CHRONOS Clinical Trials

Learn about ongoing studies investigating patients with relapsed/refractory indolent non-Hodgkin's lymphomas (iNHL).

BAY 80-6946 is being investigated for uses that are not approved by the EMA, FDA, or other health authorities.
This site contains information about BAY 80-6946 clinical trials.
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Contact us for more information on clinical trials
1-844-229-3710Bayer@emergingmed.com

Ongoing Clinical Trials

DESCRIPTION

RECRUITING STATUS

CHRONOS-3: A phase III study of BAY 80-6946 in combination with rituximab in relapsed indolent NHL. (NCT02367040)
  • Now enrolling
  • Phase III

Disease of Interest

  • Indolent Non-Hodgkin’s Lymphoma

Primary Outcome Measure:

  • Progression free survival (PFS)

Secondary Outcome Measures:

  • Objective response rate (ORR), duration of response (DOR), complete response, time to progression (TTP), overall survival (OS), quality of life (QoL)
  • Safety and tolerability

Selected Inclusion Criteria:

  • Patients ≥18 years with histologically confirmed diagnosis of CD20 positive Indolent non-Hodgkin’s lymphoma (limited to: FL grades 1-3a, SLL, LPL/WM, MZL)
  • Relapsed after ≥1 prior line of rituximab-containing therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  • Availability of fresh tumor tissue and/or archival tumor tissue at screening
  • Treatment-free interval after the last rituximab-based treatment of ≥12 months or unfit for chemotherapy (eg, age, comorbidities, residual toxicities) with treatment-free interval after the last rituximab-based treatment of ≥6 months

Selected Exclusion Criteria:

  • Histologically confirmed diagnosis of FL grade 3b or disease transformation, or CLL
  • Patients with HbA1c >8.5% at screening
  • Documented evidence of resistance to prior treatment with idelalisib or other PI3K inhibitors
  • Prior treatment with BAY 80-6946

FL=follicular lymphoma; SLL=small lymphocytic lymphoma; MCL=mantle cell lymphoma; LPL/WM=lymphoplasmacytic lymphoma/Waldenström's macroglobulinemia;
MZL=marginal zone lymphoma

For complete information please visit: http://www.clinicaltrials.gov (NCT02367040)

CHRONOS-4: A phase III study of BAY 80-6946 in combination with standard immunochemotherapy in relapsed indolent NHL. (NCT02626455)
  • Now enrolling
  • Phase III

Disease of Interest

  • Indolent Non-Hodgkin’s Lymphoma

Primary Outcome Measure:

  • Safety run-in: Determination of the recommended Phase III dose of BAY 80-6946 in combination with standard immunochemotherapy assessed by the occurrence of dose-limiting toxicities and adverse events
  • Phase III: To evaluate BAY 80-6946 in combination with standard immunochemotherapy, compared to standard immunochemotherapy assessed by progression free survival (PFS)

Secondary Outcome Measures:

  • Objective tumor response rate (ORR), duration of tumor response (DOR), complete tumor response rate (CRR), time to tumor progression (TTP), overall survival (OS), quality of Life (QoL)
  • Safety and tolerability

Selected Inclusion Criteria:

  • Patients ≥18 years with histologically confirmed diagnosis of CD20 positive indolent NHL (limited to: FL G1-2-3a, SLL, LPL/WM, MZL)
  • Relapsed after 1-3 prior lines of therapy, including rituximab and alkylating agents
  • Previous exposure to PI3K is acceptable provided there is no resistance
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  • Availability of fresh tumor tissue and/or archival tumor tissue at screening

Selected Exclusion Criteria:

  • Histologically confirmed diagnosis of FL grade 3b, transformed disease, or CLL
  • Rituximab resistance at any line of therapy
  • Patients with HbA1c >8.5% at screening
  • Uncontrolled hypertension

FL=follicular lymphoma; SLL=small lymphocytic lymphoma; MCL=mantle cell lymphoma; LPL/WM=lymphoplasmacytic lymphoma/Waldenström’s macroglobulinemia;
MZL=marginal zone lymphoma. *Patients will also be stratified by NHL histology (FL vs other iNHL) and duration of treatment-free interval (6-12 months vs >12 months)

For complete information please visit: http://www.clinicaltrials.gov (NCT02626455)

Contact us for more information on clinical trials
1-844-229-3710Bayer@emergingmed.com

Ongoing Clinical Trials

phase

DESCRIPTION

RECRUITING STATUS

Disease of Interest

Phase III
CHRONOS-3: A phase III study of BAY 80-6946 in combination with rituximab in relapsed indolent NHL. (NCT02367040)
Now enrolling
Indolent Non-Hodgkin’s Lymphoma

Primary Outcome Measure:

  • Progression free survival (PFS)

Secondary Outcome Measures:

  • Objective response rate (ORR), duration of response (DOR), complete response, time to progression (TTP), overall survival (OS), quality of life (QoL)
  • Safety and tolerability

Selected Inclusion Criteria:

  • Patients ≥18 years with histologically confirmed diagnosis of CD20 positive Indolent non-Hodgkin’s lymphoma (limited to: FL grades 1-3a, SLL, LPL/WM, MZL)
  • Relapsed after ≥1 prior line of rituximab-containing therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  • Availability of fresh tumor tissue and/or archival tumor tissue at screening
  • Treatment-free interval after the last rituximab-based treatment of ≥12 months or unfit for chemotherapy (eg, age, comorbidities, residual toxicities) with treatment-free interval after the last rituximab-based treatment of ≥6 months

Selected Exclusion Criteria:

  • Histologically confirmed diagnosis of FL grade 3b or disease transformation, or CLL
  • Patients with HbA1c >8.5% at screening
  • Documented evidence of resistance to prior treatment with idelalisib or other PI3K inhibitors
  • Prior treatment with BAY 80-6946

FL=follicular lymphoma; SLL=small lymphocytic lymphoma; MCL=mantle cell lymphoma; LPL/WM=lymphoplasmacytic lymphoma/Waldenström’s macroglobulinemia;
MZL=marginal zone lymphoma

For complete information please visit: http://www.clinicaltrials.gov (NCT02367040)

Phase III
CHRONOS-4: A phase III study of BAY 80-6946 in combination with standard immunochemotherapy in relapsed indolent NHL. (NCT02626455)
Now enrolling
Indolent Non-Hodgkin’s Lymphoma

Primary Outcome Measure:

  • Safety run-in: Determination of the recommended Phase III dose of
    BAY 80-6946 in combination with standard immunochemotherapy assessed by the occurrence of dose-limiting toxicities and adverse events
  • Phase III: To evaluate BAY 80-6946 in combination with standard immunochemotherapy, compared to placebo and standard immunochemotherapy assessed by progression free survival (PFS)

Secondary Outcome Measures:

  • Objective tumor response rate (ORR), duration of tumor response (DOR), complete tumor response rate (CRR), time to tumor progression (TTP), overall survival (OS), quality of Life (QoL)
  • Safety and tolerability

Selected Inclusion Criteria:

  • Patients ≥18 years with histologically confirmed diagnosis of CD20 positive indolent NHL (limited to: FL grades 1-3a, SLL, LPL/WM, MZL)
  • Relapsed after 1-3 prior lines of therapy, including rituximab and alkylating agents
  • Previous exposure to PI3K inhibitor is acceptable provided there is no resistance
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  • Availability of fresh tumor tissue and/or archival tumor tissue at screening

Selected Exclusion Criteria:

  • Histologically confirmed diagnosis of FL grade 3b, transformed disease, or CLL
  • Rituximab resistance at any line of therapy
  • Patients with HbA1c >8.5% at screening
  • Uncontrolled hypertension

FL=follicular lymphoma; SLL=small lymphocytic lymphoma; MCL=mantle cell lymphoma; LPL/WM=lymphoplasmacytic lymphoma/Waldenström’s macroglobulinemia;
MZL=marginal zone lymphoma. *Patients will also be stratified by NHL histology (FL vs other iNHL) and duration of treatment-free interval (6-12 months vs >12 months)

For complete information please visit: http://www.clinicaltrials.gov (NCT02626455)