Phase 1 Study of MDX-1401 in Patients With CD30-positive Refractory/Relapsed Hodgkin's Lymphoma

A Phase 1, Open-label, Dose-escalation, Multidose Study of MDX-1401 Administered Weekly for 4 Weeks in Patients With CD30-positive Refractory/Relapsed Hodgkin's Lymphoma

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00634452

Acronym

MDX1401-01

Enrollment

Registered

2008-03-13

Start date

2008-02-29

Completion date

2010-01-31

Last updated

2012-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hodgkin's Lymphomas

Keywords

Hodgkin's, Cancer, bi-measurable disease, Lymphoma

Brief summary

To establish the safety and tolerability profile of MDX-1401 in patients with relapsed or refractory Hodgkin's Lymphoma (HL).

Interventions

BIOLOGICALMDX-1401

IV weekly for 4 weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosis of CD30-positive HL by immunohistochemistry or flow cytometry * Must have failed or relapsed following second line chemotherapy or radiation or failed/relapsed following autologous stem cell transplant * Bi-measurable disease * ECOG Performance Status of 0 - 2 * Meet all screening laboratory values

Exclusion criteria

* Previous treatment with any other anti-CD30 antibody * History of allogeneic transplant * Any tumor lesion greater than or equal to 10 cm in diameter * Any active or chronic significant infection * Underlying medical condition which will make the administration of MDX- 1401 hazardous * Concomitant corticosteroids, chemotherapy, investigational agents, other anti-HL biologics, or radiation therapy

Design outcomes

Primary

Measure	Time frame
Safety and Tolerability Profile	Two years

Secondary

Measure	Time frame
Objective Response Rate (ORR)	Day 50
Tumor response assessment	Two year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026