A Study of DCDS4501A in Combination With Rituximab, Cyclophosphamide, Doxorubicin and Prednisone in Patients With B-Cell Non-Hodgkin's Lymphoma
Overview[ - collapse ][ - ]
| Purpose | This multicenter, open-label, dose-escalation study will evaluate the safety and anti-tumor activity of DCDS4501A in combination with rituximab, cyclophosphamide, doxorubicin and prednisone in patients with non-Hodgkin's lymphoma. Cohort of patients will receive escalating doses of DCDS4501A intravenously every 3 weeks in combination with standard doses of rituximab, cyclophosphamide, doxorubicin and oral prednisone. Patients will be treated for a total of six or eight cycles in accordance with local institutional practice. |
|---|---|
| Condition | Lymphoma, B-Cell, Non-Hodgkin's Lymphoma |
| Intervention | Drug: DCDS4501A Drug: rituximab [MabThera/Rituxan] Drug: cyclophosphamide Drug: prednisone Drug: doxorubicin |
| Phase | Phase 1 |
| Sponsor | Genentech |
| Responsible Party | Genentech |
| ClinicalTrials.gov Identifier | NCT01992653 |
| First Received | October 28, 2013 |
| Last Updated | April 21, 2014 |
| Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | October 28, 2013 |
|---|---|
| Last Updated Date | April 21, 2014 |
| Start Date | November 2013 |
| Estimated Primary Completion Date | January 2017 |
| Current Primary Outcome Measures |
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| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | A Study of DCDS4501A in Combination With Rituximab, Cyclophosphamide, Doxorubicin and Prednisone in Patients With B-Cell Non-Hodgkin's Lymphoma |
|---|---|
| Official Title | A PHASE Ib STUDY EVALUATING THE SAFETY, TOLERABILITY AND ANTI-TUMOR ACTIVITY OF DCDS4501A IN COMBINATION WITH RITUXIMAB, CYCLOPHOSPHAMIDE, DOXORUBICIN, AND PREDNISONE IN PATIENTS WITH B-CELL NON-HODGKIN'S LYMPHOMA |
| Brief Summary | This multicenter, open-label, dose-escalation study will evaluate the safety and anti-tumor activity of DCDS4501A in combination with rituximab, cyclophosphamide, doxorubicin and prednisone in patients with non-Hodgkin's lymphoma. Cohort of patients will receive escalating doses of DCDS4501A intravenously every 3 weeks in combination with standard doses of rituximab, cyclophosphamide, doxorubicin and oral prednisone. Patients will be treated for a total of six or eight cycles in accordance with local institutional practice. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 1 |
| Study Design | Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Lymphoma, B-Cell, Non-Hodgkin's Lymphoma |
| Intervention | Drug: DCDS4501A escalating doses IV every 3 weeks, 6 or 8 cycles Drug: rituximab [MabThera/Rituxan] 375 mg/m2 IV every 3 weeks, 6 or 8 cycles Drug: cyclophosphamide 750 mg/m2 IV every 3 weeks, 6 or 8 cycles Drug: prednisone 100 mg orally daily for five days every 3 weeks, 6 or 8 cycles Drug: doxorubicin 50 mg/m2 IV every 3 weeks, 6 or 8 cycles |
| Study Arm (s) | Experimental: DCDS4501A |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 90 |
| Estimated Completion Date | January 2017 |
| Estimated Primary Completion Date | January 2017 |
| Eligibility Criteria | Inclusion Criteria: All Patients: - Adult patients, 60 to 80 years of age, inclusive - At least one bi-dimensionally measurable lesion, defined as > 1.5 cm in its longest dimension - Life expectancy of at least 24 weeks - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 - Adequate hematologic function (unless inadequate function is due to underlying disease, as established by extensive bone marrow involvement or is due to hypersplenism secondary to the involvement of the spleen by lymphoma per the investigator) Dose-Escalation Portion of the Study: - Histologically confirmed B-cell NHL: Patients with newly diagnosed B-cell non-Hodgkin's lymphoma (NHL) or relapsed/refractory B-cell NHL are eligible - No more than one prior systemic treatment regimen for B-cell NHL (single agent anti-CD20 monoclonal antibody therapy will not be counted as a prior treatment regimen) - No prior treatment with anthracyclines Expansion Portion of the Study: - Previously untreated patients with diffuse large B-cell lymphoma (DLBCL) - Age-adjusted IPI score of 2-3 Exclusion Criteria: Dose-Escalation Portion of the Study: - Diagnosis of primary mediastinal DLBCL Expansion Portion of the Study: - Patients with transformed lymphoma - Prior therapy for NHL All Patients: - Prior stem cell transplant - History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products - Contraindication to receive any of the individual components of R-CHP - Current Grade > 1 peripheral neuropathy, with the exception of pre-phase treatment with prednisone/prednisolone - Ongoing corticosteroid use of > 30 mg/day of prednisone/prednisolone or equivalent. Patients receiving corticosteroid treatment with prednisone//prednisolone or equivalent must be documented to be on a stable dose of at least 4 weeks' duration before Cycle 1 Day 1 - Primary CNS lymphoma - History of other malignancy that could affect compliance with the protocol or interpretation of results Patients with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix are eligible. Patients with a malignancy that has been treated with surgery alone with curative intent will also be excluded unless the malignancy has been in documented remission without treatment for >/= 5 years before enrollment. - Evidence of significant, uncontrolled concomitant diseases, including renal disease that would preclude chemotherapy administration, or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm) - Significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, congestive heart failure, myocardial infarction within the previous 6 months, unstable arrhythmias, or unstable angina) - Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks before Cycle 1 Day 1 - Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis - Positive for hepatitis B or hepatitis C infection - Prior radiotherapy to the mediastinal/pericardial region - Pregnant or lactating women |
| Gender | Both |
| Ages | 60 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Reference Study ID Number: GO29044 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com |
| Location Countries | United States, France |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01992653 |
|---|---|
| Other Study ID Numbers | GO29044 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Genentech |
| Study Sponsor | Genentech |
| Collaborators | Not Provided |
| Investigators | Study Director: Clinical Trials Genentech |
| Verification Date | April 2014 |
Locations[ + expand ][ + ]
| United States, Missouri | St. Louis, Missouri, United States, 63110 Recruiting |
|---|---|
| United States, Oregon | Portland, Oregon, United States, 97239 Recruiting |
| United States, Oregon | Portland, Oregon, United States, 97210 Recruiting |
| United States, Oregon | Springfield, Oregon, United States, 97477 Recruiting |
| United States, Washington | Seattle, Washington, United States, 19024 Not yet recruiting |
| France | Creteil, France, 94010 Not yet recruiting |
| France | Lille, France, 59037 Not yet recruiting |
| France | Pessac, France, 33604 Not yet recruiting |
| France | Pierre Benite, France, 69495 Not yet recruiting |
| France | Rennes, France, 35033 Not yet recruiting |
| France | Rouen, France, 76038 Not yet recruiting |