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

a study on Hodgkin's Lymphoma Lymphoma Non-Hodgkin Lymphoma Hematopoietic Cell Transplantation

Summary

Eligibility
for people ages 40 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Carolyn Mulroney, MD
Headshot of Carolyn Mulroney
Carolyn Mulroney

Description

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.

Official 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)

Keywords

Hodgkin Lymphoma, Non Hodgkin Lymphoma, Lymphoma, Cellular Therapy

Eligibility

You can join if…

Open to people ages 40 years and up

  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.

You CAN'T join if...

  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

Locations

  • UC San Diego Moores Cancer Center accepting new patients
    San Diego California 92093 United States
  • University of California, Los Angeles accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at UCSD

  • Carolyn Mulroney, MD
    Co-Investigator on several clinical trials in the Blood and Marrow Transplantation Division: BMTCTN 0402, IRB # 101006, A Phase III Randomized, Multicenter Trial comparing Sirolimus/Tacrolimus with Tacrolimus/Methotrexate as a Graft-Versus-Host Disease (GVHD) Prophylaxis After HLA- Matched, Related Peripheral Blood Stem Cell transplantation. B.A.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Angiocrine Bioscience
ID
NCT05181540
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 148 study participants
Last Updated
Contact us about this trial