Clinical trial · Interventional
Epratuzumab and Rituximab in Treating Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma
A Phase II Trial of Extended Induction Epratuzumab (Anti-CD22 Monoclonal Antibody) (CALGB IND #XXXXX) Plus Rituximab in Previously Untreated Follicular Non-Hodgkin's Lymphoma (NHL)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Monoclonal antibodies, such as epratuzumab and rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving epratuzumab and rituximab together may be more effective in treating follicular non-Hodgkin lymphoma. PURPOSE: This phase II trial is studying how well giving epratuzumab together with rituximab works in treating patients with previously untreated follicular non-Hodgkin lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| epratuzumab | Biological | — | UNRESOLVED |
| rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Epratuzumab Plus Rituximab
- description
- Induction Therapy (Month 1): Epratuzumab 360 mg/m\^2 by IV days 1, 8, 15 \& 22; Rituximab 375 mg/m\^2 by IV day 3, 8, 15 \& 22 Extended Induction (Weeks 12, 20, 28 \& 36) Epratuzumab 360 mg/m\^2 by IV weeks 12, 20, 28 \& 36; Rituximab 375 mg/m\^2 by IV weeks 12, 20, 28 \& 36
- interventionNames
- Biological: epratuzumab
- Biological: rituximab
Primary outcomes (1)
- measure
- Number of Participants With Overall Response
- timeFrame
- 12 months
- description
- Overall response is defined as achievement of a complete response (CR) or partial response (PR) as defined by the Revised Response Criteria for Malignant Lymphoma. CR: complete disappearance of all detectable disease PR: \>=50% decrease in the sum of the product of diameters of indicator lesions
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically\* confirmed follicular non-Hodgkin lymphoma (NHL)
* Previously untreated disease
* WHO classification grade 1, 2, or 3a (\> 15 centroblasts per high power field with centrocytes present) that is stage III, IV, or bulky (i.e., single mass ≥ 7 cm in any unidimensional measurement) stage II disease NOTE: \*Bone marrow biopsies as the sole means of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies; fine-needle aspirates are not acceptable for diagnosis
* Confirmed CD20 antigen expression by flow cytometry or immunohistochemistry
* Measurable disease by physical examination or imaging studies
* Any tumor mass \> 1 cm is acceptable
* No nonmeasurable disease only, including any of the following:
* Bone lesions
* Ascites
* Pleural/pericardial effusion
* Lymphangitis cutis/pulmonis
* Bone marrow (involvement by NHL should be noted)
* No known CNS involvement by lymphoma
* Required to participate in companion FDG-PET imaging study CALGB 580701
PATIENT CHARACTERISTICS:
* ECOG performance status ≤ 2
* Absolute neutrophil count ≥ 1,000/μL
* Platelet count ≥ 50,000/μL
* Patients with HIV infection are eligible provided they meet the following criteria:
* No evidence of coinfection with hepatitis B or C
* CD4+ cell count ≥ 400/mm\^3
* No evidence of resistant strains of HIV
* If not on anti-HIV therapy, HIV viral load \< 10,000 copies HIV RNA/mL
* If on anti-HIV therapy, HIV viral load \< 50 copies HIV RNA/mL
* No history of AIDS-defining conditions
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 3 months after completion of study therapy
* No known Human Anti-Chimeric Antibody (HACA)-positivity
PRIOR CONCURRENT THERAPY:
* No prior therapy for NHL including chemotherapy, radiotherapy, or immunotherapy (e.g., monoclonal antibody-based therapy)
* More than 2 weeks since prior corticosteroids except for maintenance therapy for non-malignant disease
* No concurrent dexamethasone or other steroids as antiemetics except for the following circumstances:
* Treatment of acute infusion reactions according to institutional procedures
* No concurrent hormonal therapy except steroids for adrenal failure OR hormones for non-disease-related conditions (e.g., insulin for diabetes)
* No other concurrent chemotherapeutic agentsReferences
Publications (3)
- RESULTGrant BW, Jung SH, Johnson JL, Kostakoglu L, Hsi E, Byrd JC, Jones J, Leonard JP, Martin SE, Cheson BD. A phase 2 trial of extended induction epratuzumab and rituximab for previously untreated follicular lymphoma: CALGB 50701. Cancer. 2013 Nov 1;119(21):3797-804. doi: 10.1002/cncr.28299. Epub 2013 Aug 6. PMID 23922187
- DERIVEDRutherford SC, Yin J, Pederson L, Perez Burbano G, LaPlant B, Shadman M, Li H, LeBlanc ML, Kenkre VP, Hong F, Blum KA, Dockter T, Martin P, Jung SH, Grant B, Rosenbaum C, Ujjani C, Barr PM, Unger JM, Cheson BD, Bartlett NL, Kahl B, Friedberg JW, Mandrekar SJ, Leonard JP. Relevance of Bone Marrow Biopsies for Response Assessment in US National Cancer Institute National Clinical Trials Network Follicular Lymphoma Clinical Trials. J Clin Oncol. 2023 Jan 10;41(2):336-342. doi: 10.1200/JCO.21.02301. Epub 2022 Jul 5. PMID 35787017
- DERIVEDLansigan F, Barak I, Pitcher B, Jung SH, Cheson BD, Czuczman M, Martin P, Hsi E, Schoder H, Smith S, Bartlett NL, Leonard JP, Blum KA. The prognostic significance of PFS24 in follicular lymphoma following firstline immunotherapy: A combined analysis of 3 CALGB trials. Cancer Med. 2019 Jan;8(1):165-173. doi: 10.1002/cam4.1918. Epub 2018 Dec 21. PMID 30575311