Treatment of Relapsed T-Cell Acute Lymphoblastic Leukemia or T-Lymphoblastic Lymphoma With MabCampath

This study has been completed.
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00199030
First received: September 12, 2005
Last updated: May 29, 2008
Last verified: May 2008
  Purpose

This study tests the effectivity and tolerability of treatment with alemtuzumab (MabCampath) in patients with relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) or T-lymphoblastic lymphoma. In Arm A, patients with refractory relapse receive a 2 week treatment with MabCampath followed by remission evaluation. In case of insufficient response, treatment with cladribine is added. In Arm B, patients with molecular relapse (minimal residual disease) receive a 4 week treatment with MabCampath followed by remission evaluation. In both arms, treatment is continued in case of response for up to two months.


Condition Intervention Phase
Adult Acute Lymphocytic Leukemia T-Cell
Lymphoma, Lymphoblastic
Drug: Alemtuzumab (MabCampath)
Drug: Cladribine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: German Multicenter Phase II Trial to Study Effectivity and Feasibility of Alemtuzumab (MabCampath®) in T-ALL and T-Lymphoblastic Lymphomas With Minimal Residual Disease (MRD), in Refractory Relapse or in Primary Failure

Resource links provided by NLM:


Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Arm A: rate of molecular remissions (MRD < 10(-4), toxicity according to CTC, remission duration/survival, feasibility of s.c. dose escalation and long term therapy, mortality
  • Arm B: response (CR/PR/MR), toxicity according to CTC, SCT rate, remission duration/survival, feasibility of i.v. dose escalation/long term therapy, mortality

Estimated Enrollment: 25
Study Start Date: February 2004
Estimated Study Completion Date: December 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Both Arms:

  • T-ALL or T-lymphoblastic lymphoma
  • CD52-expression > 20%
  • Aged >= 18 years
  • ECOG/World Health Organization (WHO) performance status 0-2
  • Life expectancy of > 2 months
  • Contraception during, and for at least 6 months after, therapy
  • At least a 2 week interval to the last cycle of chemotherapy (decision in individual cases if rapid progression)
  • No persistent toxicity from earlier cycles
  • Written informed consent

Arm 1:

  • Evidence of MRD > 10(-4) with confirmation beyond week 16 in the GMALL-Study 07/2003

Arm 2:

  • Relapse with failure to at least one salvage therapy or primary failure after induction therapy and at least one salvage therapy

Exclusion Criteria:

  • Substantial restrictions of heart, lung, liver, or kidney function
  • Active infection, HIV seropositivity or cytomegalovirus (CMV) viraemia
  • Pretreatment with MabCampath®
  • Known anaphylaxis to humanised antibodies
  • Permanent systemic therapy with corticosteroids
  • Central nervous system (CNS) involvement
  • Extramedullary bulky disease
  • Active secondary malignancies
  • Pregnancy or nursing
  • Mental disease or circumstances that prohibit compliance with the protocol procedures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00199030

Locations
Germany
University Hospital, Medical Dept. II
Frankfurt, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Investigators
Study Chair: Dieter Hoelzer, MD, PhD University Hospital Frankfurt, Medical Dept. II
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00199030     History of Changes
Other Study ID Numbers: GMALL07
Study First Received: September 12, 2005
Last Updated: May 29, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johann Wolfgang Goethe University Hospitals:
Relapse
T-ALL
T-LBL
MabCampath
Minimal residual disease
Lymphoma, lymphoblastic, T-cell

Additional relevant MeSH terms:
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma
Leukemia
Neoplasm, Residual
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplastic Processes
Pathologic Processes
Alemtuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014