A study to look at how safe different doses of the study medicine - DCDS0780A - were for patients with non-Hodgkin’s Lymphoma that involved B cells

A Study of Escalating Doses of DCDS0780A in Participants With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma

Cancer
Non Hodgkin Lymphoma (NHL)

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Basic Details

Gender

All

Age

≥18 Years

Healthy Volunteers

Sponsor Hoffmann-La Roche

Phase Phase 1

Study Identifier NCT02453087, GO29687

DCDS0780A is a new medicine known as an antibody-drug conjugate or “ADC”. Patients with non-Hodgkin’s Lymphoma that involved B cells received different doses of DCDS0780A to help researchers find out which dose was safe. In a second part to this study, patients got DCDS0780A with an approved medicine called “rituximab”. Researchers wanted to know if DCDS0780A was safe when used with rituximab.

The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

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Basic Details

Sponsor Hoffmann-La Roche

Phase Phase 1

Trial Identifier NCT02453087, GO29687

Condition Non-Hodgkin's Lymphoma

Official Title An Open-label, Multicenter, Phase 1/1b Dose Escalation Study Evaluating the Pharmacokinetics, Safety, Tolerability, and Preliminary Efficacy of DCDS0780A, Alone or in Combination With Rituximab, or Obinutuzumab, in Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

Study Summary

This open-label, multicenter, Phase 1/1b study will evaluate the safety, tolerability, and pharmacokinetics of increasing doses of DCDS0780A in participants with relapsed or refractory B-cell non-Hodgkin's lymphoma. In the combination portion of the study, the safety and tolerability of DCDS0780A in combination with rituximab or obinutuzumab will be assessed.

Eligibility Criteria

Gender

All

Age

≥18 Years

Healthy Volunteers

Inclusion Criteria

Life expectancy of at least 12 weeks
Histologically confirmed B-cell non-Hodgkin's lymphoma that has relapsed after or failed to respond to at least one prior treatment regimen and for which no suitable therapy of curative intent or higher priority exists
A clinical indication for treatment as determined by the investigator
Availability of archival or freshly collected tumor tissue before study enrollment
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Fasting (greater than or equal to [>=] 8 hours) glucose less than or equal to (<=) 160 milligrams per deciliter (mg/dL)
Participants requiring anti-diabetic medications must be on a stable dose and regimen for >=4 weeks
Adequate hematologic function without growth factor or transfusion support
For women who are not postmenopausal (>= 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods as specified in protocol
For men: agreement to remain abstinent or use a condom plus an additional contraceptive method as specified in protocol

Exclusion Criteria

Prior use of any monoclonal antibody or antibody-drug conjugate within 4 weeks before Cycle 1, Day 1
Treatment with radiotherapy, any chemotherapeutic agent, systemic steroids used as an anti-neoplastic agent, or any other investigational anti-cancer agent within 2 weeks prior to Cycle 1, Day 1
Completion of autologous stem cell transplant within 100 days prior to Cycle 1, Day 1
Prior allogeneic stem cell transplant
Current or history of CNS lymphoma
Current Grade greater than (>) 1 toxicity (except alopecia and anorexia) from prior therapy
Current Grade >1 peripheral neuropathy from any cause
Glycosylated hemoglobin (HbA1c) >=7.5 percent (%)
History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
Prior irradiation to lung fields
Clinically significant pulmonary disease
Recent major surgery within 4 weeks prior to Cycle 1, Day 1, other than superficial lymph node biopsies for diagnosis
Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
Presence of positive test results for hepatitis B (hepatitis B surface antigen [HbsAg] and/or total hepatitis B core antibody [anti-HBc]) or hepatitis C (hepatitis C virus [HCV] antibody)
Known history of human immunodeficiency virus (HIV) seropositive status
Women who are pregnant or lactating or intending to become pregnant during the study
Any abnormal laboratory values as specified in protocol
Requirement for any excluded medication as specified in protocol
History of other malignancy that could affect compliance with the protocol or interpretation of results
Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications, including inadequately controlled diabetes or significant cardiovascular disease
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 intravenous antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to Cycle 1, Day 1
Participants in Phase 1b Stage Only: Vaccination with live vaccines within 6 months before Cycle 1, Day 1

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

Results Disclaimer

A study to look at how safe different doses of the study medicine - DCDS0780A - were for patients with non-Hodgkin’s Lymphoma that involved B cells

Basic Details

What you can do next

What is Clinical Research?

Basic Details

Study Summary

Eligibility Criteria

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com

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Find participating medical centers and current study status in each of them

A study to look at how safe different doses of the study medicine - DCDS0780A - were for patients with non-Hodgkin’s Lymphoma that involved B cells

Basic Details

What you can do next

Find participating medical centers and current study status in each of them

Explore related studies

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com