NM-IL-12 (rHuIL-12) In Relapsed/Refractory Diffuse Large B- Cell Lymphoma (DLBCL) Undergoing Salvage Chemotherapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02544724|
Recruitment Status : Unknown
Verified August 2016 by Neumedicines Inc..
Recruitment status was: Not yet recruiting
First Posted : September 9, 2015
Last Update Posted : August 3, 2016
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, Large B-Cell, Diffuse (DLBCL)||Biological: NM-IL-12||Phase 2|
This is a single-arm, open-label, non-randomized, multi-center study with NM-IL-12 dosed in combination with salvage chemotherapy regimens (R-ICE = rituximab plus ifosfamide-carboplatin-etoposide, R-DHAP = rituximab plus cytosine arabinoside-cisplatin-dexamethasone) for treatment of patients with relapsed/refractory DLBCL.
NM-IL-12 (150 ng/kg) will be administered subcutaneously. Patients will be monitored as routinely practiced; in addition, approximately 1 day after NM-IL-12 injection, patients will have a home visit by a nurse for blood sampling related to pharmacokinetic and pharmacodynamic (PK/PD) evaluation.
Twelve patients are planned to be enrolled into the study; initially 6 patients will be enrolled. The decision to continue and recruit the remaining six patients will be made by Data Safety Monitoring Board (DSMB) after review of relevant safety data, clinical laboratory evaluations, and vital signs collected up to 21 days post enrollment of the last patient in the first treated group. Common Terminology Grades for Adverse Events (CTCAE) guidelines will be used to determine dose-modifying criteria (DMC).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single-Arm, Open-Label Study To Evaluate The Safety, Tolerability And Preliminary Efficacy Of NM-IL-12 (rHuIL-12) In Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Undergoing Salvage Chemotherapy|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||August 2017|
|Estimated Study Completion Date :||December 2017|
NM-IL-12 will be administered subcutaneously
Single SC administration of NM-IL-12 will be administered at least 48 hours after completion of the last chemotherapy dose of each cycle
Other Name: rHu-IL12
- Safety and tolerability [ Time Frame: 4 months ]
General safety: Vital signs (temperature, blood pressure, pulse rate, respiratory rate) and physical examination.
• Toxicity according to the NCI CTCAE (v4.03) for AEs and clinical laboratory profile; AEs will be collected for all patients who received at least one dose of NM-IL-12 and up to one month post last NM-IL-12 dose.
- Immunogenicity of NM-IL-12 [ Time Frame: 4 months ]Immunogenicity of NM-IL-12 will be evaluated by the presence of anti-drug antibody (ADA)
- Response rate (Complete Response or Partial Response) as assessed by PET/CT [ Time Frame: 4 months ]Comparison will be made between the status before salvage regimen initiation, after the second chemotherapy cycle, and after completion of all salvage chemotherapy cycles. CR and PR will be assessed according to the revised International Working Group Criteria for non-Hodgkin Lymphoma.
- Time to neutrophil recovery [ Time Frame: 4 months ]Time to neutrophil recovery, as defined by first day of ANC ≥ 500/μL
- Time to platelet count recovery [ Time Frame: 4 months ]Time to platelet count recovery, as defined by first day of self-sustained platelet count ≥ 20,000/μL
- Incidence of systemic infections [ Time Frame: 4 months ]
- Incidence and duration of neutropenic fever [ Time Frame: 4 months ]
- Need for RBC and platelet transfusion [ Time Frame: 4 months ]
- Peak Plasma Concentration (Cmax) of NM-IL-12 [ Time Frame: 2 months ]
- Area under the plasma concentration versus time curve (AUC) of NM-IL-12 [ Time Frame: 2 months ]
- Peak Plasma Concentration (Cmax) of IFN-g and IP-10 [ Time Frame: 2 months ]
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): NCT02544724
|Contact: Lena A Basile, PhD, JDfirstname.lastname@example.org|
|Contact: Shawn Jackson, M.Ed.||626-773-4920|
|Principal Investigator:||Yossef Kalish, MD||Hadassah Medical Center|