Non Hodgkin Lymphoma Clinical Trial

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

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.

View Eligibility Criteria

Eligibility 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 < 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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

148

Study ID:

NCT05181540

Recruitment Status:

Recruiting

Sponsor:

Angiocrine Bioscience

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There are 20 Locations for this study

See Locations Near You

City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States More Info
Geoffrey Shouse, MD
Contact
877-467-3411
[email protected]
Geoffrey Shouse, MD
Principal Investigator
University of California, Los Angeles
Los Angeles California, 90095, United States More Info
Bruck Habtemariam
Contact
310-794-0242
[email protected]
Monica Mead, MD
Principal Investigator
UC Davis Comprehensive Cancer Center
Sacramento California, 95817, United States More Info
Leslie Mellor, CCRC
Contact
[email protected]
Mehrdad Abedi, MD
Principal Investigator
UC San Diego Moores Cancer Center
San Diego California, 92093, United States More Info
Michelle Padilla
Contact
858-822-5634
[email protected]
Carolyn Mulroney, MD
Principal Investigator
Sarah Cannon Research Institute, Colorado
Denver Colorado, 80218, United States More Info
Luke Mountjoy, DO
Contact
720-754-4800
[email protected]
Luke Mountjoy, DO
Principal Investigator
University of Miami - Sylvester Comprehensive Cancer Center
Miami Florida, 33136, United States More Info
Yolanda Davis
Contact
305-243-0494
[email protected]
Amer Beitinjaneh, MD
Principal Investigator
University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States More Info
Farhad Khimani, MD
Principal Investigator
University of Iowa Hospitals & Clinics
Iowa City Iowa, 52242, United States More Info
Karen Parrott, RN
Contact
319-353-6347
[email protected]
Umar Farooq, MD
Principal Investigator
University Of Maryland School Of Medicine
Baltimore Maryland, 21201, United States More Info
Esther Kim, RN, BSN
Contact
410-328-7339
[email protected]
Nancy Hardy, MD
Principal Investigator
Massachusetts General Hospital
Boston Massachusetts, 02114, United States More Info
Zachariah DeFilipp, MD
Contact
617-726-5765
[email protected]
Zachariah DeFilipp, MD
Principal Investigator
University of Michigan
Ann Arbor Michigan, 48109, United States More Info
Attaphol Pawarode, MD
Principal Investigator
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States More Info
Scott Rowley, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Michael Scordo, MD
Contact
646-608-3771
Michael Scordo, MD
Principal Investigator
Weill Cornell Medical College/New York Presbyterian Hospital
New York New York, 10065, United States More Info
Tsiporah Shore, MD
Principal Investigator
The Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States More Info
Samantha Jaglowski, MD
Principal Investigator
Oregon Health and Science University
Portland Oregon, 97239, United States More Info
Ariana Montoya
Contact
503-418-9382
[email protected]
Joseph Bubalo, PharmD, BCPS, BCOP
Principal Investigator
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States More Info
Rashmi Khanal, MD
Principal Investigator
Medical University of South Carolina
Charleston South Carolina, 29425, United States More Info
Irl Brian Greenwell, MD
Principal Investigator
Sarah Cannon Research Institute, Nashville
Nashville Tennessee, 37203, United States More Info
Sarah Cannon Research
Contact
615-329-7274
Jeremy Pantin, MD
Principal Investigator
Vanderbilt-Ingram Cancer Center
Nashville Tennessee, 37203, United States More Info
Bhagirathbhai Dholaria, MBBS
Principal Investigator
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Tamara Parker
Contact
713-745-3219
[email protected]
Muzaffar Qazilbash, MD
Principal Investigator
Fred Hutchinson Cancer Center
Seattle Washington, 98109, United States More Info
Jordan Gauthier, MD
Contact
[email protected]
Jordan Gauthier, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

148

Study ID:

NCT05181540

Recruitment Status:

Recruiting

Sponsor:


Angiocrine Bioscience

How clear is this clinincal trial information?

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