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

Phase 3

Terminated

• Conditions: Non Hodgkin Lymphoma; Hodgkin Lymphoma
• Interventions: Biological: AB-205; Other: Placebo

• Registration Number: NCT05181540
• Lead Sponsor: Angiocrine Bioscience

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-16
• Study First Submitted QC: 2021-12-16
• Study First Posted: 2022-01-06
• Study Start: 2022-02-21
• Primary Completion: 2023-12-29
• Status Verified: 2025-01
• Study Completion: 2025-01-31
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

1. Age ≥ 40 years old

2. Diagnosis of Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL)

3. Candidates for HDT-AHCT with one of the following conditioning regimens:

   1. BEAM (carmustine, etoposide, cytarabine, melphalan)
   2. BeEAM (bendamustine, etoposide, cytarabine, melphalan)

4. Achieved CR or PR prior to planned HDT

5. ECOG ≤ 2

6. Weight ≤ 1.6 × ideal body weight (IBW) per Devine formula

7. Serum bilirubin ≤ 2 mg/dL, unless benign congenital hyperbilirubinemia

8. AST, ALT, and alkaline phosphatase < 3 × ULN

9. Creatinine clearance ≥ 30 ml/min (calculated by Cockcroft Gault)

10. LVEF ≥ 45% by MUGA or resting echocardiogram

11. Pulmonary function (FEV1 and corrected DLCO) ≥ 45% predicted

12. Willingness and ability to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions

13. 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.

14. 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

15. Ability to provide written informed consent.

Exclusion Criteria

1. History of prior HCT
2. Primary CNS lymphoma
3. Lymphoma with CNS involvement at time of relapse prior to planned HDT-AHCT
4. 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
5. 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
6. Subjects with a known history of HIV
7. Subjects who have known hypersensitivity reactions to bovine (cow) proteins or documented allergy to DMSO
8. Subject has other conditions that in the opinion of the investigator would require reduced dose (intensity) of BEAM or BeEAM regimens

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AB-205 plus standard-of-care preventive and supportive therapies.	AB-205	-
Placebo plus standard-of-care preventive and supportive therapies.	Placebo	-

Primary Outcome Measures

Name	Time	Method
The absence of oral/GI severe regimen related toxicities (oral/GI SRRT).	21 Days

Secondary Outcome Measures

Name	Time	Method
Time to neutrophil engraftment	21 Days
Duration of oral/GI SRRT	21 Days
Symptom burden per MD Anderson Symptom Inventory (MDASI)	21 Days
Duration of febrile neutropenia	21 Days

Trial Locations

Locations (28)

Banner MD Anderson Cancer Center; 🇺🇸 Gilbert, Arizona, United States

City of Hope Comprehensive Cancer Center; 🇺🇸 Duarte, California, United States

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States

UC Davis Comprehensive Cancer Center; 🇺🇸 Sacramento, California, United States

UC San Diego Moores Cancer Center; 🇺🇸 San Diego, California, United States

Sarah Cannon Research Institute, Colorado; 🇺🇸 Denver, Colorado, United States

Medstar Georgetown University Hospital; 🇺🇸 Washington, District of Columbia, United States

University of Miami - Sylvester Comprehensive Cancer Center; 🇺🇸 Miami, Florida, United States

University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States

Emory University - Winship Cancer Institute; 🇺🇸 Atlanta, Georgia, United States

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