A Study of the Effects of AB-205 in Patients With Lymphoma Undergoing Autologous Hematopoietic Cell Transplantation

About

Brief 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.

Primary Purpose

Supportive Care

Study Type

Interventional

Phase

Phase III

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

40 Years

Maximum Age

N/A

Inclusion Criteria:

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.

Exclusion Criteria:

History of prior HCT
Primary CNS lymphoma
Lymphoma with CNS involvement at time of relapse prior to planned HDT-AHCT
Active malignancy other than the one for which the subject is undergoing HDT AHCT. 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
Subjects with a known history of HIV
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 require reduced dose (intensity) of BEAM or BeEAM regimens

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