Trial for the Treatment of Newly Diagnosed Mature B-Cell Acute Lymphoblastic Leukemia (B-ALL), Burkitt's Non-Hodgkin's Lymphoma (NHL) and Other High-Grade Lymphoma in Adults

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2008 by Johann Wolfgang Goethe University Hospitals.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Johann Wolfgang Goethe University Hospitals

ClinicalTrials.gov Identifier:

NCT00199082

First received: September 12, 2005

Last updated: May 29, 2008

Last verified: May 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

May 29, 2008

Start Date ^ICMJE

July 2002

Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Remission rate
Remission duration
Disease free survival
Overall survival

Original Primary Outcome Measures ^ICMJE

-Remission rate
-Remission duration
-Disease free survival
-Overall survival

Change History

Complete list of historical versions of study NCT00199082 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Dose and time compliance
Toxicity according to National Cancer Institute (NCI)-Common Toxicity Criteria (CTC)
Death under therapy and in complete remission (CR)
Localisations of relapse

Original Secondary Outcome Measures ^ICMJE

-Dose and time compliance
-Toxicity according to NCI-CTC
-Death under therapy and in CR
-Localisations of relapse

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Trial for the Treatment of Newly Diagnosed Mature B-Cell Acute Lymphoblastic Leukemia (B-ALL), Burkitt's Non-Hodgkin's Lymphoma (NHL) and Other High-Grade Lymphoma in Adults

Official Title ^ICMJE

Multicenter Study to Optimise Therapy of B-ALL, Burkitt's NHL and High-Grade Non-Hodgkin's Lymphoma in Adults (Amend 7)

Brief Summary

The study evaluates the efficacy and tolerability of alternating short cycles of high-dose and conventional chemotherapy in combination with rituximab in CD20 positive patients, followed by local radiation therapy in the case of initial mediastinal or central nervous system (CNS) involvement or a residual tumor after chemotherapy. A dose-reduced regimen is offered for patients estimated to be over 55 years, biologically.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Burkitt's Lymphoma
Burkitt's Leukemia
Mediastinal Neoplasms
Lymphoblastic Lymphoma
Large Cell Anaplastic Lymphoma

Intervention ^ICMJE

Drug: Adriamycin
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Dexamethasone/Prednisolone
Drug: VP16
Drug: Ifosfamide
Drug: Methotrexate
Drug: G-CSF
Drug: Rituximab
Drug: Vincristine/Vindesine
Procedure: Irradiation (in specific conditions)

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

650

Completion Date

Not Provided

Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Burkitt's leukemia or Burkitt's lymphoma or primary mediastinal large B-cell lymphoma or B-precursor lymphoblastic lymphoma or large cell anaplastic lymphoma
Age > 15 years
Written informed consent

Exclusion Criteria:

Serious secondary diseases, including psychiatric conditions, under which the required therapy compliance is not to be expected
HIV infection
Secondary lymphoma following prior chemotherapy/radiotherapy or active second malignancy
Known severe allergy to foreign proteins
Pre-treatment other than 1 cycle CHOP or similar; < 1 week of another chemotherapy.
Pregnancy or nursing
Participation in other studies that interfere with study therapy

Gender

Both

Ages

15 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Dieter Hoelzer, MD, PhD	++49(0)69 6301 5194	hoelzer@em.uni-frankfurt.de
Contact: Nicola Goekbuget, MD	++49(0)69 6301 6365	goekbuget@em.uni-frankfurt.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00199082

Other Study ID Numbers ^ICMJE

GMALL05

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Johann Wolfgang Goethe University Hospitals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Dieter Hoelzer, MD

University of Frankfurt, Medical Dept. II

Information Provided By

Johann Wolfgang Goethe University Hospitals

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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