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October 16, 2019 Leukemia

Research & Trial Information

SCHEMA S1712

Protocol#: SWOG – S1712

Cancer Type: Chronic Myeloid Leukemia CLL

Patient Eligibility:

  1. Patients must have a diagnosis of chronic phase chronic myeloid leukemia without any history of progression to accelerated or blast phase CML. No new bone marrow aspiration and biopsy is needed to prove diagnosis prior to randomization; however, documentation stating the patient is in chronic phase is required.
  2. Patients must have detectable BCR-ABL transcripts measured by RT-PCR at a CLIA-approved laboratory and reported on the International Scale (IS) with a value of > 0.0032% IS and ≤ 1.0% IS within 21 days prior to randomization. The RT-PCR assay must have the sensitivity to detect a 4.5 log reduction in BCR-ABL transcripts from baseline (at least 0.0032% IS).
  3. Patients must be receiving treatment with dasatinib (within the allowable dose range of 70-100 mg daily) or nilotinib (within the allowable dose range of 200-400 mg BID) as first or second line therapy for a minimum of 6 months prior to registration.
  4. Patients must not have received > 2 TKIs for treatment of CML (hydroxyurea prior to initiation of TKI is allowed).
  5. Patients must have been on their current TKI for a minimum of 6 months prior to randomization.
  6. If dasatinib or nilotinib is second-line therapy, the reason for stopping first-line treatment must not have been resistance to prior treatment or failure to achieve an adequate response on their first-line TKI (e.g., the patient could have stopped due to intolerance to prior TKI).
  7. Patients must have been receiving TKI treatment for CML for at least one year and no more than 10 years prior to randomization.
  8. Patients must be expected to remain on the same TKI for the next 12 months.
  9. Patients must not be receiving any other investigational agents.
  10. Patients must be ≥ 18 years of age.


October 16, 2019 Leukemia

Research & Trial Information

SCHEMA EA9161

Protocol#: ECOG – EA9161

Cancer Type: Leukemia

Patient Eligibility:

  1. Diagnosis of CLL, this includes previous documentation of: 

    Biopsy-proven small lymphocytic lymphoma

    OR

    Diagnosis of CLL according to the NCI/IWCLL criteria as evidenced by all of the following:

    Peripheral blood lymphocyte count of greater than 5 x109/L

    Immunophenotype consistent with CLL defined as:

    The predominant population of lymphocytes share both Bcell antigens [CD19, CD20 (typically dim expression), or CD23] as well as CD5 in the absence of other pan-T-cell markers (CD3, CD2, etc).

    Clonality as evidenced by κ or λ light chain restriction (typically dim immunoglobulin expression)

    Negative FISH analysis for t(11;14)(IgH/CCND1) on peripheral blood or tissue biopsy (e.g. marrow aspirate) or negative immunohistochemical stains for cyclin D1 staining on involved tissue biopsy (e.g. marrow aspirate or lymph node biopsy.

  2. No prior chemotherapy, BTK inhibitor therapy, venetoclax, small molecule signaling inhibitor, or monoclonal anti-body therapy for treatment of CLL or SLL.

  3. Has met at least one of the following indications for treatment:

    Evidence of progressive marrow failure as manifested by the development of worsening anemia (Hg < 11 g/dl) and/or thrombocytopenia (Platelets < 100 x 109/L)

    Symptomatic or progressive lymphadenopathy, splenomegaly, or hepatomegaly.

    One or more of the following disease-related symptoms:

    Weight loss ≥ 10% within the previous 6 months

    Grade 2 or 3 fatigue attributed to CLL

    Fevers >100.5oF for 2 weeks without evidence of infection

    Clinically significant night sweats without evidence of infection

    Progressive lymphocytosis (not due to the effects of corticosteroids) with an increase of >50% over a two-month period or an anticipated doubling time of less than six months.

  4. Age ≥ 18 years and < 70.
  5. ECOG performance status between 0-2.
  6. Life expectancy of ≥ 12 months.
  7. No deletion of 17p13 on cytogenetic analysis by FISH.
  8. No current use of corticosteroids.
  9. No previous autoimmune complications (e.g. autoimmune hemolytic anemia or immune thrombocytopenia) that have developed since the initial diagnosis of CLL and have required treatment with high dose corticosteroids (e.g. equivalent of >20 mg/day of prednisone), monoclonal antibody based therapy, or chemotherapy.

  10. No other active primary malignancy (other than non-melanomatous skin cancer or carcinoma in situ of the cervix) requiring treatment or limiting expected survival to ≤ 2 years.

  11. No radiation therapy ≤ 4 weeks prior to registration.
  12. Patients may not be on any other investigational agents.


October 16, 2019 Leukemia

Research & Trial Information

SCHEMA A041702

Protocol#: Alliance – A041702

Cancer Type: Chronic Lymphocytic Leukemia CLL

Patient Eligibility:

  1. Patients must have been diagnosed with CLL and have > 5000 B-cells per uL of peripheral blood at any point during the course of their disease.
  2. Patients must be intermediate or high-risk Rai stage CLL.
  3. Patients must meet criteria for treatment as defined by 2018 IWCLL guidelines[16] which includes at least one of the following criteria:o Evidence of marrow failure as manifested by the development or worsening of

    anemia or thrombocytopenia (not attributable to autoimmune hemolytic anemia

    or thrombocytopenia)

    o Massive (≥6 cm below the costal margin), progressive or symptomatic

    splenomegaly

    o Massive nodes (≥10 cm) or progressive or symptomatic lymphadenopathy

    o Progressive lymphocytosis with a lymphocyte doubling time < 6 months or an

    increase of ≥ 50% over a 2 month period

    o Autoimmune anemia and/or thrombocytopenia that is poorly responsive to

    standard therapy

    o Symptomatic or functional extranodal involvement (e.g. skin, kidney, lung,

    spine)

    o Constitutional symptoms, which include any of the following:

    ▪ Unintentional weight loss of 10% or more within 6 months

    ▪ Significant fatigue

    ▪ Fevers >100.5 degrees F for 2 weeks or more without evidence of

    infection

    ▪ Night sweats ≥1 month without evidence of infection

  4. Patients must not have had prior therapy for CLL (except palliative steroids or treatment of autoimmune complications of CLL with rituximab or steroids).
  5. Treatment with rituximab and/or high dose corticosteroids for autoimmune complications of CLL must be complete at least 4 weeks prior to enrollment. Palliative steroids must be at a dose not higher than 20 mg/day of prednisone or equivalent corticosteroid at the time of registration.
  6. Age ≥ 70 years.
  7. ECOG performance status 0-2.
  8. Patients must not be receiving active systemic anticoagulation with heparin or warfarin. Patients on warfarin must discontinue the drug for at least 10 days prior to registration on the study.
  9. Chronic concomitant treatment with strong inhibitors of CYP3A4/5 is not allowed on this study. Patients on strong CYP3A inhibitors must discontinue the drug for  14 days prior to registration on the study.
  10. Chronic concomitant treatment with strong CYP3A4/5 inducers is not allowed.
  11. Patients must not require more than 20 mg prednisone or equivalent corticosteroid daily.
  12. Patients must not have uncontrolled active systemic infection requiring intravenous antibiotics.
  13. Central FISH blood results are mandatory prior to registration/randomization.


October 16, 2019 Leukemia

Research & Trial Information

SCHEMA A041501

Protocol#: Alliance – A041501

Cancer Type: Acute Lymphocytic Leukemia

Patient Eligibility:

  1. Newly diagnosed patients with CD-22 positive B-cell acute lymphoblastic leukemia (WHO criteria) are eligible. Patients with Burkitt type ALL are NOT eligible.
  2. Patients who have BCR-ABL fusion transcript determined by FISH or RT-PCR or t(9;22)(q34;q11) by cytogenetics are not eligible and should be considered for enrollment on studies that incorporate imatinib during induction.
  3. Positivity for CD22 and CD20 is defined as baseline expression of the CD22 or CD20 antigen in more than 20% of leukemic cells using local multiparameter flow-cytometric immunophenotyping with the use of CD45 expression as a marker to gate the ALL blast population, according to recommendations from the European LeukemiaNet.
  4. No prior therapy for ALL except for limited treatment (≤ 7 days) with corticosteroids or hydroxyurea and a single dose of intrathecal cytarabine. However, patients who are being treated with chronic steroids for other reasons (for example, to treat asthma, autoimmune disorders, lupus, etc.) are eligible.
  5. No prior therapy for acute leukemia except emergency therapy (corticosteroids or hydroxyurea) for blast cell crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration of the kidneys. When indicated, leukapheresis or exchange transfusion is recommended to reduce the WBC.
  6. Single-dose intrathecal cytarabine is allowed prior to registration or prior to initiation of systematic therapy for patient convenience. This is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture. Systemic chemotherapy must begin within 72 hours of this intrathecal therapy.
  7. Age ≥ 18 years and < 40 years.
  8. ECOG Performance Status 0-2.

Genesys Hurley Cancer Institute

302 Kensington Avenue
Flint, MI 48503

810-762-8226 | 888-762-8675

Ascension Genesys Hospital
Hurley Medical Center
Michigan Cancer Consortium

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