Phase II Study of Mogamulizumab With DA-EPOCH or CHOEP in Patients With Aggressive T-cell Lymphoma

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Single-arm Phase II study evaluating the combination of mogamulizumab (MOGA) added on top of standard of care dose adjusted EPOCH (DA-EPOCH) or CHOEP in patients with newly diagnosed or relapsed/refractory (for CTCL only) aggressive T-cell lymphoma including patients with Adult T-cell leukemia/lymphoma (ATLL).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Male/female patients who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of T-cell Non-Hodgkin lymphoma (TNHL) will be enrolled in this study.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 unless compromised by lymphoma with anticipated benefit from chemotherapy as determined and documented by the investigator.

• Histologically confirmed T-cell Non-Hodgkin lymphoma (T-NHL), including but not limited to:

‣ Peripheral T-cell lymphoma not otherwise specified (PTCL nos)

⁃ Angioimmunoblastic T-cell lymphoma (AITL)

⁃ Anaplastic large-cell lymphoma (ALCL)

⁃ Cutaneous T-cell lymphoma (CTCL), including mycosis fungoides (MF)/sezary syndrome patients for whom multi-agent chemotherapy is indicated

⁃ Transformed mycosis fungoides/Sézary syndrome

⁃ Enteropathy-associated T-cell lymphoma (EATL)

⁃ Subcutaneous panniculitis-like T-cell lymphoma (SCPTCL)

⁃ Hepatosplenic T- cell lymphomas

⁃ Gamma delta T-cell lymphomas

⁃ Adult T-cell lymphoma leukemia (ATLL)

⁃ T-prolymphocytic leukemia with nodal or visceral involvement

• Prior therapy- patients with aggressive T-cell lymphoma may have received one cycle of CHOP, CHOEP or EPOCH before enrollment, if necessary, to control the disease.

• For patients with peripheral T-cell lymphoma (PTCL): At least one measurable target lesion ≥ 1.5 cm

• A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:

‣ Not a woman of childbearing potential (WOCBP) as defined in Appendix 4 OR

⁃ A woman of childbearing potential (WOCBP) - see Appendix 4 for definition of WOCBP - must have a negative serum or urine pregnancy test during screening and must agree to follow instructions for using acceptable contraception (Appendix 5) from the time of signing consent, and at least 180 days (6 months) after her final dose of mogamulizumab.

• A male patient must agree to use a contraception as detailed in Appendix 5 of this protocol during the treatment period and for at least at least 180 days (6 months) after her final dose of mogamulizumab and refrain from donating sperm during this period.

• Adequate organ and bone marrow function resulted ≤ 10 days prior to first dose of protocol-indicated treatment unless compromised by disease involvement of bone marrow, spleen, or liver as determined and documented by the investigator.

• Patients previously treated with anti-CD4 antibody or alemtuzumab are eligible provided their CD4+ cell counts are ≥ 200/mm.

Locations
United States
Connecticut
Yale Cancer Center, Clinical Trials Office
RECRUITING
New Haven
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Contact Information
Primary
Carole Ramm
carole.ramm@yale.edu
(203) 785-4095
Backup
Stephanie Ladd
stephanie.ladd@yale.edu
954-895-0576
Time Frame
Start Date: 2024-10-09
Estimated Completion Date: 2027-11
Participants
Target number of participants: 22
Treatments
Experimental: Mogamulizumab + DA-EPOCH or CHOEP
All subjects are scheduled to receive six cycles of DA-EPOCH + Mogamulizumab~Cycle 1: Mogamulizumab on days 1,8,15, of a 21-day cycle with DA-EPOCH on day 1.~Cycles 2 to 6: Mogamulizumab on day 1 with DA-EPOCH or CHOEP~Mogamulizumab will be administered modified to a 21-day cycle in combination with chemotherapy. Subjects will receive 1.0 mg/kg of mogamulizumab as an IV infusion over at least 1 hour on Days 1, 8, 15 of the first cycle and Day 1 for the subsequent cycles. This is based on prior studies with mogamulizumab in combination of chemotherapy.(15) This dosing regimen will ensure the first 4 doses are given weekly at a dose of 1 mg/kg. Subsequent dosing on a 21-day schedule to coincide with the frequency of administration of DA-EPOCH or CHOEP to allow for simpler co-administration of the study drugs. In addition, this study proposes to leverage the immunomodulatory role of mogamulizumab, the dosing for this has not been previously established or explored.
Sponsors
Collaborators: Kyowa Kirin, Inc.
Leads: Yale University

This content was sourced from clinicaltrials.gov