Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Behaviors and Mental Disorders

Infections

Symptoms and General Pathology

Rare Diseases

Lymphoma

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Aggression

Burkitt Lymphoma

Precursor B-Cell Lymphoblastic Leukemia-Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Communicable Diseases

Epstein-Barr Virus Infections

Virus Diseases

Herpesviridae Infections

DNA Virus Infections

Tumor Virus Infections

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin

Lymphosarcoma

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

B-cell Lymphoma

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

SGN-CD19A (IV) once (Day 1) or twice (Days 1 and 8) every 21 days; dose range: 0.3-6 mg/kg

SGN-CD19A

Eric Feldman, MD

This is a phase 1, open-label, dose-escalation, multicenter study to evaluate the safety and tolerability of SGN-CD19A in adult and pediatric patients with relapsed or refractory B-lineage acute lymphoblastic leukemia (B-ALL), Burkitt lymphoma or leukemia, or B-lineage lymphoblastic lymphoma (B-LBL).

A Safety Study of SGN-CD19A for Leukemia and Lymphoma

A Phase 1, Open-Label, Dose-Escalation Study of SGN-CD19A in Patients With B-Lineage Acute Lymphoblastic Leukemia and Highly Aggressive Lymphomas

Seagen Inc.

Hematologic Neoplasms

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Leukemia, Myeloid, Chronic-Phase

Preleukemia

Myelodysplastic Syndromes

Leukemia, Biphenotypic, Acute

Leukemia, Myeloid, Accelerated Phase

Disease Attributes

Myeloproliferative Disorders

Bone Marrow Diseases

Chronic Disease

Myeloid Leukemia

Acute Myeloid Leukemia

Chronic Graft Versus Host Disease

Acute Non Lymphoblastic Leukemia

Chronic Myeloid Leukemia

Acute Leukemia of Ambiguous Lineage

Chronic Myeloproliferative Disorders

Alpha beta T cell and B cell depleted allogeneic transplantation with individualized dosing of ATG for patients with hematologic malignancies

Participants in this study will receive a blood stem cell transplant, which will use an investigational device called the CliniMACs device to remove alpha/beta T cells and B cells from the blood cells collected from the donor. This is called T cell depletion and B cell depletion.

Magnetic-Activated Cell Sorter (CliniMACS, Miltenyi)

Meredith Beversdorf, RN

Amy Moskop

This is a single arm pilot study for patients with hematologic malignancies receiving unrelated or haploidentical related mobilized peripheral stem cells (PSCs) using the CliniMACS system for alpha/beta T cell depletion plus CD19+ B cell depletion with individualized ALC-based dosing of ATG to study impact on engraftment, GVHD, and disease free survival

MCW Alpha/Beta T-Cell and B-Cell Depletion With Targeted ATG Dosing

Matched Unrelated Donor and Partially Matched Related Donor Peripheral Stem Cell Transplantation With Alpha/Beta T-Cell and B-Cell Depletion for Patients With Hematologic Malignancies With Targeted ATG Dosing Pilot Study, IDE 13641

Medical College of Wisconsin

Assistant Professor

Pathologic Complete Response

Disease Progression

Childhood Acute Lymphoblastic Leukemia

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

Anti-Infective Agents

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Micronutrients

Hematinics

Vitamins

Dexamethasone

Cytarabine

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Methotrexate

Vincristine

Dexamethasone acetate

BB 1101

Ofatumumab

Ichthammol

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Antimetabolites

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Antiviral Agents

Tubulin Modulators

Antimitotic Agents

HIV Protease Inhibitors

Protease Inhibitors

Folinic Acid

Folate

Vitamin B9

COURSES 1, 3, 5, 7: Patients receive hyper-CVAD comprising cyclophosphamide IV over 3 hours every 12 hours on days 1-3; doxorubicin hydrochloride IV over 24 hours on day 4; vincristine sulfate IV over 15 minutes on days 4 and 11; and dexamethasone IV over 30 minutes or PO QD on days 1-4 and 11-14. Patients also receive ofatumumab IV over 4-6 hours on days 1 and 11 of courses 1 and 3.

COURSES 2, 4, 6, 8: Patients receive high-dose methotrexate IV over 2 hours and then over 22 hours on day 1 and cytarabine IV over 2 hours every 12 hours on days 2-3. Patients also receive ofatumumab IV over 4-6 hours on days 1 and 8 of courses 2 and 4.

Treatment repeats every 21-28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients may receive maintenance therapy for an additional 30 months.

Doxorubicin Hydrochloride

Laboratory Biomarker Analysis

Vincristine Sulfate

Elias Jabbour

This phase II trial studies how well combination chemotherapy and ofatumumab work in treating patients with acute lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with ofatumumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy together with ofatumumab may be an effective treatment for acute lymphoblastic leukemia or lymphoblastic lymphoma.

PRIMARY OBJECTIVES:

I. To evaluate the clinical efficacy of the combination of hyper-CVAD (cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, and dexamethasone) + ofatumumab in patients with newly diagnosed acute lymphoblastic leukemia with any level of CD20 expression: event-free survival; overall response rate; overall survival.

SECONDARY OBJECTIVES:

I. To evaluate the safety of this combination.

OUTLINE:

COURSES 1, 3, 5, 7: Patients receive hyper-CVAD comprising cyclophosphamide intravenously (IV) over 3 hours every 12 hours on days 1-3; doxorubicin hydrochloride IV over 24 hours on day 4; vincristine sulfate IV over 15 minutes on days 4 and 11; and dexamethasone IV over 30 minutes or orally (PO) once daily (QD) on days 1-4 and 11-14. Patients also receive ofatumumab IV over 4-6 hours on days 1 and 11 of courses 1 and 3.

COURSES 2, 4, 6, 8: Patients receive high-dose methotrexate IV over 2 hours and then over 22 hours on day 1 and cytarabine IV over 2 hours every 12 hours on days 2-3. Patients also receive ofatumumab IV over 4-6 hours on days 1 and 8 of courses 2 and 4.

Treatment repeats every 21-28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients may receive maintenance therapy for an additional 30 months.

After completion of study treatment, patients are followed up at 30 days and then every 3 months for 1 year.

Combination Chemotherapy and Ofatumumab in Treating Patients With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Phase II Study of the Hyper - CVAD Regimen in Combination With Ofatumumab as Frontline Therapy for Patients With CD-20 Positive Acute Lymphoblastic Leukemia

Complete Remission is Normalization of the peripheral blood and bone marrow with 5% or less blasts in marrow with a granulocyte count of 1 x 109/L or above and a platelet count of 100x 109/L or above. Complete resolution of all sites of extramedullary disease is required for CR.

Overall Survival is defined as time from date of treatment start until date of death due to any cause or last Follow-up. For continuous data, summary statistics including n, mean, standard deviation, median, minimum and maximum will be computed. The posterior median time to event and it 95% credible interval will be estimated. Kaplan-Meier method, Log rank test and Cox proportional hazards regression modeling will be utilized to analyze survival at 4 years.

Event Free Survival defined as the time from the start of therapy to time of primary refractory disease, relapse from CR, death from any cause or last follow-up. Kaplan-Meier method will be utilized to analyze event free survival for the 4 year percent alive and in CR.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

COURSES 1, 3, 5, 7: Patients receive hyper-CVAD comprising cyclophosphamide IV over 3 hours every 12 hours on days 1-3; doxorubicin hydrochloride IV over 24 hours on day 4; vincristine sulfate IV over 15 minutes on days 4 and 11; and dexamethasone IV over 30 minutes or PO QD on days 1-4 and 11-14. Patients also receive ofatumumab IV over 4-6 hours on days 1 and 11 of courses 1 and 3.

COURSES 2, 4, 6, 8: Patients receive high-dose methotrexate IV over 2 hours and then over 22 hours on day 1 and cytarabine IV over 2 hours every 12 hours on days 2-3. Patients also receive ofatumumab IV over 4-6 hours on days 1 and 8 of courses 2 and 4.

Treatment repeats every 21-28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients may receive maintenance therapy for an additional 30 months.

Cyclophosphamide: Given IV

Cytarabine: Given IV

Dexamethasone: Given IV or PO

Doxorubicin Hydrochloride: Given IV

Laboratory Biomarker Analysis: Correlative studies

Methotrexate: Given IV

Ofatumumab: Given IV

Vincristine Sulfate: Given IV

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Safety Study of SGN-CD19A for Leukemia and Lymphoma	NCT01786096	Burkitt Lymphom... Precursor B-cel...	SGN-CD19A	1 Year -	Seagen Inc.
MCW Alpha/Beta T-Cell and B-Cell Depletion With Targeted ATG Dosing	NCT05794880	Leukemia Acute Myeloid L... Myelodysplasia Acute Lymphobla... Chronic Myeloge... Chronic Myeloge... Chronic Myeloge... Biphenotypic Ac... Lymphoblastic L... Burkitt Lymphom... Burkitt Leukemi... Lymphoma After ... Other Malignant...	Magnetic-Activa...	0 Years - 25 Years	Medical College of Wisconsin
A Safety Study of SGN-CD19A for Leukemia and Lymphoma	NCT01786096	Burkitt Lymphom... Precursor B-cel...	SGN-CD19A	1 Year -	Seagen Inc.
MCW Alpha/Beta T-Cell and B-Cell Depletion With Targeted ATG Dosing	NCT05794880	Leukemia Acute Myeloid L... Myelodysplasia Acute Lymphobla... Chronic Myeloge... Chronic Myeloge... Chronic Myeloge... Biphenotypic Ac... Lymphoblastic L... Burkitt Lymphom... Burkitt Leukemi... Lymphoma After ... Other Malignant...	Magnetic-Activa...	0 Years - 25 Years	Medical College of Wisconsin
Combination Chemotherapy and Ofatumumab in Treating Patients With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma	NCT01363128	Acute Lymphobla... Adult Acute Lym... Burkitt Leukemi... Burkitt Lymphom... CD20 Positive Childhood Acute... Lymphoblastic L...	Cyclophosphamid... Cytarabine Dexamethasone Doxorubicin Hyd... Laboratory Biom... Methotrexate Ofatumumab Vincristine Sul...	-	M.D. Anderson Cancer Center
MCW Alpha/Beta T-Cell and B-Cell Depletion With Targeted ATG Dosing	NCT05794880	Leukemia Acute Myeloid L... Myelodysplasia Acute Lymphobla... Chronic Myeloge... Chronic Myeloge... Chronic Myeloge... Biphenotypic Ac... Lymphoblastic L... Burkitt Lymphom... Burkitt Leukemi... Lymphoma After ... Other Malignant...	Magnetic-Activa...	0 Years - 25 Years	Medical College of Wisconsin

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