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Obinutuzumab and ICE Chemotherapy in Refractory/Recurrent CD20+ Mature NHL

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment25 people
  • Recruiting US sites1
  • SponsorNew York Medical College
  • RegistryNCT02393157

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

Obinutuzumab and ICE Chemotherapy in Refractory/Recurrent CD20+ Mature NHL: a one-minute explainerNCT023931571 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age3 Years to 31 Years
  • SexAll
  • Healthy volunteersNo

You may be able to join if

  • Patients in first relapse or primary induction failure CD20 positive B-cell leukemia/lymphoma including:
  • Diffuse Large B-Cell Lymphoma
  • Burkitt Lymphoma
  • High Grade B-cell Lymphoma: Not Otherwise Specified (NOS)
  • Primary mediastinal B-cell lymphoma (PMBL)
  • CD20+ B-lymphoblastic lymphoma
  • Follicular lymphoma, Grade III
  • Karnofsky ≥ 60% for patients > 16 years of age and
  • Lansky ≥ 60 for patients ≤ 16 years of age.
  • Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study.
  • Patients may not have received prior therapy with obinutuzumab (GA101)
  • Radiation Therapy (XRT): Date of receiving prior XRT must be > 2 weeks for local palliative XRT (small port); > 6 months must have elapsed if prior craniospinal XRT or if > 50% radiation of pelvis; > 6 weeks must have elapsed if other substantial bone marrow radiation.
  • Steroids: Patients may have received prior steroid treatment, but not started greater than 7 days prior to initiation of protocol therapy.
  • Adequate organ function.

You cannot join if

  • Patients with newly diagnosed, previously untreated B-NHL.
  • Known congenital or acquired immune deficiency.
  • Prior solid organ transplantation.
  • Prior allogeneic stem cell transplant within 60 days or active acute Graft-vs-Host-Disease (GVHD) grade 3 or higher.
  • History of grade 4 anaphylactic reactions to humanized or murine monoclonal antibodies
  • Uncontrolled hepatitis B and/or C infection

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

obinutuzumab. A glycoengineered, humanized IgG1 monoclonal antibody with potential antineoplastic activity. Obinutuzumab, a third generation type II anti-CD20 antibody, selectivity binds to the extracellular domain of the human CD20 antigen on malignant human B cells. The Fc region carbohydrates of the antibody, enriched in bisected non-fucosylated glycosylation variants, contribute to its higher binding affinity for human FcgammaRIII receptors compared to non-glycoengineered antibodies, resulting in enhanced antibody-dependent cellular cytotoxicity (ADCC) and caspase-independent apoptosis. In addition, modification of elbow hinge sequences within the antibody variable framework regions may account for the strong apoptosis-inducing activity of R7159 upon binding to CD20 on target cells. NCI Drug Dictionary

Treatments listed in the registry

  • Obinutuzumab (Drug): Drug will be given alone in a pre-phase and in combination with ICE chemotherapy.
  • Liposomal ARA-C (Drug): Will be given intrathecally for both prophylaxis and treatment of CNS disease.
  • Ifosfamide (Drug): Ifosfamide 3000 mg/m2/day as a 2 hour IV infusion daily x 3 days (Days 0,1,2) of Cycle 1 and 2.
  • Carboplatin (Drug): Carboplatin: 635 mg/m2 as 1 hour IV infusion on Day 0 only of Cycle 1 and 2.
  • Etoposide (Drug): Etoposide: 100 mg/m2/day as 1 hour IV infusion daily x 3 days (Days 0,1,2).

The study

Treatment groups

Non Randomized · Parallel · masking: None

Central Nervous System (CNS) Negative (Experimental)

All patients will receive 4 doses of obinutuzumab on days -14, -10, -6 and -2. Patients without CNS involvement will receive one dose of Liposomal cytarabine for CNS prophylaxis on day -13. Dexamethasone will be given for 5 days with each Liposomal cytarabine dose starting one day prior to the Liposomal cytarabine. Dexamethasone 0.15 mg/kg/dose (max 4mg) IV BID will be given days -14 to -10. Following completion of the Prephase (or at the first sign of progressive disease), all patients will proceed to cycle 1 of O-ICE. O-ICE chemotherapy is given in 21-day (3-week) cycles. Three weekly doses of obinutuzumab will be given days -2 (during the prephase), +6 and +13. Patients will receive ICE chemotherapy (ifosfamide-carboplatin-etoposide) administered on Days 0-2 of Cycle 1.

CNS Positive (Experimental)

All patients will receive 4 doses of obinutuzumab on days -14, -10, -6 and -2. Patients with positive CSF prior to enrollment will receive treatment with two doses of Liposomal cytarabine during the prephase portion of therapy. Liposomal cytarabine will be given intrathecally on days -13 and -5. Dexamethasone will be given for 5 days with each Liposomal cytarabine dose starting the day prior to the Liposomal cytarabine. Dexamethasone will be given days -14 to -10 and days -6 through -2. Following completion of the Prephase (or at the first sign of progressive disease), all patients will proceed to cycle 1 of O-ICE. O-ICE chemotherapy is given in 21-day (3-week) cycles. Three weekly doses of obinutuzumab will be given days -2 (during the prephase), +6 and +13. Patients will receive ICE chemotherapy (ifosfamide-carboplatin-etoposide) administered on Days 0-2 of Cycle 1.

Goals

What the study measures

Main goals

  • Safety as assessed by adverse reactions and events (1 month)
  • Response rate assessed following each treatment cycle for regression of tumor (3 months)

Planned enrollment: 25 (estimated).

Where

Recruiting US sites

  • New York Medical College, Valhalla, New York

Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Oct 22, 2026. Public record; not medical advice.

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