/M2	Romidepsin is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. Romidepsin is classified as a "Histone Deacetylase Inhibitor". Dose escalation (14 mg/m2)
DRUG	Oral 5-Azacitidine 200 MG	A pyrimidine nucleoside analogue of cytidine with antineoplastic activity. Dose escalation (200 mg)
DRUG	Oral 5-Azacitidine 300 MG	A pyrimidine nucleoside analogue of cytidine with antineoplastic activity. Dose escalation (300 mg)

Timeline

• Start date: 2013-11-01
• Primary completion: 2020-01-06
• Completion: 2020-01-06
• First posted: 2013-11-28
• Last updated: 2024-08-22
• Results posted: 2024-08-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study