Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Leukemia, Lymphocytic, Chronic, B-Cell

Neoplasm, Residual

Leukemia, Biphenotypic, Acute

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Neoplastic Processes

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Chronic Graft Versus Host Disease

Lymphosarcoma

Chronic Lymphocytic Leukemia

Acute Graft Versus Host Disease

Acute Leukemia of Ambiguous Lineage

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Tisagenlecleucel

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antimetabolites

Antineoplastic Agents, Immunological

LYMPHODEPLETING CHEMOTHERAPY: Patients may receive standard chemotherapy comprised of fludarabine phosphate IV over 1 hour and cyclophosphamide IV over 3 hours on days -5 to -3 or cyclophosphamide IV every 12 hours on days -5 to -3 at the discretion of the treating physician.

Within 30 days post completion of lymphodepletion, patients receive CD19 positive chimeric antigen receptor T-cells IV over 15-30 minutes on day 0, or split into two portions on days 0 and 1.

Fludarabine Phosphate

Laboratory Biomarker Analysis

Partow Kebriaei

This phase I clinical trial studies the side effects and best dose of CD19-specific T-cells in treating patients with lymphoid malignancies that have spread to other places in the body and usually cannot be cured or controlled with treatment. Sometimes researchers change the deoxyribonucleic acid (DNA) (genetic material in cells) of donated T-cells (white blood cells that support the immune system) using a process called "gene transfer." Gene transfer involves drawing blood from the patient, and then separating out the T-cells using a machine. Researchers then perform a gene transfer to change the T-cells' DNA, and then inject the changed T-cells into the body of the patient. Injecting modified T-cells made from the patient may help attack cancer cells in patients with advanced B-cell lymphoma or leukemia.

PRIMARY OBJECTIVES:

I. To determine the safety and maximum tolerated dose of genetically modified, CD19-specific T cells administered into patients with CD19+ advanced lymphoid malignancies.

SECONDARY OBJECTIVES:

I. To screen for the development of host immune responses against the CD19-specific chimeric antigen receptor (CAR).

II. To describe the homing ability of the infused T cells. III. To assess disease response. IV. To determine persistence of CAR+ T cells.

OUTLINE: This is a dose escalation study of CD19 positive chimeric antigen receptor T-cells.

LYMPHODEPLETING CHEMOTHERAPY: Patients may receive standard chemotherapy comprised of fludarabine phosphate intravenously (IV) over 1 hour and cyclophosphamide IV over 3 hours on days -5 to -3 or cyclophosphamide IV every 12 hours on days -5 to -3 at the discretion of the treating physician.

Within 30 days post completion of lymphodepletion, patients receive CD19 positive chimeric antigen receptor T-cells IV over 15-30 minutes on day 0, or split into two portions on days 0 and 1.

After completion of study treatment, patients are followed up for at least 15 years.

CD19-Specific T-cells in Treating Patients With Advanced Lymphoid Malignancies

CD19+ Chimeric Antigen Receptor T Cells for Patients With Advanced Lymphoid Malignancies

Will be defined as the highest dose for which the posterior probability of toxicity is closest to 25%. Demographic and clinical characteristics will be summarized using descriptive statistics by dose level. The number of patients with dose limiting toxicities will be reported at each dose level.

Computed with a corresponding 95% confidence interval.

Estimated with a corresponding 95% confidence interval.

National Cancer Institute (NCI)

Ziopharm Oncology

M.D. Anderson Cancer Center

Recurrence

Philadelphia Chromosome

Translocation, Genetic

Chromosome Aberrations

Amino Acids

Epratuzumab

Cysteine

Patients receive ADCT-602 by vein over 30 minutes on day 1. Courses repeat every 21 in the absence of disease progression or unacceptable toxicity. Patients who achieve CR/CRi receive ADCT-602 every 28 days.

Starting dose of ADCT-602: 30 μg/kg given by vein.

ADCT-602

Nitin Jain

Ibrahim Aldoss, MD

This phase I/II trial studies the side effects and best dose of ADCT-602 in treating patients with B-cell lymphoblastic leukemia that has come back or does not respond to treatment. Monoclonal antibodies, such as ADCT-602, may interfere with the ability of tumor cells to grow and spread.

PRIMARY OBJECTIVES:

I. Evaluate the safety and determine the maximum tolerated dose (MTD) of ADCT-602 in patients with relapsed or refractory B-cell (B)-acute lymphoblastic leukemia (ALL) in Phase 1.

II. Determine the recommended dose of ADCT-602 for Phase 2. III. Evaluate the efficacy (complete response \[CR\] with incomplete marrow recovery \[CR/CRi\] rate) of ADCT-602 in Phase 2.

SECONDARY OBJECTIVES:

I. Evaluate the clinical activity of ADCT-602, based on duration of response (DOR), overall survival (OS), and progression-free survival (PFS).

II. Characterize the pharmacokinetic (PK) profile of ADCT-602. III. Evaluate the immunogenicity of ADCT-602. IV. Characterize the effect of ADCT-602 exposure on the QT interval.

EXPLORATORY OBJECTIVES:

I. Obtain preliminary data on the correlation between the clinical activity and PK profile of ADCT-602 with the baseline expression of CD22 and other cluster of differentiation (CD) markers in peripheral blood.

II. Assess the impact of soluble CD22 (sCD22) on ADCT-602 PK.

OUTLINE: This is a dose escalation study followed by a phase II study.

Patients receive ADCT-602 intravenously (IV) over 30 minutes on day 1. Courses repeat every 21 in the absence of disease progression or unacceptable toxicity. Patients who achieve CR/CRi receive ADCT-602 every 28 days.

After completion of study treatment, patients are followed up at 30 days and then every 12 weeks for up to 1 year.

ADCT-602 in Treating Patients With Recurrent or Refractory B-cell Acute Lymphoblastic Leukemia

A Phase I/II Study to Evaluate the Safety and Anti-Tumor Activity of ADCT-602 Targeting CD22 in Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia

The MTD is the highest dose level in which the study has treated 6 patients with at most 1 experiencing the DLT. The 3+3 algorithm along with DLTs observed during the first 21 days of the first treatment cycle will be used to guide dose escalation/de-escalation.

The recommended dose of ADCT-602 for phase 2 is the MTD or a dose lower than MTD, which is defined based on toxicity and efficacy profile.

Simon's two-stage design will be used. CR/CRi rate is defined as the best response (CR/CRi) noted during the study period.

Blood for testing the amount of ADCT-602 in the body at different time points drawn 4 times over the 6 hours after the dose.

ADC Therapeutics S.A.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CD19-Specific T-cells in Treating Patients With Advanced Lymphoid Malignancies	NCT02529813	Acute Biphenoty... Acute Lymphobla... Blasts 5 Percen... CD19 Positive Minimal Residua... Non-Hodgkin Lym... Small Lymphocyt... Stage III Chron... Stage IV Chroni...	Cyclophosphamid... Fludarabine Pho... Laboratory Biom... Tisagenlecleuce...	1 Year - 80 Years	M.D. Anderson Cancer Center
CD19-Specific T-cells in Treating Patients With Advanced Lymphoid Malignancies	NCT02529813	Acute Biphenoty... Acute Lymphobla... Blasts 5 Percen... CD19 Positive Minimal Residua... Non-Hodgkin Lym... Small Lymphocyt... Stage III Chron... Stage IV Chroni...	Cyclophosphamid... Fludarabine Pho... Laboratory Biom... Tisagenlecleuce...	1 Year - 80 Years	M.D. Anderson Cancer Center
ADCT-602 in Treating Patients With Recurrent or Refractory B-cell Acute Lymphoblastic Leukemia	NCT03698552	Blasts 5 Percen... CD22 Positive Philadelphia Ch... Recurrent B Acu... Refractory B Ac...	ADCT-602	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for blasts 5 percent or more of bone marrow nucleated cells