Protocol: SWOG – S1925

SCHEMA S1925

Please Note:  Below is partial eligibility, for full eligibility requirement’s,  please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038. Thank you!

Eligibility:

1. Participants must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
2. Participants must have CLL-International Prognostic Index (CLL-IPI) Score ≥ 4 and/or complex cytogenetics (defined as 3+ chromosomal abnormalities).
3. Cytogenetic and FISH analyses must be completed at a CLIA-approved laboratory within 12 months prior to registration. FISH panel should use probes to detect for abnormalities in chromosomes 13q, 12, 11q, and 17p.
4. TP53 mutation status (if completed) must be obtained within 12 months prior to registration.
5. IgVH mutational status must be obtained prior to registration (at any time prior to registration).
6. Serum beta-2 microglobulin level must be obtained within 28 days prior to registration.
7. Treatment with high dose corticosteroids and/or intravenous immunoglobulin for autoimmune complications of CLL must be complete at least 4 weeks prior to enrollment.
8. Steroids used for treatment of conditions other than CLL/SLL must be at a dose of at most 20 mg/day of prednisone or equivalent corticosteroid at the time of registration.
9. Prior therapy with anti CD20 monoclonal antibodies is not allowed.
10. Participants must not have received or be currently receiving any prior CLLdirected therapy, including non-protocol-related therapy, anti-cancer immunotherapy, experimental therapy, or radiotherapy.
11. Participants must not be receiving or planning to receive any other investigational agents before completing protocol therapy.
12. Must be at least 18 years of age.
13. ECOG Performance Status 0-2.
14. Participants with history of malignancy are allowed providing the cancer has not required active treatment within 2 years prior to registration (hormonal therapy is permissible). The following exceptions are permissible: basal cell, squamous cell skin, or non-melanomatous skin cancer, in situ cervical cancer, superficial bladder cancer not treated with intravesical chemotherapy or BCG within 6 months, localized prostate cancer requiring no more than chronic hormonal therapy, or localized breast cancer requiring no more than chronic hormonal therapy.

Protocol: Alliance – A041703

SCHEMA A041703

Please Note: Below is partial eligibility, for full eligibility requirement’s, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038. Thank you!

Eligibility:

Pre-Registration Step 0:

1. Submission of bone marrow aspirate and peripheral blood for MRD analysis is mandatory prior to registration; the bone marrow sample should be from the first aspiration (i.e. first pull). Aspirate needle should be redirected if needed to get first pull bone marrow aspirate. It should be initiated as soon as possible after pre-registration.

Registration Step 1:

1. Morphologic diagnosis of precursor B-cell acute lymphoblastic leukemia (ALL) based on WHO criteria. Patients with Burkitt lymphoma/leukemia are not eligible.
2. CD22-positive disease defined as CD22 expression by ≥ 20% of lymphoblasts by local hematopathology evaluation.
3. Philadelphia chromosome/BCR-ABL1-negative ALL by cytogenetics, FISH, and/or PCR. If any test is positive for Philadelphia chromosome/BCR-ABL1, then the patient is ineligible.
4. No active central nervous system (CNS) leukemia (i.e. only CNS-1 disease allowed). Active CNS leukemia is defined as morphologic evidence of lymphoblasts in the cerebrospinal fluid (CSF), use of CNS-directed local treatment for active disease within 28 days prior to registration, symptomatic CNS leukemia (i.e. cranial nerve palsies or other significant neurological dysfunction) within the 28 days prior to registration, and/or known asymptomatic parenchymal CNS mass lesions; see below for additional guidance. Prophylactic intrathecal medication alone is not an exclusion.
5. Categories of CNS Involvement for CNS Evaluation Prior to Registration:

o CNS 1: CSF has < 5 WBC/μL with cytospin negative for blasts; or ≥ 10
RBC/μL with cytospin negative for blasts.

o CNS 2: CSF has < 5 WBC/μL with cytospin positive for blasts; or ≥ 10
RBC/μL with cytospin positive for blasts; or ≥ 10 RBC /μL, WBC/μL ≥ 5
but less than Steinherz/Bleyer algorithm with cytospin positive for blasts
(see below).

CNS 3: CSF has ≥ 5 WBC/μL with cytospin positive for blasts; or ≥ 10
RBC/μL, ≥ 5 WBC/μL and positive by Steinherz/Bleyer algorithm (see
below); or clinical signs of CNS leukemia (such as facial nerve palsy,
brain/eye involvement or hypothalamic syndrome).

5. Patients with known or suspected testicular involvement by leukemia are allowed provided that the patient receives concomitant scrotal/testicular radiotherapy.

6. ECOG Performance Status 0-2.

7. Cohort 1 Patients Only:  Age ≥ 60 years.  No prior treatment for ALL except a single dose of intrathecal chemotherapy, corticosteroids, hydroxyurea, and/or leukapheresis to reduce peripheral blast count and prevent ALL complications. Allowed therapy may be administered for no more than 14 days and must be completed ≥ 24 hours prior to the initiation of protocol therapy. No plan for allogeneic or autologous hematopoietic cell transplantation (HCT).

8. Cohort 2 Patients Only: Age ≥ 18 years.  Relapsed or refractory disease in salvage 1 or 2. No isolated extramedullary relapse.  Prior allogeneic HCT permitted.  Patients with prior allogeneic HCT must have completed transplantation ≥ 4 months prior to registration.  Patients with prior allogeneic HCT must have no evidence of graft-versus-host disease and must have completed immunosuppressive therapy ≥ 30 days prior to registration. Prior treatment with inotuzumab ozogamicin, blinatumomab, other CD22-directed therapy, or other CD19-directed therapy is not allowed. Prior treatment with rituximab must be completed ≥ 7 days prior to registration.  Prior treatment with other monoclonal antibodies must be completed ≥ 6 weeks prior to registration.  Prior treatment for ALL must be completed ≥ 14 days prior to registration with the following exceptions: intrathecal chemotherapy, hydroxyurea, corticosteroids, 6-mercaptopurine, methotrexate, vincristine, and/or leukapheresis to reduce circulating absolute lymphoblast count to ≤ 10,000/μL or prevent complications related to ALL are allowed but must be completed ≥ 24 hours prior to the initiation of protocol therapy.

PROTOCOL: SWOG-S1712

SCHEMA S1712

Please Note: Below is partial eligibility, for full eligibility requirement’s,  please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038. Thank you!

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 RTPCR assay must have the sensitivity to detect a 4.5 log reduction in BCR-ABL transcripts from 100% IS (must be able to detect (0.0032% IS or lower).
3. Patients must have been on TKI therapy for CML for at least 12 months prior to randomization. Hydroxyurea prior to initiation of TKI is allowed.
4. Patients must be currently receiving treatment with bosutinib (within the allowable dose range of 200-500 mg daily), nilotinib (within the allowable dose range of 150-400 mg BID or a cumulative daily dose of 300-800 mg), imatinib (within the allowable dose range of 300-400 mg daily), or dasatinib (within the allowable dose range of 40-140 mg daily). They must have received their current TKI for a minimum of 6 months prior to randomization and must be expected to remain on the same TKI for the next 12 months.
5. Patient must not have a history of resistance to any prior TKI drug. If patient has received more than one TKI, the reason for changing treatment must have been something other than resistance or inadequate response to the prior TKI (for
   example, intolerance to the prior TKI) and the treatment change must have occurred ≥6 months prior to randomization.
6. Must be at least 18 years of age.