A Study of HDM2005 in Combination With Standard of Care in Patients With Diffuse Large B-Cell Lymphoma
Recruiting
Phase 1
Phase 2
Interventional Study
Diffuse Large B Cell Lymphoma (DLBCL)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 97 (estimated)
- Sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Industry
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About This Trial
The purpose of this phase 1b/2 study is to evaluate the safety, tolerability, and antitumor activity of HDM2005 in combination with standard of care in participants with diffuse large B-cell lymphoma. This study will include two arms: Cohort A (HDM2005 + R-GemOx) will enroll participants with relapsed/refractory DLBCL. Cohort B (HDM2005 + R-CHP) will enroll participants with untreated DLBCL. The s…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Male or female aged 18-75 years.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
3. Life expectancy \>12 weeks.
4. Histologically confirmed diffuse large B-cell lymphoma (DLBCL).
a. Cohort B: International Prognostic Index (IPI) score of 2-5.
5.…
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