Randomized Phase II/III Study of Venetoclax (ABT-199) plus Chemoimmunotherapy for MYC/BCL2 Double-Hit and Double Expressing Lymphomas

April 24, 2020

Clinical Trial Information

Schema A051701

PROTOCOL: Alliance-A051701

Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.

ELIGIBILITY:

  1. Pathologic diagnosis of Diffuse Large B-cell lymphoma (DLBCL) or High grade B-cell lymphoma (HGBCL).
  2. High grade B-cell lymphoma with translocations of MYC and BCL2 (Double Hit Lymphoma, DHL), or DLBCL or high grade B-cell lymphoma NOS with protein expression by IHC of both MYC (≥40%) and BCL2 (≥50%) in the absence of dual translocations (Double Expressing Lymphoma, DEL). Local determination of FISH and IHC will be performed per standardized guidelines and will be acceptable for study entry.
  3. The diagnosis of DLBCL/HGBCL and assessment of DEL/DHL will be performed per standardized guidelines at local institutions and patients will be enrolled based on local determination. Given the heterogeneity in diagnostic work-up and interpretation, all local determinations will be followed by central confirmation in real time. Diagnostic slides and stains (or recuts/blocks) from
    all cases will be submitted to a central reference laboratory (Cleveland Clinic Laboratories). Immunostains will be reviewed or repeated (if unavailable or technically unsatisfactory) to confirm DE status. All DE cases will also be investigated for DH status, if not already performed. To exclude DH status, FISH for translocations of BCL2 (break apart probes), BCL6 (break apart probes), and MYC (break apart and IGH/MYC dual fusion probes) must be performed (either by referring site or at the central laboratory). Any missing
    information from the referring site will be supplemented by the central lab on required submitted unstained slides or blocks. Cases submitted as DH will be accepted as such upon review of submitted laboratory report.
  4. No prior treatment for DLBCL/HGBCL is allowed with the exception of corticosteroids administered for palliation, or a single cycle of either R-CHOP or DA-EPOCH-R administered prior to enrollment. This single pre-registration cycle is being allowed to facilitate enrolling patients who required immediate initiation of therapy for rapidly progressing disease, or for patients where FISH or IHC
    results returned after initiation of chemotherapy rendered them protocol eligible.
  5. Age ≥ 18 years.
  6. ECOG Performance Status 0-2.
  7. Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to initiation of protocol therapy.
  8. Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment.

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