## Protocol Section
### Identification Module
**NCT ID:** NCT00324779

**Brief Title:** Rituximab in Treating Young Patients Who Are Receiving Chemotherapy for B-Cell Non-Hodgkin's Lymphoma or B-Cell Acute Lymphoblastic Leukemia

**Official Title:** Multicenter Therapy Study for Children With Mature B-NHL or B-ALL With a Rituximab - Window Before Chemotherapy

#### Organization Study ID Info
**ID:** CDR0000466643
#### Organization
**Class:** NIH
**Full Name:** National Cancer Institute (NCI)
#### Secondary ID Infos
**ID:** B-NHL-BFM-Rituximab
**ID:** EU-205119
**ID:** NHL-BFM-RITUXIMAB
### Status Module
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-09-25

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-09-24

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2011-04

**Type:** ACTUAL

#### Start Date
**Date:** 2004-03

**Status Verified Date:** 2015-09

#### Study First Post Date
**Date:** 2006-05-11
**Type:** ESTIMATED
**Study First Submit Date:** 2006-05-10
**Study First Submit QC Date:** 2006-05-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital Erlangen

### Description Module

**Brief Summary:** RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Giving rituximab before chemotherapy may be an effective treatment for B-cell non-Hodgkin's lymphoma or B-cell acute lymphoblastic leukemia.

PURPOSE: This phase II trial is studying how well rituximab works in treating young patients who are planning to receive chemotherapy for B-cell non-Hodgkin's lymphoma or B-cell acute lymphoblastic leukemia.

**Detailed Description:** OBJECTIVES:

* Determine the response rate in children and adolescents with B-cell non-Hodgkin's lymphoma (B-NHL) or B-cell acute lymphoblastic leukemia (B-ALL) treated with rituximab monotherapy as upfront window therapy before chemotherapy.
* Evaluate the effect of rituximab on different histological subtypes of childhood mature B-NHL or B-ALL in patients treated with this regimen.
* Investigate the rituximab response in patients treated with this regimen.
* Determine the toxicity profile of rituximab in these patients.
* Collect pharmacokinetic and pharmacodynamic data from patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive rituximab IV on day 1.

PROJECTED ACCRUAL: A total of 79 patients will be accrued for this study.

### Conditions Module

**Conditions:**

- Leukemia

- Lymphoma

**Keywords:**

- B-cell childhood acute lymphoblastic leukemia

- untreated childhood acute lymphoblastic leukemia

- stage I childhood large cell lymphoma

- stage II childhood large cell lymphoma

- stage III childhood large cell lymphoma

- stage IV childhood large cell lymphoma

- stage I childhood lymphoblastic lymphoma

- stage II childhood lymphoblastic lymphoma

- stage III childhood lymphoblastic lymphoma

- stage IV childhood lymphoblastic lymphoma

- stage I childhood small noncleaved cell lymphoma

- stage II childhood small noncleaved cell lymphoma

- stage III childhood small noncleaved cell lymphoma

- stage IV childhood small noncleaved cell lymphoma

### Design Module

#### Design Info

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 79

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** rituximab

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Measure:** Response rate

**Measure:** Effect of rituximab on different histological subtypes

**Measure:** Rituximab response

**Measure:** Toxicity

**Measure:** Pharmacokinetics and pharmacodynamics

### Eligibility Module

**Eligibility Criteria:** DISEASE CHARACTERISTICS:

* Histologically and immunohistochemically OR cytomorphologically and immunphenotypically confirmed mature B-cell non-Hodgkin's lymphoma or B-cell acute lymphoblastic leukemia
* CD20 positive disease

PATIENT CHARACTERISTICS:

* Not pregnant or nursing
* Fertile patients must use effective contraception
* Adequate general condition with sufficient organ function (hepatic, renal, and cardiac)
* No known disease that would preclude protocol therapy with rituximab
* No known allergies against proteins
* No acute or previous hepatitis B infection

PRIOR CONCURRENT THERAPY:

* At least 2 weeks since prior corticosteroids
* No prior radiotherapy
* No prior or concurrent chemotherapy
* No concurrent treatment in another investigational trial

**Maximum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Aachen

**Country:** Germany

**Facility:** Kinderklinik - Universitaetsklinikum Aachen

**Zip:** D-52074

**Location 2:**

**City:** Augsburg

**Country:** Germany

**Facility:** Klinikum Augsburg

**Zip:** DOH-86156

**Location 3:**

**City:** Berlin

**Country:** Germany

**Facility:** Charite - Campus Charite Mitte

**Zip:** D-10117

**Location 4:**

**City:** Berlin

**Country:** Germany

**Facility:** Helios Klinikum Berlin

**Zip:** D-13125

**Location 5:**

**City:** Biefeld

**Country:** Germany

**Facility:** Evangelisches Krankenhauus Bielfeld

**Zip:** 33617

**Location 6:**

**City:** Bremen

**Country:** Germany

**Facility:** Klinikum Bremen-Mitte

**Zip:** D-28205

**Location 7:**

**City:** Cologne

**Country:** Germany

**Facility:** Children's Hospital

**Zip:** D-50924

**Location 8:**

**City:** Datteln

**Country:** Germany

**Facility:** Vestische Kinderklinik

**Zip:** 45704

**Location 9:**

**City:** Dresden

**Country:** Germany

**Facility:** Universitatsklinikum Carl Gustav Carus

**Zip:** D-01307

**Location 10:**

**City:** Erfurt

**Country:** Germany

**Facility:** Helios Klinikum Erfurt

**Zip:** 99089

**Location 11:**

**City:** Erlangen

**Country:** Germany

**Facility:** Universitaets - Kinderklinik

**Zip:** 91054

**Location 12:**

**City:** Essen

**Country:** Germany

**Facility:** Universitaetsklinikum Essen

**Zip:** D-45147

**Location 13:**

**City:** Frankfurt

**Country:** Germany

**Facility:** Klinikum der J.W. Goethe Universitaet

**Zip:** D-60590

**Location 14:**

**City:** Freiburg

**Country:** Germany

**Facility:** Universitaetskinderklinik - Universitaetsklinikum Freiburg

**Zip:** D-79106

**Location 15:**

**City:** Giessen

**Country:** Germany

**Facility:** Kinderklinik

**Zip:** D-35385

**Location 16:**

**City:** Greifswald

**Country:** Germany

**Facility:** Klinik und Poliklinik Fuer Kinder-und Jugendmedizin - Universitaetsklinikum Greifswald

**Zip:** 17475

**Location 17:**

**City:** Hamburg

**Country:** Germany

**Facility:** University Medical Center Hamburg - Eppendorf

**Zip:** D-20246

**Location 18:**

**City:** Hannover

**Country:** Germany

**Facility:** Medizinische Hochschule Hannover

**Zip:** D-30625

**Location 19:**

**City:** Heidelberg

**Country:** Germany

**Facility:** Universitaets-Kinderklinik Heidelberg

**Zip:** D-69120

**Location 20:**

**City:** Homburg

**Country:** Germany

**Facility:** Universitaetsklinikum des Saarlandes

**Zip:** 66421

**Location 21:**

**City:** Jena

**Country:** Germany

**Facility:** Universitaets - Kinderklinik

**Zip:** D-07440

**Location 22:**

**City:** Karlsruhe

**Country:** Germany

**Facility:** Staedtisches Klinikum Karlsruhe gGmbH

**Zip:** 76133

**Location 23:**

**City:** Kassel

**Country:** Germany

**Facility:** Kinderkrankenhaus Park Schoenfeld

**Zip:** D-34121

**Location 24:**

**City:** Kiel

**Country:** Germany

**Facility:** University Hospital Schleswig-Holstein - Kiel Campus

**Zip:** D-24105

**Location 25:**

**City:** Leipzig

**Country:** Germany

**Facility:** Universitaets - Kinderklinik

**Zip:** D-04317

**Location 26:**

**City:** Luebeck

**Country:** Germany

**Facility:** Universitaets - Kinderklinik - Luebeck

**Zip:** D-23538

**Location 27:**

**City:** Magdeburg

**Country:** Germany

**Facility:** Universitatsklinikum der MA

**Zip:** 39120

**Location 28:**

**City:** Marburg

**Country:** Germany

**Facility:** Universitaets - Kinderklinik

**Zip:** 35033

**Location 29:**

**City:** Muenster

**Country:** Germany

**Facility:** Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster

**Zip:** D-48149

**Location 30:**

**City:** Munich

**Country:** Germany

**Facility:** Krankenhaus Muenchen Schwabing

**Zip:** 80804

**Location 31:**

**City:** Munich

**Country:** Germany

**Facility:** Dr. von Haunersches Kinderspital der Universitaet Muenchen

**Zip:** D-80337

**Location 32:**

**City:** Nuremberg

**Country:** Germany

**Facility:** Cnopf'sche Kinderklinik

**Zip:** 90419

**Location 33:**

**City:** Regensburg

**Country:** Germany

**Facility:** Klinik St. Hedwig-Kinderklinik

**Zip:** 93049

**Location 34:**

**City:** Stuttgart

**Country:** Germany

**Facility:** Olgahospital

**Zip:** D-70176

**Location 35:**

**City:** Tuebingen

**Country:** Germany

**Facility:** Universitaetsklinikum Tuebingen

**Zip:** D-72076

**Location 36:**

**City:** Ulm

**Country:** Germany

**Facility:** Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

**Zip:** D-89075

**Location 37:**

**City:** Wuerzburg

**Country:** Germany

**Facility:** Universitaets - Kinderklinik Wuerzburg

**Zip:** D-97080

**Location 38:**

**City:** Zurich

**Country:** Switzerland

**Facility:** University Children's Hospital

**Zip:** CH-8032

#### Overall Officials

**Official 1:**

**Affiliation:** University Hospital Erlangen

**Name:** Alfred Reiter, MD

**Role:** STUDY_CHAIR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000008232

- Term: Lymphoproliferative Disorders

- ID: D000008206

- Term: Lymphatic Diseases

- ID: D000007160

- Term: Immunoproliferative Disorders

- ID: D000007154

- Term: Immune System Diseases

- ID: D000006402

- Term: Hematologic Diseases

- ID: D000007945

- Term: Leukemia, Lymphoid

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10945

- Name: Leukemia

- Relevance: HIGH

- As Found: Leukemia

- ID: M10951

- Name: Leukemia, Lymphoid

- Relevance: LOW

- As Found: Unknown

- ID: M27585

- Name: Precursor Cell Lymphoblastic Leukemia-Lymphoma

- Relevance: HIGH

- As Found: Acute Lymphoblastic Leukemia

- ID: M11220

- Name: Lymphoma

- Relevance: HIGH

- As Found: Lymphoma

- ID: M18828

- Name: Lymphoma, B-Cell

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M11225

- Name: Lymphoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M11203

- Name: Lymphatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10206

- Name: Immunoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T175

- Name: Acute Lymphoblastic Leukemia

- Relevance: HIGH

- As Found: Acute Lymphoblastic Leukemia

- ID: T3533

- Name: Lymphoblastic Lymphoma

- Relevance: LOW

- As Found: Unknown

- ID: T3543

- Name: Lymphosarcoma

- Relevance: HIGH

- As Found: Lymphoma

- ID: T640

- Name: B-cell Lymphoma

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T1134

- Name: Childhood Acute Lymphoblastic Leukemia

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008223

- Term: Lymphoma

- ID: D000007938

- Term: Leukemia

- ID: D000054198

- Term: Precursor Cell Lymphoblastic Leukemia-Lymphoma

### Intervention Browse Module - Ancestors

- ID: D000074322

- Term: Antineoplastic Agents, Immunological

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018501

- Term: Antirheumatic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M373

- Name: Rituximab

- Relevance: HIGH

- As Found: Healthy

- ID: M1346

- Name: Antineoplastic Agents, Immunological

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

- ID: M20604

- Name: Antirheumatic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000069283

- Term: Rituximab

### Misc Info Module

- Version Holder: 2024-05-24
