SGN-35 in CD30-positive Lymphoproliferative Disorders (ALCL), Mycosis Fungoides (MF), and Extensive Lymphomatoid Papulosis (LyP)
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|ClinicalTrials.gov Identifier: NCT01352520|
Recruitment Status : Active, not recruiting
First Posted : May 12, 2011
Last Update Posted : December 20, 2022
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|Condition or disease||Intervention/treatment||Phase|
|CD-30 Positive Anaplastic Large T-cell Cutaneous Lymphoma Lymphoma, Primary Cutaneous Anaplastic Large Cell Lymphomatoid Papulosis Mycosis Fungoides Skin Lymphoma Cutaneous Lymphomas Lymphoma Hematologic Disorder||Drug: SGN-35||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||79 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Brentuximab Vedotin (SGN-35) at Dose of 1.8 mg/kg IV Every 3 Weeks in Patients With CD30-positive Lymphoproliferative Disorders (Cutaneous Anaplastic Large T-cell Lymphoma (ALCL), Mycosis Fungoides, and Extensive Lymphomatoid Papulosis (LyP)|
|Actual Study Start Date :||June 2011|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||January 2023|
1.8 mg/kg intravenously Day 1 of 21-day cycle.
1.8 mg/kg administered by outpatient IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle.
Other Name: Brentuximab vedotin
- Response Rate [ Time Frame: 12 months ]Response rate is percentage of participants with skin lesions that express CD30+ receiving SGN-35 in primary cutaneous ALCL, MF, and extensive lymphomatoid papulosis whose best response during the observation period is a Partial Response (PR), regression of measurable disease, or Complete Response (CR), complete disappearance of all clinical evidence of disease, (i.e. at least moderate improvement). Objective tumor response (PR, CR, PR+CR) based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
- Time to Progression [ Time Frame: Assessments through 8 treatment cycles (21 day cycle, approximately 6 months) with possible expansion to 16 cycles, up to 2 years. ]Time to progression calculated as the time (days) from date of first dose of study drug to date of first observed progression or death date if the death was due to disease progression whichever comes first.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients must have a biopsy confirmed diagnosis based on a combination of histological and clinical criteria of CD30+ lymphomatoid papulosis, CD30+ primary cutaneous anaplastic large T-cell lymphoma (pc-ALCL), or CD30+ mycosis fungoides for the phase II trial. There is no specific limit or validated amount other than positive cells on 1HC cells in tumor cells.
- Patients with pc-ALCL that has spread systemically (e.g. to lymph nodes, bone marrow or visceral organs) may be included so long as pc-ALCL was the primary diagnosis for at least 6 months before systemic involvement was confirmed. MF patients must be stage IB or greater.
- Systemic involvement (i.e., nodal, bone marrow or visceral organ involvement) will be evaluated by CT and/or PET and bone marrow biopsy(if indicated on patients with blood involvement) in patients with pc-ALCL or MF at baseline.
- Patients' biopsies must be histologically confirmed CD30 positive within 36 months of enrollment.
- pc-ALCL and MF patients must have progressed or relapsed after treatment with local radiation therapy, phototherapy, topical chemotherapy, or have failed systemic therapy of at least one single agent (e.g., methotrexate or bexarotene or other non-CD30 antibody) or one multi-agent chemotherapy (e.g. CHOP: cyclophosphamide, doxorubicin, vincristine, and prednisone). pc-ALCL classified patients are required to have one or more cutaneous tumors that by history have been present for at least 3 months.
- All patients must be considered an eligible candidate for systemic therapy as determined by the investigator. To be eligible, LYP patients must be in need of systemic therapy ie have scarring or active lesions (>/=10 per month), or any number of active lesions on face, hands or feet.
- Patients must have the following minimum wash-out from previous treatments: a. >/= 4 weeks for local radiation therapy, systemic cytotoxic anticancer therapy, treatment with other anticancer investigational agents. b. > 2 weeks for oral methotrexate, retinoids or biological response modifiers therapy for any indication, or topical prescription or topical therapy. c. >/= 12 weeks for any immunotherapy (e.g., monoclonal antibody). Patients with rapidly progressive disease may be treated earlier than the required washout period; patients should have recovered from prior treatment-related toxicities
- Patients must have an ECOG performance status of </= 2.
- Patients must be at least 18 years of age.
- Patients must be available for periodic blood sampling, study-related assessments, and management of toxicity at the treating institution.
- Females of childbearing potential [a female not post menopausal for at least 12 months or not surgically sterilized] must have a negative beta-HCG pregnancy </=7 days prior to Day 1 of Cycle 1. If the pregnancy test is outside institutional normal range at pretreatment, the subject must have a second pregnancy test. If the second pregnancy test is outside institutional normal range then a gynecology consult is needed to confirm the subject is not pregnant. All patients must agree to use an effective contraceptive method during the course of the study.
- Patients must give written informed consent. A copy of the signed informed consent form will be retained in the patient's chart.
- The following required baseline laboratory data: absolute neutrophil count (ANC) >/= 1000/microliter, platelets >/= 50,000/µL (unless documented bone marrow involvement with lymphoma), 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.
- Concomitant corticosteroid use for systemic or topical treatment of skin disease is not allowed except a dose of steroid of no more than 20 mg of prednisone or its equivalence is allowed of asthma, COPD or IBD .Stable use of topical corticosteroids of mid-potency will be allowed for patients with erythroderma-Sezary syndrome (T4) and tumor stage (T3) with intense pruritus.
- Patients with known grade 3 or higher (per CTCAE v.4.0 criteria) active systemic or cutaneous viral, bacterial or fungal infection.
- Patients who are known to be HIV, Hepatitis B, or Hepatitis C positive.
- Patients with known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation that includes trehalose, sodium citrate, and polysorbate 80.
- Patient with a history of other malignancies during the past three years. (The following are exempt from the 3-year limit: non-melanoma skin cancer, melanoma in situ, curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear.)
- Patients with congestive heart failure, Class III or IV, by the NYHA criteria.
- Patients who are pregnant or breastfeeding.
- Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment.
- Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01352520
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Ronald P. Rapini, MD||M.D. Anderson Cancer Center|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||M.D. Anderson Cancer Center|
|Other Study ID Numbers:||
NCI-2011-01045 ( Registry Identifier: NCI CTRP )
|First Posted:||May 12, 2011 Key Record Dates|
|Last Update Posted:||December 20, 2022|
|Last Verified:||December 2022|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
cutaneous anaplastic large T cell lymphoma
SGN-35 (brentuximab vedotin)
CD30-positive lymphoproliferative disorders
Lymphoma, T-Cell, Cutaneous
Lymphoma, Primary Cutaneous Anaplastic Large Cell
Neoplasms by Histologic Type
Immune System Diseases
Bacterial Infections and Mycoses
Antineoplastic Agents, Immunological