Phase 2
Completed N=53
A Phase I/II Study of Lenalidomide and Obinutuzumab With CHOP for Diffuse Large B Cell Lymphoma
Source: ClinicalTrials.gov NCT02529852 ↗Enrolled (actual)
53
Serious AEs
39.6%
Results posted
Sep 2024
Primary outcomePrimary: Safety of LO-CHOP — 70; 0 percentage of participants
Summary
There are 2 parts to this study: Part 1 (dose de-escalation) and Part 2 (dose expansion).
The goal of Part 1 of this clinical research study is to find the highest tolerable dose of lenalidomide in combination with obinutuzumab and CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) that can be given to patients with diffuse large B cell lymphoma.
The goal of Part 2 of this clinical research study is learn if the dose of lenalidomide found in Part 1 can help to control the disease.
The safety of this drug combination will be studied in both parts.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety of LO-CHOP |
70; 0 | — |
| SECONDARY Overall Survival |
91.3 | — |
| SECONDARY Progression Free Survival |
87.4 | — |
Eligibility Criteria
Inclusion Criteria
- Confirmed treatment-naïve de novo CD20+ DLBCL, regardless of cell of origin, with Stage II-IV disease, or Stage I disease if 6 cycles of chemotherapy are planned.
- Measurable disease on cross section imaging that is at least 1.5 cm in the longest diameter and measurable in two perpendicular dimensions
- Appropriate candidate for systemic immune-chemotherapy such as the standard RCHOP21 6 cycles as determined by the treating physician
- Age >/=18
- Adequate organ function (normal cardiac ejection fraction of >45%, serum bilirubin 30 mL/min (Calculated according to Cockcroft - Gault formula) unless due to lymphoma with documentation of normal function prior to onset of lymphoma. In the case of Gilberts Syndrome, or documented liver or pancreatic involvement by lymphoma, the requirement for total bilirubin is 1000/mm3, hemoglobin >8.0, and platelets >100,000/mm3. If bone marrow is involved with lymphoma and normal marrow function prior to onset of lymphoma is documented: ANC of >750, any hemoglobin, and platelets of >50,000/mm3.
- Performance status /= 12 months after the last dose of obinutuzumab. For men, effective contraception is required to continue for 3 months after the last dose of obinutuzumab treatment.
- Vaccination with a live vaccine a minimum of 28 days prior to the start of treatment
- Peripheral neuropathy >/= Grade 2
- Subjects who are unwilling to take VTE prophylaxis
Data sourced from ClinicalTrials.gov (NCT02529852). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.