Clinical trial · Interventional

Monoclonal Antibody Therapy and Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma

A Phase II Study of Epratuzumab, Rituximab (ER)-CHOP for Patients With Previously Untreated Diffuse Large B-Cell Lymphoma

NCT00301821CI-TRIAL-00041058completedPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

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. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibody therapy together with chemotherapy may kill more cancer cells.\> PURPOSE: This phase II trial is studying how well giving monoclonal antibody therapy together with combination chemotherapy works in treating patients with stage II, stage III, or stage IV diffuse large B-cell 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 (6)

Intervention	Type	Mapped drug	Match
cyclophosphamide	Drug	Cyclophosphamide	ALIAS
doxorubicin hydrochloride	Drug	Doxorubicin	ALIAS
epratuzumab	Biological	—	UNRESOLVED
prednisone	Drug	Prednisone	ALIAS
rituximab	Biological	Rituximab	ALIAS
vincristine sulfate	Drug	Vincristine	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Epratuzumab + Rituximab + CHOP
description
One arm open label.
interventionNames
1. Biological: epratuzumab
2. Biological: rituximab
3. Drug: cyclophosphamide
4. Drug: doxorubicin hydrochloride
5. Drug: prednisone
6. Drug: vincristine sulfate

Primary outcomes (1)

measure
Event-free Survival After 12 Months
timeFrame
From Baseline to 12 months
description
The primary endpoint of the trial was the percentage of the eligible patients who were alive and event-free 12 months after enrollment to the study (EFS12).

Secondary outcomes (3)

measure

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Histologically confirmed diffuse large B-cell lymphoma

  * B-cell phenotype (CD20+) as determined by immunohistochemistry (IHC) or flow cytometry
  * Stage II, III, or IV disease
* CD22+ tumor by IHC\*

NOTE: \*CD22 status may be determined after study enrollment

* Measurable disease, defined as at least 1 lesion ≥ 1.5 cm by CT scan or physical exam
* No relapsed or refractory non-Hodgkin's lymphoma
* No history of transformed lymphoma
* No CNS lymphoma

  * CNS symptoms or bone marrow or sinus involvement must have absence of CNS lymphoma confirmed by lumbar puncture

PATIENT CHARACTERISTICS:

* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3

  \- For patients with ECOG PS 3, the PS must be disease related
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Total bilirubin ≤ 2 mg/dL (if total bilirubin \> 2 mg/dL, direct bilirubin should be within normal limits)
* AST ≤ 3 times upper limit of normal (ULN) (5 times ULN if there is liver involvement)
* Creatinine ≤ 2 times ULN
* Life expectancy ≥ 12 weeks
* Negative pregnancy test
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 12 months after completion of study treatment
* No active serious infection requiring antibiotics
* No New York Heart Association class III or IV heart disease
* No other primary malignancy within the past 5 years, except for squamous cell or basal cell carcinoma of the skin, in situ carcinoma of the cervix, or previously treated prostate cancer with a stable prostate-specific antigen
* No known HIV positivity
* No known hepatitis B or C infection
* Ejection fraction ≥ 45% by MUGA or echocardiogram (required if patients has a history of heart disease or is ≥ 50 years old)
* Willing to provide blood and tissue samples for mandatory translational research component of study

PRIOR CONCURRENT THERAPY:

* No prior therapy for diffuse large B-cell lymphoma, including the following:

  * Chemotherapy
  * Immunotherapy
  * Biologic therapy
  * Radiotherapy
* Prior short course (≤ 14 days) of corticosteroids allowed
* Prior splenectomy allowed
* No prior pelvic irradiation
* No other concurrent investigational agents
* No concurrent chemotherapy, immunotherapy, or radiotherapy
* No concurrent enrollment on another treatment study involving a pharmacologic agent (e.g., drugs, biologics, immunotherapy, or gene therapy)

References

Publications (5)

BACKGROUNDMicallef IN, Kahl BS, Maurer MJ, Dogan A, Ansell SM, Colgan JP, Geyer S, Inwards DJ, White WL, Habermann TM. A pilot study of epratuzumab and rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy in patients with previously untreated, diffuse large B-cell lymphoma. Cancer. 2006 Dec 15;107(12):2826-32. doi: 10.1002/cncr.22342. PMID 17099879
RESULTMaurer MJ, Micallef IN, Cerhan JR, Katzmann JA, Link BK, Colgan JP, Habermann TM, Inwards DJ, Markovic SN, Ansell SM, Porrata LF, Johnston PB, Nowakowski GS, Thompson CA, Gupta M, Syrbu SI, Kurtin PJ, Macon WR, Nikcevich DA, Witzig TE. Elevated serum free light chains are associated with event-free and overall survival in two independent cohorts of patients with diffuse large B-cell lymphoma. J Clin Oncol. 2011 Apr 20;29(12):1620-6. doi: 10.1200/JCO.2010.29.4413. Epub 2011 Mar 7. PMID 21383282
RESULTMicallef IN, Maurer MJ, Wiseman GA, Nikcevich DA, Kurtin PJ, Cannon MW, Perez DG, Soori GS, Link BK, Habermann TM, Witzig TE. Epratuzumab with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy in patients with previously untreated diffuse large B-cell lymphoma. Blood. 2011 Oct 13;118(15):4053-61. doi: 10.1182/blood-2011-02-336990. Epub 2011 Jun 14. PMID 21673350
RESULTMicallef IN, Maurer MJ, Nikcevich DA, et al.: Final results of NCCTG N0489: epratuzumab and rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy (ER-CHOP) in patients with previously untreated diffuse large B-cell lymphoma. [Abstract] J Clin Oncol 27 (Suppl 15): A-8508, 2009.
DERIVEDGhesquieres H, Larrabee BR, Haioun C, Link BK, Verney A, Slager SL, Ketterer N, Ansell SM, Delarue R, Maurer MJ, Fitoussi O, Habermann TM, Peyrade F, Dogan A, Molina TJ, Novak AJ, Tilly H, Cerhan JR, Salles G. FCGR3A/2A polymorphisms and diffuse large B-cell lymphoma outcome treated with immunochemotherapy: a meta-analysis on 1134 patients from two prospective cohorts. Hematol Oncol. 2017 Dec;35(4):447-455. doi: 10.1002/hon.2305. Epub 2016 Jun 10. PMID 27282998

Registry

Dates and enrollment

Start: Jan 1, 2006
Primary completion: Oct 1, 2008
Completion: Apr 1, 2015
First posted: Mar 13, 2006
Last update posted: Oct 9, 2019
Results first posted: Mar 24, 2015
Enrollment: 107 (actual)
Lead sponsor: Alliance for Clinical Trials in Oncology OTHER
Collaborators: National Cancer Institute (NCI)
Keywords: contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma

Data updated 22 days agoSource updated Oct 9, 2019source: clinicaltrials

Locations

Locations by country (162)

Country	Sites	Recruiting
United States	162	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.