February 22, 2021 Hematology/Lymphoma

Clinical Trial Information

Protocol – SWOG – S1608

SCHEMA S1608

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

Eligibility:

  1. Patients must have follicular lymphoma (Grade I, II or IIIa) confirmed at initial diagnosis and at relapse with identifiable FDG avid disease on PET/CT. Patients that have involvement with large cell lymphoma are not eligible.
  2. Patients must not have clinical evidence of central nervous system involvement by lymphoma, since the proposed treatment strategies are not designed to address CNS involvement adequately. If performed, any laboratory or radiographic tests performed to assess CNS involvement must be negative.
  3. Patients must have a whole body or limited whole body PET/CT scan performed within 42 days prior to registration.
  4. Patients must have bone marrow biopsy performed within 42 days prior to registration.
  5. The intent is to enroll patients with FL relapsed within 2 years of completing their first course of chemotherapy (CHOP or bendamustine based therapy) + anti-CD20 therapy. Patient is still eligible if he/she received radiation therapy or anti-CD20 therapy prior to chemoimmunotherapy or if maintenance anti-CD20 therapy was administered after chemoimmunotherapy.
    1. Patients must have either failed to achieve a complete remission, or must have relapsed within 2 years after completing CHOP or bendamustine-containing chemoimmunotherapy (including an anti-CD20 monoclonal antibody), as measured from the last dose of CHOP or bendamustine
    2. Relapsed patients must not have received any intervening chemotherapy.  Patients must have received only 1 course of chemotherapy, containing at least 3 cycles of CHOP or bendamustine. (Note that no minimum dose is required.).
    3. Patients who received any anti-CD20 antibody therapy prior to CHOP or bendamustine are eligible.
    4. Patients who additionally received any maintenance anti-CD20 antibody therapy or consolidative radioimmunotherapy within 2 years of the last dose of the CHOP or bendamustine therapy are eligible.
    5. Involved field or involved site radiation is not considered a line of therapy.
  6. Examples of eligible prior treatment regimens (note this list is not all inclusive):
    1. 1st line Rituximab treatment followed years later by bendamustine rituximab.
    2. Bendamustine rituximab x 4 cycles.
    3. 1st line rituximab treatment, 2nd line ibrutumomab tiuxetan, followed by bendamustine bortezomib rituximab x 6 cycles followed by rituximab maintenance.
    4. Bendamustine obinutuzumab x 3 cycles.
    5. CHOP rituximab x 6 cycles followed by rituximab maintenance
  7. For all forms of systemic therapy, patients must have completed therapy at least 21 days prior to registration. Patients must have completed any radioimmunotherapy at least 84 days prior to registration. Patients must have recovered from all treatment related toxicities from these therapies prior to registration.
  8. Patients must not have any prior treatment with any PI3K inhibitor, or lenalidomide.
  9. Patients must be able to discontinue CYP2C9 substrates with a narrow therapeutic index (e.g. warfarin, phenytoin), if randomized to TGR-1202. Patients must discontinue such agents at least 1 week or 5 half-lives prior to beginning protocol therapy (whichever is longer). A list of 2C9 substrates is available at http://medicine.iupui.edu/clinpharm/ddis/main-table/. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently updated medical reference.
  10. No second prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease free for three years.

 



April 24, 2020 Hematology/Lymphoma

Clinical Trial Information

PROTOCOL: Alliance-A051701

SCHEMA 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.

Genesys Hurley Cancer Institute

302 Kensington Avenue (Print a Map)
Flint, MI 48503

810-762-8226 | 888-762-8675

Ascension Genesys Hospital
Hurley Medical Center
Michigan Cancer Consortium

Newsletter

Ⓒ 2020 Genesys Hurley Cancer Institute | All Rights Reserved.