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Clinical Trials Search

Clinical Trial 21412

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT05181540

Phase: Phase III
Principal Investigator: Khimani, Farhad

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study Title

A Phase 3 Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of AB-205 plus Standard of Care versus Placebo plus Standard of Care in Adults with Lymphoma Undergoing High-Dose Therapy and Autologous Hematopoietic Cell Transplantation (HDT-AHCT) (E-CELERATE)

Summary

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.

Objective

Treatments

Therapies

Chemotherapy (NOS); Immunotherapy

Medications

Inclusion Criteria

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 > 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

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.

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.