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Clinical picture: NHL (Non Hodgkin Lymphoma)

Trial: HOVON-associated GO29365


News
1. Overview
Study details
2. Patient eligibility criteria
3. Registration (& randomization) of patients
4. Participating parties
5. Participating sites
6. Instruction videos
7. Download documentation / forms


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News


HOVON-associated GO29365 news

13-06-2016: The study is closed for patients with refractory/relapse DLBCL. The study is still open for patients with refractory / relapse FL. Please feel free to contact the local PI’s in case of any questions or to discuss the eligibility of a patient.


1. Overview



Summary

GO29365; a multicenter, open-label, phase 2 study of polatuzumab vendotin in combincation with bendamustine and rituximab versus bendamustine and rituximab in relapsed or refractory follicular lymphoma or diffuse large B-cell lymphoma


Status

closed


Members

RadboudUMC (W. Stevens),
UMCU (M. Minnema),
UMCG (GW van Imhoff) and
VUMC (M. Chamuleau)



Study details



Type of study

Prospective Phase II study


Echelon level

Limited site selection


Type of monitoring for this study

Study specific


Target number of patients

160


2. Patient eligibility criteria



Inclusion criteria

Histologically confirmed FL (Grade 1, 2 or 3a) or DLBCL
Patients must have either relapsed or have become refractory to a prior regimen:
– R/R FL
• Relapsed after having a documented history of response (CR, CRu, or PR) of >6 months in duration from completion of regimen(s)
• Refractory to any prior regimen, defined as no response to, or progression within 6 months of completion of the last dose of therapy
– R/R DLBCL in patients who are ineligible for second or third-line SCT
• with PD or SD < 6 months from start of initial therapy (2L or 3L refractory)
• with disease relapse after initial response <6 months from start of initial therapy (2L or 3L relapsed)
If patient received prior bendamustine, response duration must have been >1 year
At least one bi-dimensionally measurable lesion on imaging scan defined as >1.5 cm in its longest dimension
Confirmed availability of archival or freshly collected tumor tissue
Life expectancy of at least 24 weeks
ECOG Performance Status of 0, 1, or 2
Adequate hematologic function (unless due to underlying disease*) defined as: Hb > 9 g/dL, ANC > 1.5 x 10^9/L, Platelet count >75 x 10^9/L

For women who are not post-menopausal or surgically sterile they must agree to:
– Remain abstinent or
– Use contraceptive method(s) that result in a failure rate of <1% per year during treatment period and for ≥18 months after last dose of study drug
For women of childbearing potential, a negative serum pregnancy test result within 7 days prior to commencement of dosing
For men they must agree to:
- Remain abstinent or
– Use contraceptive method(s) that result in a failure rate of <1% per year during treatment period and for ≥6 months after last dose of study drug
– Refrain from donating sperm
– Consider preserving fertility by banking sperm prior to starting polatuzumab vedotin


Exclusion criteria

Grade 3b follicular lymphoma
History of transformation of indolent disease to DLBCL
Primary or secondary CNS lymphoma
History of other malignancy that could affect compliance with protocol or interpretation of results exceptions:
- History of curatively treated basal or squamous cell carcinoma of skin or in situ carcinoma of cervix at any time prior to the study start is eligible
- Other malignancy treated with surgery alone with curative intent and patient has been in remission without treatment for >= 3 years is eligible
- Patients with low-grade, early-stage prostate cancer with no requirement for therapy at any time prior to study are eligible
Contraindication to bendamustine or rituximab
Prior use of MAbs, radioimmunoconjugate, or ADC <4 weeks before C1D1
Autologous stem cell transplant within 100 days prior to C1D1
Prior allogeneic stem cell transplant
Eligibility for autologous SCT
Radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent to treat cancer <2 weeks prior to C1D1
Current Grade >1 peripheral neuropathy
All acute, clinically significant treatment-related toxicity from prior therapy, except for alopecia, must have resolved to Grade 2 prior to C1D1
History of severe allergic or anaphylactic reactions to humanized or murine MAbs (or recombinant antibody-related fusion proteins), or known sensitivity or allergy to murine products
Active infection at study enrollment, or any major episode of infection requiring IV antibiotics or hospitalization <4 weeks prior to C1D1
Patients with suspected or latent tuberculosis (confirmed by positive interferon-gamma release assay)
Positive test results for hepatitis B (hepatitis B surface antigen [HBsAg] and/or total hepatitis B core antibody [HBcAb])
– Patients positive for HBcAb are eligible only if PCR is negative for HBV DNA
Positive test results for hepatitis C virus (HCV) antibody
– Patients who are positive for HCV antibody must be negative for HCV by PCR to be eligible for participation
Known infection with HIV or human T-cell leukemia virus 1(HTLV-1) virus
Vaccination with a live vaccine within 28 days prior to treatment
Recent major surgery (<6 weeks prior to C1D1) except for diagnosis
Women who are pregnant or lactating or who intend to become pregnant within a year of the last dose of rituximab
Any of the following abnormal laboratory values (unless abnormal lab values are due to underlying lymphoma per investigator):
- Creatinine > 1.5 x ULN or a measured creatinine clearance <40 mL/min
- AST or ALT > 2.5 x ULN
- Total bilirubin > 1.5 x ULN. Patients with documented Gilbert disease may be enrolled if total bilirubin is ≤ 3 x ULN
- INR > 1.5 x ULN in the absence of therapeutic anticoagulation
- PTT or a PTT > 1.5 x ULN in the absence of a lupus anticoagulant
Any other diseases or findings that contraindicates the use of an investigational drug, could affect protocol compliance or that may affect interpretation of results


3. Registration (& randomization) of patients



4. Participating parties



5. Participating sites



6. Instruction videos



7. Download documentation / forms




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