Description:
A phase 1, open label, multi-center trial of AB-205 in adults with Hodgkin or non-Hodgkin
lymphoma who are in chemo-sensitive remission undergoing high-dose therapy, with or without
radiation, and autologous stem cell transplantation (HDT-ASCT). Subjects will receive AB-205
infusion following autologous stem cell transfusion on Day 0.
Title
- Brief Title: Trial of AB-205 in Adults With Lymphoma Undergoing High-Dose Therapy and Autologous Stem Cell Transplantation
- Official Title: A Phase 1, Open Label, Non-randomized, Multi-Center Trial of AB-205 in Adults With Lymphoma Undergoing High-Dose Therapy and Autologous Stem Cell Transplantation
Clinical Trial IDs
- ORG STUDY ID:
AB-205-001
- NCT ID:
NCT03925935
Conditions
- Hodgkin Lymphoma
- Non-hodgkin Lymphoma
Interventions
Drug | Synonyms | Arms |
---|
AB-205 | | Experimental |
Purpose
A phase 1, open label, multi-center trial of AB-205 in adults with Hodgkin or non-Hodgkin
lymphoma who are in chemo-sensitive remission undergoing high-dose therapy, with or without
radiation, and autologous stem cell transplantation (HDT-ASCT). Subjects will receive AB-205
infusion following autologous stem cell transfusion on Day 0.
Trial Arms
Name | Type | Description | Interventions |
---|
Experimental | Experimental | Up to 3 sequential dose escalation cohorts of AB-205 | |
Eligibility Criteria
INCLUSION CRITERIA
- Diagnosis of Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL) who are candidates
for HDT-ASCT with one of the following conditioning regimens:
- carmustine, etoposide, cytarabine, melphalan (BEAM)
- cyclophosphamide, carmustine, etoposide (CBV)
- thiotepa, busulphan, cyclophosphamide (TBC)
- additional myeloablative chemotherapy-based conditioning regimens may be
permitted with the approval of the medical monitor
- Adjunct radiation therapy to HDT will be allowed.
- Adequate organ function is required, defined as follows:
- Serum bilirubin ≤ 2 mg/dL, unless benign congenital hyperbilirubinemia
- AST, ALT, and alkaline phosphatase < 3 times the upper limit of normal
- Creatinine clearance ≥ 40 ml/min (calculated by Cockcroft Gault)
- LVEF ≥ 45% by MUGA or resting echocardiogram
- Pulmonary function (FEV1 and corrected DLCO) ≥ 45% predicted
- Adequate performance status ECOG ≤1
- For female subjects of childbearing potential:
- A negative serum or urine pregnancy test at screening.
- Subject must be willing to use a recommended method of contraception from the
start of the screening period and throughout the study period.
- For males who can father a child and are having intercourse with females of
childbearing potential who are not using adequate contraception:
- Subject must be willing to use a recommended method of contraception and refrain
from sperm donation from the start of conditioning therapy for at least 1 year after
completion and discussion with a treating physician.
- Willingness and ability to comply with scheduled visits, drug administration plan,
protocol-specified laboratory tests, other study procedures, and study restrictions.
- Ability to provide written informed consent.
EXCLUSION CRITERIA
- History of prior ASCT.
- Active malignancy other than the one for which the subject is undergoing HDT-ASCT.
(Subjects with cervical carcinoma in situ or localized basal or squamous cell
carcinoma treated with definitive surgery are eligible.)
- Subjects with a serious concomitant medical condition that could interfere with the
conduct of the clinical trial, such as unstable angina, renal failure requiring
hemodialysis, or active infection requiring IV antibiotics.
- Active Human Immunodeficiency Virus (HIV) infection and Acquired Immunodeficiency
Syndrome (AIDS).
- Females who are pregnant or breastfeeding or planning to become pregnant or breastfeed
during treatment and for an additional 30 days or longer after chemotherapy treatment
discontinuation if required by prescribing information for chemotherapy agents
received during the study.
- Subjects who have known hypersensitivity reactions to bovine (cow) proteins or
documented allergy to DMSO.
- Subject has other conditions that in the opinion of the investigator would place the
subject at increased risk for toxicity by participation in the study.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Occurrence of adverse events grade ≥ 3 as assessed by CTCAEv5 |
Time Frame: | 24 hours |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Occurrence of adverse events grade ≥ 3 as assessed by CTCAEv5 |
Time Frame: | 100 days |
Safety Issue: | |
Description: | |
Measure: | Severity and duration of grade ≥ 3 mucosal toxicities including oropharyngeal mucositis, nausea, vomiting, and/or diarrhea. |
Time Frame: | Day 0 to hospital discharge |
Safety Issue: | |
Description: | |
Measure: | Time to neutrophil engraftment |
Time Frame: | First of three consecutive days after ASCT of absolute neutrophil count (ANC) > 500/μL |
Safety Issue: | |
Description: | |
Measure: | Time to platelet engraftment |
Time Frame: | First of seven consecutive days after ASCT of platelet count ≥ 20,000/μL without transfusion support |
Safety Issue: | |
Description: | |
Measure: | Time to lymphoid recovery |
Time Frame: | 14, 28 and 100 days post-ASCT |
Safety Issue: | |
Description: | |
Measure: | Progression-free survival |
Time Frame: | 100 and 365 days post-ASCT |
Safety Issue: | |
Description: | |
Measure: | Non-relapse mortality |
Time Frame: | 100 and 365 days post-ASCT |
Safety Issue: | |
Description: | |
Measure: | Overall survival |
Time Frame: | 100 and 365 days post-ASCT |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Angiocrine Bioscience |
Last Updated
May 24, 2021