Treatment with SGN-35 in patients with CD30-positive hematologic malignancies who have previously participated in an SGN-35 study
- Conditions
- CD30-positive hematologic malignanciesMedDRA version: 12.1Level: LLTClassification code 10002229Term: Anaplastic large cell lymphoma T- and null-cell types recurrentMedDRA version: 12.1Level: LLTClassification code 10002230Term: Anaplastic large cell lymphoma T- and null-cell types refractoryMedDRA version: 12.1Level: LLTClassification code 10020267Term: Hodgkin's disease refractoryMedDRA version: 12.1Level: LLTClassification code 10020266Term: Hodgkin's disease recurrentMedDRA version: 12.1Level: LLTClassification code 10012821Term: Diffuse large B-cell lymphoma recurrentMedDRA version: 12.1Level: LLTClassification code 10012822Term: Diffuse large B-cell lymphoma refractory
- Registration Number
- EUCTR2010-019932-11-FR
- Lead Sponsor
- Seattle Genetics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 125
Retreatment Arm:
1. Experienced either complete or partial remission with known SGN-35 treatment, and had disease progression or relapse after discontinuing treatment in the prior SGN-35 study.
2. Completed any prior treatment with radiation, chemotherapy, biologics, and/or any other investigational agents at least 4 weeks prior to the first dose of SGN-35 in this study.
3. Documentation of CD30 expression status after most recent treatment for hematologic malignancy. If tissue from the most recent post diagnostic biopsy of relapse/refractory disease is not available, a fresh biopsy should be obtained unless rebiopsy would result in unacceptable risk in the setting of potential marginal benefit.
4. Computed tomography (CT) scan within 4 weeks preceding enrollment in this study.
5. An Eastern Cooperative Oncology Group (ECOG) performance status =2 (see Appendix D of protocol).
6. The following required baseline laboratory data: absolute neutrophil count (ANC) =1000/µL, platelets =50,000/µL, bilirubin =1.5X upper limit of normal (ULN) or =3X ULN for patients with Gilbert’s disease, serum creatinine =1.5X ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5X ULN.
7. Females of childbearing potential must have a negative serum or urine ß-hCG pregnancy test result within 7 days prior to the first dose of SGN-35 in this study. Females of nonchildbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.
8. Both females of childbearing potential and males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days following the last dose of study drug.
9. Patients or their legally authorized representative must provide written informed consent.
Extension Treatment Arm:
1. Completed treatment in a prior SGN-35 study without unacceptable toxicity and experienced clinical benefit as assessed by the Investigator. Permission from the Sponsor must be granted prior to enrollment on the extension treatment arm of the study.
2. Females of childbearing potential must have a negative serum or urine ß-hCG pregnancy test result within 7 days prior to the first dose of SGN-35 in this study. Females of nonchildbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.
3. Both females of childbearing potential and males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days following the last dose of study drug.
4. Patients or their legally authorized representative must provide written informed consent.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Retreatment Arm:
1. Withdrew consent to participate in any prior SGN-35 study.
2. Congestive heart failure, Class III or IV, by the NYHA criteria (see Appendix E of the protocol).
3. History of another primary malignancy that has not been in remission for at least 3 years. (The following are exempt from the 3-year limit: nonmelanoma skin cancer, curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear.)
4. Patients with acute or chronic graft-versus-host disease (GvHD) or receiving immunosuppressive therapy as treatment for or prophylaxis against GvHD.
5. Known cerebral/meningeal disease.
6. Any active viral, bacterial, or fungal infection requiring treatment with antimicrobial
therapy within 2 weeks prior to the first dose of SGN-35 in this study. Routine antimicrobial prophylaxis is acceptable.
7. Current therapy with other systemic antineoplastic (with the exception of corticosteroids) or investigational agents.
8. Women who are pregnant or lactating.
9. Patients with a known hypersensitivity to any excipient contained in the drug
formulation.
10. Patients with dementia or an altered mental state that would preclude the understanding and rendering of informed consent.
11. Patients <100 days from allogeneic transplant.
12. Post-allogeneic transplant patients with any detectable level of cytomegalovirus (CMV) by polymerase chain reaction (PCR). Prior PCR positivity that was successfully treated is acceptable provided the baseline PCR result is negative prior to first dose of study drug (see Section 7.5.5).
13. Patients with Grade 2 or higher peripheral neuropathy at baseline.
Extension Treatment Arm:
1. Withdrew consent to participate in any prior SGN-35 study.
2. Unable to receive first infusion of SGN-35 in this study between 21-28 days of last dose in the prior study, unless a dosing delay of up to 3 weeks is warranted for toxicity.
3. Current therapy with other systemic antineoplastic (with the exception of corticosteroids) or investigational agents.
4. Women who are pregnant or lactating.
5. Patients with a known hypersensitivity to any excipient contained in the drug formulation.
6. Post-allogeneic transplant patients must have documented CMV quantitation by PCR. If a patient has detectable levels of CMV, permission to enter the study must be granted by the Medical Monitor.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method