A continued study in patients with Hematologic Cancers previously treated with Tafasitamab.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Incyte Corp.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

3 Nov 2022 → ongoing

Decision date (initial)

2024-04-29

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy

To provide continued treatment and evaluation of safety in patients receiving tafasitamab.

Conditions and MedDRA coding

Hematologic malignancies

Study design 1 period

Regulatory references

Plan to share IPD

No

IPD plan description

Not applicable

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
2. Having been enrolled and is still receiving treatment with tafasitamab at the end of a MorphoSys/Incyte-sponsored clinical study.
3. Is tolerating tafasitamab treatment at the dose specified in the parent protocol as assessed by the Investigator.
4. Is in complete/partial response or stable disease and is receiving clinical benefit from treatment with tafasitamab in the parent study, as assessed by the Investigator.
5. Has demonstrated compliance, as assessed by the Investigator, with the parent protocol requirements.
6. Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures indicated in this protocol.

Exclusion criteria 6

1. Patient who is legally institutionalized, or under judicial protection.
2. Has met one or more criteria for permanent tafasitamab treatment discontinuation as stipulated in the parent protocol.
3. Able to access tafasitamab outside a clinical study.
4. Patient with an uncontrolled intercurrent illness or any concurrent condition that, in the Investigator’s opinion, would jeopardize the safety of the patient or compliance with the protocol.
5. A female patient who is pregnant confirmed by a pregnancy test prior to enrollment, breastfeeding, or a woman of childbearing potential (WOCBP) (as defined in Appendix 5: Contraceptive Guidance and Collection of Pregnancy Information) who does not agree to follow the contraceptive guidance in Appendix 5: Contraceptive Guidance and Collection of Pregnancy Information during the treatment period and for at least 3 months after the last dose of study treatment, and does not refrain from donating oocytes during this period.
6. A male patient who does not agree to use contraception as detailed in Appendix 5: Contraceptive Guidance and Collection of Pregnancy Information during the treatment period and for at least 3 months after the last dose of study treatment (if they have a heterosexual partner who is a woman of childbearing potential) and who does not refrain from donating sperm during this period.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Incidence and severity of SAEs, AESIs and selective AEs in patients receiving tafasitamab

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Incyte Corp.

Sponsor organisation

Incyte Corp.

Address

1801 Augustine Cut Off

City

Wilmington

Postcode

19803-4404

Country

United States

Scientific contact point

Organisation

Incyte Corp.

Contact name

Clinical Trial Information

Public contact point

Organisation

Incyte Corp.

Contact name

Clinical Trial Information

Third parties 3

Locations

3 EU/EEA countries · 5 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 47 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

13 submissions — initial application plus substantial / non-substantial modifications