A Study of the Effects of AB-205 in Patients With Lymphoma Undergoing Autologous Hematopoietic Cell Transplantation
Hodgkin Lymphoma
Lymphoma
Non-Hodgkin Lymphoma
40 Years and older, Male and Female
AB-205-301 (primary)
NCI-2022-00998
Summary
High-dose chemotherapy followed by blood stem cell transplantation is administered to
lymphoma patients with an intention to cure. However, high-dose chemotherapy
simultaneously causes damage to healthy tissues that frequently result in severe
complications that lead to hospitalization and can be life threatening. These severe
complications involve the blood, immune, gastro-intestinal systems, and other vital
organs.
The purpose of this study is to determine if experimental therapy AB-205 (study drug) can
prevent or reduce the occurrence and duration of the severe chemotherapy related
complications when compared to placebo in patients with lymphoma undergoing treatment
with high-dose chemotherapy and blood stem cell transplantation. All patients, whether
treated with AB-205 or placebo, will receive standard preventive and supportive care
therapies.
Eligibility
- Age = 40 years old
- Diagnosis of Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL)
- Candidates for HDT-AHCT with one of the following conditioning regimens:
- BEAM (carmustine, etoposide, cytarabine, melphalan)
- BeEAM (bendamustine, etoposide, cytarabine, melphalan)
- Achieved CR or PR prior to planned HDT
- ECOG = 2
- Weight = 1.6 × ideal body weight (IBW) per Devine formula
- Serum bilirubin = 2 mg/dL, unless benign congenital hyperbilirubinemia
- AST, ALT, and alkaline phosphatase < 3 × ULN
- Creatinine clearance = 30 ml/min (calculated by Cockcroft Gault)
- LVEF = 45% by MUGA or resting echocardiogram
- Pulmonary function (FEV1 and corrected DLCO) = 45% predicted
- Willingness and ability to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions
- Sexually active females of childbearing potential must have a negative urine pregnancy test and agree to use two accepted methods of contraception during the study and for 3 months after their last dose of study drug.
- Male subjects who are sexually active and who are partners of females of childbearing potential: agreement to use two forms of contraception as in criterion 12 above and to not donate sperm during the treatment period and for at least 3 months after the last dose of study drug
- Ability to provide written informed consent.
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