Venetoclax in Combination With BEAM Conditioning Regimen for ASCT in Non-Hodgkin Lymphoma

Completed · Phase 1

Conditions studied: Non-hodgkin Lymphoma

In brief

The purpose of this study is to determine the correct dose and safety of adding a new cancer drug, Venetoclax, to a standard combination of chemotherapy drugs used prior to Autologous stem cell transplant (ASCT) in participants with Non-Hodgkin Lymphoma (NHL). In this study, Venetoclax will be added to BEAM (BCNU or carmustine, etoposide, cytarabine or ara-c, and melphalan). All NHL participants are admitted for conditioning chemotherapy which is given prior to the infusion of stem cells. Venetoclax is a new anti-cancer drug that works by targeting a protein (known as the Bcl-2 protein). By inhibiting or "blocking" this protein, a downstream cascade occurs which results in cancer cells to die. Adding Venetoclax to the standard BEAM conditioning chemotherapy with autologous stem cell transplant is believed to increase the chance of remission. Venetoclax is Food and Drug Administration (FDA) approved for participants with chronic lymphocytic leukemia (CLL). However, Venetoclax is investigational for this study because it is not yet approved for use in participants with NHL or in combination with BEAM chemotherapy.

Key facts

Study ID: NCT03713580
Run by: Case Comprehensive Cancer Center
People needed: 25
Starts: 2019-03-12
Expected to finish: 2025-11-07
Last updated by the study team: 2026-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients must have histologically confirmed Non-Hodgkin Lymphoma (NHL) including T-cell lymphomas, after at least one prior systemic treatment regimen such as CHOP, R-CHOP, CHOEP, R-EPOCH, R-HyperCVAD, BR, VR-CAP alternating with rituximab and cytarabine, etc.
Patients in complete or partial remission, or in the case of patients with stable or refractory disease are undergoing autologous transplantation because it has been recommended by their treating physician as representing their best treatment option.
ECOG Performance status ≤ 2 at time of consent [See Appendix I].
Patients must have normal organ and marrow function as defined below:
Hemoglobin ≥ 8.0 g/dl
Absolute neutrophil count ≥ 1,000/mcL
Platelet count ≥ 75,000/mcL
Total bilirubin ≤ 1.5X the upper limit of normal (ULN) unless a known history of impaired bilirubin conjugation such as Gilbert's.
AST (SGOT) ≤ 2.5 X institutional ULN
ALT (SGPT) ≤ 2.5 X institutional ULN
Patients must have a calculated serum creatinine clearance > 50 mL/min using Cockcroft-Gault calculation or based on 24-hour urine collection performed within 7 days prior to treatment.
Cardiac ejection fraction >45% or clearance by PI or Cardiology
DLCO of >45% predicted or clearance by PI or Pulmonology
Specific guidelines will be followed regarding inclusion of NHL based on Hepatitis B serological testing as follows:
HBsAg negative, HBcAb negative, HBsAb negative patients are eligible.
HBsAg negative, HBcAb negative, HBsAb positive patients are eligible.
Patients who test positive for HBsAg are ineligible.
Patients with HBsAg negative, but HBcAb positive (regardless of HBsAb status) should have a HBV DNA testing performed and protocol eligibility determined as follows:
If HBV DNA is positive, the patient is ineligible.
If HBV DNA is negative, the patient may be included but must undergo HBV DNA PCR testing monthly x 3 months beginning from the start of treatment
Female patients who are not surgically sterile or postmenopausal (for at least 1year) must practice at least one of the following methods of birth control throughout the duration of study participation and for at least 30 days after study treatment:
Total abstinence from sexual intercourse
A vasectomized partner
Hormonal contraceptives (oral, parenteral, vaginal ring, or transdermal) that started at least 3months prior to study drug administration
Double-barrier method (condom+diaphragm or cervical cup with spermicidal contraceptive sponge, jellies, or cream)

Where it is running

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center — Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.