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A Randomized, Phase IIB, Multicenter, Trial of Oral Azacytidine Plus Romidepsin versus Investigator's Choice in Patients with Relapse or Refractory Periperal T-cell lymphoma (PTCL).

Award Number: R01FD006814
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/15/2020
PERIOD OF PERFORMANCE END DATE: 01/31/2027

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A Randomized, Phase IIB, Multicenter, Trial of Oral Azacytidine Plus Romidepsin versus Investigator's Choice in Patients with Relapse or Refractory Periperal T-cell lymphoma (PTCL). - Project Abstract CHOP-based regimens, the present standard of care for peripheral T-cell lymphoma (PTCL), were established in aggressive B-cell malignancies and extrapolated to the PTCL. As a result, the median survival of patients with PTCL is only 1 to 3 years, with a median 5-year survival of only 20-25%. Major challenges to develop PTCL- specific treatment relate to their rarity and heterogeneity. Specifically, the annual incident rate ratio of all PTCLs is 1.3673 per 100,000 among all races on average and their prevalence rate is 5.30 per 100,000. The extreme heterogeneity is affirmed by the fact that the WHO recognizes 30 distinct subtypes of the disease. Many lines of data now suggest that the PTCL exhibit a unique vulnerability to epigenetic modifiers. In order to identify potentially new standards for the disease, we will conduct a randomized, phase IIB, multicenter trial of Oral Azacytidine (AZA) plus Romidepsin (ROMI) versus Investigator’s Choice (IC) including romidepsin, belinostat, pralatrexate and gemcitabine in patients with Relapse or Refractory (R/R) PTCL. We anticipate generating sufficient data that will inform a ‘go-no-go’ decision regarding a full scale randomized Phase 3. To date, several agents have gained FDA accelerated approval for the treatment of R/R PTCL. Based on these examples, the logic for a potential regulatory study design is as follows: the patient population is “patients with PTCL who have received one prior systemic therapy.” This patient population was studied in all precedent examples of accelerated approvals (pralatrexate, romidepsin, belinostat). While the term PTCL encompasses multiple T-cell lymphoma histology’s, the FDA has permitted registration trials to be conducted in this category of T-cell lymphoma malignancies due to the rarity of the disease. We will adopt the traditional endpoint of progression free survival (PFS), used for regular approvals of new agents in R/R lymphomas (B- and T-lymphomas), in contrast to response rate or CR rate used for accelerated approvals. Lastly, the control arm is an investigator choice that includes appropriate and clinically meaningful drugs for this trial. Finally, the correlative samples obtained from patients on trial will determine how the genetic features of the disease influence clinical outcome and will clarify the immunologic effects induced by the combination. We believe this study will transform how we think about future treatment paradigms, and improve the outcomes of patients with PTCL.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $808,684 )
2025	2025	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 EMMET ST N	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Food and Drug Administration Research	000	3	6/2/2025	NON-COMPETING CONTINUATION	$808,684
														Subtotal = $808,684

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2022	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 EMMET ST N	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Food and Drug Administration Research	001	2	8/13/2024	NON-COMPETING CONTINUATION	$0
2024	2022	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 EMMET ST N	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Food and Drug Administration Research	002	2	9/20/2024	NON-COMPETING CONTINUATION	$0
2024	2022	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 EMMET ST N	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Food and Drug Administration Research	000	2	8/2/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 N EMMET ST	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Food and Drug Administration Research	000	2	8/24/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $808,153 )
2022	2022	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 N EMMET ST	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Food and Drug Administration Research	000	2	8/29/2022	NON-COMPETING CONTINUATION	$808,153
														Subtotal = $808,153

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2020	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 N EMMET ST	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Food and Drug Administration Research	000	1	7/9/2021	NEW	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $807,732 )
2020	2020	RECTOR & VISITORS OF THE UNIVERSITY OF VIRGINIA	1001 N EMMET ST	CHARLOTTESVILLE	VA	22903	CHARLOTTESVILLE CITY	USA	Food and Drug Administration Research	000	1	8/20/2020	NEW	$807,732
														Subtotal = $807,732

Grand Total All Awards = $2,424,569

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A Randomized, Phase IIB, Multicenter, Trial of Oral Azacytidine Plus Romidepsin versus Investigator's Choice in Patients with Relapse or Refractory Periperal T-cell lymphoma (PTCL).

Award Number: R01FD006814

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/15/2020

PERIOD OF PERFORMANCE END DATE: 01/31/2027

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